Tag Archives: European Medicines Agency

Are Residual DNA In mRNA Vaccines Dangerous?!

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 from that article by The Epoch Times:

Billions of Copies of Residual DNA in a Single Dose of COVID-19 mRNA Vaccine: Preprint

Recommended : Are mRNA Vaccines Contaminated With SV40 DNA?!

 

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!

Fact #1 : 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.

Fact #2 : 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.

Recommended : mRNA Vaccines Created Spike Protein In Human Heart?!

Fact #3 : No Evidence Residual DNA Is Dangerous

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.

Fact #4 : 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.

Recommended : New Study Proves Pfizer mRNA Vaccine Causes Turbo Cancer?!

Fact #5 : mRNA Vaccines Meet Residual DNA Limits

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!

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.

Recommended : Did Health Canada Confirm SV40 DNA In Pfizer Vaccine?!

Fact #6 : VAERS Reports Are Unverified

Hilariously, the Speicher et 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.

Fact #7 : Study Showed Fewer Adverse Events With More DNA Fragments!

Even more hilariously, the Speicher et 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.

Recommended : Did EMA Confirm Pfizer Hid SV40 DNA In Vaccine?!

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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.

 

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Did EMA Confirm Pfizer Hid SV40 DNA In Vaccine?!

Did the EMA (European Medicines Agency) just confirm that Pfizer hid the presence of SV40 DNA in its mRNA COVID-19 vaccine?!

Take a look at the viral claim, and find out what the facts really are!

 

Claim : EMA Confirmed Pfizer Hid SV40 DNA In Vaccine!

Some people are sharing an article by The Epoch Times, which claimed / suggested that the European Medicines Agency just confirmed that Pfizer “hid” the presence of SV40 (Simian Virus 40) DNA in its mRNA vaccine for COVID-19!

Here is an excerpt from that article by The Epoch Times:

European Regulator Confirms Pfizer Did Not Highlight DNA Sequence in COVID-19 Vaccine

Recommended : Are mRNA Vaccines Contaminated With SV40 DNA?!

 

Truth : EMA Did Not Say Pfizer Hid SV40 DNA In Vaccine!

Let’s take a closer look at what the EMA and Health Canada actually said about the presence of SV40 DNA in the Pfizer mRNA vaccine for COVID-19!

Fact #1 : SV40 Promoter Is Not SV40 Virus

First, I should point out that the SV40 promoter is not the SV40 virus. It is unknown if the writers are aware of the difference, or are simply trying to conflate the two to confuse readers.

What you need to know is that gene enhancers and promoters are DNA sequences that stimulate gene expression, and have long been used in molecular biology. The SV40 promoter is merely a DNA sequence that was derived from the SV40 (Simian Virus 40) virus, and is not the same thing as the SV40 virus.

Think of the SV40 promoter 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.

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)

To be clear – mRNA vaccines do not contain the SV40 virus. And the SV40 promoter is not the same thing as the SV40 virus.

Recommended : Are mRNA Vaccines Contaminated With SV40 DNA?!

Fact #2 : Pfizer Submitted Entire Plasmid DNA Sequence

Both Health Canada and EMA pointed out to The Epoch Times that Pfizer submitted the entire DNA sequence of the plasmid, as part of the approval process, but did not highlight the SV40 promoter sequence because it was a non-functional part of the plasmid.

It is unknown if The Epoch Times forgot / missed what Health Canada or the EMA wrote, or they were trying to confuse readers by insinuating that the SV40 promoter sequence was somehow being hidden from regulators.

EMA : 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.

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.

Health Canada : Health Canada expects sponsors to identify any biologically functional DNA sequences within a plasmid (such as an SV40 enhancer) at the time of submission. Although the full DNA sequence of the Pfizer plasmid was provided at the time of initial filing, the sponsor did not specifically identify SV40 sequence. When the presence of the SV40 enhancer was raised publicly by McKernan and Buckhaults, it was possible for Health Canada to confirm the presence of the enhancer based on the plasmid DNA sequence submitted by Pfizer against the published SV40 enhancer sequence.

the residual plasmid DNA is present in the final product as DNA fragments, due to the enzyme digestion step in the downstream process. As such, the original risk benefit analysis that supported the initial approval of the Pfizer vaccine continues to be valid.

