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
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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.
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Fact #3 : Health Canada Confirms mRNA Vaccines Meet Regulatory Limit
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!
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Fact #5 : SV40 Promoter Does Not Cause Cancer
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.
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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.
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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.
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