Did Moderna just confirm that mRNA COVID-19 vaccines cause cancer?! Take a look at the viral claim, and find out what the facts really are!
Claim : Moderna confirms mRNA COVID-19 vaccines cause cancer!
People are sharing an article (archive) by The Expose (formerly The Daily Expose), which claims that Moderna has admitted that mRNA COVID-19 vaccines cause cancer!
Here is an excerpt of the long and (intentionally?) confusing article. Feel free to skip to the next section for the facts!
Moderna confirms mRNA COVID Vaccines cause Cancer
Moderna has admitted its mRNA COVID vaccine causes CANCER after billions of DNA fragments were found in vials of the dangerous injection.
The revelation was made after Dr. Robert Malone recently made an appearance at an “Injuries Caused by COVID-19 Vaccines” hearing led by Congresswoman Marjorie Taylor Greene (R-Ga.), at which he revealed how Moderna’s patent shows that its (COVID-19) “vaccine” vials contain billions of DNA fragments and other contaminants linked to birth defects and cancer.
At the hearing, Dr. Malone spoke about how Moderna acknowledges in its patent that RNA is preferable to DNA in vaccines because of the risks involved, but that the company’s mRNA injection, which was administered to tens of millions of people, is contaminated with the latter.
“Moderna has a patent on the use of RNA for vaccines,” Dr Malone stated. “And in that, Moderna explicitly acknowledges that RNA is superior to DNA for vaccine purposes because problems, including the possibility of insertional mutagenesis that could lead to the activation of oncogenes or the inactivation of tumour suppressor genes.”
“FDA says they’re not aware of any concerns, but Moderna, in its own patent, lays out exactly the same concerns that exist about DNA in insertional mutagenesis and genotoxicity.
“So, Moderna knows it – DNA is a contaminant. It is left in because of the way they make it … they use DNA to make RNA, and then they degrade the DNA, and then they have to purify the degraded DNA away from the RNA, and the process they are using is not that good.”
Scientists from the United States and Canada were able to get their hands on unopened vials of Moderna’s COVID jab, with a clear chain of custody, and sampled them. This is their expertise, just to be clear: they do deep sequencing on samples and relay their findings for the public good.
What they discovered were large numbers of DNA fragments in the RNA preparation, to which they applied standard reconstruction tools to see what the circular plasmid DNAs looked like – none of this was disclosed to the public, by the way.
The documentation suggests that there are certain DNA sequences present in the vials that are normally not allowed in anything that is going to go into humans, “not the least of which is an antibiotic resistance gene,” Dr. Malone explained.
“They include these sequences from Simian Virus 40 – not the whole virus, but highly active promoter sequences – which is exactly the thing that the FDA in their older regulations said must be avoided because it confers even more risk for insertional mutagenesis.”
Truth : Moderna did not confirm mRNA COVID-19 vaccines cause cancer!
This is yet another example of fake news created / promoted by The Expose, and here are the reasons why…
Moderna did not admit mRNA COVID-19 vaccines cause cancer
Let me start by pointing out that Moderna did not admit that mRNA COVID-19 vaccines cause cancer.
If that actually happened, it would have been reported widely by the mainstream media across the world, and sparked mass outrage, criminal investigations and lawsuits. Yet, none of that happened, because Moderna did not admit that mRNA COVID-19 vaccines cause cancer.
Unsurprisingly, The Expose article did not provide any evidence to back up its shocking claim.
Moderna patent was for HPIV3 vaccines
Robert Malone referred to Moderna’s patent application US 2019/0240317 A1 in his testimony. However, that patent has nothing to do with mRNA vaccines for COVID-19.
The Moderna patent was about RNA vaccines for the Human Parainfluenza 3 (HPIV3) virus – a completely different virus from SARS-CoV-2, which causes COVID-19.
Insertional mutagenesis happens with virus infections
Robert Malone appears to refer to the Moderna patent application for saying that RNA is preferable to DNA in vaccines due to risks of insertional mutagenesis, which might activate oncogenes, or inhibit tumour suppressor genes.
But if you read the actual patent application, you can see that Moderna was referring to possible risk of insertional mutagenesis in DNA vaccines that directly inject genetically-engineered DNA into a living host:
Deoxyribonucleic acid (DNA) vaccination is one technique used to stimulate humoral and cellular immune responses to foreign antigens, such as hMPV antigens and/or PIV antigens and /or RSV antigens. The direct injection of genetically engineered DNA ( e.g., naked plasmid DNA ) into a living host results in a small number of its cells directly producing an antigen, resulting in a protective immunological response. With this technique, however, comes potential problems, including the possibility of insertional mutagenesis, which could lead to the activation of oncogenes or the inhibition of tumor suppressor genes.
There has been no known case of vaccines causing insertional mutagenesis. On the other hand, insertional mutagenesis can occur naturally in viral infections, as many viruses integrate their own genomes into the genome of the host cells.
Residual DNA isn’t something new, or exclusive to mRNA vaccines for COVID-19. Residual DNA is found in all vaccines and biological products manufactured in any kind of cell.
The risk of residual DNA has also been investigated for about 60 years now, and the US FDA has pointed out that residual DNA do not integrate into our DNA, or cause cancer.
[W]ith regard to the mRNA vaccines, while concerns have been raised previously as theoretical issues, available scientific evidence supports the conclusion that the minute amounts of residual DNA do not cause cancer or changes to a person’s genetic code.
Residual DNA is also “chopped up” into tiny pieces by the DNase enzyme, to no more than 200 bp in length. This ensures that they don’t pose any threat, even if they don’t all get filtered out.
The Expose article suggests that the SV40 (Simian Virus 40) promotor sequence used in the Moderna vaccine can cause cancer through insertional mutagenesis. That is not true.
Michael Imperiale, a molecular biologist at the University of Michigan Medical School, explained that the SV40 promoter, on its own, can’t cause cancer. The part of SV40 that’s potentially cancer-causing, known as the T-antigen, isn’t present in the vaccine.
Even the scientist whose testimony to the South Carolina Senate has been used to drive this controversy, has come out to dismiss the concerns that the SV40 promoter is dangerous, or can cause cancer:
It’s just the volume knob that drives high level expression of anything put under its control, which in this case is just an antibiotic resistance marker.
The fear about the SV40 sequences is total nonsense. The vaccine is not going to cause cancer. There is no cancer causing gene in the vaccine.
– Phillip Buckhaults, director of the Cancer Genetics Lab at the University of South Carolina
Like Real Raw News and The People’s Voice, The Daily Expose is a website that capitalises on making shocking but fake or misleading stories to generate page views and money. It was later rebranded as The Expose.
Founded in November 2020 by Jonathan Allen-Walker – a welder from Lincolnshire, The Expose / Daily Expose is infamous for publishing COVID-19 and vaccine misinformation.
Its articles have been regularly debunked as fake news or misinformation, so you should NEVER share anything from Daily Expose / The Expose. Here are some of its stories that I personally debunked earlier:
Everything posted by The Expose / Daily Exposemust be considered fake news, until proven otherwise.
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
The CDC just recommended 3 doses of the Pfizer COVID-19 vaccine for babies 6 months and older – is that safe? Here is what you need to know…
Are 3 doses of Pfizer COVID-19 vaccine safe for babies?
The Children’s Health Defense, which is chaired by Robert F. Kennedy Jr., just posted an article (archive) which claims or suggests that it might not be safe for babies to receive 3 doses of the Pfizer COVID-19 vaccine because it’s unlicensed for children under 12.
There Are No Licensed COVID Vaccines for Kids Under 12 — But CDC Wants Babies to Get 3 Pfizer Shots by Age 9 Months
According to the latest CDC guidance, 9-month-old babies must receive multiple doses of an unlicensed mRNA COVID-19 vaccine to be considered “up to date” with their COVID-19 vaccination.
Nine-month-old babies must receive multiple doses of an unlicensed mRNA COVID-19 vaccine to be considered “up to date” with their COVID-19 vaccination, according to the Centers for Disease Control and Prevention (CDC).
The CDC’s updated guidance, issued Aug. 30, states that children — as young as 6 months old — should get either two doses of the 2024-2025 Moderna vaccine or three doses of the 2024-2025 Pfizer-BioNTech vaccine.
If getting the new Pfizer shot, the baby is supposed to receive the first dose at 6 months, the second dose three weeks later and the third dose at least eight weeks after the second dose — meaning, that by 9 months old, babies are supposed to have received three Pfizer shots.
Children’s Health Defense (CHD) CEO Mary Holland told The Defender, “The earlier COVID shots have been proven unsafe and ineffective. Now we’re asked to believe that newer versions are miraculously safe and effective?”
“This is an insult to people’s intelligence,” she said, “I pray that parents will have the good sense to say no to these dangerous and unnecessary shots for babies.”
As of July 28, 37,814 deaths following COVID-19 vaccination had been reported to VAERS, the Vaccine Adverse Event Reporting System, run by the FDA and CDC.
It has since been shared and promoted as evidence that the Pfizer COVID-19 vaccine is dangerous for babies.
Robert F. Kennedy Jr. : The CDC recommends THREE Pfizer Covid shots for babies by age 9 months. These shots are unsafe and ineffective, especially over the long term. And babies are at near-zero risk from Covid. So whose benefit is the CDC serving here?
Mary Talley Bowden : All babies are expected to get 3 C0VID shots before their 1st birthday.
Eliminating mandates is not enough. All risk, no benefit. Profits over safety. Any other product would have been pulled off the market a long time ago.
CDC : 3 doses of Pfizer COVID-19 vaccine are safe + effective for babies
In this article, I will go through some of their points, and show you what the facts really are!
Fact #1 : FDA authorised Pfizer COVID-19 vaccines for babies
First, let’s start by pointing out that the US FDA just authorised the latest, updated Pfizer COVID-19 vaccine, including for babies 6 months or older:
Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated, authorized Moderna COVID-19 Vaccine.
Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
In other words – there is nothing wrong with the CDC’s recommendation that the babies as young as 6 months old should receive 3 doses of the Pfizer COVID-19 vaccine.
Fact #2 : FDA authorised two COVID-19 vaccines for babies
In fact, the US FDA actually authorised two COVID-19 vaccines for babies 6 months and older (archive):
Moderna COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age
Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age
So why is Children’s Health Defense article focusing only on the Pfizer COVID-19 vaccine? After all, the Moderna COVID-19 vaccine is also based on a similar mRNA platform.
Does this mean that Children’s Health Defense believes only the Pfizer COVID-19 vaccine is dangerous for babies, but not the Moderna COVID-19 vaccine? Why only Pfizer, but not Moderna – they didn’t say.
In that case, well, just go ahead and opt for the Moderna COVID-19 vaccine! Problem solved for people who are hesitant about the Pfizer COVID-19 vaccine for babies.
In case you are wondering – the Pfizer COVID-19 vaccine has full FDA approval for children and adults who are 12 years and older, and is authorised for emergency use in children between 6 months and 11 years of age.
This does not mean that the Pfizer COVID-19 vaccine is dangerous or ineffective in children. After all, both EUA and full FDA approval undergo the same approval process, with this major difference in post-study follow-up:
EUA : At least half of the participants in the studies must be followed for at least two months after vaccination.
Full FDA Approval : All of the participants in the studies must be followed for at least six months.
In addition, full FDA approval requires more details on manufacturing plans and processes, as well as extra time for FDA to conduct oversight and inspections of manufacturing facilities.
You can read more about the differences between full FDA approval, and Emergency Use Authorisation (EUA) here.
Fact #4 : Pfizer COVID-19 vaccine was proven safe + effective for babies
As the Mayo Clinic points out, both the Pfizer and Moderna COVID-19 vaccines were tested to confirm their safety and effectiveness in children aged 6 months and older:
To find out the effectiveness of the Pfizer-BioNTech vaccine for children ages 6 months through 4 and the Moderna COVID-19 vaccine for children ages 6 months through 17 years old, the FDA looked at the immune responses of children in these age groups after they were fully vaccinated.
The FDA compared those responses to the immune responses of young adults who’d been given higher doses of the same mRNA vaccine.
As with the other vaccines, side effects were recorded. Some of the children were monitored for safety for at least two months after being fully vaccinated.
So it would be false to suggest that the Pfizer or Moderna COVID-19 vaccine was never tested in babies as young as 6 months old.
The Children’s Health Defense article said that there were “37,814 deaths following COVID-19 vaccination had been reported to VAERS, the Vaccine Adverse Event Reporting System, run by the FDA and CDC.”
As I pointed out many times before, VAERS data is unverified, and notoriously susceptible to abuse, and false reporting. That’s because it’s an open system that anyone – not just doctors, can report anything they want.
In addition, the reports may be duplicated and have not been verified to be related to the vaccine or drug in question. That’s why VAERS specifically warns against using its reports to reach any conclusion about the risks or safety of vaccines / drugs in question.
But that is probably why anti-vaccination activists love using VAERS data – it’s unverified, and very susceptible to abuse and false reporting.
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Did Pfizer documents just reveal that mRNA vaccines are actually a US weapon system?! Take a look at the viral claim, and find out what the facts really are!
Claim : Pfizer docs reveal mRNA vaccines as US weapon system!
People are sharing an article (archive) by The People’s Voice (formerly NewsPunch), which claims that Pfizer documents just revealed that mRNA vaccines are actually a US weapon system!
Here is an excerpt of the (intentionally?) rambling and confusing article. Feel free to skip to the next section for the facts!
Bombshell Pfizer documents obtained through Freedom of Information Act (FOIA) requests have revealed the Big Pharma giant sought to suppress the release of damaging information about vaccine side-effects for 75 years because the releasing the information would “impair the application of state-of-the-art technology within a US weapons system.”
Due to FOIA requests, Pfizer was forced to release a “Confidential Report” titled “5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021.”
Pfizer knew their vaccine were killing unprecedented numbers of recipients, but they refused to stop distribution or application.
Even worse, Pfizer wanted these reports blocked from release for 75 years. This constitutes willful mass murder and crimes against humanity.
However, there is new information in the FOIA-released document that is raising eyebrows among researchers.
What is of particular concern is the government redaction coding applied to the documents by the National Archives.
As the National Archives explain, “The declassified documents will usually contain redactions, which indicate portions that contain information not releasable to the public. Each redaction will be associated with a redaction code, which gives the reason for why the information cannot be released.”
Throughout the Pfizer document we find redactions coded “(B) (4)”. The National Archives redaction coding page defines redaction code (B) (4) as: 3.3 (b) (4) Reveal information that would impair the application of state-of-the-art technology within a U.S. weapon system.
The revelation that the government consider mRNA vaccines to be part of a “weapons system” adds further weight to evidence present by Big Pharma whistleblowers who allege the mRNA vaccines is a “bioweapon” designed to depopulate humanity.
Truth : Pfizer docs do not reveal mRNA vaccines as US weapon system!
This is yet another example of fake news created / promoted by The People’s Voice, and here are the reasons why…
Fact #1 : mRNA vaccines are not a US weapon system
Let me start by simply pointing out that mRNA vaccines are not a US weapon system.
In fact, the Pfizer document in question do not show that the Pfizer mRNA COVID-19 vaccine was defined as a US weapon system.
Fact #2 : Pfizer document was not released by National Archives
The People’s Voice article claims that the (b)(4) redaction code refers to “state-of-the-art technology within a U.S. weapon system”, using the National Archives redaction codes as reference.
However, that’s utter nonsense, because the Pfizer document was not redacted and released by the National Archives. It was redacted and released by the US FDA under the Freedom of Information Act (FOIA).
In addition, the National Archives clearly states that its redaction code (b)(4) only applies to “records over 25 years old“. Documents related to the Pfizer COVID-19 vaccine would definitely be less than 25 years old, and would never have a (b)(4) redaction code applied by the National Archives.
Under the Freedom of Information Act (FOIA), the (b)(4) redaction code refers to “trade secrets“:
Exemption 4 of the FOIA protects “trade secrets and commercial or financial information obtained from a person [that is] privileged or confidential.”
In short, when the US FDA redacted the Pfizer 5.3.6 document, it did so using the FOIA redaction code for Exemption 4. It obviously would not use the National Archives redaction code for documents over 25 years old!
Fact #4 : Pfizer 5.3.6 document is no longer redacted!
More importantly – the Pfizer 5.3.6 document is no longer redacted! If you compare the redacted (PDF) and uncensored (PDF) documents, you will see that only 3 small pieces of information (which I highlighted in bold) were originally redacted:
To date, Pfizer has onboarded approximately 600 additional full time employees (FTEs).
More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021.
It is estimated that approximately 126,212,580 doses of BNT162b2 were shipped worldwide from the receipt of the first temporary authorisation for emergency supply on 01 December 2020 through 28 February 2021.
As you can tell, the (b)(4) redactions (which I highlighted in bold) had nothing to do with US weapon systems!
Fact #5 : Pfizer 5.3.6 document was released long ago!
On top of that, the Pfizer 5.3.6 document wasn’t released recently. It is actually very old news.
The Pfizer 5.3.6 document was first released by the FDA to the PHMPT (Public Health and Medical Professionals for Transparency) group, with three small pieces of information redacted on 17 November 2021 – almost 3 years ago!
The FDA later decided that the redacted information were not confidential after all, and reissued the same document in full on 1 April 2022 – almost 2.5 years ago! You can read more about that here.
In other words – this is old news that has been regurgitated as something new, but is really stale and unpalatable like old vomit.
Fact #6 : Pfizer was not forced to release its documents
Finally, I should point out that Pfizer was not forced to release its documents.
Pfizer actually submitted those documents to health authorities in various countries way back in December 2020 or early 2021, when Pfizer applied for its mRNA COVID-19 vaccine to be approved.
It was really the US FDA (not Pfizer) that released those documents under a Freedom of Information Act (FOIA) request.
Fact #7 : The People’s Voice is known for fake news
The People’s Voice is the current name for NewsPunch, which possibly changed its name because its brand has been so thoroughly discredited after posting numerous shocking but fake stories.
Founded as Your News Wire in 2014, it was rebranded as NewsPunch in November 2018, before becoming The People’s Voice. A 2017 BuzzFeed report identified NewsPunch as the second-largest source of popular fake news on Facebook that year.
Its articles have been regularly debunked as fake news, so you should think twice about sharing anything from NewsPunch / The People’s Voice. Here are some of its fake stories that I fact checked earlier:
Please help us FIGHT FAKE NEWS by sharing this fact check article out, and please SUPPORT our work!
Please Support My Work!
Support my work through a bank transfer / PayPal / credit card!
Name : Adrian Wong Bank Transfer : CIMB 7064555917 (Swift Code : CIBBMYKL)
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Are Bill Gates and Jeff Bezos selling fake, lab-grown chickens in stores?! Take a look at the viral claim, and find out what the facts really are!
Claim : Bill Gates is selling fake, lab-grown chickens in stores!
People are sharing an article (archive) by The People’s Voice (formerly NewsPunch), which claims or suggests that Bill Gates and Jeff Bezos have partnered up to sell fake, lab-grown chickens in stores!
It also shared a method by which you can spot and avoid such fake, lab-grown chickens being sold by Bill Gates and Jeff Bezos.
Here is excerpts of the article. Feel free to skip to the next section for the facts!
How to Spot and Avoid Bill Gates’ Lab-Grown Chicken in Stores for Your Health
Lab-grown chicken has started appearing on US supermarket shelves following Bill Gates’ multi-million dollar investments in the fake meat industry.
Researchers from the University of São Paulo and Imperial College London assessed the diets of more than 118,000 people living in the UK aged 40 to 69 years old. They found that those who ate Bill Gates’ fake meat products became severely sick and disease-ridden within a matter of months.
What can you do to make sure you do not accidentally purchase a Bill Gates chicken that has been raised in a lab?
A woman uploaded a viral video to social media offering important guidance for consumers in the supermarket in this era of fake meat.
“Make sure you are checking your labels,” said the woman. “Make sure when you guys are buying chicken, you look for this: ‘hatched, raised and harvested in the USA.’”
“If it does not say ‘hatched’ then you will know that it is lab-grown fake meat.”
Truth : Bill Gates is not selling fake, lab-grown chickens in stores!
This is yet another example of fake news created / promoted by The People’s Voice, and here are the reasons why…
Fact #1 : There is no such thing as lab-grown chickens
Let me start by pointing out that technically, there is no such thing as lab-grown chickens. What people refer to as “lab-grown chicken” is actually “cultivated meat” or “lab-grown meat”.
Such cultivated meat is grown in steel tanks from cells of animals like chicken or cow. The cells are then formed into shapes to make them look like cutlets, nuggets, shredded meat, etc.
In other words, lab-grown chicken-based meat will look like chicken meat products, not actual chickens. So claims that the slaughtered whole chicken you see at the stores might be fake, lab-grown chicken is nonsense.
Fact #2 : Hatched label is used to denote origin
It is not true that the only to determine whether you are buying a real chicken is to look for the label “hatched, raised and harvested in the USA“. That label is used to denote the origin of the chicken – it was born, raised, slaughtered and processed in the United States of America (USA).
As the American National Chicken Council explained, USDA Agriculture Marketing Service regulations require that chickens sold in retail stores “clearly and accurately identify” its “country of origin”.
USDA AMS regulations already require that chicken sold at retail clearly and accurately identify the product’s country of origin. Consumers seeking USA chicken can already find the ‘Hatched, Raised & Harvested in the U.S.’ label on American chicken.
– NCC President Mike Brown
In short – that label only tells you where the chickens were born or raised. It has nothing to do with whether the chicken product is fake or lab-grown, or made from chickens hatched at a farm.
Fact #3 : Almost all chickens in US will have this label
Almost all slaughtered chickens and chicken products sold in the US were hatched, raised and processed in the United States, and will come with that “hatched, raised and harvested in the USA” label.
More than 99% of the chicken we consume is of domestic origin and can easily be identified.
The remainder are imported from Canada, which has food safety and quality standards similar to the US. Those chickens would not have the “hatched, raised and harvested in the USA” label, but that does not mean they are fake or lab-grown chickens!
Fact #4 : Hatched label may be replaced by Product of USA
In 2023, the USDA proposed allowing meat, poultry and egg products made from animals born, bred and processed in the US to use the alternative labels of “Product of USA” or “Made in the USA“.
Real chickens and chicken products made in the United States may use those labels instead of the usual “hatched, raised and harvested in the USA” label. So just because you don’t see the “hatched, raised and harvested in the USA” label, it does not mean that the chicken is fake, lab-grown, or imported from some unknown country.
Fact #5 : Lab-grown meat is very expensive
Instead of listening to bad advice from people who don’t even understand what origin labels are for, here’s a simple way to differentiate lab-grown chicken meat from “naturally-farmed” chicken meat – lab-grown meat is rare and expensive.
Because the production of cultivated or lab-grown meat cannot be scaled like farmed chickens, it is rare and much more expensive than regular chicken meat. Hence, companies offering cultivated meat will highlight its uniqueness in their packaging and labels in order to justify the high cost.
In short – you are unlikely to be “tricked” into buying cultivated meat. Only those who are willing to pay a premium price to try lab-grown meat will actively look for, and purchase, these rare meat products.
The People’s Voice article suggests that cultivated meat or lab-grown meat is dangerous to consume. That’s not true.
Cultivated meat is basically meat cells grown in a steel tank, and so has similar nutritional content. It even tastes the same – people who have actually tried cultivated chicken meat have said that it looks slightly paler (due to a lack of blood vessels), but tastes just like chicken.
There is nothing in cultivated meat that makes it dangerous to consume, which is why the US FDA are approving such meat products for sale after testing them.
Fact #7 : The People’s Voice Is Known For Fake News
The People’s Voice is the current name for NewsPunch, which possibly changed its name because its brand has been so thoroughly discredited after posting numerous shocking but fake stories.
Founded as Your News Wire in 2014, it was rebranded as NewsPunch in November 2018, before becoming The People’s Voice. A 2017 BuzzFeed report identified NewsPunch as the second-largest source of popular fake news on Facebook that year.
Its articles have been regularly debunked as fake news, so you should never share anything from NewsPunch / The People’s Voice. Here are some of its fake stories that I fact checked earlier:
Please help us FIGHT FAKE NEWS by sharing this fact check article out, and please SUPPORT our work!
Please Support My Work!
Support my work through a bank transfer / PayPal / credit card!
