FDA Should Recall ‘Adulterated’ Pfizer COVID-19 Vaccine: Robert Malone

Experts believe Pfizer’s COVID-19 vaccine is tainted due to the presence of an unknown DNA sequence.

According to Dr. Robert Malone, a vaccine expert whose work has been cited by Pfizer, this should prompt a recall by the US Food and Drug Administration (FDA).
“It should absolutely be recalled,” Dr. Malone told The Epoch Times.
“Will the FDA do its job?” he later inquired.

Authorities in Canada confirmed to The Epoch Times that Pfizer’s vaccine contains a Simian Virus 40 (SV40) DNA sequence. Outside researchers, including Kevin McKernan, discovered the sequence in the shot, which led authorities to it.
Because the entire SV40 virus can cause cancer, it was previously removed from polio vaccines. While the primary genetic sequence of the cancer-causing virus is not included in Pfizer’s vaccine, there is a portion of the sequence known as a promoter-enhancer that “can get things into the nucleus, so that is a concern,” according to David Wiseman, a former Johnson & Johnson scientist.
According to some experts, the FDA should find the product adulterated because of the presence of the sequence, which is defined under federal law as having a “strength, quality, or purity differing from the official compendium.”

Dr. Malone noted in an essay that Congress directed the FDA to direct the manufacturer to issue a recall if tests on a suspected adulterated drug fail to meet the standards in the compendium and there is a health hazard.

If the manufacturer fails to issue a recall, “seizure should be considered,” according to the law.

“The general policy is that if there’s adulteration and a reasonable risk of toxicity, there must be immediate action,” Dr. Malone explained to The Epoch Times. “This is a core mandate from Congress to the FDA to prevent drug, medical device, and food adulteration.” The next question is whether or not that is adulteration. Is it associated with a reasonable risk of human toxicity? And, in my opinion, absolutely.”

Other experts, such as Dr. Janci Lindsay, believe the presence of the sequence indicates that the vaccine is tainted.

The FDA did not respond.

Pfizer has not responded to requests for comment.

Senator Ron Johnson (R-Wisconsin), the ranking member of the Senate Homeland Security and Governmental Affairs Permanent Subcommittee on Investigations, stated 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 wrote in an email to The Epoch Times. “The FDA must provide answers to the legitimate questions being raised.”

If the FDA does not act, state attorneys general may seek to seize the vaccine due to adulteration, according to Dr. Malone.

The Epoch Times asked several attorneys general if such a move is being considered or would be considered, but they did not respond.

‘We don’t know what was revealed.’

When submitting applications for clearance, sponsors such as Pfizer are expected to identify biologically functional DNA sequences within a plasmid, such as the SV40 sequence.
Pfizer provided the entire DNA sequence of the plasmid but “did not specifically identify the SV40 sequence,” according to the health agency.

Following the discovery of the sequence by Mr. McKernan and other scientists, Health Canada “confirmed the presence of the enhancer,” it added.

It’s unclear whether Pfizer also failed to identify the sequence for the FDA.

“We have no idea what was disclosed to the FDA prior to approval.” If it was disclosed, its presence is not surprising. “If it wasn’t disclosed, I believe there’s a case to be made that this is adulteration,” Mr. Wiseman said.

However, the rules under which the vaccine was initially granted emergency use authorization (EUA) may provide the agency with a defense.

“Could the FDA argue that no action is required on their part because of the EUA, or because they were aware of it, or for some other reason, and there is nothing to see here?” They may try to refute this. “However, the overall impression is that this is completely incorrect,” Mr. Wiseman stated.

Mr. McKernan presented his findings and demonstrated that Pfizer did not disclose the sequence to the European Medicines Agency (EMA) during a public comment session at an FDA meeting in June. The FDA does not typically respond to what is presented during or after the public comment period of its meetings.

“The most upsetting aspect here is that Pfizer never disclosed the SV40 information to the EMA.” “They gave them a plasmid map of what the plasmid was made of, with all of the features labeled except for the SV40 site,” Mr. McKernan told EpochTV’s “American Thought Leaders.” “They did that because they know the SV40 region is a very controversial base in its history in the vaccine field.”

New Publication

Mr. Wiseman, Mr. McKernan, and other researchers tested 27 vials of the Moderna and Pfizer COVID-19 vaccines and discovered the SV40 sequence in the Pfizer vials but not the Moderna ones in a preprint paper published this month.
The testing, along with the statement from Health Canada, helps to confirm the results of Mr. McKernan’s earlier testing, which revealed the presence of the sequence.
Dr. Phillip Buckhaults, a cancer genomics expert and professor at the University of South Carolina, discovered plasmid DNA fragments in the vaccine as well. He said in a statement that “no one knows if this DNA does anything clinically significant, but it is prudent to check vaccinated people for any evidence of genome modification.”
Dr. Wafik El-Deiry, director of the Legorreta Cancer Center at Brown University and another cancer expert, has stated that the findings should spur more research into the impact of the vaccines on various parts of the body, including the heart and brain.
This story was contributed to by Matthew Horwood.