Pfizer’s COVID-19 vaccine is adulterated due to the undisclosed presence of a DNA sequence, experts say.
“It absolutely should be recalled,” Dr. Malone told The Epoch Times.
“Will the FDA do its job?” he added later.
Due to the presence of the sequence, some experts say, the FDA should find the product adulterated, which is defined under federal law as having a “strength, quality, or purity differing from the official compendium.”
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.”
Other experts, such as Dr. Janci Lindsay, also say the sequence presence means the vaccine is adulterated.
The FDA declined to comment.
Pfizer has not responded to inquiries.
Sen. Ron Johnson (R-Wis.), ranking member of the Senate Homeland Security and Governmental Affairs’ Permanent Subcommittee on Investigations, said that regulators must provide answers.
“I have been researching and consulting experts on the issue of DNA contamination in COVID-19 vaccines since it was exposed,” Mr. Johnson told The Epoch Times via email. “The FDA must provide answers to the legitimate questions being raised.”
If the FDA does not take action, state attorneys general could move to seize the vaccine due to the adulteration, Dr. Malone said.
‘We Do Not Know What Was Disclosed’
Health Canada said sponsors are expected to identify biologically functional DNA sequences within a plasmid, such as the SV40 sequence, when submitting applications for clearance.The Pfizer-BioNTech sponsor did provide the full DNA sequence of the plasmid but “did not specifically identify the SV40 sequence,” the health agency said.
After Mr. McKernan and other scientists uncovered the sequence, Health Canada did “confirm the presence of the enhancer,” it added.
It’s not clear whether the sequence was also not identified for the FDA by BioNTech or Pfizer.
“We don’t know what was disclosed to the FDA prior to authorization. If it was disclosed, then its presence is not unexpected. If it was not disclosed, I think there is a case that this is adulteration,” Mr. Wiseman said.
The rules under which the vaccine was initially given emergency use authorization (EUA) may provide a defense for the agency, though.
“Could FDA argue that because of the EUA, or because they knew about it, or some other reason, no action is required on their part, and there is nothing to see here? They may try to argue that. But the totality is that this is completely wrong,” Mr. Wiseman said.
Mr. McKernan in June, during an FDA meeting’s public comment, presented his findings and showed that the sponsor did not disclose the sequence to the European Medicines Agency (EMA). The FDA does not typically respond during the public comment portion of its meetings, or afterwards to what was presented.
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