Name : Adrian Wong Bank Transfer : CIMB 7064555917 (Swift Code : CIBBMYKL)
Credit Card / Paypal : https://paypal.me/techarp
Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Are Dr. Anthony Fauci and top NIH officials getting $150K per year in Big Pharma kickbacks from the Moderna mRNA vaccine?! Take a look at the viral claims, and find out what the facts really are!
Claim : Dr. Fauci + NIH Officials Make $150 Yearly From mRNA Vaccine!
People are sharing a video clip from a Dr. Phil interview, in which Robert F. Kennedy Jr. (RFK Jr) claimed or suggested that Dr. Anthony Fauci and top NIH officials are getting $150,000 per year in Big Pharma kickbacks from the Moderna mRNA vaccine!
Kat A : RFK jr stuns Dr Phil with the level of kickbacks Fauci and the NIH get on the Moderna vaccine.
Not only does the NIH own half of that vaccine, several high level officials under Fauci collect $150000 a year forever as long as that MRNA technology is on the market.
A topic banned from discussion on MSM!
Canada Free Press : RFK jr stuns Dr Phil with the level of kickbacks Fauci and the NIH get on the Moderna vaccine
Proud MAGA! -Lynch : RFK Jr Left Dr. Phil Stunned With the Amount of Kickbacks Fauci and NIH Get From the Moderna Vaccine
Truth : Dr. Fauci + NIH Officials Do Not Make $150 Yearly From mRNA Vaccine!
This is yet another example of fake news created or promoted by anti-vaccine activists, and here are the reasons why…
Fact #1 : FDA Does Not Get Payments For Vaccine Approval
Let me start by pointing out that the US FDA does not get payments for approving vaccines.
In the video, Robert F. Kennedy Jr. appears to repeat what his running mate, Nicole Shanahan recently suggested – that the FDA is approving “poorly-tested” vaccines because it’s partly funded by pharmaceutical companies.
That’s simply not true. As I explained in my earlier article, the US Congress passed the Prescription Drug User Fee Act in 1992, which requires pharmaceutical companies to pay the US FDA for the time and cost of reviewing the drugs and vaccines for regulatory approval.
The user fee that the FDA charges has no effect on its review process, as those standards are “written into law” and the FDA has to follow those standards, “regardless of the source of funding”.
As long as the FDA meets the review timeline goals, it receives the user fee even if it denies approval for the new drug / vaccine / medical device. So the user fee has no bearing on its approval process.
In the video, Robert F. Kennedy Jr. appears to confuse the US Food and Drug Administration (FDA), with the US National Institutes of Health (NIH).
When Dr. Phil asked him to confirm his claim that the FDA has been “bought off by Big Pharma”, RFK Jr. appears to have confused the FDA (which is a regulatory agency) with the NIH, which is responsible for biomedical and public health research.
Dr. Phil : The government regulators have been bought off by Big Pharma. I think that’s what you’re saying when you say that this entanglement has occurred. You said agency employees are actually getting royalties, getting payments on vaccines and drugs that they approve. Is that true?
RFK Jr : Yes, there’s a couple of things happening. With FDA, about 50% of the FDA’s budget comes from regulated industries, mainly the pharmaceutical industries. Mainly, you have agency capture on steroids. The principle objective of the FDA today is to serve the market interest of pharmaceutical companies.
For example, the Moderna vaccine. NIH owns half of that vaccine – 50%, so the billions of dollars that the vaccine makes, half of that goes to NIH, the agency. But there is [sic] also individuals, at least four and maybe six, individuals who work for NIH, who are high-level deputies under Anthony Fauci, who get to collect $150,000 a year forever, not just for their lives, but their children’s. So long as that mRNA technology is on the market, they are going to be making money from. That is a conflict.
To be clear – the FDA regulates food, drugs, and medical devices, but it does not receive royalties as it does not conduct research. On the other hand, the NIH conducts research and receives royalties for the technologies it develops, but it does not review or approve new drugs or vaccines.
If Robert F. Kennedy Jr. cannot differentiate between the FDA and the NIH, how much stock should we put into his wild claims???
Moderna licensed two technologies developed at the NIH for use in its mRNA vaccine for COVID-19. Those patents are owned by the US government, and not the individual inventors working at the NIH.
Moderna reported in its financialreports that it paid a “catch-up royalty payment of $400 million to the National Institute of Allergy and Infectious Diseases“, which is one of the NIH’s 27 institutes and centres, but this payment is also split between NIH, Dartmouth College, and the Scripps Research Institute.
By the end of 2021, seven other pharmaceutical companies (including BioNTech) also paid those same three institutions for using the same techniques in their COVID-19 vaccines.
Moderna also revealed in its financial report, that it would also pay the NIAID “low single-digit royalties on future net sales, a minimum annual royalty payment, and certain contingent development, regulatory and commercial milestone payments“.
Fact #4 : Anthony Fauci Is Not Named In mRNA-Related Patents
Six NIAID scientists are listed as inventors on those two patent applications licensed by Moderna for its mRNA vaccine. They would profit financially from the Moderna mRNA vaccine, as the Federal Technology Act of 1986 requires government agencies that licence inventions to share some of the royalty money with those inventors.
However, Dr. Anthony Fauci is not one of those six NIAID scientists named on the two patent applications. Dr. Anthony Fauci holds six patents, but none are related to mRNA, and all six patents predate the COVID-19 pandemic.
Therefore, claims or suggestions that Dr. Anthony Fauci financially benefitted from the two NIH patents used in the Moderna mRNA vaccine appear to be completely untrue.
Fact #5 : Patent Protection Only Lasts 20 Years
In the video, Robert F. Kennedy Jr. claimed that NIH officials would receive $150,000 per year forever – not only during their lifetime but also their children’s.
That is rather absurd as patent protection generally lasts only 20 years in the United States. There won’t be a need to licence for any pharmaceutical companies to licence those two patents from the NIAID / NIH for future mRNA vaccines after patent protection expires 20 years later.
In other words – those inventors in NIH can only expect to receive royalty payments for a maximum of 20 years, not forever…
Fact #6 : NIH Inventor Royalty Is Limited To $150,000 Per Year
This isn’t the first time Robert F. Kennedy Jr. claimed that top NIH officials are being paid $150,000 a year for life for the Moderna mRNA vaccine against COVID-19. Back in March 2021, RFK Jr. made similar claims in a NewsGuard interview.
The Moderna vaccine—his agency owns half, but six of the top guys who work for him own pieces of that patent, so they will each get $150,000 a year for life for every patent that they own.
However, he never provided any evidence – then or now, that Dr. Anthony Fauci, or any top NIH official are actually receiving $150,000 per year from the Moderna mRNA vaccine patents.
The truth is – the $150,000 per year figure is the official limit on royalty that any scientist may receive from all inventions while working at the NIH. As NIAID spokesperson Jennifer Routh explained in February 2021:
[In NIH licensing agreements,] the first $2,000 of royalties received under a license go to the inventor, and then at least 15 percent thereafter per year are shared with the inventors as a group under that license. Inventors are capped at $150,000 per year per person from all licenses. Very few NIH inventors receive that amount.”
In other words – even if an NIH scientist invents ten groundbreaking drug that makes BILLIONS each for the NIH, he/she is only entitled to $150,000 per year for all ten drugs.
While it is plausible that the six NIH scientists listed in the two patents used by Moderna and other pharmaceutical companies may receive $150,000 per year, there is still no actual evidence that they actually received that much.
But to be clear – the only people getting this royalty money are the scientists whose names are listed in the patent applications, and simply “top NIH officials”.
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Are vaccines poorly-tested because the US FDA is partly funded by Big Pharma?!
Take a look at the latest controversial claim by Vice Presidential candidate Nicole Shanahan, and find out what the facts really are!
Nicole Shanahan : Vaccines Poorly-Tested Because FDA Is Funded By Big Pharma!
Vice Presidential candidate, and Robert F. Kennedy Jr.‘s running mate, Nicole Shanahan just claimed or suggested (archive) that vaccines are poorly tested because the US FDA is partly funded by pharmaceutical companies!
Our only protection from poorly tested vaccines is our regulatory agencies like the FDA. Yet, 46% of the FDA’s total operating budget is funded by pharmaceutical companies. This is what is meant by AGENCY CAPTURE.
A Kennedy-Shanahan administration will end the rampant conflicts of interest in the regulation of the medicines and vaccines we need. We can reverse the explosion of chronic diseases in our population by demanding that drugs and vaccines undergo proper, long-term testing. We will make manufacturers responsible for the damage caused by their products, so they are again incentivized to make them as safe as possible.
Truth : Vaccines Are Properly Tested Even Though FDA Is Funded By Big Pharma!
This is unfortunately more misinformation by the Vice Presidential candidate, and Robert F. Kennedy Jr.‘s running mate, and here are the reasons why…
Fact #1 : Vaccines Are Not Poorly Tested
Let me start by pointing out that there is no evidence that the FDA ever approved any “poorly-tested” vaccine. Nicole Shanahan certainly provided no evidence that the FDA has ever done that, although the insinuation appears to be that there is “rampant conflicts of interest” due to “AGENCY CAPTURE”.
Even the COVID-19 vaccines, which were accused of being “rushed”, underwent massive clinical trials, and were only approved after they were shown to be safe and effective. To date, there has been no evidence that those clinical trials were compromised in any way by the pharmaceutical industry’s funding of the US FDA.
Fact #2 : FDA User Fees Improve Efficiency
In her post, Nicole Shanahan shared a screenshot of an article titled Why is the FDA Funded in Part by the Companies It Regulates?, but oddly enough did not provide a direct link to the article itself.
Perhaps that’s because the May 2021 article by C. Michael White of the UConn School of Pharmacy explained how user fees have helped to improve efficiency at the US FDA.
Because of the additional funding generated by user fees and performance measures that the FDA has to meet, the FDA is quicker and more willing to discuss what it wants to see in an application with manufacturers. It also offers clearer guidance for manufacturers.
The author also pointed out that FDA user fees are “a viable way to shift some of the financial burden to manufacturers who stand to make money from the approval and sale of drugs in the lucrative U.S. market.”
The user fees that the US FDA charges go towards paying people and other related costs of assessing and either approving or denying new drugs, vaccines, and medical devices.
They don’t affect its review process, as the FDA explained in its article that has been around since October 2022:
For products where premarket review is required, there are standards for FDA product review that are written into law and that the agency follows regardless of the source of funding. The FDA’s work, high standards, and decisions are guided by science and focused on protecting and promoting the public health.
Importantly, there is no direct connection between a fee paid to submit an application and the review outcome for that application. The fees are not a “fee-for-service” payment. Rather, the user fees, including application fees, are authorized by Congress to help the FDA fund payroll and related costs to deliver on program goals.
User fees provide the FDA with supplemental resources for reviewing product applications based on the scientific and clinical evidence, and for conducting related activities.
While the agency strives to meet the review timeline goals established as a part of the user fee program agreements, the timeline does not force the FDA to decide on a product application before the agency’s work is complete. If additional work is necessary, the FDA continues working past the applicable goal date. The user fee performance goals anticipate this may happen and do not count on meeting the timeline 100% of the time.
Arguably, user fees help FDA improve its review of new drugs and vaccines, not the other way around.
Fact #4 : There Are Other Regulatory Agencies
I should point out that even if the US FDA is somehow compromised by its funding by pharmaceutical companies, there are other regulatory agencies in other countries like the European Medicines Agency (EMA), Health Canada, the Australian Therapeutic Goods Administration (TGA), the Japanese Ministry of Health, Labour, and Welfare (MHLW), etc.
Vaccines that are approved by the US FDA are only approved for use in the United States. They still need to undergo assessment by each country’s regulatory agency. All those foreign regulatory agencies are not funded by the pharmaceutical industry, and therefore, provide a kind of verification for the regulatory work done by the US FDA.
Fact #5 : FDA User Fees Are Used For Specific Purposes
FDA also pointed out that it is required by law to spend user fees only on specific activities:
The FDA is required by law to spend user fee funds only on specified activities. For example, human prescription drug user fee funds can only be used for activities specified in the law, which include monitoring of research, review of human drug applications and post-market safety activities.
Similarly, medical device user fee funds can only be used for activities specified in the law, which include monitoring of research, review of device applications, and a defined set of post-market activities.
In short – FDA user fees are used to fund its critical regulatory and review activities, which would otherwise by paid for by taxpayers, instead of pharmaceutical companies.
Fact #6 : FDA User Fees Are Reauthorised By Congress
The user fees came about after the FDA was too slow in studying and approving experimental HIV drugs during the height of the AIDS crisis in the 1980s and early 1990s.
The US Congress then passed the Prescription Drug User Fee Act in 1992, which was signed into law by President George H.W. Bush. Since then, it has to be reauthorised every five years by Congress, before being signed into law by the President of the United States.
So even if the Kennedy-Shanahan administration does come to pass (which appears to be highly unlikely), it is highly unlikely that Congress would agree to provide additional funding to make up for the shortfall should user fees be eliminated.
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He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Did Pfizer give its employees a different COVID-19 vaccine from what it supplied to countries around the world?! Take a look at the viral claim, and find out what the facts really are!
Claim : Pfizer Gave Employees A Different COVID-19 Vaccine!
People are sharing a screenshot of an email, claiming or suggesting that it shows Pfizer giving its employees and contractors a different COVID-19 vaccine from what it supplied to countries around the world!
Infowars : Pfizer Whistleblower Leaks Company Email Offering “Separate and Distinct” COVID-19 Vaccines to Workers
Leaked Email: “The vaccine doses to be used for this program are separate and distinct from those committed by Pfizer to governments around the world and will not impact supply to national governments in any way.”
Whistleblower warns: “I know we employees at Pfizer were receiving different vaccines and/or placebos and this was the word around my site when I worked there.”
Camus : A Pfizer whistleblower has raised the alarm that Pfizer workers were offered a “separate and distinct” COVID-19 vaccine and were told their jab would “not impact supply to national governments in any way.”
William Makis MD : Pfizer made special COVID-19 mRNA Vaccine batches for their employees that were “distinct” from the toxic injections Pfizer sold globally
A Pfizer whistleblower has recently raised the alarm that Pfizer workers were offered a “separate and distinct” COVID-19 vaccine and were told their jab would “not impact supply to national governments in any way.”
These special COVID-19 mRNA Vaccine batches were created at a cost of millions of dollars and were given to Pfizer employees around the world
Truth : Pfizer Did Not Give Employees A Different COVID-19 Vaccine!
This is yet another fake news created or promoted by anti-vaccine supporters, and here are the reasons why…
Fact #1 : The Email Was Sent To Many People
First, let me point out that the “leaked email” wasn’t some top secret email that Pfizer did not want you to know.
It was actually sent out to all “on-site essential employees and contractors” working at Pfizer’s Pearl River research campus. In fact, the email stated clearly that the Pfizer COVID-19 vaccine was being offered to all “site-essential” workers and contractors at Pfizer Global Supply, Worldwide Research, Development, and Medical / Global Product Development sites across the world.
I am pleased to inform you that we will begin offering COVID-19 vaccinations to eligible on-site essential colleagues and contractors over the next several weeks. As you are aware, Site-essential colleagues are the colleagues and contractors based at PGS [Pfizer Global Supply] and WRDM/GPD [Worldwide Research, Development, and Medical / Global Product Development] sites whose presence is required at a Pfizer location to ensure supply of our medicines and vaccines, critical research and development programs continue, and to maintain and keep secure our labs and buildings as defined by site management.
That means all those workers and contractors – thousands of them across the world, received a similar email, offering the Pfizer COVID-19 vaccine.
In short – this wasn’t a secret at all. It appears that someone only dredged it up in 2024 because anti-vaccine supporters failed to prove that the Pfizer COVID-19 vaccine was killing millions of people like they have been claiming over the past 3 years…
The “leaked” email itself did not claim that Pfizer was giving its workers and contractors a different or special version of its mRNA COVID-19 vaccine. It only stated that the vaccine doses used in this vaccination program is “separate and distinct” from those vaccine doses that Pfizer already committed to governments across the world.
In other words – Pfizer reserved these vaccine doses for its essential workers and contractors, instead of diverting them from batches that were already committed to governments across the world. That’s why the email clearly stated that these vaccine doses will not impact supply to those governments.
The vaccine doses to be used for this program are separate and distinct from those committed by Pfizer to governments around the world and will not impact supply to national governments in any way.
To be fair – it is possible that English may not be the first language for those who read that and understood it differently…
What’s clear is that – those were the same Pfizer mRNA vaccine for COVID-19 that everyone around the world received. They were just reserved for essential Pfizer employees and contractors, and not taken from supply already promised to world governments.
Fact #3 : Only One Pfizer mRNA Vaccine Was Approved In Jan 2021
Making a COVID-19 vaccine isn’t like making a cocktail. You can’t just make a different COVID-19 vaccine, and use it, without getting it first approved by the FDA in the United States.
Obviously, only one Pfizer mRNA vaccine for COVID-19 was approved by the US FDA when this email was sent out on January 8, 2021.
And those who claim or suggested that Pfizer gave its employees and contractors a different COVID-19 vaccine have never provided any actual evidence to prove that.
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Did the US FDA just lose its war against the use of ivermectin for COVID-19?! Take a look at the viral claims, and find out what the facts really are!
Claim : FDA Lost Its War On Using Ivermectin For COVID-19!
People are claiming or suggesting that the US FDA just lost its war against the use of ivermectin for COVID-19!
Mary Talley Bowden MD : 🚨BREAKING: FDA loses its war on ivermectin and agrees to remove all social media posts and consumer directives regarding ivermectin and COVID, including its most popular tweet in FDA history.
This landmark case sets an important precedent in limiting FDA overreach into the doctor-patient relationship.
DC_Draino : Remember when Ivermectin won a Nobel Prize and had decades of data showing its safety and effectiveness, and then the FDA called it a “horse drug” during Covid b/c its Big Pharma vax sponsors told it to? Well a Federal court just ruled the FDA broke the law & needs to delete its propaganda The truth about the Covid cartel keeps coming out
The Gateway Pundit : FDA Loses its War on Ivermectin: Agrees to Remove All Related Social Media Content and Consumer Advisories on Ivermectin Usage for COVID-19
Right Angle News Network : The FDA is now being forced to remove all of its blatant disinformation, including the “You’re not a horse, stop it” post, the most viewed post in FDA history, regarding the use of ivermectin to treat COVID.
It’s exhausting always being correct. The FDA is now backtracking and mass deleting all of its posts that directed consumers not to use Ivermectin to treat COVID.
Let’s take a look back to when Ashley Cheung Honold, a senior lawyer for the FDA, tried to say the DEMANDS of the FDA were only simple “Quips.”
It’s time to hold ALL of these clowns accountable. People died when they could have used ivermectin.
Truth : FDA + Plaintiffs Settled, Ivermectin Still Not Approved For COVID-19
Let’s take a closer look at the claims, and find out what the facts really are!
Fact #1 : Both Sides Agreed To Settle Lawsuit
Let me start by pointing out that neither side in this lawsuit actually lost the case, as both sides agreed on a settlement. That was stated in the Stipulation Of Dismissal (PDF), which was filed on 21 March 2024.
Fact #2 : Case Was Dismissed With Prejudice
The plaintiffs, Robert L. Apter, Mary Talley Bowden, and Paul E. Marik, agreed to dismiss “with prejudice” all claims in the case. That means they agreed to dismiss the claims forever.
This means that the settlement is final, and not subject to further action; and the plaintiffs are prohibited from bringing any other lawsuit based on the claim, absent a successful appeal to a higher court.
Fact #3 : FDA Agreed To Remove Some Posts
While some people are claiming or suggesting that the FDA agreed to all posts on the use of ivermectin against COVID-19, that’s not really accurate. The FDA only agreed to do the following within 21 days:
retire an old 2021 article called Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, and delete and not republish all social media posts that link to the article; but the FDA retains the right to post a revised version,
delete and not republish its old Twitter, LinkedIn, and Facebook posts from 21 August 2021, that read “You are not a horse. You are not a cow. Seriously, y’all. Stop it“,
delete and not republish its old Instagram post from 21 August 2021, that read “You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID“, and
delete and not republish its old Twitter post from 26 April 2022, which read, “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.“
Another article called Frequently Asked Questions was already retired by the FDA, and played no part in this settlement.
In short, the FDA agreed to remove an old article and some old social media posts about not using ivermectin to treat COVID-19. That said, all removed materials will be archived, as required by federal law.
Fact #4 : Case Was Settled Without Admission Of Wrongdoing
According to Reuters, the three plaintiffs filed their lawsuit in 2022, stating that their reputations were harmed by the FDA campaign. Bowden lost admitting privileges at a Texas hospital, while Marik alleged he lost his positions at a medical school, and a hospital, for promoting the use of ivermectin against COVID-19.
But interestingly, this lawsuit appears to be settled without the FDA admitting to any wrongdoing, misconduct, or liability.
Neither this Stipulation of Dismissal nor the actions described herein shall constitute an admission or evidence of any issue of fact or law, wrongdoing, misconduct, or liability on the part of any party in this litigation.
In other words, the plaintiffs appear to have settled for the removal of an old article, and some old social media posts, without any change in FDA’s stance on ivermectin, or its use against COVID-19.
Overall, it seems to be a rather expensive way to remove an old article, and some old social media posts…
Fact #5 : Ivermectin Still Not Approved For Use Against COVID-19
It is important to point out that the FDA still has not approved or authorised the use of ivermectin in preventing or treating COVID-19. The FDA also pointed out that it has not stated that ivermectin is safe or effective for use against COVID-19.
Although FDA has approved ivermectin for certain uses in humans and animals, it has not authorized or approved ivermectin for use in preventing or treating COVID-19, nor has the agency stated that it is safe or effective for that use.
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Did an FDA document just prove that COVID-19 vaccine shedding is real?! Take a look at the viral claim, and find out what the facts really are!
Claim : FDA Doc Proves COVID Vaccine Shedding Is Real!
People are sharing articles (archive | archive) by Natural News and Infowars, which claimed or suggested that an FDA document just proved that COVID-19 vaccine shedding is real!
Here is an excerpt from those articles. Feel free to skip to the next section for the facts!
PROOF: Documents from FDA, Pfizer show that COVID “vaccine” shedding is REAL
Up until now, most of the research exposing Wuhan coronavirus (COVID-19) “vaccines” as dangerous – and exposing those who take them as disease and death spreaders – has come from independent sources. Now, the truth is coming from the federal government and Big Tech.
It took the sleuthing public, including the diligent truth-seekers at the Front Line COVID-19 Critical Care Alliance (FLCCC) advocacy group, a while to find all this, but we now know from the U.S. Food and Drug Administration (FDA) itself that mRNA gene therapy products like those manufactured by Pfizer-BioNTech and Moderna do, in fact, shed onto others from those who take them.
A 2015 FDA document called “Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products” defines shedding as “the release of [viral or bacterial gene therapy products] … from the patient through one or all of the following ways: excreta (feces); secreta (urine, saliva, nasopharyngeal fluids etc.); or through the skin (pustules, sores, wounds).”
The same document goes on to explain, according to the FDA, what gene therapy products are:
“All products that mediate their effects by transcription and/or translation of transferred genetic material.”
Since both the mRNA injections for COVID and adenovirus vaccines fall into this category, this is a clear-cut admission from the FDA itself that people who are “fully vaccinated” for COVID shed these poisons onto others through contact or close proximity, vindicating independent researchers who have been warning about this threat for years.
Truth : FDA Doc Does Not Prove COVID Vaccine Shedding Is Real!
This is yet another example of anti-vaccine fake news, and here are the reasons why…
Fact #1 : The FDA Document Is From 2015
Let me start by pointing out that the FDA document in question is almost 9 years old, being originally published in August 2015.
In other words – it was published 4 years before the COVID-19 pandemic, and 5 years before the first COVID-19 vaccines were approved.
Fact #2 : FDA Document Does Not Apply To COVID-19 Vaccines!
The FDA document was an industry guidance paper (PDF) called Design and Analysis of Shedding Studies for Virus or Bacteria-based Gene Therapy and Oncolytic Products.
The title itself is clear – it only refers to “Virus or Bacteria-based Gene Therapy and Oncolytic Products“.
COVID-19 vaccines are not gene therapy (gene modification) products, and they are not oncolytic (cancer killing) products either. So the FDA document does not apply to them!
