The U.S. Food and Drug Administration (FDA) is refusing to recall the Pfizer-BioNTech COVID-19 vaccine, promoting the view that the inclusion of a previously-undisclosed DNA sequence that leaves behind fragments is not of concern.
The FDA is not required to take the COVID-19 vaccine, or other COVID-19 shots, off the market, an agency spokeswoman told The Epoch Times via email.
“With over a billion doses of the mRNA vaccines administered, no safety concerns related to the sequence of, or amount of, residual DNA have been identified. With regard to the FDA-approved mRNA vaccines, available scientific evidence supports the conclusion that they are safe and effective,” the spokeswoman added.
The FDA did not provide any evidence to back up its position.
The email came in response to 10 questions about the inclusion of the Simian Virus 40 (SV40) DNA sequence in the Pfizer-BioNTech shot.
The Epoch Times has submitted a Freedom of Information Act query to try to unlock when the FDA learned about the sequence, and from whom. The FDA denied expedited processing for the request, claiming there is not a “compelling need” to quickly provide the information.
The FDA would not answer a number of questions about the sequence, including when the agency learned about its inclusion and whether it learned about it from Pfizer or BioNTech .
BioNTech and Pfizer have not responded to inquiries.
The inclusion was first identified by Kevin McKernan, a former researcher and team leader for the Massachusetts Institute of Technology Human Genome Project.
“Nothing will be identified if they continue to choose not to look,” Mr. McKernan told The Epoch Times via email.
Federal law states that the FDA can test drugs suspected of being adulterated. If the drugs fail to meet certain standards, and a health hazard is found, the FDA is directed to advise the manufacturer to issue a recall.
If the manufacturer then fails to issue a recall, “seizure should be considered,” the law states.
“The general policy is that if there’s adulteration and reasonable risk of toxicity, there must be immediate action,” Dr. Malone told The Epoch Times. “This is a core mandate to the FDA from Congress to prevent adulteration of drugs, medical devices, and food. And then the next question is, is that adulteration? Is it associated with a reasonable risk of toxicity in humans? And my opinion is, absolutely.”
Dr. Malone, after reviewing the FDA’s response, said that regulators have not done their job.
“The normal process worldwide has been that that risk must be rigorously assessed proactively. But they haven’t done it, and their rationale for not doing it is the reason why they were so adamant that this is not a gene therapy technology,” Dr. Malone said.
Why Was SV40 Included?SV40 sequences have been used by biotechnology companies in drug products.
“Specific sequences for the non-infectious parts of SV40 are commonly present in plasmids used for manufacturing of biological active substances,” the European Medicines Agency (EMA) told The Epoch Times via email.
EMA alleged that Pfizer considered the sequence “a non-functional part of the plasmid.”
But the result is residual DNA left behind, according to testing. That could have negative effects, some scientists say.
If it does that, “it can disrupt gene regulation and potentially lead to the oncogenesis,” Mr. McKernan said.
Phillip Buckhaults, professor of cancer genomics and director of the Cancer Genetics Lab at the University of South Carolina, said earlier this year that he tested vials of the Pfizer-BioNTech vaccine and detected DNA.
“I’m kind of alarmed about the possible consequences of this both in terms of human health and biology, but you should be alarmed about the regulatory process that allowed it to get there,” he told the South Carolina Senate.
Mr. Buckhaults said the DNA “could be causing some of the rare but serious side effects like death from cardiac arrest.”
He has encouraged regulators to test the Pfizer-BioNTech vaccine.
“This is probably not a problem, but it is surprising and therefore causing concern,” Mr. Buckhaults wrote on X, formerly known as Twitter, tagging the FDA. “You should address with rigorous safety review ASAP.”