Is Canada destroying Pfizer and Moderna COVID-19 vaccine vials to hide evidence of a crime?! Take a look at the viral claims, and find out what the facts really are!
Claim : Canada is destroying Pfizer + Moderna vials to hide evidence!
Some people are suggesting that Canada is now destroying all vials of the Pfizer and Moderna mRNA vaccine for COVID-19, in an effort to hide evidence of some kind of crime.
William Makis MD : BREAKING NEWS: COVID-19 Vaccine Clinics across Canada have been ordered to destroy all vials of Pfizer & Moderna COVID-19 mRNA Vaccines! My urgent message to all who have access: DO NOT RETURN OR DESTROY any Vaccine vials, they are priceless! Hide them
COVID-19 vaccine clinics across Canada have been instructed to dispose of all vials of Pfizer and Moderna mRNA vaccines.
Ontario Alliance : As Ontario COVID-19 vaccine clinics & others across Canada have now been ordered by Health Canada & Public Health Agency of Canada to withdraw & destroy of all vials of Pfizer & Moderna mRNA vaccines ... we realize they are now just trying hard to destroy the evidence for any future legal or political ramification & retribution, just like when Ford Tories said they would lock up Wynne Liberals after 15 years of government corruption & gross mismanagement, Premier Doug the Thug did nothing other than repeat the same & do worse
Lee Golden : BREAKING Burn the evidence 🔥 C19 vax clinics across Canada have been instructed to dispose of all vials of Pfizer and Moderna mRNA vaxxes!
Truth : Canada is not destroying Pfizer + Moderna vials to hide evidence!
This appears to be yet another example of fake news about the COVID-19 vaccines, and here are the reasons why...
Fact #1 : Canada is replacing current COVID-19 vaccines with newer versions
First, let me start by pointing out that Canada is just withdrawing the current COVID-19 vaccines to make way for newer versions.
On 27 August 2024, the Public Health Agency of Canada (PHAC) issued a memo (PDF) stating that it has ordered a market withdrawal of all COVID-19 XBB vaccines in Canada, in order to facilitate the approval of the newer KP.2 vaccines from Pfizer and Moderna.
This is because Health Canada will remove the strain identifier - XBB / KP.2, etc. so that the COVID-19 vaccines it approves in the future will have one drug identification number (DIN), presumably to avoid confusing people who might be wondering if they are getting the latest COVID-19 vaccine.
In short - Canada is withdrawing the current COVID-19 vaccines to make way for the newer COVID-19 vaccines that offer better protection against the current COVID-19 strains.
Fact #2 : Three COVID-19 vaccines are being replaced
Canada isn't just withdrawing and replacing the Pfizer and Moderna COVID-19 vaccines. Canada is also withdrawing and replacing the Novavax COVID-19 vaccine, which is known as Nuvaxovid.
As mentioned above - Canada is withdrawing ALL of its currently approved COVID-19 vaccines (which target the XBB.1.5 strain), to replace with newer COVID-19 vaccines that will target the KP.2 strain.
Fact #3 : Canada expects new KP.2 vaccines in late September 2024
As the memo explained, the Canadian National Advisory Committee on Immunization has recommended that people wait for the new KP.2 formulation of COVID-19 vaccines that offer better protection against the newer COVID-19 strains that are circulating now, compared to the earlier XBB formulation.
While the current COVID-19 vaccines are no longer available starting 1 September, the new KP.2 vaccines from Pfizer, Moderna, and Novavax, are expected to be approved and distributed in late September 2024.
Fact #4 : British Columbia continues to provide COVID-19 vaccines
While the Public Health Agency of Canada has ordered the market withdrawal of current XBB.1.5 COVID-19 vaccines, it is allowing each province and territory the "flexibility" to transition to the newer vaccines (source).
British Columbia, for example, will make the current XBB.1.5 vaccines available until the new KP.2 vaccines are approved. On the other hand, Manitoba has stopped giving out doses of the current XBB.1.5 vaccine, but will consider giving them to patients who request, on a case-by-case basis.
Dr. Brian Conway, the medical director of the Vancouver Infectious Diseases Centre, says that British Columbia's decision to continue providing doses of the XBB vaccine is a "reasoned" approach:
If you really need a shot now for a medical reason, this is still a very good vaccine that has good cross-protection against the currently circulating strain.
This clearly shows that there is nothing wrong with the current XBB.1.5 vaccines, whether they are from Pfizer, Moderna, or Novavax. At least one province continues to provide them, while at least one more province will provide them on request.
Please help us FIGHT FAKE NEWS by sharing this fact check article out, and please SUPPORT our work!
Don't forget to protect yourself, and your family, by vaccinating against COVID-19!
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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 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
Pfizer did not highlight a DNA sequence in its COVID-19 vaccine, a European regulator has confirmed.
“While the full DNA sequence of the plasmid starting material was provided in the initial marketing authorization application for Comirnaty, the applicant did not specifically highlight the SV40 sequence,” the European Medicines Agency (EMA) told The Epoch Times in an email.
The email came after Health Canada told The Epoch Times it expects sponsors to identify sequences such as the Simian Virus 40 (SV40) DNA enhancer but that Pfizer did not.
Pfizer did not highlight the inclusion of the enhancer in its vaccine because “it was considered to be a non-functional part of the plasmid,” EMA said. “They have since clarified this information in response to questions raised by EMA.”