Fact #3 : Shedding Only Occurs With Live Attenuated Virus Vaccines
Vaccine shedding actually refers to viral shedding, which can only (potentially) occur with live attenuated virus vaccines. Such vaccines alters the virus to make it weakened or even harmless, but still “live”.
There are no COVID-19 vaccines that are based on the live attenuated SARS-CoV-2 virus. Therefore, vaccine shedding cannot possibly occur with any COVID-19 vaccine currently-approved by the WHO.
All currently-approved COVID-19 vaccines are based on other vaccine technologies like inactivated virus (killed virus), viral vector (using a different virus), mRNA (using mRNA instructions), or subunit vaccines (using isolated viral proteins).
To be clear – mRNA vaccines from Pfizer-BioNTech and Moderna, highlighted in the Natural News and Infowars articles, do not cause vaccine shedding.
I should also point out that if the spike protein is so dangerous, then it is even more important to get vaccinated against COVID-19. After all, viruses multiply, while the vaccines won’t!
Even if we simply look at the mRNA vaccines alone, they contain a limited number of mRNA instructions that encode for the SARS-CoV-2 spike protein. The mRNA instructions enter a limited number of cells, which then produce and display those spike proteins on their surfaces, to trigger our immune system.
If you are infected by the actual SARS-CoV-2 virus though, it quickly hijacks your cells to produce millions of copies – each covered with spike proteins, which then infect even more cells, in an ever-expanding chain reaction.
Until your immune system learns to stop and defeat the SARS-CoV-2 virus, it will keep producing millions and millions of viruses that will circulate through your body, delivering those nasty spike proteins everywhere.
So if you are really worried about the spike protein, you should really get vaccinated against COVID-19!
Fact #5 : Natural News Is Known For Fake News
Natural News is a far-right, anti-vaccination conspiracy theory and fake news website that is known for publishing / promoting pseudoscience, disinformation, and far-right extremism.
Writing in the journal Vaccine, Anna Kata identified Natural News as one of numerous websites spreading “irresponsible health information”. According to John Banks, Natural News founder Mike Adams uses “pseudoscience to sell his lies” and is “seen as generally a quack and a shill by science bloggers.”
Dr. David Gorski called Natural News “one of the most wretched hives of scum and quackery on the Internet,” and the most “blatant purveyor of the worst kind of quackery and paranoid anti-physician and anti-medicine conspiracy theories anywhere on the Internet”.
Its articles have been regularly debunked as fake news, so you should never share anything from Natural News. Here are some of its fake stories that I fact checked earlier:
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Did McDonald’s just lose its legal battle against Jamie Oliver over its toxic pink slime meat?! Take a look at the viral claims, and find out what the facts really are!
Claim : McDonald’s Loses Legal Battle With Jamie Oliver!
People are claiming on social media that McDonald’s just lost its legal battle against British chef Jamie Oliver over its toxic pink slime meat!
Keep it Real : [McDonald’s loses the legal battle with chef Jamie Oliver, who proved that the food they sell is not fit to be ingested because it is highly toxic.
Chef Jamie Oliver has won a battle against the world’s largest junk food chain. Oliver proving how buyers are made.
Colin Young : Did anyone hear Jamie Oliver took McDonald’s to court last week and winning the case stating their food wasn’t suitable for human consumption
Didn’t think you would but it’s true
Absolutely disgusting 🤮
Amanda RN :🚨 [McDonald’s loses the legal battle with chef Jamie Oliver, who proved that the food they sell is not fit to be ingested because it is highly toxic.
Chef Jamie Oliver has won a battle against the world’s largest junk food chain. Oliver proving how burgers are made.
According to Oliver, the fat parts of meat are “washed” with ammoniac hydrogen and then used in the packaging of the meat “cake” to fill the burger. Before this process, according to the presenter, already this meat was not suitable for human consumption.
Oliver, a radical activist chef, who has waged a war against the food industry, says: We’re talking about meat that would be sold as dog food and after this process it’s served to humans. In addition to the quality of meat, ammonium acid is harmful to health. Oliver says this: “The process of the pink crap”.
What sane human being would put a piece of meat soaked in ammonium hydrogen in the mouth of a child?
In another of his initiatives Oliver has demonstrated how chicken nuggets are made: after selecting the “best parts”, the rest: fat, skin, cartilage, visuals, bones, head, legs, are subjected to a mec split smoothie canica – it’s the euphemism that engineers use in food, and then that blood pink paste is deodorant, bleached, re-refreshed and repainted, dipped in flour and fried melcocha, this is left in usually partially hydrogenated oils, that is, toxins.
The food industry uses ammonium hydrogen as an anti-microbial agent, which allowed McDonald’s to use meat in its burgers, which is not suitable for human consumption.
But even more disturbing is the situation that these substances based on ammonium hydrogen are considered ‘lawful components in the production process’ in the food industry with the blessings of health authorities worldwide. So consumers will never be able to discover what substances they put in our food.
Truth : McDonald’s Did Not Lose Legal Battle With Jamie Oliver!
This is yet another example of fake news circulating on WhatsApp, and social media platforms like X (formerly Twitter), and Facebook, and here are the reasons why…
Fact #1 : There Was No McDonald’s – Jamie Oliver Lawsuit
Let me start by pointing out that there was no legal battle between McDonald’s and Jamie Oliver. McDonald’s did not sue Jamie Oliver, and Jamie Oliver also did not sue McDonald’s.
Fact #2 : Jamie Oliver Did Not Target McDonald’s
Jamie Oliver did not actually target McDonald’s. So there is really no reason for McDonald’s or Jamie Oliver to sue one another.
In the episode of Jamie Oliver’s Food Revolution that aired on 12 April 2011, Jamie Oliver spoke out against Lean Finely Textured Beef (LFTB), which he derisively referred to as “pink slime”.
Fact #3 : Jamie Oliver Did Not “Discover” Pink Slime
While much has been made about Jamie Oliver’s “battle” against pink slime, he did not create that term, and he wasn’t even amongst the first to speak out against LFTB, which has been sold since 2001.
The term “pink slime” was reportedly coined by USDA microbiologist Gerald Zirstein in a 2002 email to his colleagues. He was, arguably, also the first to criticise LFTB.
I do not consider the stuff to be ground beef, and I consider allowing it in ground beef to be a form of fraudulent labeling.
Michael Moss from The New York Times posted not one article, but at least two articles on the safety of LFTB – on 3 October 2009, and then on 30 December 2009,.
Two years later, ABC News would air a series of reports on LFTB in March 2011. It was only after the extensive coverage by ABC News that Jamie Oliver actually featured LFTB on his show.
Despite its gross sounding name and look, LFTB is simply meat that has been separated from the fat in beef trimmings, and treated with ammonia to kill pathogens like Salmonella and E. coli.
The LFTB technology basically recovers meat that would otherwise be wasted and thrown away. Think of LFTB as low-fat beef paste. Regular ground beef consists of about 30% fat, while LFTB only has about 5% fat.
Fact #5 : McDonald’s Stopped Using LFTB In 2011
McDonald’s announced on 31 January 2012, that it stopped adding Lean Finely Textured Beef (LFTB) to its burgers since the beginning of 2011, and that it was no longer available in its products since August 2011:
At the beginning of 2011, we made a decision to discontinue the use of ammonia-treated beef in our hamburgers. This product has been out of our supply chain since August of last year. This decision was a result of our efforts to align our global standards for how we source beef around the world.
In other words – McDonald’s made the decision to stop using LFTB in its burgers in early 2011 – months before ABC News or Jamie Oliver covered LFTB. It was only in August 2011 that all of its LFTB-based products were cleared out of its supply chain.
Fact #7 : Ammonia In LFTB Isn’t Toxic
Even though McDonald’s no longer uses “pink slime” in their burgers, I should point out that the amount of ammonia used in LFTB isn’t dangerous.
The amount of ammonia present in Lean Finely Textured Beef (LFTB) is actually comparable to ammonia levels present in existing foods:
Food
Ammonia Level
American Cheese
813 ppm
Unblended LFTB
400-500 ppm
Ketchup
411 ppm
Onions
342 ppm
Blended Beef Patty
with 15% LFTB
200 ppm
Ground Beef
101 ppm
Ammonium hydroxide isn’t just used to treat LFTB meat trimmings, it is also used to produce a wide variety of foods like cheese, puddings, chocolate, and even as a leavening agent in bread. In fact, the ammonium hydroxide is classified as GRAS (Generally Recognised as Safe) by the US FDA, when used in appropriate concentrations.
Fact #8 : LFTB Uses Ammonium Hydroxide Gas
In his viral video, Jamie Oliver is seen showing a front loading washing machine filled with meat, with ammonia-based cleaning products in the background. He then pours from a bottle marked with “Ammonia” and a skull and crossbones symbol into a large tub filled with pieces of beef.
That is not an accurate reflection of how LFTB products are made, because the ammonium hydroxide used in the LFTB process is gaseous, not liquid. In addition, the LFTB process only uses the ammonium hydroxide gas to increase the pH of the separated meat trimmings, from 5.7 to 9.6 (source).
If there ever is a lawsuit over that Jamie Oliver video, he would be hard-pressed to explain how that demonstration accurately replicates how LFTB meat is really produced.
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He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Did Pfizer just admit that the mRNA COVID-19 vaccines are the deadliest drug in history?! Take a look at the viral claim, and find out what the facts really are!
Claim : Pfizer Calls mRNA Vaccines Deadliest Drug In History!
People are sharing an article (archive) by The People’s Voice (formerly NewsPunch), which claims that Pfizer just admitted that the mRNA COVID-19 vaccines are the deadliest drug in history!
Here is an excerpt from the article, which is long and (intentionally?) rambling. Feel free to skip to the next section for the facts!
Covid Vaccines Are Officially Deadliest Drug In History and Nobody Is Allowed to Talk About It
The Pfizer Covid-19 mRNA vaccine is now officially the most deadly drug in the history of Western medicine, killing and injuring hundreds of millions of people, with new cases emerging every single day as the fallout from the rollout continues to blow out exponentially.
But don’t take my word from it. The data that proves Covid vaccines are the deadliest drug in the long history of Western medicine is taken from Pfizer’s own documents. That’s right – Pfizer have released documents admitting the unprecedented carnage caused by their product.
This is the deadliest drug ever rolled out in human history by Pfizer’s own legally mandated 90-day post-rollout document known as Pfizer 5.3.6.
Dropped on April Fools Day 2022 after being ordered by a federal judge, this Pfizer document is available to everybody – but of course the mainstream media has done everything they can to suppress knowledge about what it contains.
This is the same document in the video above. The page shown in the video proves Pfizer’s experimental mRNA vaccine is not only the deadliest drug ever rolled out in human history, it is also by far and away the most injurious drug.
You can see an injure-to-kill ratio in the video above. 33.4 to 1. For every death, more than 33 people have been injured by the vaccine. Remember this is Pfizer’s own data.
Truth : Pfizer Did Not Call mRNA Vaccines Deadliest Drug In History!
This is yet another example of FAKE NEWS created / promoted by The People’s Voice, and here are the reasons why…
Fact #1 : Pfizer Did Not Call mRNA Vaccines Deadliest Drug In History
This is really silly, but let me start by pointing out that Pfizer never said / admitted / called the mRNA COVID-19 vaccines the deadliest drug in history.
The People’s Voice article certainly offered no evidence to back up its “fact checked” claim. Did it include a link to a Pfizer statement? A quote by Pfizer CEO Albert Bourla whose visage featured prominently in their video cover?
Nope. Zilch. Nada. Not a single shred of evidence that Pfizer ever called the mRNA vaccines the “deadliest drug in history”.
Fact #2 : FDA Released Pfizer Documents
The People’s Voice article claimed that Pfizer released documents “admitting the unprecedented carnage caused by their product”. That’s not true – Pfizer did not release any documents.
It was the US FDA that was releasing those Pfizer documents under a Freedom of Information Act (FOIA) request by the PHMPT (Public Health and Medical Professionals for Transparency) group.
Fact #3 : FDA Released Pfizer 5.3.6 Document In 2021
The People’s Voice article claimed that the Pfizer 5.3.6 document was “dropped on April Fools Day 2022”, but that’s not exactly true either.
The Pfizer 5.3.6 Postmarketing Experience document was first released by the FDA to the PHMPT (Public Health and Medical Professionals for Transparency) group, with three small pieces of information redacted on 17 November 2021.
The FDA later decided that the redacted information were not confidential after all, and reissued the same document in full on 1 April 2022. You can read more about this here.
Fact #4 : Pfizer 5.3.6 Deaths + Injuries Were Not Vaccine-Linked
The People’s Voice video pointed out that the Pfizer 5.3.6 document appears to list 42,086 injuries, and 1,223 deaths. That’s not accurate.
The deaths and injuries listed in the Pfizer 5.3.6 document were not linked to the mRNA vaccine, because it was based on the “List of Adverse Events of Special Interest” (AESI).
This AESI list is not a list of side effects caused by the Pfizer mRNA COVID-19 vaccine. Rather, it is a list of adverse events that Pfizer must look for post-vaccination case reports. As the Pfizer document noted on Page 16 (with my emphasis in bold) :
The AESI terms are incorporated into a TME list and include events of interest due to their association with severe COVID-19 and events of interest for vaccines in general.
Pfizer also pointed out that this adverse event evaluation is different (distinct) from the safety evaluation of its COVID-19 vaccine.
This is distinct from safety signal evaluations which are conducted and included, as appropriate, in the Summary Monthly Safety Reports submitted regularly to the FDA and other Health Authorities.
Claiming that these are vaccine side effects is like pointing to a list of prosecutable crimes in a legislation, and calling it a list of crimes the government actually committed. That’s how stupid it really is.
Fact #5 : Adverse Events Are Not Side Effects
I should now point out that adverse events are not necessarily side effects. Adverse events are “unfavourable” or “unintended” events that happen after vaccination or taking a drug, like having an anaphylactic reaction or getting into a car accident.
All reported adverse events have to be investigated to find out if they are related (anaphylactic reaction) or not (getting into a car accident) to the vaccine or drug that was taken.
Even if an adverse event was “possibly caused” by the vaccine, it must still be confirmed that the vaccine directly caused it, because an anaphylactic reaction (for example) can also occur from a bee sting, or an existing peanut allergy.
Only once an adverse event is confirmed to be caused by the vaccine, is it then a vaccine side effect. Otherwise, it is merely an adverse event, not a side effect.
Fact #6 : The People’s Voice Is Known For Publishing Fake News
The People’s Voice is the current name for NewsPunch, which possibly changed its name because its brand has been so thoroughly discredited after posting numerous shocking but fake stories.
Founded as Your News Wire in 2014, it was rebranded as NewsPunch in November 2018, before becoming The People’s Voice. A 2017 BuzzFeed report identified NewsPunch as the second-largest source of popular fake news on Facebook that year.
Its articles have been regularly debunked as fake news, so you should never share anything from NewsPunch / The People’s Voice. Here are some of its fake stories that I fact checked earlier:
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Does the FDA now allow medical experiments on people without their knowledge or informed consent?!
Take a look at the viral claim by US Presidential candidate Robert F. Kennedy Jr., and find out what the facts really are!
Claim : FDA Now Allows Experiments On People Without Consent!
People are sharing a series of posts (here, here, here, and here) on X (formerly Twitter) by Robert F. Kennedy Jr., who claimed or suggested that the FDA just issued a new ruling allowing clinical trials to be conducted on people without their knowledge or informed consent!
New FDA ruling exempts clinical trials with “minimal risk” from informed consent. That means that researchers can experiment on you without your knowledge or permission, so long as they claim that what they are testing is “safe.”
This is a direct violation of the Nuremberg Code.
Can you think of any therapy that all the experts agreed was perfectly safe, but turned out not to be?
This opens the door for testing of new “medicines” via the water supply or aerosolized spraying. It wouldn’t be the first time. To name one example of many, the U.S. army tested germ warfare dispersion in the NYC subway in 1966.
Truth : FDA Has Long Allowed Some Experiments On People Without Consent!
This is yet another example of MISINFORMATION created / spread by Robert F. Kennedy Jr., and here are the reasons why…
Fact #1 : Medical Research Without Consent Was Permitted Since 1991
Let me just start by pointing out that the the FDA has permitted “minimal risk” medical research without informed consent since 18 June 1991, when the Common Rule was issued (Federal Register archive PDF).
At that time, the Common Rule had four criteria for the waiver or alteration of informed consent for minimal risk research. It was then revised on 19 January 2017, to add a fifth criteria – “[i]f the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format”.
So the claim by Robert F. Kennedy Jr. that it was a recent 21 December 2023 FDA ruling (PDF) called “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations” that exempts “minimal risk” clinical trials from informed consent is false.
This was specifically mentioned in Section III A. of the FDA ruling, so it is odd that Robert F. Kennedy Jr. would make such a claim.
Fact #2 : Final FDA Rule Has Strict Limits
The new FDA rule basically allows Institutional Review Boards (IRBs) to decide on the waiver or alteration of informed consent for “certain minimal risk clinical investigations”.
FDA is issuing this final rule to permit an IRB waiver or alteration of informed consent in limited circumstances, consistent with the Cures Act. We believe that this rule will both safeguard the rights, safety, and welfare of human subjects and enable minimal risk clinical investigations that may facilitate medical advances and promote public health.
To be clear – the FDA is not simply waiving the need for informed consent where researchers can simply “claim that what they are testing is safe“. Such medical research have to be approved by an Institutional Review Board (IRB).
Fact #3 : Informed Consent Waiver Only Permitted For Minimal Risk
In addition, I should point out that IRBs are only allowed to grant or alter informed consent waivers for research that meet FDA’s definition of “minimal risk”:
“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
In short – the new FDA rule strictly limits the waiver or alteration of informed consent only to “minimal risk” research in which the subjects are not exposed to harm or discomfort that they would not normally experience in their daily life, or routine examinations.
It would therefore not be possible to get IRB approval for the “testing of new medicines via the water supply or aerolized spraying” as Robert F. Kennedy Jr. suggested.
Fact #4 : FDA Amended Its Rules To Comply With Law
The FDA isn’t simply creating this new rule for fun. It was more or less compelled to do so by the 21st Century Cures Act (Cures Act), which was was signed into law by President Barack Obama on 16 December 2016.
Amongst its provisions were Section 3024, which specifically amended sections 505(i)(4) and 520(g)(3) of the FD&C Act (21 U.S.C. 355(i)(4) and 360j(g)(3)) to “provide FDA with the authority to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject”.
In addition, Section 3023 of the Cures Act directs the Secretary of the Department of Health and Human Services (HHS) to “harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations,” to the extent practicable and consistent with other statutory provisions.
In short – the US FDA was only issuing its final ruling based on the Cures Act, which was enacted by Congress and signed into law by President Obama.
Fact #5 : FDA Amendment Was Open For Public Comment
It is odd that concerned citizens like Robert F. Kennedy Jr. are only now complaining about the FDA rule amendment, when it was open for public comment years ago!
The FDA issued the proposed rule changes in the Federal Register of 15 November 2018, and asked the public to submit any electronic or written comments to the proposed rule changes by 15 January 2019.
In the end, the FDA received fewer than 50 comment letters from the academia, Institutional Review Boards (IRBs), public advocacy groups, industry, trade organizations, public health organizations, individuals, and other organizations.
Where were these concerned citizens when the FDA asked for their comments, before making its decision on the final rule?
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Did the US FDA just quietly amend the 21st Century Cures Act to allow medical research without consent?!
Take a look at the viral claim, and find out what the facts really are!
Claim : FDA Changed Law To Allow Medical Research Without Consent!
People are sharing an article (archive) by The People’s Voice (formerly NewsPunch), which claims that the US FDA just quietly amended the 21st Century Cures Act to allow medical research without consent!
Here is an excerpt from the article, which is (intentionally?) long and confusing. Feel free to skip to the next section for the facts!
FDA Just Quietly, Deceitfully Changed Law To Allow ‘Medical Research Without Consent’
The Food and Drug Administration (FDA) has quietly amended the 21st Century Cures Act and “finalized a rule” to allow “medical research without consent” in certain situations.
According to the FDA’s new rule, “certain clinical trials” will be allowed “to operate without obtaining informed consent from participants.” The new rule came into effect on January 22, 2024 and can be read in full at the government’s Federal Register.
The intentionally vague language raises the nightmare scenario of the elite mass vaccinating humanity without consent during the next pandemic. Remember the “safe and effective” mRNA vaccines? No doubt they would have qualified under the new rule.
When this news eventually reaches the mainstream, the media and fact checkers will use this caveat to claim that the FDA and their Big Pharma colleagues will not be engaging in any dangerous practices. They will say anybody who opposes the new rules is a “conspiracy theorist.”
This is where pandemic 2.0 enters the equation. You know, the one the global elite at the WEF have been talking about for the last few months. The one they say will “get your attention this time.”
When Disease X strikes, and people are getting sick and dying, Big Pharma will be able to test you for the virus and within that testing mechanism will be the treatment and it will be legal, without your knowledge or consent.
It will be legal according to the FDA because people will be getting sick and dying, and the study will not pose more than minimal risk to humans given the context (people getting sick and dying) in which the experimentation will take place.
This is how the elite will be able to put the “slew of injectibles,” which they have admitted are on the conveyer belt, into the arms of anybody and everybody without informed consent in the future.
Truth : FDA Did Not Change Law To Allow Medical Research Without Consent!
This is yet another example of FAKE NEWS created / promoted by The People’s Voice, and here are the reasons why…
Fact #1 : FDA Did Not Change Any Law
The People’s Voice article claimed that the US FDA just amended the 21st Century Cures Act to allow “medical research without consent” in certain situations. That’s simply not true, and is easily proven false.
All you have to do is read the FDA’s final ruling on the “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations“.
As the summary at the top explained, the FDA was amending its own regulations (not any law), to implement a provision of the 21st Century Cures Act (Cures Act).
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act).
The People’s Voice article provided the same link, so it is certainly aware of what it actually said.
Fact #2 : Congress Enacts Laws, Not Agencies
For the benefit of people who are not aware of how laws are enacted or amended in the United States, I should point out that Congress is the legislative branch of the US government.
Established by Article 1 of the US Constitution, the Legislative Branch consists of the House of Representatives, and the Senate. Together, they are known as the United States Congress.
Only the US Congress that has the power to enact and/or amend laws in the United States of America. Not the executive branch, or the judicial branch. Certainly not government agencies like the FDA, which fall under the executive branch.
Fact #3 : Cures Act Permitted FDA Amendment In 2016
The 21st Century Cures Act (Cures Act) was signed into law by then President Barack Obama on 16 December 2016.
Amongst its provisions were Section 3024, which specifically amended sections 505(i)(4) and 520(g)(3) of the FD&C Act (21 U.S.C. 355(i)(4) and 360j(g)(3)) to “provide FDA with the authority to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject”.
In addition, Section 3023 of the Cures Act directs the Secretary of the Department of Health and Human Services (HHS) to “harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations,” to the extent practicable and consistent with other statutory provisions.
In short – the US FDA was only issuing its final ruling based on the Cures Act, which was enacted by Congress and signed into law by the President.
Fact #4 : Medical Research Without Consent Was Permitted Since 1991
What The People’s Voice article does not point out is that minimal risk medical research without informed consent has been permitted since 18 June 1991, when the Common Rule was issued (Federal Register archive PDF).
At that time, the Common Rule had four criteria for the waiver or alteration of informed consent for minimal risk research. It was revised on 19 January 2017, to add a fifth criteria – “[i]f the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format”.
Fact #5 : FDA Amendment Was Open For Public Comment
The People’s Voice article suggested that the FDA “quietly” made those amendments out of sight and public discourse. That’s simply not true.
The FDA issued the proposed rule changes in the Federal Register of 15 November 2018, and asked the public to submit any electronic or written comments to the proposed rule changes by 15 January 2019.
In the end, the FDA received fewer than 50 comment letters from the academia, Institutional Review Boards (IRBs), public advocacy groups, industry, trade organizations, public health organizations, individuals, and other organizations.
Fact #6 : Amendment Does Not Affect Informed Consent For Vaccinations
The People’s Voice article suggested that the removal of consent for minimal risk medical research may eventually spill over to allowing people to be injected without informed consent. That’s simply not true.
Not only was the FDA ruling an amendment of existing rules which have permitted minimal risk without informed consent since 1991, it has nothing to do with informed consent for medical treatments and/or vaccinations.
