FDA responds to study on DNA contamination in Pfizer vaccine

The regulator states the study "does not belong to the FDA," despite it being conducted at FDA labs, with FDA resources, by students under the supervision of FDA staff.

The U.S. Food and Drug Administration (FDA) has responded to a peer-reviewed study conducted within its own laboratory, which uncovered excessively high levels of DNA contamination in Pfizer’s mRNA COVID-19 vaccine.

The study revealed that residual DNA levels exceeded regulatory limits by 6 to 470 times, validating earlier studies from independent researchers that the FDA had previously disregarded.

Published by students in the Journal of High School Science, the study has garnered significant attention since the story broke, with its altimetric score rivalling those of major studies in leading medical journals.

FDA’s Response

Despite the study being conducted at the FDA’s White Oak campus in Maryland, the agency has sought to distance itself from the findings.

A spokesperson stated that the study “does not belong to the FDA” and is therefore not theirs to disclose.

“The FDA does not comment on individual studies,” the spokesperson added, declining to acknowledge the new scientific findings.

The agency also refused to address the involvement of three of its own scientists—Dr Shuliang Liu, Dr Tony Wang, and Dr Prabhuanand Selvaraj—who supervised the students conducting the study.

When questioned about potential regulatory actions, such as issuing a public alert, recalling affected vaccine batches, or notifying other agencies, the FDA stood firm in its defence of mRNA vaccine safety.

“Based on a thorough assessment of the entire manufacturing process by the agency’s scientific experts, the FDA is confident in the quality, safety, and effectiveness of the COVID-19 vaccines that the agency has approved and authorised,” stated the FDA spokesperson.

“The agency’s benefit-risk assessments and ongoing safety surveillance demonstrate that the benefits of their use clearly outweigh their risks. Additionally, with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.”

This statement effectively shuts down any immediate plans for further investigation.

Calls for Accountability

The FDA’s response has provoked sharp criticism from scientists. Genomics expert Kevin McKernan, who first identified excessive DNA contamination in Pfizer vials in early 2023, called the agency’s stance evasive and deeply concerning.

“It’s the same script on auto-repeat at every regulatory agency,” McKernan said.

“They always say, ‘billions of doses given, benefits outweigh the risks, we’ve seen no evidence of harm.’ But billions of cigarettes were smoked too, and that didn’t make them safe.”

McKernan also questioned the FDA’s attempts to distance itself from the study.

“If the FDA supplied the materials for the study and provided technical advice through staff supervision, then how can they not be responsible for the data?” McKernan asked. “Do they only deny their connection when the data becomes inconvenient?”

Professor Nikolai Petrovsky, Professor of Immunology and Infectious Disease at the Australian Respiratory and Sleep Medicine Institute, shared McKernan’s concerns.

“The FDA’s response is extremely disappointing,” he said.

“It completely circumvents whether or not the level of DNA contamination in mRNA vaccines exceeds regulatory limits (as the study performed in their lab would indicate), and what they intend to do about it.”

“Just claiming there’s no safety issue and pointing to the billions of doses administered, without offering any evidence of safety, is far from satisfactory,” added Prof Petrovsky.

Regulatory Silence

The Australian Therapeutic Goods Administration (TGA), which has previously dismissed similar findings from independent researchers as “misinformation,” was contacted for comment but did not provide a response before publication.

Russell Broadbent, Victorian Member for Monash, expressed his disbelief at the regulatory inaction.

“I cannot fathom why the TGA isn’t making this their number one priority, given their charter is to regulate therapeutics to help ensure Australians stay healthy and safe,” he said.

In light of the FDA laboratory findings, Broadbent urged regulators to “immediately pause the rollout of the vaccines, and investigate the claims.”

The Stakes Could Not Be Higher

These revelations carry immense implications. mRNA vaccines are hailed as the dawn of a new era in vaccinology, with the world increasingly relying on this platform technology to supersede traditional vaccine methods.

Failure to address the safety of this technology will torpedo public trust in both the vaccines and the regulatory systems meant to ensure their safety.

“The public deserves clear answers, not regulatory hand-waving,” McKernan said.

As calls for accountability grow louder, the FDA faces mounting pressure to engage with the scientific evidence—particularly that which originates from its own laboratory.

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NB: a comprehensive critique of the student study from FDA’s lab has been published by Kevin McKernan.

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