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
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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.
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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.
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.
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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.
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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.
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.
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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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