The FDA final ruling cannot be used to void the need for informed consent for any medical treatment and/or injections of drugs and vaccines. The People’s Voice article certainly offered no evidence to back up its claims or suggestions.
Fact #7 : The People’s Voice Is Known For Publishing Fake News
The People’s Voice is the current name for NewsPunch, which possibly changed its name because its brand has been so thoroughly discredited after posting numerous shocking but fake stories.
Founded as Your News Wire in 2014, it was rebranded as NewsPunch in November 2018, before becoming The People’s Voice. A 2017 BuzzFeed report identified NewsPunch as the second-largest source of popular fake news on Facebook that year.
Its articles have been regularly debunked as fake news, so you should never share anything from NewsPunch / The People’s Voice. Here are some of its fake stories that I fact checked earlier:
Please help us FIGHT FAKE NEWS by sharing this fact check article out, and please SUPPORT our work!
Please Support My Work!
Support my work through a bank transfer / PayPal / credit card!
Name : Adrian Wong Bank Transfer : CIMB 7064555917 (Swift Code : CIBBMYKL)
Credit Card / Paypal : https://paypal.me/techarp
Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Can foreign DNA enter our cells through mRNA vaccines, and change our DNA and humanity forever?!
Take a look at the viral claim, and find out what the facts really are!
Claim : Foreign DNA In mRNA Vaccines Can Change Our DNA!
People are sharing a video clip of Tucker Carlson interviewing Florida Surgeon General Joseph Ladapo, which claims or suggestions that foreign DNA can enter our cells through the mRNA vaccines and change our DNA and humanity forever!
Tucker Carlson : Could foreign DNA enter your cells through the mRNA COVID vax and change your DNA — and humanity itself — forever? Sounds nutty. It’s not. “Absolutely that could happen,” says Dr. Joseph Ladapo, the surgeon general of Florida. A shocking conversation.
SimonTimothy :We’ve screamed for a long time that the mRNA shots changed your DNA and we’ve been mocked, ridiculed, fact checked and canceled.
But now the truth is coming out…
“Could foreign DNA enter your cells through the mRNA COVID vax and change your DNA — and humanity itself — forever? Sounds nutty. It’s not. “Absolutely that could happen,” says Dr. Joseph Ladapo, the surgeon general of Florida. A shocking conversation.”
The Dibster :BREAKING: Dr. Joseph Ladapo, the surgeon General of Florida says foreign DNA could enter your cells through the mRNA COVID vax and change your DNA
Truth : Foreign DNA In mRNA Vaccines Cannot Change Our DNA!
Let’s take a closer look at these claims about foreign DNA fragments in mRNA vaccines changing our DNA, and find out what the facts really are!
Fact #1 : Ladapo Claims Were Refuted By FDA Earlier
First, I should point out that Joseph Ladapo’s claims about foreign DNA fragments changing our DNA have already been refuted by the US Food & Drug Administration (FDA) on 14 December 2023 (PDF).
Here’s a quick summary of what Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research replied to Ladapo’s claims:
After a “thorough assessment of the entire manufacturing process, FDA is confident in the quality, safety, and effectiveness of the COVID-19 vaccines“.
No safety concerns regarding “residual DNA” were identified after over a billion doses of mRNA vaccines being administered.
Animal studies using the mRNA vaccine with residual DNA demonstrated “no evidence for genotoxicity from the vaccine“.
Pharmacovigilance data from hundreds of millions of vaccinated people also showed “no evidence” of genotoxicity from the mRNA vaccines.
Reproductive toxicology studies to test the possible integration of residual DNA fragments in reproductive cells found “no concerns” with the mRNA COVID-19 vaccines.
As you can see, the FDA had already addressed Ladapo’s claims about testing the mRNA vaccines for DNA integration.
The FDA reply (PDF) was also succinct – just two pages long, and did not divert to irrelevant topics like “what time the sun sets in China” or “their third cousin’s Bar Mitzvah” as Ladapo claims in the Tucker Carlson interview.
So the question you should be asking is – why is Joseph Ladapo still flogging these claims, when the FDA has clearly stated that tests were conducted on mRNA vaccines, and have shown them to be safe and effective, and that they do not pose any DNA integration (genotoxicity) risks?
In the Tucker Carlson interview, Ladapo claimed or suggested that the FDA did not mention its own guidance on DNA contamination. That’s not true.
The FDA letter to Ladapo (PDF) actually addressed his claims, pointing out that the guidance (PDF) only applied to DNA vaccines, not mRNA vaccines. Even the name clearly states that the guidance was meant for DNA vaccines.
In your letter, you raise questions, citing to the 2007 Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications. This guidance was developed for DNA vaccines themselves, not for DNA as a contaminant in other vaccines, and is not applicable to the mRNA COVID-19 vaccines.
DNA vaccines work by introducing a DNA sequence into the cell nucleus, so DNA contamination would be a real concern. In contrast, mRNA vaccines do not enter the cell nucleus, so DNA contamination isn’t a real concern.
It is unknown if Ladapo understands the difference between DNA and mRNA vaccines. But it’s clear that the FDA already informed him that the guidance he quoted was not relevant.
It’s like a bit like quoting the manual for a motorcycle as “evidence” that his diesel truck only needs two wheels, instead of four. So why does he still persist in mentioning the FDA guidance?
Ladapo claims that there are billions to hundreds of billions of foreign DNA fragments in each dose of the mRNA vaccine. That sounds scary, doesn’t it? The truth is – it’s really a red herring.
The DNA fragments in mRNA vaccines are produced as a result of its manufacturing process using a DNA template. After the DNA template creates the mRNA vaccine, DNAse is used to break down the residual DNA into tiny fragments.
Focusing on the number of these DNA fragments is also wrong, as you want the DNAse enzyme to really do a good job and cut up the residual DNA into tiny pieces. Naturally, the more you cut DNA up into smaller fragments, you get more (but smaller) fragments. It is consequently harder to filter these smaller fragments out, but the smaller they are, the less likely they are biologically active.
Think of residual DNA as parts of the mRNA factory that was dismantled once the vaccine was manufactured. If you chop it up real good, you get nothing more than small pieces of scrap metal. Sure, the disposal team may have left a couple of bolts and screws lying on the floor, but can they be used to recreate the factory? No.
Fact #4 : mRNA Vaccines Meet DNA Fragment Limit
Instead of focusing on the “number” of DNA fragments, it makes much more sense to focus on the “total weight” of residual DNA, and the “size” of those fragments.
Currently, the WHO and US FDA guidelines recommend that residual DNA in vaccines and other biological products should not exceed 10 nanograms (ng) per purified dose, and the DNA fragments should be no greater than 200 bp in length.
Even that limit appears to be out of an abundance of caution, as studies have not shown any actual danger from residual DNA, as they are tiny fragments.
In its December 2023 reply (PDF), the FDA actually pointed out to Ladapo that the amount of residual DNA fragments was less than 1/1000 the amount of mRNA in each vaccine dose.
The specification for the COVID-19 mRNA vaccines for residual DNA following DNAse treatment results in the presence of DNA fragments at a quantity that is less than three orders of magnitude lower than the quantity of the RNA dose by weight.
This has been determined (and continues to be determined during production of lots) with a validated quantitative PCR assay.
Fact #5 : DNA Fragments Can’t Integrate With Our Genome
The presence of residual DNA fragments does not mean that they will integrate into our genome. For one thing – these are DNA fragments that have been broken down by the DNase enzyme.
These DNA fragments can only enter the cell nucleus if there is an enzyme called integrase, is not present in any COVID-19 vaccine. So they simply cannot enter the cell nucleus, never mind integrate with DNA.
On top of that, the mRNA vaccines are injected into the muscle, whose cells are “post-mitotic”, which means they are no longer able to change.
Fact #6 : Viruses Integrate With Cell DNA
Viruses like SARS-CoV-2 and HIV-1 (diagram below) integrate their genes with the host cell DNA, to hijack the cell and use it to produce copies of itself.
You can see how a typical RNA virus would infect a host cell, convert its RNA into DNA which is moved into the cell nucleus using the integrase enzyme.
Once inside, the viral DNA integrates with the host cell DNA, which gets transcribed into instructions for the cell to produce copies of the virus.
This is the same way how the SARS-CoV-2 virus infects our cells, to produce copies of itself to infect even more cells.
If you are truly worried about anything modifying your cell’s DNA, you should try to avoid viral infections like COVID-19. Better still – vaccinate yourself, and get protected against COVID-19!
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He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Colombian Health Minister Guillermo Alfonso Jaramillo just walked back his “anti-vaccine” comments!
Take a look at what he said, and find out what the facts really are!
Claim : Colombian Health Minister Slams COVID Vaccines!
People are sharing a video, which shows the Colombian Health Minister, Guillermo Alfonso Jaramillo, calling the COVID-19 vaccines “experimental”
aussie17 : 🚨🚨🚨🚨🚨💥💥Wow!! Health Minister of Colombia, Guillermo Alfonso Jaramillo slams experimental vaccine in an astonishing outburst!
———————————— We are playing with the lives of Colombians, we cannot be a factor of experimentation. All of us who are vaccinated today, today, with the exception of those who took Sinovac,
I have three from Sinovac, all the new technology is a technology and all the vaccines entered here without permission, we went and became an experiment.
All Colombians who are vaccinated served for the largest experiment that has been carried out in the entire history of humanity.
We cannot continue experimenting with the Colombian community, much less with the indigenous people, with the blacks and with the poorest of this country, with the peasants.
Health Minister of Colombia, Guillermo Alfonso Jaramillo strongly criticizes the experimental covid-19 vaccine, stating that risking the lives of Colombians by being a part of an experiment is totally unacceptable…..
Michaelia 8:32 : Experimental Vaccine Under Fire: Colombia’s Health Minister Denounces Experimental Vaccine in Astonishing Outburst!
“Every vaccinated Colombian has contributed to the largest experiment ever conducted in human history”
Colombian Health Minister Walks Back Antivax Comments!
What you may not realise is that the Colombian Health Minister quickly walked back his “anti-vaccine” comments. Here is what you need to know…
Fact #1 : Viral Video Appears Legitimate
The video appears to be legitimate, and recorded during a political control debate in the First Commission of the Colombian Senate on Tuesday, 28 November 2023.
In that video, Guillermo Alfonso Jaramillo – the Minister of Health and Social Protection of Colombia – claimed that Colombians were vaccinated against COVID-19 as part of the “largest experiment in history”, referring to the approval and use of mRNA vaccines before their full approval by regulatory agencies like the FDA and EMA.
Fact #2 : Guillermo Jaramillo Walked Back His Antivax Comments
After the Minister’s video went viral, organisations like the Association of Epidemiology of Colombia expressed their disagreement with his claims. They pointed out that his comments contradict scientific evidence, and will jeopardise trust in COVID-19 vaccines.
Guillermo Jaramillo then officially responded to the criticism, clarifying that he was only referring to the “experimental phase” that mRNA vaccines went through. He also affirmed his “consistent support for vaccination“, and emphasised the importance of “timely vaccination” and the “completion of vaccination schemes“.
Colombian President Gustavo Pedro also defended the Health Minister, labelling accusations that Jaramillo is “anti-vaccine” as “slander”.
Fact #3 : mRNA Vaccines Are No Longer Experimental
mRNA vaccines from Pfizer and Moderna underwent and passed large clinical trials, and received their Emergency Use Authorisations (EUA) in December 2020.
Regardless of what people claim – the mRNA vaccines were no longer experimental, once they received their EUA.
There are some differences between an EUA and a full FDA approval, but the EUA means the vaccines have officially been approved for use by the health regulator.
While Guillermo Jaramillo suggested that the Sinovac vaccine is not “new technology”, it is still a new vaccine that underwent the same clinical trials as the mRNA vaccines. I should point out that the Sinovac vaccine never received EUA or full authorisation from Western health regulators like the US FDA or EMA.
Fact #4 : mRNA Vaccines Received Their Full FDA Approval
In any case, the mRNA vaccines from Pfizer and Moderna received their full FDA approval on 23 August 2021, and 31 January 2022 respectively.
So there is really no reason for anyone to claim that these mRNA vaccines are still experimental. Even if you “believe” that the mRNA vaccines were “experimental” until they received full regulatory approval, we crossed that bridge a long time ago.
To be clear – the mRNA vaccines from Pfizer and Moderna have long ceased to be experimental.
Fact #5 : mRNA Vaccines Proven Safe + Effective
No vaccine or drug is perfectly safe, or perfectly effective. But the mRNA vaccines from Pfizer and Moderna have proven to be safe and effective for the vast majority of people.
Not only did they pass their large clinical trials with flying colours, post-marketing monitoring showed that they remained safe and effective for the vast majority of people after tens of billions of doses have been administered worldwide.
Yes, post-marketing monitoring have shown that the mRNA vaccines can cause rare side effects like myocarditis. But what anti-vaccine activists don’t tell you is that – the risk of developing myocarditis is much higher with COVID-19 infections!
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Are residual DNA impurities in mRNA vaccines dangerous, and can they integrate into our DNA?!
Take a look at the viral claims, and find out what the facts really are!
Claim : Residual DNA in mRNA vaccines are dangerous!
Anti-vaccine activists are sharing and/or promoting an article by The Epoch Times, which claimed / suggested that residual DNA in mRNA vaccines are dangerous, and can potentially integrate into our DNA! Here is an excerpt:
Billions of Copies of Residual DNA in a Single Dose of COVID-19 mRNA Vaccine: Preprint
A new preprint study up for peer review finds billions of residual DNA fragments in the COVID-19 mRNA vaccine vials.
The lead author of the study, molecular virologist David Speicher, who has a doctorate in virology, told The Epoch Times that their study is “the largest study” on residual DNA in COVID-19 vaccines to date.
“In our study, we measured DNA copies of spike, ori (origin of replication), and SV40 enhancer genes,” he told The Epoch Times. “The loads of SV40 enhancer-promoter, ori, and virus spike in Pfizer are up to 186 billion copies per dose.”
The spike he refers to is the DNA sequence of the SARS-CoV-2 spike protein, which can be transcribed to spike mRNA to be used in the COVID-19 mRNA vaccines to be translated to spike protein. The other two DNAs—SV40 enhancer genes and ori—help facilitate the replication of spike DNA.
However, the final mRNA vaccines should only include RNA and not residual DNA instructions for spike production.
The researchers sequenced the gene material in 27 mRNA vaccine vials from 12 different lots. Nineteen vials were from Moderna, and eight were from Pfizer.
It should be noted that the SV40 enhancer gene is a genetic sequence from the polyomavirus simian virus 40 (SV40), a DNA virus known to cause cancer in laboratory animals. The gene is not the SV40 virus itself. Once the mRNA and DNA are harvested from the bacteria, the DNA is then supposed to be removed.
However, it wasn’t cleared efficiently, as the billions of copies of spike, ori, and SV40 enhancer DNA detected in the Pfizer vials suggest. Several millions of copies of ori and spike DNA were also found in the Moderna vials, but the SV40 enhancer gene was not detected.
Foreign DNA introduced into the cell alongside the mRNA is at risk of being mistaken as human DNA. If it is, it can then be integrated into the cell’s blueprint. The presence of SV40 enhancer genes increases the risk of DNA integration, said the lead author, citing a study published in 1999 that found maximal transport of DNA using the SV40 enhancer.
No evidence Residual DNA in vaccines are dangerous
Let’s take a closer look at these claims about Residual DNA in vaccines, and find out what the facts really are!
mRNA Vaccines were proven safe + effective
First, I should point out that the mRNA vaccines underwent large clinical trials before they received their Emergency Use Authorisation (EUA), and even after that, they continue to be monitored for safety and efficacy.
So health regulators and health authorities are well-aware of how safe and effective the mRNA vaccines are. That’s why new mRNA vaccines continue to be approved by health regulators around the world.
Residual DNA is not new
These papers and articles may suggest that residual DNA is a new kind of contaminant, or one that is only found in mRNA vaccines. Neither are true.
Residual DNA is found in all vaccines and biological products manufactured in any kind of cell. The risk of residual DNA has also been investigated for about 60 years now.
To be clear – residual DNA isn’t new, and it is a byproduct of using cells to produce biologicals, and not part of mRNA vaccine technology.
In the beginning, some studies raised potential safety issues with residual DNA. So, the FDA set an upper limit of just 10 picograms of residual DNA per medicinal dose in 1985.
In 1986, a WHO study group looked into new cell substrates that are being used to produce biological products, and concluded that the risk is negligible when the amount of residual DNA is 100 picograms per dose.
Then 10 years later – the WHO Expert Committee on Biological Standardization (ECBS) increased the limit to 10 nanograms (ng) per purified dose, albeit not for microbial, diploid, or primary cell cultures.
In 1997, the European Medicines Agency (EMA) said that further data of DNA from continuous mammalian cell lines showed that it poses even less risk than previously thought.
Currently, the WHO and US FDA guidelines recommend that residual DNA in vaccines and other biological products should not exceed 10 nanograms (ng) per purified dose, and the DNA fragments should be no greater than 200 bp in length.
Even that limit appears to be out of an abundance of caution, as studies have not shown any actual danger from residual DNA, as they are tiny fragments.
The US FDA said that “with regard to the mRNA vaccines, while concerns have been raised previously as theoretical issues, available scientific evidence supports the conclusion that the minute amounts of residual DNA do not cause cancer or changes to a person’s genetic code.”
Residual DNA is fragmented into tiny pieces
The production of mRNA vaccines at scale do not use any animal cells, but is done through in vitro transcription (IVT). The enzyme DNase is then used to destroy the DNA template and polymerase used in the reaction, and further filtration can be performed to reduce the amount of DNA fragments.
In other words – the DNA used to produce the mRNA vaccines are broken into tiny pieces, and most of it is filtered out. Think of the remnants as pieces of scrap metal left over from a dismantled chemical factory.
Sure, the workers left a ton of scrap metal pieces behind, but so what? The scrap metal may be an eyesore, but it’s not going to give you cancer, or turn you into Spiderman!
In short – there is no evidence that these tiny fragments of DNA will integrate into your genome, or cause your cells to become cancerous.
The David J Speicheret al. preprint (which has not yet peer-reviewed) actually showed that the amount of residual DNA “contamination” was far below FDA regulatory limits.
As Professor David Gorski noted, the study authors found that the residual DNA in the mRNA vaccines was far below regulatory limits, and used a logarithmic scale to make them appear much closer to the limit than they really are:
Basically, by the authors’ own measurements, the amount of DNA/vial fell below the FDA guidance of 10 ng DNA/dose.
Did you also notice the little trick they did? They used a log scale to make the total DNA appear to be much closer to the FDA-recommended limit than it really is.
For instance, in all the Moderna vials, the amount of DNA isn’t half of the recommended limit, it’s less than one-tenth the recommended limit, and, in the case of the ori sequence, well under 1/100 of the limit.
The abstract itself even notes that the authors found DNA at “0.28 – 4.27 ng/dose and 0.22 – 2.43 ng/dose (Pfizer), and 0.01 -0.34 ng/dose and 0.25 – 0.78 ng/dose (Moderna), for ori and spike respectively measured by qPCR.”
So, from McKernan and Rose’s own data, the vial with the very highest concentration of DNA was one Pfizer vial that had less than one-half the maximum DNA amount recommended by the FDA, while the Moderna vial with the most plasmid DNA contamination had less than one-tenth the maximum recommended by the FDA.
In short – even the much touted Speicher preprint itself showed that the amount of residual DNA in mRNA COVID-19 vaccines are far below regulatory limits.
The whole controversy is really much ado about nothing. What a bloody waste of time!
Perhaps that’s why they are repackaging the drama in terms of “billions of copies of residual DNA”, instead of just telling us about the actual quantity they found.
The truth is – there are billions of fragments because the DNA was chopped up pretty damn small to ensure that it would pose no threat. And because the fragments so small, it’s pretty impossible to filter them all out.
Hilariously, the Speicheret al. preprint suggested that mRNA vaccine vials with higher doses of residual DNA correlated with more adverse reactions, as reported in the Vaccine Adverse Reaction Reports System (VAERS).
As I pointed out many times before, VAERS data is unverified, and notoriously susceptible to abuse, and false reporting. That’s because it’s an open system that anyone – not just doctors, can report anything they want.
In addition, the reports may be duplicated and have not been verified to be related to the vaccine or drug in question. Hence, VAERS specifically warns against using its reports to reach any conclusion about the risks or safety of vaccines / drugs in question.
But that is precisely why anti-vaccination activists love using VAERS data – it’s unverified, and very susceptible to abuse and false reporting.
Study showed fewer adverse events with more DNA fragments!
Even more hilariously, the Speicheret al. preprint actually showed that the detection of more DNA fragments (as determined by Qubit fluorometry) correlated with fewer serious adverse events (SAEs).
In other words – this study has inadvertently “proven” that getting mRNA vaccines with more residual DNA will result in fewer adverse effects!
I meant that only in jest, because the study simply does not prove any correlation. It’s just asinine to even attempt to correlate unverified VAERS reports with quantity of residual DNA fragments in any vaccine.
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Protect yourself and your family, by vaccinating against COVID-19 and other preventable diseases!
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
The US FDA just proposed a ban of BVO – brominated vegetable oil – a potentially toxic stabiliser used in soft drinks!
FDA To Ban BVO – A Stabiliser Used In Soft Drinks!
On Thursday, 2 November 2023, the US Food and Drug Administration (FDA) finally moved to revoke its authorisation for BVO – brominated vegetable oil – a stabiliser mostly used in soft drinks.
BVO is a vegetable oil that has been modified by bromine, a pungent and oily chemical, to create an emulsifier that keeps the citrus flavouring in fruit beverages from separating and floating to the top.
BVO has long been banned in Europe and Japan over health safety concerns, but was permitted to be used in the United States, at up to 15 parts per million.
While many beverage makers have already reformulated their drinks to replace BVO with other stabilisers, about 90 food products in the United States – mostly sodas, still use brominated vegetable oil. This was partly due to FDA’s past restrictions, and the ban on BVO in Europe and Japan:
In 1970, the FDA determined BVO was no longer ‘Generally Recognized as Safe’ … and began overseeing its use under our food additive regulations.
Over the years many beverage makers reformulated their products to replace BVO with an alternative ingredient, and today, few beverages in the U.S. contain BVO.
– James Jones, FDA Deputy Commissioner for Human Foods
The proposed ban is not yet a certainty. The FDA is opening up the proposed ban for public comments until January 17, 2024. That will be followed by a review process, before a final decision is made.
However, the publicity of this potential ban by the FDA will steer consumers away from soft drinks still containing BVO, and encourage brands to reformulate their products to replace brominated vegetable oil with an alternative stabiliser.
The FDA decision came after California banned the BVO in October, with the passing of the California Food Safety Act. But officially – the FDA came to its conclusion based on studies that showed bioaccumulation of bromine, and its toxic effects on the thyroid:
The FDA conducted studies that clearly show adverse health effects in animals in levels more closely approximating real-world exposure. Therefore, the FDA can no longer conclude that this use of BVO in food is safe.
The studies were conducted in collaboration with the National Institute of Environmental Health Sciences’ (NIEHS) Division of Translational Toxicology (formerly the Division of the National Toxicology Program), to assess unresolved toxicological questions. Results from these studies demonstrate bioaccumulation of bromine and toxic effects on the thyroid – a gland that produces hormones that play a key role in regulating blood pressure, body temperature, heart rate, metabolism and the reaction of the body to other hormones.
Those studies were conducted between 2016 and 2022. Initially, they started to more accurately measure the amount of BVO in commercial soft drinks. Then they studied the health effects of BVO in test rats, and the study results showed toxic effects on the thyroid:
Between 2016 and 2020, the FDA published improved methods to more accurately measure the amount of BVO in commercial soft drinks on the market and to measure small amounts of fats in vegetable oil. These research efforts enabled the development and validation of the method used in our later animal studies to detect the level of brominated fats in tissues of animals fed BVO.
On May 16, 2022, the FDA published a study in the journal Food and Chemical Toxicology that evaluated potential health effects related to BVO consumption in rodents. The FDA measured the amounts of BVO present in the animal food and brominated fats in tissues from test animals. We also fed test animals amounts of BVO that simulate real-life exposure.