Recommended : New Study Proves Pfizer mRNA Vaccine Causes Turbo Cancer?!

Fact #3 : Plasmid DNA Are Broken Down + Removed

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.

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.

The European Medicines Agency (EMA) also concurred, stating that the plasmid is broken down and removed during the manufacturing process:

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.

The WHO has set a recommended limit of 10 ng of residual DNA per dose.

Recommended : Is FDA Refusing To Release Vaccine Myocarditis Results?!

Fact #4 : McKernan Paper Shows Vaccines Meet Regulatory Limit!

The McKernan et al. preprint (which has not yet peer-reviewed) that fuelled the SV40 promoter DNA in Pfizer vaccine controversy, actually showed that the amount of residual DNA “contamination” was far below 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 McKernan 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!

Recommended : Did CDC Say COVID Vaccines Cause AIDS + Cancer?!

Fact #5 : 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 the residual DNA 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.

 

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Why Mislav Kolakušić called WHO terrorist organisation!

Mislav Kolakusic – a Member of the European Parliament, just called WHO a terrorist organisation!

Find out why Kolakusic called WHO a terrorist organisation, and what the facts really are!

 

Mislav Kolakusic : WHO Is A Terrorist Organisation!

People are sharing video clips on Twitter, Instagram, YouTube and TikTok which shows Mislav Kolakusic – a Member of the European Parliament (MEP) calling the WHO (World Health Organisation) a terrorist organisation.

The Gateway Pundit also posted an article on Mislav Kolakusic declaring the WHO as a terrorist organisation, which are being shared by anti-vaccination activists and conspiracy theorists.

The MEP said that while voicing his opposition to an upcoming agreement which would allegedly give WHO the “sole authority to declare pandemics and acquire vaccines and drugs”. Here is a transcript of his video.

I would like to briefly make the people aware of the upcoming danger for humanity.

The World Health Organization wants all countries to sign an agreement on handing over the authority to declare a pandemic, procure vaccines, and drugs.

Recommended : Why International COVID Summit III Criticised Vaccine!

 

Truth : Mislav Kolakusic Is Wrong, WHO Is Not Terrorist Organisation

This is yet another example of MISINFORMATION created and spread by politicians and/or conspiracy theorists / anti-vaccination activists, and here are the reasons why…

Fact #1 : It Was Not A Deep Fake Video

First, let me just point out that this is not a deep fake video. Mislav Kolakusic (Mislav Kolakušić) did indeed call for the WHO to be declared a terrorist organisation.

That video came from his official press conference which he posted on his Twitter account on May 22, 2023. It has been viewed by over 1.1 million people to date.

Fact #2 : Mislav Kolakusic Is A Controversial Politician

Mislav Kolakusic was elected as a Croatian independent Member of the European Parliament (MEP) in May 2019. Since then, he has been a controversial politician.

In January 2022, he compared COVID-19 vaccine mandates with capital punishment, claiming that tens of thousands of people died from vaccines citing data from the European Medicines Agency (EMA). In response, the EMA said that the cited EudraVigilance data was a public, self-reporting system (like VAERS) which require investigation to prove a causal link. Even more damning, the EudraVigilance data did not report deaths, contradicting Kolakusic’s claims.

In March 2022, Kolakusic criticised Canada’s response to vaccine mandate protests, saying that Canada now resembled more like a “dictatorship of the worst kind”.

In October 2022, Kolakusic claimed that there was a lack of disclosure of vaccine ingredients, saying, “no one in the world, except maybe 2 or 3 people, knows what it contains”, and called it “the biggest corruption scandal in the history of mankind”. However, we do know what COVID-19 vaccines contain, and there has not been any evidence of any corruption scandal surrounding any COVID-19 vaccine so far.

Fact #3 : No Evidence WHO Lied About COVID-19 / Vaccines

There is no evidence that the WHO lied about the COVID-19 pandemic or the COVID-19 vaccines. The truth is:

  • SARS-CoV-2 was a new coronavirus when it was discovered in Wuhan, China, in December 2019, and
  • the COVID-19 vaccines are effective at preventing deaths and hospitalisation.

