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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