The data from the study suggest that oral exposure to BVO is associated with increased tissue levels of bromine and that at high levels of exposure the thyroid is a target organ of potential negative health effects in rodents. The agency also conducted a study to identify the level of BVO in the body after consumption of BVO.
The FDA concluded that after assessing existing animal and human data, together with the more recent FDA studies, it can no longer conclude that BVO is safe to use in food.
Needless to say – even if the FDA has not yet finalised the ban, we should all avoid any food products that contain BVO, even if they meet current regulations.
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Are mRNA COVID-19 vaccines from Pfizer and Moderna contaminated with SV40 virus DNA that can cause turbo cancer and other health problems?!
Take a look at the viral claims, and find out what the facts really are!
Claim : mRNA Vaccines Are Contaminated With SV40 DNA!
Some people are sharing video clips, messages, and articles which claim that the mRNA COVID-19 vaccines from Pfizer and Moderna are contaminated with SV40 virus DNA that can cause turbo cancer and other health problems!
Jikkyleaks : BOOM 💥💥 Yet another lab confirms therapeutic levels of DNA and SV40 contamination of Pfizer and Moderna “vaccines”
This time, @DJSpeicher& @JesslovesMJKshow that the DNA contamination correlates to adverse events (and presumably deaths).
Criminal prosecutions are needed
💙Lyndsey, RN🐭 :Do NOT take Pfizer or Moderna as plasmid dna contamination and SV40 found in the vials that were distributed to the population. BUT the dna and sv40 were not found in the trial vials. HUGE REGULATORY ISSUE THERE FOR YOUR BIG MOMMA AND POP POP!
#VaxInjuries #VaxDeaths
Chuck Callesto : BREAKING REPORT: Pfizer accused of NOT DISCLOSING the presence of the Simian Virus 40 [SV40] DNA sequence in its mRNA COV-D-19 vaccine.
The complete SV40 virus was ELIMINATED from Polio vaccines during the 1950s and 1960s because of concerns about its association with CANCER.
Truth : mRNA Vaccines Are Not Contaminated With SV40 DNA!
This is yet another example of FAKE NEWS created / propagated by anti-vaccine proponents, and here are the reasons why…
Fact #1 : SV40 Promoter Is Not SV40 Virus
First, I should point out that gene promoters are DNA sequences that stimulate gene expression, and have long been used in molecular biology.
The SV40 promoter is a DNA sequence that was derived from the SV40 (Simian Virus 40) virus, and is not the same thing as the SV40 virus DNA. Think of it as a genetic tool obtained from the SV40 virus, just like how botulinum toxin is a treatment derived from the bacteria, Clostridium botulinum.
Finding botulinum toxin in a vial of Botox does not mean there is bacteria in that vial. Similarly, finding the SV40 promoter in the Pfizer vaccine does not mean there is SV40 virus in the vaccine.
According to Professor David Gorski, a professor of surgery and oncology at the Wayne State University School of Medicine, “the SV40 promoter-enhancer is often used in plasmids because it is a very strong promoter that can drive the production of lots of the desired mRNA encoded by the cDNA sequence attached to it.”
Fact #2 : SV40 Promoter Is Not Dangerous
Michael Imperiale, a molecular biologist at the University of Michigan Medical School, explained that the SV40 promoter, on its own, can’t cause cancer. The part of SV40 that’s potentially cancer-causing, known as the T-antigen, isn’t present in the vaccine.
Even the scientist whose testimony to the South Carolina Senate has been used to drive this controversy, has come out to dismiss the concerns that the SV40 promoter is dangerous, or can cause cancer:
It’s just the volume knob that drives high level expression of anything put under its control, which in this case is just an antibiotic resistance marker.
The fear about the SV40 sequences is total nonsense. The vaccine is not going to cause cancer. There is no cancer causing gene in the vaccine.
– Phillip Buckhaults, director of the Cancer Genetics Lab at the University of South Carolina
Fact #3 : mRNA Vaccines Are Not Contaminated With SV40 Virus
To be clear – mRNA vaccines do not contain the SV40 virus, because they were manufactured using in vitro transcription (IVT) technology.
The presence of the SV40 virus in some of the polio vaccine manufactured from 1955-1963 occurred because that vaccine was manufactured in monkey kidney cell cultures that were contaminated with the SV40 virus.
Even then, decades later, there is still no conclusive evidence that the SV40 virus can cause cancers in humans. However, out of an abundance of caution, the SV40 virus is considered to potentially cause cancer in humans.
There is no evidence to indicate the presence of SV40, a virus found in monkey kidneys that can potentially cause cancer in humans, in the formulation of COVID-19 vaccines.
– Alessandro Faia, spokesperson for the European Medicines Agency (EMA)
Fact #4 : Health Canada + EMA Confirm Residual DNA Meet Regulations
Health Canada actually wrote a detailed explanation (archive) of why DNA fragments are expected in mRNA vaccine manufacturing, and why the quantity in the vaccines is not a concern.
Plasmids are an essential starting material for the production of mRNA vaccines. During the downstream process in mRNA vaccine manufacturing, the plasmid DNA is digested with enzymes to small fragments, and further removed to a level of not more than 10 ng/human dose, which is in line with the World Health Organization’s recommendation concerning residual DNA in biological drugs. The DNA is digested with enzymes post-transcription.
Health Canada was aware of the presence of residual plasmid DNA as a process-related impurity during review and prior to the authorization of the mRNA COVID-19 vaccines. In addition, the release testing data for every COVID-19 vaccine lot released into the Canadian market were reviewed and deemed to meet the requirements approved by Health Canada. Furthermore, different assays assessing the same vaccine property, or even the same assay being performed in different laboratories, may generate different results.
It is important to assess the results using the authorized validated assays performed by the vaccine manufacturers to ensure that the quality of commercial vaccine lots are comparable to lots shown to be safe and efficacious in clinical studies.
The European Medicines Agency (EMA) also concurred, stating that the SV40 sequence is considered “a non-functional part” of the DNA plasmid that was used to manufacture the mRNA vaccines:
We can confirm that an SV40 sequence is present in the DNA plasmid. The sequence is not directly relevant for plasmid production in E. coli or for the mRNA production process so it is considered to be a non-functional part of the structure of the source plasmid.
Specific sequences for the non-infectious parts of SV40 are commonly present in plasmids used for manufacturing of biological active substances. The sequence for non-infectious parts of SV40 is only a small fraction of the entire SV40 sequence.
While the full DNA sequence of the plasmid starting material was provided in the initial marketing authorisation application for Comirnaty, the applicant did not specifically highlight the SV40 sequence, as it was considered to be a non-functional part of the plasmid. They have since clarified this information in response to questions raised by EMA.
We would also like to point out that during the manufacturing process, this sequence and other plasmid DNA sequences are broken down and removed. Fragments of the SV40 sequence may only be present as residual impurities at very low levels that are routinely controlled.
In short – the mRNA vaccines meet regulatory limits for residual DNA. This isn’t new or shocking to Health Canada, or the EMA, or other regulatory agencies.
The production of mRNA vaccines at scale do not use any animal cells, but is done through in vitro transcription (IVT). The enzyme DNase is then used to destroy the DNA template and polymerase used in the reaction, and further filtration can be performed to reduce the amount of DNA fragments.
In Canada, the limit was set at 10 ng of DNA per dose, which is in line with WHO recommendations. According to Health Canada, the mRNA vaccines all comply with this requirement.
The David J Speicher et al. preprint (which has not yet peer-reviewed) actually showed that the amount of residual DNA “contamination” was far below FDA regulatory limits.
As Professor David Gorski noted, the study authors found that the residual DNA in the mRNA vaccines was far below regulatory limits, and used a logarithmic scale to make them appear much closer to the limit than they really are:
Basically, by the authors’ own measurements, the amount of DNA/vial fell below the FDA guidance of 10 ng DNA/dose.
Did you also notice the little trick they did? They used a log scale to make the total DNA appear to be much closer to the FDA-recommended limit than it really is.
For instance, in all the Moderna vials, the amount of DNA isn’t half of the recommended limit, it’s less than one-tenth the recommended limit, and, in the case of the ori sequence, well under 1/100 of the limit.
The abstract itself even notes that the authors found DNA at “0.28 – 4.27 ng/dose and 0.22 – 2.43 ng/dose (Pfizer), and 0.01 -0.34 ng/dose and 0.25 – 0.78 ng/dose (Moderna), for ori and spike respectively measured by qPCR.”
So, from McKernan and Rose’s own data, the vial with the very highest concentration of DNA was one Pfizer vial that had less than one-half the maximum DNA amount recommended by the FDA, while the Moderna vial with the most plasmid DNA contamination had less than one-tenth the maximum recommended by the FDA.
In short – even the much touted Speicher preprint itself showed that the amount of residual DNA in mRNA COVID-19 vaccines are far below regulatory limits.
The whole controversy is really much ado about nothing. What a bloody waste of time!
Fact #6 : Residual DNA Won’t Integrate Into Our Genome
The presence of residual DNA itself does not mean that they will integrate into our genome. For one thing – these are DNA fragments that have been broken down by the DNase enzyme.
Think of them as parts of a factory which were used to build the mRNA vaccine, but dismantled once the vaccine has been manufactured. Sure, the disposal team may have left a couple of bolts and screws lying on the floor, but can they be used to recreate the factory? No.
To be clear – neither the COVID-19 vaccines, not any residual DNA they may contain, can change our genome. On top of that, the vaccines are injected into the muscle, whose cells are “post-mitotic”, which means they are no longer able to change.
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Did the US FDA ask to fully release the Pfizer vaccine data only by the year 2076?!
Find out what’s going on, and what the facts really are!
Claim : FDA Asked To Fully Release Pfizer Vaccine Data By 2076!
The infamous DiedSuddenly account on X (formerly Twitter) just posted a screenshot of an article which claims that the US FDA just asked to fully release the Pfizer vaccine data only by the year 2076!
FDA Asks Federal Judge to Grant it Until the Year 2076 to Fully Release Pfizer’s COVID-19 Vaccine Data
The fed gov’t shields Pfizer from liability. Gives it billions of dollars. Makes Americans take its products. But won’t let you see the data supporting its safety/efficacy. Who does the gov’t work for?
Truth : FDA Did NOT Ask To Fully Release Pfizer Vaccine Data Only By 2076!
This is yet another example of misinformation posted by the infamous DiedSuddenly account on X (formerly Twitter), and here are the reasons why…
Fact #1 : Screenshots Was From November 2021
First, let me just point out that the screenshot is not new or even recent, but was apparently taken in November 2021.
Aaron Siri posted that article on his Substack on 17 November 2021, and based on the time, the screenshot was likely taken on 17 or 18 November 2021.
Why would DiedSuddenly repost this screenshot almost 2 years later?
Fact #2 : FDA Did Not Ask To Fully Release Pfizer Vaccine Data By 2076
First, let me be clear – the US FDA did not ask to fully release the Pfizer COVID-19 vaccine data only by the year 2076. In fact, as best as I could tell – the FDA never mentioned the date 2076.
That appears to be the “interpretation” of Aaron Siri, the lawyer working for PHMPT (Public Health and Medical Professionals for Transparency) – the group requesting the data that the FDA used to licence the Pfizer COVID-19 vaccine.
As you will see below, it appears to be based on ignoring facts and basic math…
Fact #3 : FDA Has To Redact Files Before They Are Released
It is not simply a matter of handing over the documents to PHMPT. The FDA has to go through every document and redact information that are exempt from disclosure under FOIA, before it can release them.
That process is not only time-consuming, it is resource-intensive because it requires government information specialists to review each page line-by-line.
The FDA estimated that it would take 8 minutes per page to read and review records for FOIA production.
Fact #4 : FDA Had 400 Other Pending FOIA Requests
The FOIA request by PHMPT is being handled by the Access Litigation and Freedom of Information Branch at the FDA’s Center for Biologics Evaluation and Research (CBER).
That is a small department with just ten employees, including the director and two trainees. So they really only had just seven people who were trained well enough to process FOIA requests.
At that time, that small team was processing “approximately 400 currently pending FOIA requests“, while being embroiled in “6 active FOIA litigation matters“.
Needless to say, the heavy workload greatly limits how many pages this office can go through and redact every month.
Fact #5 : PHMPT Demanded 329,000 Pages!
The FDA asked PHMPT to narrow their request by specifying records they don’t require, so they can focus on processing the important documents they need.
The PHMPT, however, insisted that the FDA process and deliver ALL documents related to the approval of the Pfizer COVID-19 vaccine – some 329,000 pages!
That would require a processing rate of over 80,000 pages per month – far in excess of what the FDA FOIA office is capable of handling.
The FOIA process, on the other hand, involves FDA information specialists going through each page line-by-line to identify and redact proprietary information.
Fact #7 : FDA Vaccine Approval Process Adds A Ton Of New Documents
The FDA vaccine approval team went through fewer documents, because they only need to look at relevant information provided by Pfizer and BioNTech.
The FDA team in charge of this FOIA request would necessarily have to go through far more documents, because the approval process itself adds a ton of new documentation.
Even the PHMPT acknowledged that, specifically asking for “all correspondence and written summaries of oral discussions” related to the FDA approval of the Pfizer COVID-19 vaccine.
Hence, it is ludicrous for the PHMPT to suggest that the two processes were similar in effort and time.
Fact #8 : FDA Processes FOIA Requests In 500-Page Blocks
The FDA processes FOIA requests in 500-page blocks, which allow them to provide documents to more requesters, and avoid a few large requests monopolising their “finite processing resources”.
This is not a special processing limitation on the Pfizer COVID-19 vaccine data, but a standard FDA processing rate that the courts have upheld for a long time.
Fact #9 : FDA Processing FOIA Requests Faster Than Proposed
The FDA was able to process some records faster than the 500-page rate, as they noted in their 6 December 2021 brief. They also said that they can release more than 12,000 pages by end of January 2022.
Even back in December 2021, the FDA was doing above and beyond what it pledged to do, delivering almost 5000 pages per month – about 10X its promised rate.
At that rate, the FDA would finish processing 329,000 pages in 69 months – just under 6 years. Obviously, 6 years is far less than the 55 years claimed… and would put the end date at sometime in 2027, not 2076.
Fact #10 : It Would Take PHMPT Months To Read Everything
PHMPT stated that they are a group of over 30 people. Let’s say they are 35 strong, and they take the same 8 minutes to read through each page.
Even if they all sat down and read for 8 hours a day, it would take them over 7 months just to read through the 329,000 pages ONCE.
And it should be noted that this involves 5X more people than the FDA FOIA team, and they are all dedicated to this singular task of reading those Pfizer documents.
Fact #11 : PHMPT Took Almost 108 Days To Read 5 Documents!
PHMPT took almost 108 days to read through the first batch of five documents that the FDA released to them on 17 November 2021.
It was only in early March 2022 when they found the 9 pages listing some 1,291 adverse events of special interest.
This not only proves that the FDA was right about how much time it takes to read these documents, it also shows that the PHMPT does not really need all 329,000 documents within 108 days.
After all, it took the PHMPT almost that long just to read 5 documents! At this rate, it will take them some 16,450 years to read all 329,000 Pfizer documents…
Fact #12 : FDA Released Almost All Of PHMPT Priority List By Jan 2022
PHMPT appears to be cognisant that it is stupid to request for “everything” when most of the pages may not be relevant at all.
That’s why they sent the FDA a priority list of eight (8) items. And guess what – the US FDA was able to provide seven (7) of those items by January 31, 2022!
So Aaron Siri’s public griping about the FDA taking so long appears to be nothing more than theatre.
Fact #13 : Judge Asked FDA To Release 55,000 Pages A Month
On 6 January 2022, US District Judge Mark Pittman ordered a compromise, noting that “the Court recognises the “unduly burdensome” challenges that this FOIA request may present to the FDA“.
The FDA will produce “more than 12,000 pages” as it proposed, by 31 January 2022.
The FDA will produce the remaining documents at a rate of 55,000 pages per month, starting 1 March 2022.
Granted, the FDA did not win the right to continue processing at its own pace, but neither did the judge agree to let PHMPT force the FDA to deliver all documents within 108 days. It was ultimately a compromise.
For certain, Judge Pittman’s order would mean that the FDA would have to fully release the Pfizer vaccine documents by August 2022!
His January 2022 judgement effectively wiped out the claim that FDA will only fully release the data by 2076. So it is curious why the DiedSuddenly account on X (formerly Twitter) would repost this old claim…
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Did the FDA refuse to release results from studies investigating subclinical myocarditis caused by the Moderna COVID-19 vaccine?!
Take a look at the viral claim, and find out what the facts really are!
Claim : FDA Refused To Release Vaccine Myocarditis Results!
People are sharing an article by The Epoch Times which claims or suggests that the US FDA is refusing to release results from studies investigating subclinical myocarditis caused by the Moderna COVID-19 vaccine!
Here is an excerpt of The Epoch Times article. Feel free to skip to the next section for the facts:
FDA Has Results of Subclinical Myocarditis Studies, but Won’t Release Them Yet
The U.S. Food and Drug Administration (FDA) has received results from two studies of subclinical heart inflammation following Moderna COVID-19 vaccination, but is refusing to release them to the public—at least for now.
FDA officials in January 2022 directed Moderna to run three prospective studies on subclinical myocarditis, or heart inflammation without symptoms, after COVID-19 booster vaccination. One study, mRNA-1273-P204, would examine the incidence of subclinical myocarditis in children aged 6 months through 11 years. Another, mRNA-1273-P203, would examine the incidence in adolescents aged 12 years through 17 years. The third, mRNA-1273-P301, would examine the incidence in adults.
Moderna has shared the results of the P203 study with the FDA, an FDA spokeswoman told The Epoch Times in an email. But she declined to provide them. To obtain the results, she said, The Epoch Times would need to request them under the Freedom of Information Act (FOIA).
“The FDA doesn’t post PMR/PMC study reports,” she said, using acronyms for postmarketing requirements and postmarketing commitments, or requirements and commitments pharmaceutical companies make when receiving FDA clearance for their products. “They may be requested under FOIA.”
The spokeswoman did not disclose why the FDA doesn’t release the results absent a FOIA request. Moderna has not responded to requests for comment. The Epoch Times has submitted a FOIA request for the results but has not yet received them.
Jessica Adams, a former FDA officer, asked for the P301 study results in July. She requested quick processing because, according to cardiologists, subclinical myocarditis can result in serious problems. She cited a recent study that discovered some sudden deaths in South Korea were caused by myocarditis, even though no inflammation was detected until autopsy.
The matter “represents an urgent and imminent threat to young people who may be mandated to take this vaccine,” Ms. Adams told the FDA.
A number of U.S. colleges have required COVID-19 vaccination for attendance. Some are requiring the newest version of the shots from Moderna, Pfizer, and Novavax, even though they were authorized with human data from just 50 people.
The FDA rejected the bid for quick processing.
“You have not demonstrated a compelling need that involves an imminent threat to the life or physical safety of an individual,” Sarah Kotler, an FDA FOIA official, told Ms. Adams. “Neither have you demonstrated that there exists an urgency to inform the public concerning actual or alleged federal government activity.”
No Evidence FDA Refused To Release Vaccine Myocarditis Results
In this article, I will go through some of their points, and show you what the facts really are!
Fact #1 : Moderna Studies Started In 2020-2021
First, let me start by pointing out that the three Moderna studies mentioned in The Epoch Times article did not begin in 2022. Rather, they started in 2020 / 2021:
The Epoch Times article claimed that “FDA officials in January 2022 directed Moderna to run three prospective studies on subclinical myocarditis“, and provided this FDA document (PDF download as evidence.
If you actually look at the FDA document, titled Summary Basis for Regulatory Action, you’ll realise that it tells a completely different story:
it stated that the Review Committee recommended the approval of the Moderna SPIKEVAX mRNA vaccine for COVID-19
it mentioned the P203, P204, and P301 studies which were already running by then.
it stated that Moderna requested the deferment of three paediatric studies, including P203 and P204.
it stated that the FDA approved Moderna’s request to defer the paediatric studies in December 2021.
To address requirements of the Pediatric Research Equity Act, the Applicant submitted a request for deferral of the following studies in pediatric individuals ˂18 years of age because the mRNA-1273 vaccine would be ready for approval for use in adults before such studies could be completed. The deferred studies are:
Deferred pediatric study P203 to evaluate the safety and effectiveness of mRNA-1273vaccine in children 12 years through 17 years of age
Deferred pediatric study P204 to evaluate the safety and effectiveness of mRNA-1273vaccine in children 6 months to <12 years of age
Deferred pediatric study to evaluate the safety and effectiveness of mRNA-1273 vaccine ininfants <6 months of age
The deferral request and pediatric plans were accepted without revisions by the FDA PediatricReview Committee on December 14, 2021.
To be clear – the P203, P204, and P301 studies were already running in 2021 – long before the FDA released that PDF.
The FDA requires manufacturers of certain drug products (including vaccines) to conduct postmarket studies and clinical trials to assess for possible serious risks associated with those drugs / vaccines.
Referred to as postmarket requirements (PMRs) and postmarket commitments (PMCs), these studies are conducted after the approval of the drugs / vaccines.
You can actually look up PMR / PMC studies on the FDA website (link). Here are the results of the three Moderna trials mentioned in the article:
mRNA-1273-P203 : Final report submitted to FDA on 13 January 2023
mRNA-1273-P204 : Study is ongoing
mRNA-1273-P301 : Study is ongoing
Fact #4 : PMR / PMC Report May Be Requested
Even though the FDA regularly releases information about PMR / PMC studies, it does not release the actual data or results. This is not just for COVID-19 vaccines. This policy extends to all PMR / PMC studies.
As an FDA spokesperson explained to The Epoch Times, those reports may be requested through a FOIA (Freedom of Information Act) request.
The FDA doesn’t post PMR/PMC study reports. They may be requested under FOIA.
You may wondering why the FDA cannot publicly release PMR / PMC study results. That’s because those documents may contain classified information, personal information, confidential business details, or even trade secrets.
Anyone can make a FOIA request for these reports, but the FDA must first go through the reports, and redact information that are exempt from disclosure under FOIA, before they can be released.
Ironically, a key reason why the FDA cannot expedite FOIA requests for those three Moderna studies is because it was compelled by US District Judge Mark Pittman to expedite the processing of some 329,000 pages of documents requested by PHMPT looking into the Pfizer COVID-19 vaccine!
That decision came after the PHMPT demanded that the FDA release all those documents within 108 days. Now that the FDA is compelled to focus on processing those documents, it has far less resources to process other FOIA requests.
Fact #6 : No Evidence Of Vaccine Subclinical Myocarditis
While the article appears to suggest that the Moderna P203 study results may prove that the Moderna mRNA vaccine causes subclinical myocarditis, it offers no proof of that. The article only points out that:
Moderna submitted its final report on the P203 study to the FDA
The Epoch Times requested for the Moderna report
The FDA told The Epoch Times to file an FOIA request
The Epoch Times filed its FOIA request in July 2023
The Epoch Times has not received the report as of 11 October 2023
Jessica Adams, who requested the P301 study results in July 2023, was told by the FDA that it would take “at least two years” for her to receive the results.
The Epoch Times article actually mentioned this, so there is no reason to believe that its P203 request made in the same month would be released anytime soon.
To be clear – there is not even a hint of smoke, because none of them actually have access to any of the three Moderna study results – two of which are still ongoing!
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Did the Mayo Clinic just admit that hydroxychloroquine may be used to treat COVID-19?!
Take a look at the viral claims, and find out what the facts really are!
Claim : Mayo Clinic Admitted Hydroxychloroquine Can Treat COVID-19!
People are sharing a Mayo Clinic article, or screenshots of that Mayo Clinic article, claiming that it shows the Mayo Clinic quietly admitting that hydroxychloroquine (HCQ) can be used to treat COVID-19 patients!
Peter Navarro : From Mayo Clinic website grudging admission of glaring truth: “Hydroxychloroquine may be used to treat coronavirus (COVID-19) in certain hospitalized patients.” For all you murderers at @CNN
@johnberman who spread lies about hydroxy, this one’s for u.
Truth : Mayo Clinic Did Not Admit Hydroxychloroquine Can Treat COVID-19!
This is yet another example of FAKE NEWS about COVID-19 treatments, and here are the reasons why…
Fact #1 : Mayo Clinic Posted This Back In 2020
First, I should address the claim that the Mayo Clinic “quietly” updated its website recently to say that hydroxychloroquine (HCQ) can be used to treat COVID-19 patients.
