FDA Should Recall ‘Adulterated’ Pfizer COVID-19 Vaccine: Dr. Robert Malone
“It absolutely should be recalled,” “Will the FDA do its job?” ~Dr. Malone
By Zachary Stieber via The Epoch Times
Pfizer’s COVID-19 vaccine is adulterated due to the undisclosed presence of a DNA sequence, experts say.
That should prompt a recall by the U.S. Food and Drug Administration (FDA), according to Dr. Robert Malone, a vaccine expert whose work has been cited by Pfizer.
A health worker fills a syringe with a Pfizer-BioNTech COVID-19 vaccine in a file image. (Emmi Korhonen /Lehtikuva/AFP via Getty Images)
“It absolutely should be recalled,” Dr. Malone told The Epoch Times.
“Will the FDA do its job?” he added later.
Pfizer’s vaccine contains a Simian Virus 40 (SV40) DNA sequence, authorities in Canada confirmed to The Epoch Times. Authorities found the sequence after outside researchers, including Kevin McKernan, discovered the sequence in the shot.
The whole SV40 virus can cause cancer, prompting its removal from polio vaccines in the past. While the primary genetic sequence of the virus associated with cancer is not in Pfizer’s vaccine, there is a portion of the sequence called a promoter-enhancer, which “can get things into the nucleus, so that is a concern,” David Wiseman, a former Johnson & Johnson scientist, told The Epoch Times.
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.”
Congress directed the FDA that if tests are run on a drug suspected of being adulterated and the drug fails to meet the standards in the compendium, and there is a health hazard, to direct the manufacturer to issue a recall, Dr. Malone noted in an essay.
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.
The Epoch Times asked several attorneys general if they are considering or would consider such a move, but they did not respond.
‘We Do Not Know What Was Disclosed’
Health Canada said sponsors such as Pfizer are expected to identify biologically functional DNA sequences within a plasmid, such as the SV40 sequence, when submitting applications for clearance.
Pfizer 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 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 Pfizer 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.
“The really crushing thing here is Pfizer never disclosed the SV40 information to the EMA. They gave them a plasmid map of what the plasmid consisted of, with all of the features labeled, with the exception of 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 Paper
In a preprint paper published this month, Mr. Wiseman, Mr. McKernan, and other researchers tested 27 vials of the Moderna and Pfizer COVID-19 vaccines and found the presence of the SV40 sequence in the Pfizer vials, not the Moderna ones.
The testing, along with Health Canada’s statement, helps confirm the results of Mr. McKernan’s earlier testing, which identified the presence of the sequence.
Dr. Phillip Buckhaults, a cancer genomics expert and a professor at the University of South Carolina, also found pieces of plasmid DNA in the vaccine. He told The Epoch Times 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, another cancer expert who serves as director of the Legorreta Cancer Center at Brown University, has said that the findings should spur more research into the impact of the vaccines on different parts of the body, including in the heart and brain.
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Matthew Horwood contributed to this report.
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(TLB) published this report by Zachary Stieber via The Epoch Times as posted at ZeroHedge
Header featured image (edited) credit: Dr, Malone/YouTube screen grab
Emphasis added by (TLB)
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To TLB Staff:
With regard to this Zachary Stieber article: Two crucial points from the work of Katherine Watt and Sasha Latypova:
1) “Congress and US Presidents legalized and funded the overthrow of the U.S. Constitution, the U.S. government and the American people, through a massive domestic bioterrorism program relabeled as a public health program, conducted by the HHS Secretary and Secretary of Defense on behalf of the World Health Organization and its financial backers.”
American Domestic Bioterrorism Program – Building the case to prosecute members of Congress, presidents, HHS and DOD secretaries and federal judges for treason under 18 USC 2381.
https://bailiwicknews.substack.com/p/american-domestic-bioterrorism-program
“A whole lot of things that once were federal and state crimes and civil rights violations have been legalized by Congress through legislative, statutory revisions to the United States Code, signed by US Presidents, and implemented at the administrative, regulatory level by the Department of Health and Human Services and Department of Defense through the Code of Federal Regulations.
…The basic goal of the architects, which has been achieved, was to set up legal conditions in which all governing power in the United States could be automatically transferred from the citizens and the three Constitutional branches into the two hands of the Health and Human Services Secretary, effective at the moment the HHS Secretary himself declared a public health emergency, legally transforming free citizens into enslaved subjects.
That happened on Jan. 31, 2020, in effect as of Jan. 27, 2020 through the present day.
In other words: Congress and US Presidents legalized and funded the overthrow of the U.S. Constitution, the U.S. government and the American people, through a massive domestic bioterrorism program relabeled as a public health program, conducted by the HHS Secretary and Secretary of Defense on behalf of the World Health Organization and its financial backers.”
2) Malone may have a different objective than what appears to be reported in this Zachary Stieber article:
“Whatever is in the biochemical weapons bearing Pfizer and other pharma labels, is there because US SecDefs and their WHO-BIS handlers ordered it to be there.”
https://bailiwicknews.substack.com/p/whatever-is-in-the-biochemical-weapons
“What Malone, Steve Kirsch and other DoD spokesmen are doing is a distraction maneuver to keep attention away from the intentional toxicity of the biochemical weapons, the DoD/WHO control of the programs, and the fact that “biodefense” is camouflage for straight-up State-sponsored biowarfare, conducted by bringing pharmaceutical companies into the military-industrial-Congressional complex, calling bioweapons “vaccines,” and terrifying people into taking them under “public health emergency” and “pandemic” narratives.
More county and state lawmakers are starting to figure out the federal mass murder program and work on responses to protect the people in their political jurisdictions. (see: https://bailiwicknews.substack.com/p/some-county-and-state-lawmakers-are )
So the Monster is deploying Malone, Kirsch and the rest of the narrative-management team to take the SV-40 story in the wake of Kevin McKernan and others doing more sequencing studies, and direct it away from US kill box laws, DoD, WHO, intentionality and the intrinsic lethality of all mRNA platform technologies, toward civil suits against Pfizer for “adulteration” and “contamination.”
They are trying to shield the mRNA technology and ‘vaccination’ program platforms, and the public health emergency geopolitical and legal platforms from growing public understanding of what’s really going on, so that the Monster can keep using “public health emergency” laws, orchestrated “pandemics,” “vaccines,” and mRNA-platform poisons to sicken and kill many more people for many years to come.”
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Nothing will happen to Pfizer because of US law:
§360bbb–3a. Emergency use of medical products
(2) Effect – Notwithstanding any other provision of this chapter or the Public Health Service Act, an eligible product shall not be considered an unapproved product and shall not be deemed adulterated or misbranded under this chapter because, with respect to such product, the Secretary has authorized deviations from current good manufacturing practices under paragraph (1).
https://uscode.house.gov/view.xhtml?req=(title:21%20section:360bbb-3a%20edition:prelim)
NEVER, NEVER take an emergency use authorized medical product, EVER