The EMA said parts of the SV40 sequence are “commonly present in plasmids used for manufacturing of biological active substances,” but neither authorities nor Pfizer have been able to say why the sequence was made part of the Pfizer shot.
An EMA spokesperson said earlier this year that there was “no evidence to indicate the presence of SV40 … in the formulation of COVID-19 vaccines.” The EMA is now acknowledging that statement was not correct.
But the regulator said it “has seen no evidence of an association between mRNA vaccines and adverse events that could be linked to the presence of DNA material, nor are we aware of any scientific evidence showing that the very small amounts of residual DNA that may be present in vaccine batches could integrate into the DNA of vaccinated individuals.”
It also said, “we have not seen any reliable evidence of residual DNA exceeding approved/safe levels for” the Pfizer vaccine.
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.
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.
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.
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!
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.
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 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.
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.
Did Health Canada just confirm the presence of SV40 DNA in the Pfizer mRNA vaccine for COVID-19?!
Take a look at the viral claim, and find out what the facts really are!
Claim : Health Canada Confirmed SV40 DNA In Pfizer Vaccine!
Some people are sharing an article by The Epoch Times, which claimed / suggested that Health Canada just confirmed the presence of SV40 (Simian Virus 40) DNA in the Pfizer mRNA vaccine for COVID-19!
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.
Health Canada CONFIRMS Undisclosed Presence of DNA Sequence in Pfizer Shot. -The Epoch TImes
Here is an excerpt from that article by The Epoch Times:
EXCLUSIVE: Health Canada Confirms Undisclosed Presence of DNA Sequence in Pfizer Shot
The health regulator says Pfizer did not disclose the presence of the Simian Virus 40 (SV40) DNA sequence in its mRNA COVID-19 vaccine at the time of filing.
Health Canada has confirmed the presence of a Simian Virus 40 (SV40) DNA sequence in the Pfizer COVID-19 vaccine, which the manufacturer had not previously disclosed. There is debate among scientists with regards to the significance of the finding, with some saying it has the potential to cause cancer, and others saying it poses little to no threat.
“Health Canada expects sponsors to identify any biologically functional DNA sequences within a plasmid (such as an SV40 enhancer) at the time of submission,” the agency said in an email to The Epoch Times.
“Although the full DNA sequence of the Pfizer plasmid was provided at the time of initial filing, the sponsor did not specifically identify the SV40 sequence.”
The regulator said that after scientists Kevin McKernan and Dr. Phillip J. Buckhaults publicly raised the presence of SV40 enhancers in the vaccines earlier this year, “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.”
Truth : Health Canada Only Confirmed SV40 Enhancer Sequence In Pfizer Vaccine!
Let’s take a closer look at what Health Canada 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 gene enhancers and 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 in the vaccine. To be clear – mRNA vaccines do not contain the SV40 virus:
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 #2 : Pfizer DNA Plasmid Won’t Integrate With Genome
In response to The Epoch Times‘ question about SV40 plasmids integrating into the genome, Health Canada explained why that is simply not possible (archive):
The Pfizer DNA plasmid used to produce the COVID-19 vaccine is distinct from DNA adenovirus vectors in sequence and biological functions.
Furthermore, the Pfizer plasmid does not contain sequences corresponding to SV40 proteins studied in the paper cited. Therefore, the integration mechanisms described are not applicable.
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.
In short – the mRNA vaccines approved in Canada meet regulatory limits for residual DNA. This isn’t new or shocking to Health Canada, or other regulatory agencies.
Fact #4 : McKernan Study Is In Dispute
The Epoch Times had earlier written about the McKernan et al. preprint (which has not yet peer-reviewed that fuelled the SV40 promoter DNA in Pfizer vaccine controversy.
The problem though was – the study tested vials of “unknown provenance” which were sent to the authors “anonymously in the mail without cold packs“. Even though they claimed that the vials were “unopened”, it was impossible to know if they were tampered with.
In addition, qualifying residual DNA levels is based on measurements relative to RNA levels. Because the vials were not kept cold, their contents would certainly have been degraded. Since RNA is less stable than DNA and would degrade far more under such conditions, it would likely have resulted in abnormal DNA-RNA levels by the time the tests were conducted.
Finally, the McKernan preprint itself showed that the amount of residual DNA in mRNA COVID-19 vaccines are far below regulatory limits. So it was really much ado about nothing!
The Epoch Times article suggested that there is a risk of the SV40 promoter causing cancer. That has been refuted by scientists:
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
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.
– Michael Imperiale, molecular biologist at the University of Michigan Medical School
Fact #6 : mRNA Vaccines Meet Residual DNA Limits
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.
It was the use of an incorrect DNase stock that resulted in a batch of Pfizer vaccines having more residual DNA than usual – 815 ng of DNA per mL of RNA. Other than that one batch, all other batches had at most – 211 ng of DNA per mL of RNA, which was below the “commercial acceptance criterion” of the European Medicines Agency of ≤330 ng of DNA / per mg of RNA.
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.
Here is the takeaway – any mRNA vaccine that does not meet regulatory limits would not be allowed to be used.
Fact #7 : 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 was 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.
Please help us FIGHT FAKE NEWS by sharing this fact check article out, and please SUPPORT our work!
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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.