The truth is the Mayo Clinic first mentioned hydroxychloroquine as a possible treatment for COVID-19 more than 3 years ago – on 22 May 2020, to be specific.
It was not a recent development, or even a quiet change. The last time Mayo Clinic appears to have changed its hydroxychloroquine article regarding COVID-19 was in June 2020!
Just because some people did not notice the changes until three years later in September 2023, does not mean the Mayo Clinic “quietly” admitted anything.
Fact #2 : Mayo Clinic Warned About Hydroxychloroquine
The Mayo Clinic article only stated that hydroxychloroquine “may also be used” to treat COVID-19 in “certainhospitalised patients“.
Hydroxychloroquine may also be used to treat coronavirus (COVID-19) in certainhospitalized patients.
More importantly, the next paragraph actually warned people against self-medicating with hydroxychloroquine, and said that it “should only be used for COVID-19 in a hospital or during clinical trials“.
The Mayo Clinic article also explicitly pointed out that hydroxychloroquine may increase the risk of developing heart rhythm problems.
Using this medicine alone or with other medicines (eg, azithromycin) may increase your risk of heart rhythm problems (eg, QT prolongation, ventricular fibrillation, ventricular tachycardia). Hydroxychloroquine should only be used for COVID-19 in a hospital or during clinical trials. Do not take any medicine that contains hydroxychloroquine unless prescribed by your doctor.
Fact #3 : Mayo Clinic Article Changed According To Evidence
The Mayo Clinic article on hydroxychloroquine actually changed twice in 2020, as new evidence presented itself during the COVID-19 pandemic.
To make it easier for you to understand, here is the timeline of the Mayo Clinic updates on hydroxychloroquine, and some significant points in the use of HCQ to treat COVID-19:
18 March 2020 : The WHO announced that chloroquine and HCQ would be tested in the multinational Solidarity clinical trial for COVID-19 treatments using existing drugs.
19 March 2020 : US President Donald Trump encouraged the use of chloroquine and HCQ during a national press conference, causing a massive increase in demand for both drugs in the US.
28 March 2020 : US FDA authorised the use of chloroquine phosphate and hydroxychloroquine sulfate to treat COVID-19, under an Emergency Use Authorisation as an experimental treatment for emergency use in hospitalised patients.
8 April 2020 : The US National Institutes of Health (NIH) began the first clinical trial to assess whether hydroxychloroquine is safe and effective to treat COVID-19.
24 April 2020 : US FDA cautioned against using chloroquine / hydroxychloroquine outside of a hospital or clinical trial, after reports of adverse events including heart problems and deaths.
Between 8-22 May 2020 : Mayo Clinic first updated its hydroxychloroquine article to say that it “may be used” to treat COVID-19 patients in “certain hospitalised patients”
5 June 2020 : Hydroxychloroquine was discontinued in the UK RECOVERY Trial when a preliminary analysis of the data showed that it provided “no beneficial effect” in patients hospitalised with COVID-19.
Between 5-13 June 2020 : Mayo Clinic updated its HCQ article to warn about the risk of heart rhythm problems while taking hydroxychloroquine. It also warned that HCQ should only be used “in a hospital or during clinical trials“.
15 June 2020 : US FDA revoked the EUA for both chloroquine and hydroxychloroquine, while allowing clinical trials for both drugs to continue.
20 June 2020 : US NIH halted its clinical trial of hydroxychloroquine, after it showed that HCQ was “unlikely to be beneficial to hospitalised patients with COVID-19”.
4 July 2020 : WHO discontinued the hydroxychloroquine arm of the Solidarity Trial, after HCQ produced “little or no reduction in the mortality of hospitalised COVID-19 patients“.
24 September 2023 : Mayo Clinic article from 13 June 2020 went viral on social media after former Trump advisor, Peter Navarro, posted it on X (formerly known as Twitter).
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Former Florida surgeon general Dr. Scott Rivkees and the CDC just publicly slammed the state’s advice against getting the updated 2023-2024 COVID-19 vaccine!
Find out what he said, and what’s going on!
Florida Recommends Against 2023 Updated COVID-19 Vaccines!
Just one day after the CDC recommended that everyone 6 months and older should get the new 2023 updated COVID-19 vaccines, Florida Surgeon General Joseph Ladapo issued a statement recommending against people under 65 getting the updated vaccine.
In his statement, Ladapo claimed that getting the mRNA COVID-19 vaccines make it easier for people to get infected, while running risk of getting cardiac problems. Instead of getting the new COVID-19 vaccines, Ladapo recommends staying physically active outdoors, and eating more vegetables…
As the federal government makes new boosters for COVID-19 available, the Florida Department of Health (Department) reminds health care providers of their obligation to remain up to date with the current literature related to the mRNA COVID-19 vaccines.
A new mRNA COVID-19 booster was approved on September 11, 2023, by the federal government. While the initial mRNA COVID-19 vaccines were authorized by the United States Food and Drug Administration (FDA) utilizing human clinical trial data, the most recent booster approval was granted in the absence of any meaningful booster-specific clinical trial data performed in humans. In both cases the federal government has failed to provide sufficient data to support the safety and efficacy of the COVID-19 vaccines. Health care providers are expected to include the information in this guidance in discussions with patients regarding the mRNA COVID-19 vaccines.
Based on the high rate of global immunity and currently available data, the State Surgeon General recommends against the COVID-19 booster for individuals under 65. Individuals 65 and older should discuss this information with their health care provider, including potential concerns outlined in this guidance.
Providers and patients should be aware of outstanding safety and efficacy concerns:
Throughout the pandemic, studies across geographic regions have found that the mRNA COVID-19 vaccines are associated with negative effectiveness after 4 to 6 months. As efficacy waned, studies showed that COVID-19 vaccinated individuals developed an increased risk for infection. This is not found in other vaccines, including the flu vaccine.
The mRNA COVID-19 vaccines present a risk of subclinical and clinical myocarditis and other cardiovascular conditions among otherwise healthy individuals. There is unknown risk of potential adverse impacts with each additional dose of the mRNA COVID-19 vaccine; currently individuals may have received five to seven doses (and counting) of this vaccine over a 3-year period.
Elevated levels of spike protein from the mRNA COVID-19 vaccine persist among some individuals for an indefinite period of time, which may carry health risks.
Improving habits and overall health help manage and reduce the risk of serious health problems such as heart disease, type 2 diabetes, and obesity. The State Surgeon General and the Department continue to encourage Floridians to prioritize their overall health by:
Staying physically active,
Minimizing processed foods,
Maximizing vegetables and healthy fats, and
Spending time outside to support necessary vitamin D levels.
Former Surgeon General Slams Florida Vaccine Advice!
Former Florida surgeon general Dr. Scott Rivkees just publicly slammed the DeSantis administration and Dr. Joseph Ladapo for advising people against getting the updated 2023 COVID-19 vaccines.
Dr. Scott Rivkees preceded Dr. Joseph Ladapo as the state surgeon general, resigning in September 2021 after being shunned by Ron DeSantis for encouraging COVID-19 precautions when the Florida governor wanted virtually no preventive measures.
When the current Florida surgeon general issued that advice against getting the updated COVID-19 vaccine, he spoke up against it to USA TODAY NETWORK – Florida.
Dr. Rivkees, who is a pediatrician and now a professor at the Brown University School of Public Health, pointed out that the COVID-19 vaccines have been proven to be “very safe” and “very effective”.
Rates of COVID vaccination are lower in Florida than they had been. I think the cumulative effect of this anti-vaccine messaging is being felt.
COVID is a vaccine preventable disease. These vaccines are very safe and very effective.
The CDC also publicly criticised both Florida governor Ron DeSantis and his surgeon general Joseph Ladapo for advising against getting the updated 2023 COVID-19 vaccine, with CDC Director Dr. Mandy Cohen calling their comments “dangerous“.
Vaccination against COVID-19 remains the safest protection for avoiding hospitalizations, long-term health challenges, and death.
As we head into the fall and winter seasons, it is important that Americans get the updated COVID-19 vaccine. They are proven safe; they are effective, and they have been thoroughly and independently reviewed by the FDA and CDC.
Public health experts are in broad agreement about these facts, and efforts to undercut vaccine uptake are unfounded and dangerous.
The US FDA has also stated publicly that the new 2023 COVID-19 vaccines have been thoroughly reviewed and tested for safety:
The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality.
We very much encourage those who are eligible to consider getting vaccinated.
– Peter Marks, Director of the FDA Center for Biologics Evaluation and Research
Please help us FIGHT FAKE NEWS by sharing this fact check article out, and please SUPPORT our work!
And please protect yourself and your loved ones, by vaccinating against COVID-19 and other preventable diseases!
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Should you listen to Florida Surgeon General Joseph Ladapo who claimed that the 2023 COVID-19 vaccines have “a lot of red flags”?!
Find out what he said, and what the facts really are!
Claim : 2023 COVID-19 Vaccines Have “A Lot Of Red Flags”
Days before the FDA approved the updated 2023 COVID-19 vaccines that the CDC later recommended for everyone 6 years and older, Florida’s Surgeon General Joseph Ladapo went on a rant.
During a “Mandate Freedom” press conference with Florida Governor Ron DeSantis on September 7, 2023, Ladapo criticised the 2023 COVID-19 vaccines, claiming that there are “a lot of red flags”.
There’s a new vaccine that’s coming around the corner, a new mRNA COVID-19 vaccine, and there’s essentially no evidence for it.
There’s been no clinical trial done in human beings showing that it benefits people. There’s been no clinical trial showing that it is a safe product for people — and not only that, but then there are a lot of red flags.
So something that you don’t hear much about, but we’ll be talking more about is that there are multiple studies now from around the world – Brazil, I think Australia, United States, that show that over time, these vaccines, these mRNA COVID-19 products actually increase your chances of contracting COVID-19.
That’s not normal, and unfortunately, you are going to have people who are going to get on television and try to explain why you should be comfortable with that, you should be comfortable with taking a product that ultimately, like its predecessors, increases your chance of contracting something.
No Evidence 2023 COVID-19 Vaccines Have “A Lot Of Red Flags”
Let’s take a look at the claims Florida Surgeon General Joseph Ladapo made at the “Mandate Freedom” press conference, and see what the facts really are…
Fact #1 : Joseph Ladapo Was Appointed By Ron DeSantis
First, I think it is important to note that most US states do not have a surgeon general. State surgeon generals are a recent “invention”, with only five states creating this position:
Pennsylvania : 1996
Michigan : 2003
Arkansas and Florida : 2007
California : 2019
Even so, Michigan has not filled its Surgeon General post since 2010. All other US states and territories do not their own state surgeon generals, and rely on the US Surgeon General, who is currently Vivek Murthy.
Joseph Abiodun Ladapo was appointed to the post of Florida Surgeon General by Florida governor Ron DeSantis on September 21, 2021, following his op-eds promoting unproven COVID-19 treatments like hydroxychloroquine and ivermectin, questioning the safety of vaccines, and opposing lockdowns and mask mandates.
At that time, he claimed that these opinions were based on his “experience in treating COVID-19 patients at the University of California, Los Angeles (UCLA). However, UCLA staff roster do not show him treating any COVID-19 patients. Several of his colleagues also stated that Ladapo had never treated any COVID-19 patient.
Fact #2 : Ladapo’s Advice Are Often Controversial
After he was appointed as Florida Surgeon General, Joseph Ladapo’s first move was to repeal quarantine requirements for schoolchildren exposed to COVID-19.
He also recommended that children in Florida should not be vaccinated against COVID-19, making Florida the first state to contradict COVID-19 vaccine guidelines by the CDC and the American Academy of Pediatrics.
Ladapo also suggested that men aged 18 to 39 should not be vaccinated, claiming high cases of cardiac-related deaths for those who took the mRNA COVID-19 vaccines – a claim that was rejected by many medical professionals.
In a sign that his views were possibly disgraceful, the UCLA David Geffen School of Medicine removed Ladapo’s name and biography from its websites.
In January 2023, the Faculty Council of the University of Florida College of Medicine said that Ladapo’s recommendation was based on “careless and contentious research practice” and might have violated the university policies on research integrity.
On March 10, 2023, the CDC and the FDA publicly rebuked Joseph Ladapo (PDF download) for claiming that the mRNA COVID-19 vaccines cause widespread adverse events.
Fact #3 : Ladapo Comments Were Made Before Vaccine Approval
Florida Surgeon General Joseph Ladapo made those comments on 7 September – four days before the US FDA approved the updated 2023 vaccines, and five days before the CDC recommended their use in people 6 months and older.
So how did Ladapo know that these updated 2023 COVID-19 vaccines have “a lot of red flags” days before the FDA and the CDC announced their findings?
Fact #4 : Ladapo Did Not Offer Any Evidence
Even more troubling – Florida Surgeon General Joseph Ladapo did not offer any evidence to back up his claim that the updated 2023 COVID-19 vaccines have “a lot of red flags”.
What exactly are those red flags? He didn’t say.
Fact #5 : Ladapo Asked People To “Feel” Instead
Instead of providing evidence that the updated 2023 COVID-19 vaccines are dangerous, Florida Surgeon General Joseph Ladapo asked people to “feel” instead.
Listen inside to what makes sense, what feels right, you know, what feels like truth. What has that feeling, and that resonance of truth. That clarity of truth, like we all know it when we feel it inside.
Ladapo also explained that some people are more able to “feel” the truth, because they are more advanced in their “spiritual journeys”.
Some of us know it more readily than others, and it’s because we are all in different points in our spiritual journeys”.
To be clear – that’s not what they teach in medical school. Doctors are not taught to “feel” what is right, or what is wrong, for their patients.
Doctors are trained to examine patients, and use a variety of investigative tools like x-ray, ECG, MRI, ultrasound, etc. to come to a diagnosis. Then they prescribe a treatment based on the research conducted by other doctors and scientists.
Whether they are religious (or spiritual) or not, should not be a factor in the diagnosis or treatment of any patient.
The truth is – COVID-19 vaccines have been proven to be safe and effective. And we know this because not only have they passed large Phase 3 clinical trials, billions of doses have been administered worldwide in the past 2.5 years.
Thanks to the efficacy of the COVID-19 vaccines in preventing hospitalisation and death from the SARS-CoV-2 virus, hospitals are no longer filled with people gasping for breath. In fact, the world has successfully reopened, thanks to the COVID-19 vaccines.
COVID-19 vaccines do not make it easier for people to get infected. It only appears that way because many people are now vaccinated. If 90% of the world is vaccinated, then it is only natural that 90% of infected people have been vaccinated.
I should also point out that the COVID-19 vaccines were designed to prevent death and severe disease. They are not force fields that block you from being infected, so fully-vaccinated people will still get infected.
However, because the COVID-19 vaccines have trained your own immune system to fight against the SARS-CoV-2 virus, you are more likely to suffer a mild disease, or even remain asymptomatic.
Please help us FIGHT FAKE NEWS by sharing this fact check article out, and please SUPPORT our work!
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Support my work through a bank transfer / PayPal / credit card!
Name : Adrian Wong Bank Transfer : CIMB 7064555917 (Swift Code : CIBBMYKL)
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
The FDA just approved two new 2023-2024 COVID-19 vaccines, which the CDC is now recommending for everyone 6 months and older!
Here is what you need to know about these new COVID-19 vaccines for 2023-2024!
FDA Approves Two 2023-2024 COVID-19 Vaccines!
On September 11, 2023, the US Food and Drug Administration (FDA) approved updated COVID-19 vaccines from Pfizer and Moderna for 2023-2024.
In tandem, the US FDA also removed authorisation for the previous Pfizer and Moderna Bivalent vaccine in the United States.
FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death.
Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.
Individuals 5 years of age and older regardless of previous vaccination are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least 2 months since the last dose of any COVID-19 vaccine.
Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of an updated mRNA COVID-19 vaccine (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated authorized Moderna COVID-19 Vaccine.
The FDA is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks.
Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines as described in the respective prescribing information or fact sheets.
The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants. Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.
You may not notice but the FDA is not calling these vaccines a “booster dose”. Instead, both vaccines are considered as “updated vaccines” that will better target the currently circulating SARS-CoV-2 virus variants.
Both 2023-2024 updated vaccines from Pfizer and Moderna are based on the same mRNA vaccine technology as their original and bivalent vaccines. But the updated 2023-2024 COVID-19 vaccines no longer targets the original, ancestral SARS-CoV-2 virus.
Instead, they both target the XBB.1.5 variant, which was dominant when these vaccines were developed. Even though the XBB.1.5 variant is no longer the dominant variant, the FDA has determined that it is similar enough to most prevailing variants to offer good cross-protection.
As before, these updated 2023-2024 COVID-19 vaccines are designed to prevent death and severe disease, and not avoid mild disease or symptomatic infections.
The FDA is still reviewing a third updated 2023-2024 COVID-19 vaccine from Novavax. The Novavax COVID-19 vaccine does not use mRNA, and is based on a synthetic spike protein with an adjuvant instead.
On Tuesday, September 12, 2023, the US Centers for Disease Control and Prevention (CDC) officially recommended that everyone 6 months and older get the updated 2023-2024 COVID-19 vaccines that were just approved by the US FDA.
CDC Recommends Updated COVID-19 Vaccine for Fall/Winter Virus Season
CDC recommends everyone 6 months and older get an updated COVID-19 vaccine to protect against the potentially serious outcomes of COVID-19 illness this fall and winter. Updated COVID-19 vaccines from Pfizer-BioNTech and Moderna will be available later this week.
Vaccination remains the best protection against COVID-19-related hospitalization and death. Vaccination also reduces your chance of suffering the effects of Long COVID, which can develop during or following acute infection and last for an extended duration. If you have not received a COVID-19 vaccine in the past 2 months, get an updated COVID-19 vaccine to protect yourself this fall and winter.
The virus that causes COVID-19 is always changing, and protection from COVID-19 vaccines declines over time. Receiving an updated COVID-19 vaccine can restore protection and provide enhanced protection against the variants currently responsible for most infections and hospitalizations in the United States.
Last season, those who received a 2022-2023 COVID-19 vaccine saw greater protection against illness and hospitalization than those who did not receive a 2022-2023 vaccine. To date, hundreds of millions of people have safely received a COVID-19 vaccine under the most intense safety monitoring in U.S. history.
This recommendation came after the CDC’s Advisory Committee on Immunization Practices (ACIP) was presented with new data which showed that the highest rates of hospitalisation and deaths from COVID-19 were for the very old – adults over 75, and the very young – infants younger than 6 months.
CDC Recommendations For 2023-2024 COVID-19 Vaccines
CDC just released its recommendations for who should get the 2023-2024 updated COVID-19 vaccines:
Everyone 6 Years And Older
The CDC recommends that everyone 6 years and older should get one dose of the updated 2023-2024 COVID-19 vaccine from Pfizer-BioNTech or Moderna, regardless of whether they received any original COVID-19 vaccine in the past or not.
People 65 Years And Older
People who are 65 years and older may get one additional dose of the updated 2023-2024 COVID-19 vaccine from Pfizer-BioNTech or Moderna, four or more months after receiving the first dose.
Immunocompromised People
People who are moderately or severely-immunocompromised may get one additional dose of the updated 2023-2024 COVID-19 vaccine from Pfizer-BioNTech or Moderna, two or more months after receiving the first dose.
Unvaccinated Children 6 Months To 4 Years (Pfizer)
The CDC is recommending three doses of the updated Pfizer-BioNTech 2023-2024 COVID-19 vaccines:
First dose of the 2023-2024 Pfizer-BioNTech COVID-19 vaccine
Second dose : 3-8 weeks after first dose
Third dose : at least 8 weeks after second dose
Vaccinated Children 6 Months To 4 Years (Pfizer)
The CDC is recommending that children who received the original Pfizer-BioNtech COVID-19 vaccine should receive these updated doses:
3 doses of the original vaccine : get one updated Pfizer-BioNTech vaccine dose
2 doses of the original vaccine : get one updated Pfizer-BioNTech vaccine dose
1 dose of the original vaccine : get two updated Pfizer-BioNTech vaccine doses
2 doses of the original vaccine + bivalent booster : no need for updated vaccine
Unvaccinated 5 Year Old Children (Pfizer)
The CDC is recommending that unvaccinated 5 year-old children should receive one dose of the updated 2023-2024 Pfizer-BioNTech COVID-19 vaccine.
Vaccinated 5 Year Old Children (Pfizer)
The CDC is recommending that 5 year-old children who received the original Pfizer-BioNtech COVID-19 vaccine should receive one dose of the updated vaccine:
1 or more doses of the original vaccine : get one updated Pfizer-BioNTech vaccine dose
Unvaccinated Children 6 Months To 5 Years (Moderna)
The CDC is recommending two doses of the updated Moderna 2023-2024 COVID-19 vaccines:
First dose of the 2023-2024 Moderna COVID-19 vaccine
Second dose : 4-8 weeks after first dose
Vaccinated Children 6 Months To 5 Years (Moderna)
The CDC is recommending that children who received the original Moderna COVID-19 vaccine should receive these updated doses:
2 doses of the original vaccine : get one updated Moderna vaccine dose
1 dose of the original vaccine : get two updated Moderna vaccine doses
2 doses of the original vaccine + bivalent booster : no need for updated vaccine
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Support my work through a bank transfer / PayPal / credit card!
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Did the FDA and CDC hide data that show the COVID-19 vaccines failing as early as January 2021?!
Take a look at the viral claim, and find out what the facts really are!
Claim : FDA + CDC Hid Data On Failing COVID-19 Vaccines!
People are sharing an article by The Epoch Times which claim or suggest that FDA and/or CDC hid data that show the COVID-19 vaccines failing as early as January 2021!
Here is an excerpt of The Epoch Times article. Feel free to skip to the next section for the facts:
FDA, CDC Hid Data on Spike in COVID Cases Among the Vaccinated: Documents
COVID-19 cases among vaccinated seniors soared in 2021, according to newly disclosed data that was acquired by U.S. health agencies but not presented to the public.
Humetrix Cloud Services was contracted by the U.S. military to analyze vaccine data. The company performed a fresh analysis as authorities considered in 2021 whether COVID-19 vaccine boosters were necessary amid studies finding waning vaccine effectiveness.
Humetrix researchers found that the proportion of total COVID-19 cases among the seniors was increasingly comprised of vaccinated people, according to the newly disclosed documents.
For the week ending on July 31, 2021, post-vaccination COVID-19 cases represented 73 percent of the cases among people 65 and older, the company found. The elderly were 80 percent fully vaccinated at the time.
Breakthrough infection rates were higher among those who were vaccinated early, the researchers found. They estimated that the rates were twice as high in those who had been vaccinated five to six months prior, when compared to people vaccinated three to four months before.
The breakthrough cases started in January 2021, according to the data. Protection against hospitalization was also fading, researchers discovered.
In the week ending on July 31, 2021, 63 percent of the COVID-19 hospitalizations in seniors were among the fully vaccinated, according to the documents. The same pattern of weaker protection among people who were vaccinated early was found.
Researchers calculated that the vaccine effectiveness (VE) against infection was just 33 percent while the effectiveness against hospitalization had dropped to 57 percent.
Seniors who previously had COVID-19 and recovered were more likely to avoid hospitalization, the researchers also found. Risk factors included serious underlying conditions such as obesity and being in the oldest age group, or older than 85.
“Our observational study VE findings show a very significant decrease in VE against infection and hospitalization in the Delta phase of the pandemic for individuals vaccinated with either the Pfizer or Moderna vaccine for those 5–6 months post vaccination vs. those 3–4 months post vaccination,” Dr. Bettina Experton, Humetrix’s president and CEO, said in a Sept. 15, 2021, email to top U.S. Food and Drug Administration (FDA) officials.
Humetrix also found that among the beneficiaries, there had been 133,000 cases, 27,000 hospitalizations, and 8,300 intensive care admissions among the fully vaccinated since the start of the COVID-19 pandemic.
Dr. Experton disclosed that Humetrix shared the data with the U.S. Centers for Disease Control and Prevention (CDC) in August 2021.
Dr. Francis Collins, the director of the U.S. National Institutes of Health at the time, wrote in a separate email obtained through FOIA that the results of the study provided “pretty compelling evidence that VE is falling 5–6 months post vaccination for both infection and hospitalization for those over 65.”
He added, “Even for those 3–4 months out there is a trend toward worsening VE.”
