COVID-era FDA chief sounded internal alarm over calling mRNA shots ‘safe and effective’

The claim that the synthetic mRNA-based COVID-19 genetic therapies were “safe and effective” was repeated ad nauseam not only by former President Joe Biden during the pandemic but by health officials in his administration — including former Health and Human Services Secretary Xavier Becerra, former National Institute of Allergies and Infectious Diseases Director Anthony Fauci, and former Centers for Disease Control and Prevention Director Rochelle Walensky.

It may then come as a surprise that not all high-ranking federal health officials were keen on this particular characterization.

‘Science doesn’t tell you what your actions should be.’

When reached for comment about a new tranche of recently released emails of Anthony Fauci, former Biden administration acting FDA Commissioner Janet Woodcock told Blaze News that she protested the “safe and effective” description.

But first let’s rewind. On Sunday, Senator Ron Johnson (R-Wis.) published a May 27, 2021, email sent by Dr. Woodcock to Fauci and then-National Institutes of Health Director Francis Collins regarding the perceived need to set aside scientific research funds to later investigate COVID-19 vaccine side effects.

“I have been contacted by a number of people who have experienced adverse events post COVID-19 vaccination (from all three of the current vaccines),” wrote Woodcock. “Many are healthcare professionals, some of whom I know. The symptoms do not fit together into a distinctive syndrome and most are not easily quantifiable or evaluated with standard laboratory testing.”

Woodcock, who became acting FDA commissioner in January 2021 as the vaccines were being pushed on the nation, was sympathetic to the concerns of some apparent vaccine casualties that “no one takes them seriously, no one knows how to treat them” and that there had been “no effort to study this.”

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“I think it would be worthwhile to do a study and evaluate a cohort of these individuals,” said Woodcock. “But of course $ need to be made available, and you would need an investigator who is interested in ‘medical mysteries.’ I doubt the industry would support, for obvious reasons.”

Woodcock provided Blaze News with insights into her proposal.

“I was thinking, ‘Could we find some kind of treatment to offer these folks?’ But first, you have to understand what’s going on, right? You can’t just sort of go out and treat people,” Woodcock told Blaze News. “So that was my objective in this. … I don’t think it’s probably different than any other immune challenge, and I wouldn’t want anyone to think that I felt the vaccine was dangerous or should not be used or anything. By no means. It was simply that if people were having this reaction, we could find a way to study it.”

When pressed — in light of her concerns at the time — about the “safe and effective” description, Woodcock responded, “Well, look. I always told our press office, ‘Don’t call it safe and effective, because no medical intervention is 100% safe.’ Even water. You could kill yourself by drinking too much water, literally.”

The FDA noted in recent years that it was “confident in the safety and effectiveness” of the COVID-19 vaccines. While apparently hesitant herself to use that phrasing, Woodcock stated in 2021 that “the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”

Woodcock offered Blaze News what she regards as a better pitch for the vaccine: “What it is is the benefits far outweigh the risks, and that’s the standard for all drugs that are approved, all medicines that are approved, because none of them are free of side effects, which is the kind of ordinary, you know, meaning of the term ‘safe.'”

While the former acting commissioner noted that many health experts suggested during the pandemic that the “benefits way outweigh the potential harms” of the vaccines, people nevertheless “do use the term ‘safe and effective’ a lot, which is a statutory term.”

Woodcock emphasized that any intervention “that you do has to be pretty safe, right? But that doesn’t mean it’s totally without adverse events.”

Adverse events were in some cases deadly.

The FDA admitted in an internal letter last year that FDA Office of Biostatistics and Pharmacovigilance career staff had “found that at least 10 children have died after and because of receiving COVID-19 vaccination.”

Dr. Vinay Prasad, the former chief medical officer at the FDA and director at the Center for Biologics Evaluation and Research, said in the letter that the OBPV performed an analysis of 96 deaths between 2021 and 2024 and concluded “that no fewer than 10 are related. If anything, this represents conservative coding, where vaccines are exculpated rather than indicated in cases of ambiguity. The real number is higher.”

On the matter of takeaways from the handling of the pandemic, Woodcock told Blaze News that while the “development of the vaccines was a scientific triumph,” “science doesn’t tell you what to do. Scientists often forget that.”

“Science just tells you the facts,” she continued. “What do to do — especially about society, right — is a value judgement that should take into account the facts, but science doesn’t tell you what your actions should be.”

HHS and the FDA did not immediately respond to Blaze News’ requests for comment.

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