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FDA Shuts Down Enquiries About COVID Vaccines Contaminated With DNA Fragments

vaccine vials

The recent findings of DNA fragments in the Pfizer and Moderna COVID-19 vaccines has led many to question why the FDA, which is responsible for monitoring the quality and safety of the vaccines, has failed to sound the alarm.

For years, the FDA has known about the risk posed by residual DNA in vaccines. Its own guidance to industry states:

Residual DNA might be a risk to your final product because of oncogenic and/or infectivity potential. There are several potential mechanisms by which residual DNA could be oncogenic, including the integration and expression of encoded oncogenes or insertional mutagenesis following DNA integration.

Put simply, the FDA acknowledges the possibility that fragments of DNA left over by the manufacturing process can be incorporated into a patient’s own DNA, to potentially cause cancer.

FDA and WHO guidelines consider the amount of residual DNA in a single dose of traditional vaccine should not exceed 10 ng (one billionth of a gram).

But this limit—used for traditional vaccines—is unlikely to be relevant to the mRNA vaccines whose lipid nanoparticles can penetrate inside cells to deliver the mRNA efficiently.

A recent preprint paper by Speicher et al analyzed batches of the monovalent and bivalent mRNA vaccines in Canada.

The authors found “the presence of billions to hundreds of billions of DNA molecules per dose in these vaccines. Using fluorometry all vaccines exceed the guidelines for residual DNA set by FDA and WHO of 10 ng/dose.”

Speicher et al also reported finding fragments of DNA larger than 200 base pairs (a measure of the length of the DNA) which also exceeds FDA guidelines.

Notably, the authors commented that for the Pfizer product, the higher the level of DNA fragments found in the vaccine, the higher the rate of serious adverse events.

Some experts say the risk of genome integration in humans is very low, but a recent publication in Nature found that around seven percent of cells are integrated when mixed with a transfection solution containing linear pieces of DNA.

Is the FDA Concerned?

The U.S. Food and Drug Administration (FDA) continues to insist that any residual DNA contamination in the Covid vaccines is not a problem and that it “stands behind its findings of quality, safety, and efficacy for 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,” added the FDA.

The FDA would not provide the “available scientific evidence” to support its claim, but it’s worth noting that the vaccines’ own product labels show that genotoxicity and carcinogenicity tests were not carried out prior to their use.

David Wiseman, a research bioscientist involved in medical product development and co-author on the study by Speicher et al said the FDA’s claim that there is no evidence of a cancer link is becoming “untenable.”

“The CDC’s own analysis on the vaccine’s safety signal in VAERS shows there could be a signal for some cancers,” said Wiseman pointing to a report he co-authored and sent to the National Academies.

In the table (highlighted in yellow), a safety signal is considered to be significant, and worthy of further investigation, if the value in the column marked PRR exceeds 2 and the value in the Chi-Square column exceeds 4.

The FDA would not confirm if it found levels of DNA that exceeded acceptable levels, nor if it was investigating further.

Instead, after months of enquiries, the FDA sent boilerplate responses to me (and other media) saying, “With over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.”

In response to a list of questions about its testing and oversight, the FDA said it “does not have any additional information to provide at this time.”

Poor Manufacturing Oversight

We now know that Pfizer’s vaccine used in the clinical trials (PROCESS 1) was manufactured differently to the vaccine that was injected into the wider population (PROCESS 2).

This switch from PROCESS 1 to PROCESS 2 is what introduced the plasmid DNA impurities (see red circles), which could change the safety profile of the vaccine.

I asked the FDA if it had any human data on the comparison of the two processes.

The agency pointed me to the FDA’s EUA review memo dated Nov. 20, 2020 which suggested that the testing was “ongoing.”

The three-year old document stated that “A more comprehensive comparability assessment encompassing additional lots from multiple DP manufacturing nodes is ongoing and the results will be provided to the EUA upon completion of the study.”

When I asked the FDA for access to the “ongoing” results, I was instructed to obtain the information from Pfizer, but the drug company did not respond to my enquiries.

A Freedom of Information request by Nick Hunt of the Daily Sceptic may explain why.

Pfizer promised the regulator that it would compare the safety and immunogenicity of the two processes in participants and report back by February 2021, but it seems those studies were never done.