The CDC, FDA, and National Institutes of Health did not share the data with the public as they considered whether to clear and recommend COVID-19 vaccine boosters.
The CDC held a meeting with its vaccine advisers on Aug. 30, 2021. During the meeting, CDC officials went over emerging data on waning vaccine effectiveness. But the military study was not included.
The FDA held a similar meeting on Sept. 17, 2021. The CDC participated. The Humetrix analysis was also not presented during that meeting.
Both agencies have aggressively promoted COVID-19 vaccines throughout the pandemic, including hyping them as strongly protective against severe disease even after their own data have suggested that is not the case.
The CDC did present data from COVID-NET, one of its systems, that showed effectiveness against COVID-19-associated hospitalization was falling among the elderly since the emergence of the Delta variant but that data still showed 80 percent effectiveness.
The presentation also included data from outside researchers and Israel that estimated the protection during the Delta era against infection ranged from 39 percent to 84 percent and that the effectiveness against hospitalization ranged from 75 to 95 percent.
The FDA ended up clearing a Pfizer booster for many Americans. The CDC advised most people to receive it. The agencies later expanded booster clearance and recommendations to virtually all Americans aged 5 and older, with Moderna’s shot as another option. Authorities have since replaced the old shots due to their lack of durability, and are preparing to roll out another slate of shots this fall.
No Evidence FDA + CDC Hid Data On Failing COVID-19 Vaccines!
In this article, I will go through some of their claims, and show you what the facts really are!
Fact #1 : Humetrix Study Was Commissioned By US DOD
First, let’s start by pointing out that the Humetrix study in question was commissioned by JAIC – the US Department of Defense Joint Artificial Intelligence Center. This was stated explicitly in an email by Humetrix President and CEO, Bettina Experton, to the FDA:
This study has been conducted by my company under contract with the DoD JAIC (Joint Artificial Intelligence Center) since March 2020, when we were t asked to analyze Medicare claim data to monitor, map and conduct Covid-19 predictive analytics for the military.
What this means is – the data belonged to the US Department of Defense, not Humetrix, the FDA, or the CDC.
Fact #2 : Humetrix Published Study Results In December 2022
It seems odd to accuse the US FDA and CDC of hiding data from the Humetrix study, when Humetrix publicly published its results in the open-access journal, Biology in December 2022.
The study is called “Enhanced Vaccine Effectiveness during the Delta Phase of the COVID-19 Pandemic in the Medicare Population Supports a Multilayered Prevention Approach“.
Fact #3 : No Evidence CDC / FDA Hid Humetrix Study
There is no evidence that the FDA or CDC hid the Humetrix study or its data. The Epoch Times article did not offer any evidence, beyond pointing out that the Humetrix analysis was “not presented” during a meeting to approve the booster dose.
Ironically, the same article pointed out that the CDC presented data from its COVID-NET data that showed falling vaccine effectiveness in the elderly against the Delta variant. So why should the CDC / FDA try to “hide” the Humetrix data?
Is it not possible that the CDC preferred to rely on its own data? Or perhaps, the CDC decided that the COVID-NET data was compelling enough, it did not need to supplement with the similar data from the Humetrix study?
Fact #4 : Vaccines Were Not Meant To Prevent Infection
While many anti-vaccine activists harp on the fact that COVID-19 vaccines fail to prevent transmission or breakthrough infections, the truth is – the vaccines were designed to prevent severe disease and deaths from COVID-19.
It would be nice if they can significantly block transmission, or breakthrough infections, but those were never the endpoints in any COVID-19 vaccine trial. If you look back at the vaccine trial results, they were only looking at protection against “symptomatic infection“, “severe disease“, and “death“.
COVID-19 Vaccine
Protection Against
Symptomatic
Infection
Severe
Disease
Death
Pfizer Comirnaty
95.0%
100%
100%
Gamaleya Sputnik V
91.6%
100%
100%
Moderna mRNA-1273
94.1%
100%
100%
AstraZeneca AZD1222
62% ~ 90%
100%
100%
Sinopharm BBIBP-CorV
79% ~ 86%
90%
100%
Sinovac Biotech
50.65%
83.7%
100%
J&J Janssen COVID-19
66.0%
85%
100%
CanSino Biologics
65.7%
90.98%
100%
Therefore, their constant harping of the “inability” or “failure” of COVID-19 vaccines to block transmission, or completely prevent infections, is a red herring. That was never the goal of these vaccines.
Even if you are fully-vaccinated, you can continue to get breakthrough infections, and that’s fine. The key thing is vaccines help to prevent severe disease and death COVID-19 infections.
Fact #5 : Humetrix Study Looked At Delta Variant
It is also important to note that the Humerix study looked at the Delta variant, as its title stated clearly – Effectiveness of mRNA COVID-19 Vaccines Against the Delta Variant Among 6M Medicare Beneficiaries 65 Years and Older.
The original COVID-19 vaccines were designed to target the original (ancestral) SARS-CoVo-2 virus. The Delta variant did not exist at that time.
The Humerix study did not address or disparage the effectiveness of the vaccines against the original SARS-CoV-2 virus that they were originally meant to target. It was looking to see if the original mRNA vaccine could also protect against the Delta variant.
Fact #5 : Reduced Protection vs. Delta Variant Spurs Need For Booster Dose
The Humerix study, at that time, was presented to the FDA for its use in the consideration whether to approve the booster dose looked at the effectiveness of the Pfizer and Moderna mRNA vaccines against the new (at that time) Delta variant.
Because it showed reduced vaccine effectiveness against infections and hospitalisations, that would actually support the approval of a booster dose to boost protection against COVID-19.
If the Humetrix study actually showed the original mRNA vaccines’ strong protection against the Delta variant, the FDA and/or CDC might not feel the need to approve or support a booster dose at that time.
This was actually mentioned in the Executive Summary of the Humetrix presentation on Page 2:
Salus breakthrough hospitalization risk model can be applied to prioritize the over 65 population for booster vaccine
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Here is what you need to know about the FDA import alert 99-33 on Japanese food over radioactive wastewater from the Fukushima nuclear plant!
Updated @ 2023-08-25 : Updated the article Originally posted @ 2023-03-21
Claim : FDA Issued Import Alert 99-33, Banning Japanese Food!
This message has gone viral on and off over the years, being shared again and again on WhatsApp, and social media. It’s long, so feel free to skip to the next section for the facts…
The US Food and Drug Administration has issued a notice
A week ago, the US law came into force: 🎯 FDAIssued Alert No. 99-33, prohibiting the following 🅾️ Japanese food entering the US: 📎 Fresh milk, 📎 Butter, 📎Milk powder, 📎Baby milk powder, and others 📎Dairy products; 📎Vegetables, sweet potatoes, salt, and other products 📎Rice, 📎 Whole wheat; 📎Fish; 📎Meat and poultry; 📎Clams; 📎 sea urchin; 📎Citrus pomelo fruits; 📎 Apples, kiwis and other fruits.
❌The reason is radionuclide contamination. Japan finally admits that its inability to control Fukushima’s daily discharge of millions of tons of radioactive wastewater into the Pacific Ocean has caused many people to suffer from cancer or Disease has seriously affected human beings and the ecological environment around the world. I can’t imagine it! ❌Don’t eat Japanese food. 💢In the coastal waters of the United States, it was found that the radioactivity value is getting higher and higher. Try not to go to Japan, preferably not. 💢The Australian government has stopped visa issuance for Japanese, 💢 The US also stopped Japanese immigration to the US. At present, the situation in Japan is more serious than we imagined. More than 70% of the entire Japanese territory is polluted. Japan’s radioactive material has flowed into the ocean, and the affected area of the ocean is getting wider and wider. It is more serious than imagined. The Japanese government is afraid of causing panic, and they will give up or lie to inform the surrounding people. Japanese seafood, mushrooms do not eat. After the last earthquake, radioactive material from the damaged Japanese nuclear power plant began to flow into the ocean or surrounding areas, and began to find ❌Deformed seafood and plants ❌ Mutated mushrooms ❌ mutated fish, ❌Varied seafood, Foods exposed to radioactive substances will be induced within 1-2 years after eating 🅾️Esophageal cancer 🅾️Lymphoma 🅾️ Leukemia, etc., especially for young children, pregnant women will have a greater impact. Neighboring countries have stopped seafood trade with Japan: It is prohibited to import 📎herring, 📎shells, 📎shiitake mushrooms from Japan. The fish caught in the waters near Japan had 380 times the radioactivity. From now on, never eat Japanese seafood or sashimi. Since the nuclear explosion of the tsunami in Japan, a survey of Chinese tourists to Japan who have traveled to Japan and eaten Japanese food many times shows that there are strange diseases of varying degrees, and they are on the rise! And Japan’s radioactive nuclear-contaminated local products are all supplied to foreign tourists! Japan eats food imported from other countries! Dear friends and compatriots For the health of your loved ones and the next generation, please share it in your WeChat space, and immediately boycott all nuclear-contaminated food in Japan. Do not buy! Remember!
The Truth About FDA Import Alert 99-33 On Japanese Food!
This is yet another example of FAKE NEWS created by the Chinese 50 Cent Army (wumao, 五毛) to scare people into boycotting Japan and Japanese food, and here are the reasons why…
Fact #1 : FDA Issued Import Alert #99-33 In March 2011
On March 11, 2011, Japan was hit by a massive tsunami triggered by a 9-magnitude earthquake off its Pacific coast. The force of the tsunami greatly damaged the Fukushima Daiichi nuclear plant, contaminating the surrounding area with radioactive material.
The Government of Japan determined that certain food products in affected prefectures were therefore not fit for human consumption, due to the risk of contamination by the radioactive material. They banned those food products from sale within Japan, and for export.
The US FDA responded by issuing Import Alert #99-33 – “Detention Without Physical Examination of Products from Japan due to Radionuclide Contamination.”
This part of the viral post is true, but everything else is false.
Fact #2 : FDA Import Alert #99-33 Was Limited To Certain Prefectures
The FDA Import Alert #99-33 did not ban the import of all Japanese food products, as the viral post claimed.
It only targeted Japan’s own restrictions at the prefecture level, using Section 801(a)(2) of the Federal Food, Drug, and Cosmetic Act:
FDA-regulated products are subject to refusal and will be refused admission into the United States if the products appear to be forbidden or restricted for sale in the country in which they were produced or from which they were exported.
Fact #3 : FDA Cancelled Import Alert #99-33 In September 2021
On September 21, 2022, the US FDA deactivated (cancelled) Import Alert #99-33. Since then, there has been no ban on any food product from the five affected prefectures of Aomori, Iwate, Miyagi, Fukushima and Ibaraki.
Now, after an extensive analysis of Japan’s robust control measures that include decontamination, monitoring and enforcement; after reviewing the results of 10 years of sampling food products from Japan; and after determining a very low risk to American consumers from radioactive contaminated foods imported from Japan, FDA has decided that the IA is no longer necessary to protect public health and therefore should be deactivated.
Despite this cancellation of the import ban more than a year ago, the Chinese 50 Cent Army (wumao, 五毛) continues to spread this fake story on WhatsApp, as well as social media platforms like Facebook and Twitter.
Fact #4 : Australia Did Not Stop Issuing Visa To Japanese Travellers
Australia never suspended visa issuance for Japanese travels over the Fukushima Daiichi nuclear accident.
Fact #5 : US Did Not Suspend Japanese Immigration
The United States never suspended immigration of Japanese citizens over the Fukushima Daiichi nuclear accident.
Fact #6 : Japan Did Not Supply Contaminated Food To Tourists
This claim has been repeatedly promoted by the Chinese 50 Cent Army (wumao, 五毛), and is categorically false.
Japan did not reserve their contaminated food supply for consumption by tourists, while importing food for their own citizens. Neither did Chinese tourists to Japan suffer “strange diseases of varying degrees”.
Those are just lies created by the wumao to scare Chinese citizens into boycotting Japan and Japanese food products.
Fact #7 : Fukushima Radiation Only Affected A Small Area Of Japan
The Fukushima Daiichi nuclear accident did not affect 70% of Japanese territory.
The Government of Japan established a 30 kilometre no-fly zone, and a 20 kilometre exclusion zone, around the Fukushima Daiichi nuclear plant.
Aerial survey of the radioactive caesium levels in May 2012 show that only a small part of Japan was affected.
Fact #8 : Harmful Radionuclides Were Removed From Wastewater
Both fresh water and seawater were used to cool down the melting nuclear fuel rods and spent fuel rods stored at the facility.
Measures were quickly taken to block the seepage of the contaminated wastewater into the sea and water table. For example, TEPCO poured a 60 cm-thick concrete wall covering 70,000 square meters of ocean seabed.
There were occasional accidental discharges of radioactive wastewater, but generally the radioactive wastewater was stored in massive storage tanks and treated using the Advanced Liquid Processing System (ALPS).
ALPS removed harmful radionuclides like caesium and strontium from the wastewater, leaving only tritium – a mildly radioactive and far less harmful hydrogen isotope.
Fact #9 : Decontaminated Wastewater Used To Keep Reactors Cooled
The water treatment system became fully-functional, together with water recycling systems on 3 July 2011.
The decontaminated wastewater thereafter is being 100% reused to keep the reactors cooler, so no additional volume of contaminated water would be generated.
Fact #10 : Excess Decontaminated Wastewater To Be Released
A large amount of treated wastewater remain at the Fukushima Daiichi plant, and on April 13, 2021, the Government of Japan announced that the treated wastewater would be released in 2023.
The US FDA says that the treated wastewater presents an “extremely low” health risk even if consumed, which is rather minimised because it’s being discharged into the vast ocean.
According to scientific experts from interagency advisory teams and FDA representatives to the US Advisory Team for Environment, Food and Health, the release of the treated wastewater will have “no effect on the safety of foods imported from Japan“.
In other words, the FDA considers food from Japan to be perfectly safe to import and consume, even after the treated wastewater is released into the ocean.
This is just another example of Chinese propaganda created by the infamous 50 Cent Army (wumao, 五毛).
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Support my work through a bank transfer / PayPal / credit card!
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Do newly-released clinical trial documents show that Moderna tried to cover up deaths caused by its COVID-19 vaccine?!
Take a look at the viral claim, and find out what the facts really are!
Updated @ 2023-08-08 : Updated with some additional information. Originally posted @ 2023-07-25
Claim : Moderna Tried To Cover Up Vaccine Deaths!
People are sharing articles by The Epoch Times and Children Health Defense which claim or suggest that newly-released clinical trial documents show that Moderna covered up deaths caused by its COVID-19 vaccine!
Here is an excerpt of The Epoch Times article. Feel free to skip to the next section for the facts:
‘Serious Doubt’ About COVID-19 Vaccine Safety After Forced Release of 15,000 Pages of Clinical Trial Data: Legal NGO
Conservative public interest advocacy group Defending the Republic (DTR) has obtained almost 15,000 pages of Moderna’s COVID-19 vaccine clinical trial data, claiming the data show an “utter lack of thoroughness” of the trials and calls the vaccine’s safety into “serious doubt.”
As a result of successful Freedom of Information Act (FOIA) litigation against the U.S. Food and Drug Administration (FDA), the group recently announced it had obtained—and is releasing—nearly 15,000 pages of documents relating to testing and adverse events associated with “Spikevax,” Moderna’s COVID-19 vaccine.
One of the key takeaways from the documents is that many of those who died after receiving the Moderna vaccine were not given an autopsy.
“According to one study, 16 individuals died after being administered the Moderna vaccine. The study’s authors indicated that out of those 16 deaths, only two autopsies were performed, five of the dead were not autopsied, and the autopsy status of nine of the dead was ‘unknown,’” DTR said in a statement.
“Yet this did not stop those running these ‘studies’ from concluding, despite the absence of evidence, that the Moderna vaccine was not related to these deaths,” the group added.
As an example, the group gave the case of a 56-year-old woman who experienced ‘sudden death’ 182 days after receiving the second dose of the Moderna vaccine.
“The cause of death was unknown, and no autopsy was conducted. It seems they purposely decided not to investigate suspicious deaths in case the Moderna vaccine might be the cause,” the group stated.
And here is an excerpt of Children Health Defense article. Feel free to skip to the next section for the facts:
Exclusive: Clinical Trial Documents Suggest Moderna Skimped on Autopsies, Discounted Serious Injuries — Did FDA Know?
A 13,685-page tranche of documents related to Moderna’s COVID-19 vaccine clinical trials released Tuesday contain details about the deaths of 16 trial participants, the prevalence of severe adverse events (SAEs) and other abnormalities.
The documents, previously submitted by Moderna to the U.S. Food and Drug Administration (FDA) as part of the licensing process for Moderna’s Spikevax COVID-19 vaccine, also exposed an “utter lack of thoroughness” in how the trials were conducted, according to Defending the Republic (DTR), a Dallas-based nonprofit that obtained the documents via a a still-pending Freedom of Information Act lawsuit against Moderna.
The documents, shared with The Defender in advance of their public release, are the first set of “Moderna documents” to be released as part of the lawsuit — with approximately 8,000 more pages expected to follow later this year.
Travis Miller, a Fort Worth-based attorney representing DTR, told The Defender, “These documents include over 13,500 pages relating to serious adverse event listings that document injuries — such as shingles and Bell’s palsy and other more serious conditions — which we believe may be related to the Moderna COVID-19 vaccine.”
Miller criticized Moderna’s lack of scientific rigor in determining the causes of the deaths and adverse events, saying that, in several cases, “Individuals who died after receiving the Moderna vaccine were not given an autopsy.”
According to DTR, “The study’s authors indicated that of those 16 deaths, only two autopsies were performed, five of the dead were not autopsied, and the autopsy status of nine of the dead was ‘unknown.’”
In one instance, a 56-year-old woman experienced “sudden death” 182 days after receiving her second dose of the Moderna vaccine. The cause of death was listed as “unknown” and no autopsy was performed.
“It seems they purposely decided not to investigate suspicious deaths in case the Moderna vaccine might be the cause,” DTR stated in its summary.
Yet the deaths “did not stop those running these ‘studies’ from concluding, despite the absence of evidence, that the Moderna vaccine was not related to these deaths,” DTR added.
No Evidence Moderna Tried To Cover Up Vaccine Deaths!
In this article, I will go through some of their claims, and show you what the facts really are!
Fact #1 : Adverse Events Are Not Necessarily Vaccine Side Effects
First, let’s start with the fact that adverse events are not necessarily vaccine side effects.
Like with Pfizer, Moderna has to monitor for these adverse events, which are “unfavourable” or “unintended” events that happen after vaccination or taking a drug, like having an anaphylactic reaction or getting into a car accident.
All reported adverse events have to be investigated to find out if they are related (anaphylactic reaction) or not (getting into a car accident) to the vaccine or drug that was taken.
Even if an adverse event was “possibly caused” by the vaccine, it must still be confirmed that the vaccine directly caused it, because an anaphylactic reaction (for example) can also occur from a bee sting, or an existing peanut allergy.
Only once an adverse event is confirmed to be caused by the vaccine, is it then a vaccine side effect. Otherwise, it is merely an adverse event, not a side effect.
Fact #2 : Moderna Sponsored Trial, But Did Not Run It
It is important to point out that Moderna only sponsored and created the protocol (PDF download) for the Phase 3 clinical trial of its mRNA-1273 vaccine candidate for COVID-19. Moderna itself did not conduct the mRNA-1273 vaccine trial.
The Moderna mRNA-1273 Phase 3 clinical trial was conducted by CoVPN investigators funded by the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response and NIAID.
Moderna is leading the trial as the regulatory sponsor and is providing the investigational vaccine for the trial. The Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response and NIAID are providing funding support for the trial.
The NIH Coronavirus Prevention Network (CoVPN) will participate in conducting the trial. The network brings together expertise from existing NIAID-supported clinical research networks. The mRNA-1273 vaccine candidate will be tested at approximately 89 clinical research sites in the United States, 24 of which are part of the CoVPN.
Hana M. El Sahly, M.D., principal investigator of the NIAID-funded Infectious Diseases Clinical Research Consortium site at Baylor College of Medicine in Houston; Lindsey R. Baden, M.D., principal investigator of the NIAID-funded Harvard HIV Vaccine Clinical Trials Unit at Brigham and Women’s Hospital in Boston; and Brandon Essink, M.D., principal investigator and medical director of Meridian Clinical Research, will serve as co-principal investigators for the Phase 3 trial of mRNA-1273.
Defending the Republic (DTR) – the NGO that obtained and released the Moderna documents highlighted that only two autopsies were performed even though 16 people died during the clinical trial.
Just to be clear – Moderna itself did not conduct the clinical trial. Therefore, it does not have any say on whether an autopsy should or should not be conducted.
In fact, it is likely that the attending doctors / hospitals were the ones deciding whether to conduct the autopsies, while study authors only collected the data. That’s why many of the deaths were listed with Unknown autopsies. If the study authors were the ones conducting the autopsies (and refusing to do so), they would have listed them as None.
As I will show you below, there is no evidence that the study authors deliberately refused to conduct autopsies or investigate suspicious deaths in the Moderna vaccine clinical trial.
Fact #4 : Half The Deaths Were On Placebo
Many of these articles pointed out that sixteen people who received the Moderna vaccine died. What they did not tell you is that sixteen other people who received the placebo also died. In other words, a total of 32 people died during the clinical trial – half received the vaccine, and half received the placebo.
While that sounds like a lot – I should point out that the Moderna mRNA-1273 Phase 3 clinical trial involved 30,420 volunteers, and ran for approximately 3 months.
The mortality rate in the US for 2021 was 879.7 per 100,000 people, so for those three months, we should expect 89 people to die out of those 30,420 participants. Yet only 32 people died. There is simply no evidence in the clinical trial’s data to show an increase in deaths from the Moderna vaccine.
Fact #4 : Subject US3292023 Died From Heart Failure
In its summary, DTR highlighted some of those suspicious deaths that lack an autopsy. Sounds suspicious, right? Not really, if you actually look at the Moderna documents.
The first case was Subject US3292023 – an 80 year-old White male who died on 23 January 2021 due to an Adverse Event, and his autopsy status was listed as None.
If you search through the Moderna document (PDF download), you will see that this sequence of reports:
He had history of significant cardiac disease and diabetes.
He received Dose 1 on 4 August 2020, and Dose 2 on 1 September 2020.
He reported no adverse effects from both vaccinations.
He suffered from diabetic ketoacidosis (serious complication from his existing diabetes) on 26 October 2020.
He suffered from End Stage Congestive Heart Failure on 23 January 2023.
I’m sure you can see why there was absolutely no need for anyone to conduct an autopsy on this man.
Fact #5 : Subject US3472001 Likely Died From Heart Attack
The second case was Subject US3472001 – a 70 year-old White male who died on 27 November 2020 due to an Adverse Event, and his autopsy status was listed as Unknown.
If you search through the Moderna document (PDF download), you will see that this sequence of reports:
He had history of significant cardiac disease and severe obesity.
He received Dose 1 on 31 August 2020, and Dose 2 on 1 October 2020.
He reported no adverse effects from both vaccinations.
He tested positive for Hepatitis C on 29 September 2020.
He suffered from a sudden fatal event, likely myocardial infarction on 27 November 2020.
It is unknown if an autopsy was conducted, but with a history of significant cardiac disease and severe obesity, it would not be surprising if the doctor / hospital did not bother to conduct an autopsy, especially during a pandemic that was straining doctors and hospital facilities.
Fact #6 : Subject US3512042 Died From Cardiac Arrest
The third case is Subject US3512042 – a 78 year-old White male who died on 1 September 2020 due to an Adverse Event, and his autopsy status was listed as Unknown.
If you search through the Moderna document (PDF download), you will see that this sequence of reports:
He received Dose 1 on 12 August 2020, but never received a second dose.
On 30 August 2020, he reported nausea and malaise.
On 31 August 2020, he vomited three times.
On 1 September 2020, he suffered from cardiopulmonary arrest and died.
It is unknown if an autopsy was conducted, but it is not uncommon for a 78 year-old man to die from cardiopulmonary arrest.
Fact #7 : Subject US3622169 Died From Metastatic Liver Cancer
The fourth case was Subject US3622169 – a 56 year-old White male who died on 21 January 2021 due to an Adverse Event, and his autopsy status was listed as Unknown.
If you search through the Moderna document (PDF download), you will see that this sequence of reports:
He had history of severe obesity and diabetes.