In fact, the world has reopened up after many people were vaccinated against COVID-19, preventing massive waves of hospitalisations and deaths.

Mislav Kolakusic notably did not offer any evidence that the WHO lied, when he called for it to be labelled as a terrorist organisation.

Recommended : Did US Intentionally Release COVID Virus In Wuhan?!

Fact #4 : WHO Agreement Was Initiated By World Leaders

Mislav Kolakusic’s claims are based on a WHO agreement which started with not with WHO itself, but its member states, which wanted to amend the existing International Health Regulations to strengthen the world’s preparedness against future global pandemics.

The International Health Regulations (IHR) were first adopted by member states in 1969, empowering the WHO to monitor global diseases. Those regulations have since been revised over the years, including in 2005 – after the SARS outbreak.

On 1 December 2021, world leaders agreed to kickstart the process to draft and negotiate an agreement or convention to “strengthen pandemic prevention, preparedness and response“.

Fact #5 : Recommendations Came From WHO Member States

The proposed recommendations came from WHO member states, and not WHO itself. Among the more than 200 recommendations on how to better prepare for the next pandemic were:

  • sharing of data and genomic sequences on emerging viruses
  • a plan for equitable vaccine distribution
  • a ban on wildlife markets
  • incentives for reporting new viruses or variants

Fact #6 : Some Countries Don’t Want A Binding Agreement

The European Union has proposed that the changes be adopted as a new treaty, which would be binding. This is perhaps what Mislav Kolakusic was so agitated about, but this was an EU proposal, not a WHO proposal.

The United States, on the other hand, has opposed a binding treaty. India and Brazil are similarly reluctant about adopting a treaty.

The EU proposed the treaty and is its biggest backer, with support from Britain, Indonesia, Kenya and others.

The United States will take part in the talks but has opposed a binding treaty. India and Brazil have also voiced reservations.

With so many member countries involved, securing agreement is likely to be tricky.

Recommended : Is Biden Admin signing over US sovereignty to WHO?!

Fact #7 : No Country Is Signing Over Its Sovereignty To WHO

The zero draft (PDF download) of the proposed WHO agreement on preparing for future pandemics even addresses the issue of national sovereignty on Article 4 (3):

3. Sovereignty – States have, in accordance with the Charter of the United Nations and the principles of international law, the sovereign right to determine and manage their approach to public health, notably pandemic prevention, preparedness, response and recovery of health systems, pursuant to their own policies and legislation, provided that activities within their jurisdiction or control do not cause damage to their peoples and other countries. Sovereignty also covers the rights of States over their biological resources.

Anyone who read the zero draft can clearly see that even the “draft” has clarified that no country is signing over its national sovereignty to the WHO.

Fact #8 : WHO DG Dismissed Sovereignty Claim In May 2022

On May 17, 2022, WHO Director-General Dr. Tedros Ghebreyesus dismissed the claim that countries signing up for this new agreement would be giving up their sovereignty.

The accord process is led by Member States with their own Intergovernmental Negotiating Body (called INB), representing all regions of the world. The INB has now started a two-year process that includes global public hearings with all stakeholders. This represents the world’s opportunity to plan together, detect pathogens quicker, share data broadly and collectively respond more effectively to the next diseases X or known pathogens.

Unfortunately, there has been a small minority of groups making misleading statements and purposefully distorting facts.

I want to be crystal clear. WHO’s agenda is public, open and transparent. WHO stands strongly for individual rights. We passionately support everyone’s right to health and we will do everything we can to ensure that that right is realized.

The first ever World Health Assembly, which took place soon after the WHO Constitution entered into force in 1948, was a watershed event in global public health. And like the proposed pandemic preparedness accord, this did not mean WHO usurped nations’ sovereignty; in fact it strengthened countries’ ability to fight diseases together.

WHO is an expression of Member States’ own sovereignty and WHO is entirely what the sovereign 194 Member States want WHO to be.

Every year, these sovereign governments come together at the World Health Assembly to set the health agenda for the world. Individually we can’t beat pandemics; our best chance is together.

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Support my work through a bank transfer /  PayPal / credit card!

Name : Adrian Wong
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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.

 

Recommended Reading

Go Back To > Fact Check | HealthTech ARP

 

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