The FOI stated:

… in October 2020 an exploratory objective was added in the C4591001 study to describe safety and immunogenicity of vaccines produced by manufacturing “Process 1” or “Process 2” in participants 16 to 55 years of age. This exploratory objective was removed and documented in protocol amendment 20 in September 2022 due to the extensive usage of vaccines manufactured via “Process 2”. Thus, this process comparison was not conducted as part of the formal documentation within the protocol amendment.[emphasis added]

Wiseman said, “Given the magnitude of the process change, from my experience in medical product development, these sorts of biological comparability studies would certainly have been expected to be undertaken by Pfizer.”

He added, “the fact that Pfizer was given a free pass indicates a significant lapse in regulatory oversight.”

Kevin McKernan, the genomics expert who made the discovery of DNA fragments in the vaccines earlier this year, says there’s “no incentive” now for Pfizer to carry out this comparative testing.

“It’s speculation on my part, but I suspect they might’ve seen increased adverse events with the commercial batch and buried the data knowing the train had left the station at that point,” said McKernan.

“There was no political will to stop vaccinating, and Pfizer probably knew the regulators would let them get away with not testing the commercial batches for the population,” he added.


This article was originally published by the Brownstone Institute. Maryanne Demasi is an investigative medical reporter with a PhD in rheumatology, who writes for online media and top tiered medical journals. For over a decade, she produced TV documentaries for the Australian Broadcasting Corporation (ABC) and has worked as a speechwriter and political advisor for the South Australian Science Minister. Her work can be accessed on her website at maryannedemasi.com.

5 Responses

  1. why in the world would anyone inject this poison into themselves??
    This is truly massive crimes against humanity….
    it’s time to stand up for your own health and work diligently on your immune system. the goal is to destroy our immune system it’s very clear now.
    when your immune system dies
    so do we.
    do research and trust yourself. the master manipulaters are banking on your fear. literally!!!
    do not comply.
    stay free….

  2. ‘A significant lapse in regulator oversight’… There is no regulatory oversight! How long will people continue to buy this charade that the FDA is anything other than a corporate partner to these pharmasuetical corporations. Who’s still buying this? I know of an even better way to protect yourself from all these incredibly complex process errors and blatantly deceptive misleading production failures; simply don’t take vaccines ever again for any reason.

    My aunt just passed away. She had two if not three covid vaccines. A few years later, spontaneous crash of multiple systems within her body during a relatively routine knee surgery. It was the heart attack which caused loss of brain function which put her into a state between coma and vegetative. When life support was removed she passed away shortly after. Brought to you by Phizer. We tried to warn our family members about these issues, but all they heard was the government sponsored messaging of safe product profiles and resolutely sound testing. All of that was just lies.

    Call this issue in a more truthful manner; Phizer continues to mislead the public, game the faux regulatory oversight, in concerted criminal racketeering efforts which have defrauded taxpayers of billions of dollars and caused grave harm and death to millions of people. The proving it phase is over, and it’s time to arrest these people at both the pharmasuetical companies, research labs, manufacturing facilities, and the FDA, for gross incompetence and about twenty million charges of manslaughter, just for starters.

    Then we can slam dunk the rest of this organized cartel with embezzlement and product fraud charges. Remember the one where in an attempt to relieve the pressure of rising public awareness, the vaccine product purveyors assured the public that at least half of all those shots were saline anyways? That’s called product fraud but because it’s vaccines, oh no big deal. People are literally propagandized and mind controlled to such a state they can not recognize the utter failure of the vaccination approach having failed at every possible level from conception to research to production to delivery to records keeping and liable responsibility. A total and complete failure through the entire chain, top to bottom. Repeat after me; Safe AND Effective.

  3. Depopulation, it’s what this has always been about. Be a Dodo bird or not, it’s everyone’s personal choice. To use an open mind, discernment, and critical thinking without fear is the only way to survive. I’m think about sending all my bills to the WEF. Att: Klaus Shwabb, you know that self appointed god that wants all of us to eat bugs while they eat steak and lobster. All the while playing with little girls. Who do you think really controls our politicians? Who do you think is doing a hostile takeover of American? You see they know they’re running out of time, too many people have awakened to their crimes. The only way out for them is to kill off their adversaries, us.
    Keep this in mind when debating on pharmaceuticals.
    Be well 🙏

  4. i subscribe to several youtube channels that produce content about covid and about vaccines, then i look at channels that criticize those views. when i read the comments there, i am amazed at how many liberals are becoming what i assumed they despised- promoters of censorship and that they seem oblivious to its dangers

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