He received Dose 1 on 9 September 2020, and Dose 2 on 7 October 2020.
On 29 November 2020, he reported worsening dyspnea (breathing difficulties) with nasal congestion.
On 6 December 2020, he was diagnosed with pneumonia.
On 30 December 2020, he was diagnosed with metastatic hepatocellular carcinoma (metastatic liver cancer).
On 16 January 2021, he suffered sepsis and his metastatic liver cancer worsened, and he ultimately died on 21 January 2021.
Needless to say, there was simply no need to perform an autopsy, after confirming his metastatic liver cancer diagnosis.
The fifth case was Subject US3702010 – a 74 year-old Hispanic male who died on 25 February 2021 due to an Adverse Event, and his autopsy status was listed as Unknown.
If you search through the Moderna document (PDF download), you will see that this sequence of reports:
He had history of liver disease and HIV infection.
He received Dose 1 on 4 September 2020. He never received a second dose.
He complained of nausea issues on the same day, which resolved.
He complained of fatigue and pain of the injection site on 5 September 2020, which resolved.
He complained of fatigue again on 11 September 2020, which resolved.
He complained of lower abdominal pain on 23 October 2020, which resolved.
He got infected with COVID-19 on 1 January 2021, with diagnosis confirmed on 5 January 2021
On his last follow-up 175 days after his first dose, he was still suffering from COVID-19
He died from COVID-19 on 25 February 2021
I’m sure you can see why there was absolutely no need for anyone to conduct an autopsy on this man.
Fact #9 : Subject US3752173 Died From Heart Attack
The sixth case was Subject US3752173 – a 77 year-old American Indian / Alaskan native male who died on 1 November 2020 due to an Adverse Event, and his autopsy status was listed as None.
If you search through the Moderna document (PDF download), you will see that this sequence of reports:
He received Dose 1 on 20 August 2020, and Dose 2 on 18 September 2020.
He did not report any adverse events from both Moderna vaccine injections.
He suffered a myocardial infarction (heart attack) on 1 November 2020, and died from it.
Again, you can see why there was absolutely no need for anyone to conduct an autopsy on this man.
Fact #10 : Subject US3862141 Died From Cardiac Arrest
The seventh case was Subject US3862141 – a 72 year-old Asian male who died on 9 March 2021 due to an Adverse Event, and his autopsy status was listed as Unknown.
If you search through the Moderna document (PDF download), you will see that this sequence of reports:
He received Dose 1 on 8 September 2020, and Dose 2 on 6 October 2020.
He did not report any adverse effects from both vaccinations.
On 9 March 2021, he suffered from cardiopulmonary arrest and died.
It is unknown if an autopsy was conducted, but it is not uncommon for a 72 year-old man to die from cardiopulmonary arrest.
The eighth case was Subject US3872318 – a 62 year-old White male who died on 16 September 2020 due to an Adverse Event, and his autopsy status was listed as None.
If you search through the Moderna document (PDF download), you will see that this sequence of reports:
He received Dose 1 on 27 August 2020, but never received a second dose.
He did not report any adverse effects from the first vaccination.
On 16 September 2020, he died after committing suicide.
Needless to say – an autopsy was completely unnecessary in this case.
Fact #12 : Subject US3872496 Died From Unknown Cause
The ninth case was Subject US3872496 – a 61 year-old Native Hawaiian / Pacific Islander male who died on 17 December 2020 due to an Adverse Event, and his autopsy status was listed as Unknown.
If you search through the Moderna document (PDF download), you will see that this sequence of reports:
He had history of severe obesity and diabetes.
He received Dose 1 on 9 September 2020, and Dose 2 on 9 October 2020.
He did not report any adverse effects from both vaccinations.
On 17 December 2020, he died but the details behind his death is unknown.
It is unknown how the man died, and unknown if an autopsy was conducted.
Fact #13 : Subject US3912024 Died From Organ Failure
The tenth case was Subject US3912024 – a 72 year-old White male who died on 22 November 2020 due to an Adverse Event, and his autopsy status was listed as None.
If you search through the Moderna document (PDF download), you will see that this sequence of reports:
He received Dose 1 on 28 August 2020, and Dose 2 on 24 September 2020.
On 31 October 2020, he was diagnosed with obstructing nephrolithiasis (kidney stones blocking the flow of urine).
On 3 November 2020, he was diagnosed with thrombocytopenia (low platelets), as well as acute renal failure, Klebsiella-complicated pyelonephritis (kidney infection), and atelectasis (collapse) of the lower lobes of both lungs.
On 8 November 2020, he was found to have ascites (intra-abdominal fluid), anasarca (severe, generalised accumulation of fluid in the interstitial space), and a perforated duodenal ulcer with bleeding.
On 15 November 2020, he was diagnosed with anaemia.
On 18 November 2020, the collapse of his lungs worsened and he developed pleural effusion (accumulation of fluid in the pleural cavity) as well.
On 20 November 2020, he died from multi-system organ failure and acute hypoxic respiratory failure.
Needless to say – an autopsy was also completely unnecessary in this case.
Fact #14 : Subject US3932197 Died From Unknown Cause
The eleventh case was Subject US3932197 – a 37 year-old Black female who died on 13 March 2021 due to an Adverse Event, and her autopsy status was listed as None.
If you search through the Moderna document (PDF download), you will see that this sequence of reports:
She received Dose 1 on 26 September 2020, and Dose 2 on 27 October 2020.
On 13 March 2021, she died, but her cause of death was unknown.
In this case, an autopsy might be warranted. However, that is impossible to determine, because we do not know the circumstances behind her death – she could have died from any number of causes – an accident, suicide, a fall, a surgical procedure, an infection, etc.
Fact #15 : Subject US3962094 Died From Suicide
The twelfth case was Subject US3962094 – a 56 year-old White female who died on 15 October 2020 due to an Adverse Event, and her autopsy status was listed as None.
If you search through the Moderna document (PDF download), you will see that this sequence of reports:
She had history of severe obesity.
She received Dose 1 on 9 September 2020, but never received a second dose.
On 12 September 2020, she was diagnosed with high triglycerides
On 7 October 2020, she suffered from acid reflux.
On 15 October 2020, she fell and died from head trauma.
Needless to say – an autopsy was also completely unnecessary in this case.
Fact #16 : Subject US3972010 Is Pending Autopsy
The thirteenth case was Subject US3972010 – a 27 year-old Black male who died on 8 January 2021 due to an Adverse Event, and his autopsy status was listed as Unknown.
If you search through the Moderna document (PDF download), you will see that this sequence of reports:
He received Dose 1 on 24 August 2020, and Dose 2 on 21 September 2020.
He did not report any adverse effects from both vaccinations.
On 8 January 2021, he died but the details behind his death is unknown, pending an autopsy.
It is unknown how the man died, but in this case, an autopsy was conducted.
Fact #17 : Subject US3972045 Likely Died From Heart Disease
The last case was Subject US3972045 – a 62 year-old White male who died on 3 December 2020 due to an Adverse Event, and his autopsy status was listed as Unknown.
If you search through the Moderna document (PDF download), you will see that this sequence of reports:
He had history of diabetes.
He received Dose 1 on 27 August 2020, and Dose 2 on 24 September 2020.
He did not report any adverse effects from both vaccinations.
On 21 October 2021, he was diagnosed with diabetic gastroparesis – delayed stomach emptying due to diabetes.
On 3 December 2020, he died from a suspected coronary artery disease – a complication of his diabetes mellitus.
It is unknown if an autopsy was conducted, but it is not uncommon for a 62 year-old man to die from heart disease.
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Did the US FDA just ban the Pfizer and Moderna mRNA vaccines, because they caused too many deaths and injuries?!
Take a look at the viral claims, and find out what the facts really are!
Claim : US FDA Just Announced Ban of Pfizer + Moderna Vaccines!
People are claiming that the US FDA just announced a ban of the Pfizer and Moderna COVID-19 vaccines, because they caused too many deaths and injuries!
Paul Hookem : Breaking: The US FDA no longer authorizes Moderna and Pfizer monovalent ‘vaccines’ for use in the US. For the 100 plus million Americans previously injected with this stuff? “Our bad!”
SNEAKO : Last year you couldn’t enter a restaurant without a vaccine card. That same vaccine today is BANNED.
Last year I was canceled off Youtube for saying the vaccine doesn’t work. Today the FDA agrees. Do you still believe their lies?
Remember the Covid-19 shots from Pfizer and Moderna we were all led to get two years ago? They were even FDA approved!
Well now the FDA has banned them. Look it up for yourselves. Which, you’ll probably have to because I doubt MSM will want you to know about it.
Truth : US FDA Did Not Announce Ban of Pfizer + Moderna Vaccines!
This is yet another example of FAKE NEWS created by anti-vaccination activists, and here are the reasons why…
Fact #1 : Pfizer + Moderna mRNA Vaccines Were Approved In December 2020
First, I think it is important to remember that the US FDA issued emergency use authorisations for the Pfizer and Moderna mRNA vaccines on 11 December 2020, and 18 December 2020 respectively.
The US FDA subsequently issued full authorisations for both Pfizer and Moderna monovalent mRNA vaccines on May 10, 2021, and January 21, 2022 respectively.
This is important to know because since their introduction in December 2020, the SARS-CoV-2 virus has evolved into many variants like Delta and Omicron, and even more subvariants like XBB.
Fact #2 : Pfizer + Moderna Introduced Bivalent Vaccines In 2022
Thanks to evolutionary pressures, these variants and subvariants have evolved to evade the protections offered by both vaccines and natural immunity from a prior infection.
To combat these new variants, Pfizer and Moderna developed bivalent mRNA vaccines, which target both the ancestral SARS-CoV-2 virus as well as the newer and much more infectious Omicron variant.
Pfizer and Moderna announced, on 25 June and 8 June respectively, that they successfully tested their bivalent COVID-19 vaccines. With the introduction of bivalent vaccines, there really isn’t any use for the older monovalent vaccine.
Fact #3 : US FDA Did Not Ban Pfizer + Moderna Vaccines
Just to be clear – the US FDA did not ban the Pfizer or Moderna COVID-19 vaccine.
The FDA only announced that the monovalent Pfizer and Moderna COVID-19 vaccines are no longer authorised for use in the United States, because there are now better bivalent Pfizer and Moderna COVID-19 vaccines.
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals.
This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
Fact #4 : US FDA Removed EUA For Pfizer + Moderna Monovalent Vaccines
The FDA also clarified later that the monovalent Pfizer and Moderna COVID-19 vaccines remain approved. The FDA did not rescind the approval of the monovalent vaccines. It only remove the emergency use authorisation for the monovalent vaccines.
It’s probably worth clarifying that the monovalent vaccines are still approved (licensed). That hasn’t changed. But they are no longer authorized for *emergency use* in the United States.
I should also take this opportunity to point out that the US FDA just simplified COVID-19 vaccinations using the new bivalent Pfizer and Moderna COVID-19 vaccines.
Instead of getting two doses of the monovalent vaccine, and then getting one or two booster doses of the bivalent vaccine, the FDA now recommends getting just one bivalent vaccine dose.
Most individuals, whether vaccinated or unvaccinated, may receive a single bivalent vaccine dose.
Individuals 65 years and older, or immunocompromised, may receive up to two bivalent vaccine doses.
Children 6 months through 5 years old may receive two doses of the bivalent Moderna vaccine.
Children 6 months through 4 years old may receive three doses of the bivalent Pfizer vaccine. Children 5 years old may receive a single dose of the bivalent Pfizer vaccine.
The new FDA recommendation is based on data that shows that most of the US population 5 years and older have protection from COVID-19, either through vaccination or a prior infection.
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Did the FDA just confirm that the Pfizer COVID-19 vaccine has a toxic substance called Graphene Oxide?!
Take a look at the viral claim, and find out what the facts really are!
Claim : FDA Just Admitted Pfizer Vaccine Has Graphene Oxide!
People are sharing an article by The Expose (formerly Daily Expose), which claims that the FDA just confirmed that the Pfizer COVID-19 vaccine has a toxic substance called Graphene Oxide!
Here is an excerpt from the really long article, so feel free to skip to the next section for the facts!
BREAKING: FDA confirms Graphene Oxide is in the mRNA COVID-19 Vaccines after being forced to publish Confidential Pfizer Documents by order of the US Federal Court
The Covid-19 vaccines have been at the centre of a heated debate since their introduction, with many questions and concerns raised about their safety and effectiveness.
Speculation has also been rife that the Covid-19 injections may contain traces of Graphene Oxide, a highly toxic and conductive substance.
Medicine regulators, with the support of the Mainstream Media, have repeatedly denied these claims.
But they were lying to you.
Because recent evidence has emerged that confirms the presence of Graphene Oxide, a highly toxic and conductive substance, in the Pfizer vaccine. And it has come from the US Food and Drug Administration (FDA) which has been forced to publish the confidential Pfizer documents by order of the Federal Court in the USA.
The FDA had initially attempted to delay the release of Pfizer’s Covid-19 vaccine safety data for 75 years, despite approving the injection after only 108 days of a safety review on December 11th, 2020.
However, a group of scientists and medical researchers sued the FDA under FOIA to force the release of hundreds of thousands of documents related to the licensing of the Pfizer-BioNTech Covid-19 vaccine.
In early January 2022, Federal Judge Mark Pittman ordered the FDA to release 55,000 pages per month, and since then, PHMPT has posted all of the documents on its website as they have been published.
One of the most recent documents published by the FDA saved as 125742_S1_M4_4.2.1 vr vtr 10741.pdf, confirms the use of Graphene Oxide in the manufacturing process of the Pfizer Covid-19 vaccine.
The document is a description of a study carried out by Pfizer between April 7th 2020 and 19th August 2020, with the objective being “to express and characterize the vaccine antigen encoded by BNT162b2.”
In layman’s terms, the study was conducted to determine how the vaccine works. The study found that the vaccine used mRNA to instruct your cells to produce a protein (called P2 S), which is the Spike protein of the alleged Covd-19 virus.
The millions of spike proteins then bind to a receptor called ACE2 on the surface of your cells, inducing an immune system response.
But what is most interesting about the study is that it confirms on page 7 that reduced Graphene Oxide is required to manufacture the Pfizer Covid-19 vaccine because it is needed as a base for the lipid nanoparticles.
Pfizer states on page 7 of the study in section 3.4 the following –
This is most peculiar because medicine regulators with the help of the Mainstream Media, have denied for months on end that Graphene Oxide is an ingredient of the Covid-19 vaccine. They’ve been able to say this because those who’ve proven and speculated Graphene Oxide is in the Pfizer Covid19 injection have been asking the wrong question.
What everyone should have been asking is, ‘is Graphene Oxide used in the manufacturing process of the Pfizer Covid vaccine?’
Because as this document, which the FDA attempted to keep confidential and sealed the 75 years, shows, Graphene Oxide is indeed used in the manufacturing process of the vaccine because it is vital in helping to make the vaccine’s lipid nanoparticles stable.
Therefore, trace amounts or large amounts, depending on the batch, of reduced Graphene Oxide inevitably make their way into the Pfizer Covid-19 injections.
Truth : FDA Did Not Admit Pfizer Vaccine Has Graphene Oxide!
This is yet another example of FAKE NEWS by The Expose (formerly Daily Expose), and here are the reasons why…
Fact #1 : Daily Expose Is A Fake News Website
Like Real Raw News and NewsPunch, Daily Expose is a FAKE NEWS website that capitalises on making shocking but fake stories to generate page views and money. It was later rebranded as The Expose.
It was founded in November 2020 by Jonathan Allen-Walker, a mechanic from Lincolnshire, and is infamous for publishing COVID-19 and vaccine misinformation that were quoted by Brazilian president Jair Bolsonaro, and Chinese state media.
Its articles have been regularly debunked as fake news, so you should NEVER share anything from Daily Expose / The Expose. Here are some of its fake stories that I personally debunked earlier:
Everything posted by The Exposemust be considered fake news, until proven otherwise.
Fact #2 : FDA Did Not Try To Delay Release Of Pfizer Vaccine Safety Data
The Expose falsely claimed that the FDA attempted to delay the release of Pfizer’s COVID-19 vaccine safety data for 75 years.
For one thing – Pfizer publicly released its COVID-19 vaccine trial results and safety data (PDF download) for the Vaccine and Related Biological Products Advisory Committee (VRBPAC) on 10 December 2020.
Also, the 75 year claim was the “interpretation” of Aaron Siri, the lawyer working for PHMPT (Public Health and Medical Professionals for Transparency) – the group requesting the data that the FDA used to licence the Pfizer COVID-19 vaccine.
And that was because the PHMPT insisted on asking for everything related to the approval process, not just what Pfizer released to the FDA, including “all correspondence and written summaries of oral discussions”.
Fact #4 : Pfizer Document Does Not Refer To Vaccine Components
The Pfizer document that The Expose claim was “proof” that graphene oxide was used in the manufacturing process of the Pfizer COVID-19 vaccine is nothing of the sort.
The document doesn’t show that graphene oxide was used to create or manufacture the Pfizer COVID-19 vaccine. Neither does it show that the Pfizer COVID-19 vaccine contains graphene oxide.
In fact, the document does not even refer to the components of the Pfizer COVID-19 vaccine at all!
Rather, the document describes how Pfizer scientists analysed the structural and biophysical characteristics of the SARS-CoV-2 spike protein (P2 S) that the vaccine produces in our cells.
The study then determines if the vaccine antigen that is produced by the body accurately replicates the ACE2 binding site and other epitopes (part of an antigen that produces an immune response) targeted by neutralising antibodies.
PF-07302048 : Structural and Biophysical Characterization of SARS-CoV-2 Spike Glycoprotein (P2 S) as a Vaccine Antigen
OBJECTIVESThe purpose of this study was to express and characterize the vaccine antigen encoded by BNT162b2.
If you read Section 3.2 of the Pfizer PF-07302048 document (PDF download), it will explain how the scientists obtained those P2 S spike proteins from Expi293F embryonic kidney cells used for research.
Section 3.3 then explains how they used the P2 S spike proteins to test binding kinetics – to see how quickly they bind to human ACE2 and a neutralising monoclonal antibody.
It is fascinating how The Expose missed all that…
Fact #5 : Graphene Oxide Was Only Used In Electron Microscopy
Now, we come to Section 3.4, which The Expose claims is evidence that “Graphene Oxide is required to manufacture the Pfizer Covid-19 vaccine because it is needed as a base for the lipid nanoparticles“.
That’s utter nonsense, because the section title specifically referred to Cryogenic Electron Microscopy (Cryo-EM) of the P2 S spike protein. In other words – Section 3.4 detailed how Pfizer scientists used cryogenic electron microscopy to determine its 3D structure.
Graphene oxide is commonly used in cryogenic electron microscopy to fix the sample onto a meshed grid before it is frozen to extremely low temperatures for the electron microscope to take its images.
Here is an example of a gold Quantifoil R1.2/1.3 300 mesh grid coated with graphene oxide – similar or even exactly what Pfizer scientists used:
As the Pfizer document detailed, its scientists applied 4 μL of the purified P2 S spike protein sample onto two gold Quantifoil R1.2/1.3 300 mesh grids overlaid with graphene oxide.
After blotting the sample and plunge-freezing it in liquid ethane, the Titan Krios electron microscope took 27,701 micrographs, to determine the 3D structure of the spike protein that the Pfizer COVID-19 vaccine produces in our cells.
Page 11 of the Pfizer PF-07302048 document actually shows how they created the 3D structure of the P2 S spike protein using those images from the cryogenic electron microscope.
Fact #6 : Pfizer COVID-19 Vaccine Does Not Contain Graphene Oxide
Anti-vaccination activists and conspiracy theorists have been claiming for years that the Pfizer COVID-19 vaccine contains graphene oxide, and they have never been able to prove that to date.
And this new claim is no different. That’s because there is NO graphene oxide in the Pfizer COVID-19 vaccine.
In addition to the tozinameran mRNA vaccine, each vial contains these excipients (inactive substances).
The first four are components of the lipid nanoparticles that protect the delicate mRNA vaccine. Trometamol, which is also known as tromethamine or Tris, is a buffer to maintain the vaccine’s pH level, and stabilise the nucleic acid macromolecules.
The Pfizer COVID-19 vaccine does not contain graphene oxide, because the vaccine does not require it.
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Support my work through a bank transfer / PayPal / credit card!
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.
Did Bill Gates call for the withdrawal of all COVID-19 vaccines, because they are “far more dangerous than anyone imagined”?
Find out what’s going on, and what the FACTS really are!
This article was originally posted in August 2021, and was updated and reposted because people keep re-circulating this fake story on WhatsApp, and social media platforms!
Please help to stop the circulation of fake news, by sharing this fact check article!
Claim : Bill Gates Calls For Withdrawal Of ALL COVID-19 Vaccines!
People are sharing an article by Daily Expose, claiming that Bill Gates is calling for the withdrawal of ALL COVID-19 vaccines, because they are “far more dangerous than anyone imagined”!
It’s a VERY long article, so please skip to the next section for the FACTS!
BREAKING – Bill Gates calls for the withdrawal of all Covid-19 Vaccines; “The vaccines are far more dangerous than anyone imagined”
In a shocking announcement, Bill Gates, billionaire Microsoft co-founder and the major force behind the COVID-19 vaccines, called for all the COVID-19 genetic-based vaccines to be taken off the market immediately.
In an often anguished 19-minute televised speech, Gates said: “We made a terrible mistake. We wanted to protect people against a dangerous virus. But it turns out the virus is much less dangerous than we thought. And the vaccine is far more dangerous than anyone imagined.”
By W. Gelles
“These vaccines—Pfizer, Moderna, Johnson & Johnson, AstraZeneca—they’re killing people left and right—and they’re injuring some people very badly,” Gates continued, waving his hands in the air at times for dramatic effect.
“The government’s own data shows us this is what’s happening. The CDC’s reporting system is showing, what?…around 13,000 deaths so far in the U.S. and over half a million adverse events. Well, we all know the reporting system is a sham.
“We know that VAERS [Centers for Disease Control and Prevention’s Vaccine Adverse Events Reporting System] captures only around one percent of what’s going on. So we’re talking over a million deaths from these Covid vaccines, and more than 60 million people with bad side effects.”
“This is not what we wanted. This is not acceptable,” Mr. Gates asserted.
Wall Street shares of all the major Covid vaccine companies plummeted by 20% to 30% as Mr. Gates announced that he was joining the urgent Citizen Petition filed by Robert F. Kennedy Jr.’s Children’s Health Defense organization calling on the U.S. Food and Drug Administration to immediately withdraw all the COVID vaccines from the market.
Gates continued: “Too many people who take these vaccines drop dead…one day, two days, five days after getting the shot. Other people suffer paralysis, blindness, convulsions, heart attacks, immune system collapse, blood clots, brain inflammation, lung or kidney damage, miscarriages, autoimmune disease, multiple organ system failure, permanent profound fatigue, and many other horrible problems.
“Of course, our Media Mouthpieces—I mean the mainstream news media, dismiss all these tragedies as ‘just a coincidence.’”
“The reason they say that,” Gates explained, “is because of what I did at Event 201, a Coronavirus Pandemic Simulation held in New York in October 2019 just a few weeks before we announced the actual pandemic. I got all the major newspapers, TV channels, and radio stations to agree to stick with the Official Narrative—‘the vaccines are safe and effective’—and to censor anybody who questions this line of BS.
“So the public never got to hear the evidence from hundreds of distinguished doctors and medical researchers who warned that the vaccines are dangerous and often lethal.”
“That was a huge mistake on my part,” Gates maintained, looking weary and at times teary-eyed. “We never should have done that. People have every right to be well-informed, to get all the facts so they can make a rational decision.”
Changing the topic as if to elicit sympathy, Mr. Gates confided: “I’ve been going through a rough time and doing a lot of soul-searching since Melinda dumped me. This divorce has caused me to take a good hard look at myself. I don’t want to be remembered as a monster who killed millions of people through deadly vaccines. I am not a monster. I am not a mass murderer. I don’t want to be remembered as a mass murderer by my family, my friends, and my company.
“Some people have called me a sociopath or even a psychopath because of my visionary schemes to help humanity—like reducing global warming by spraying dust into the upper atmosphere, or releasing millions of genetically-modified mosquitoes to combat dengue and Zika virus.”
