Former FDA Commissioners Say They Are Concerned About Agency’s New Position on Vaccines

‘The proposed guidelines would dramatically change vaccine regulation,’ they said.

Former Food and Drug Administration Commissioner Dr. Robert Califf in Washington, in an undated file photograph. Joe Raedle/Getty Images

Twelve former Food and Drug Administration commissioners on Dec. 3 said they oppose the agency’s new position on vaccines, as outlined in a recent memorandum.

“The proposed guidelines would dramatically change vaccine regulation on the basis of a reinterpretation of selective evidence and by a process that breaks sharply with the norms that have anchored the FDA’s globally respected scientific integrity,” Dr. Robert Califf, the last FDA commissioner during the Biden administration, and 11 other ex-commissioners wrote in a opinion piece published by The New England Journal of Medicine.

“If enacted, the framework would impede the ability to update vaccines to keep up with the natural evolution of respiratory viruses or changes in the prevalence of bacterial serotypes; it would also suppress innovation and competition. The net effect would be to disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections.”

The article was written after Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER), said in a memo sent to FDA staffers on Nov. 28, and obtained by The Epoch Times, that an investigation determined COVID-19 vaccines contributed to the deaths of at least 10 children and that the agency would update its policies on vaccines moving forward.

“I want to outline a path forward,” Prasad wrote. “Our general approach in CBER will be to direct vaccine regulation towards evidence based medicine.”

That will include requiring pre-market randomized trials with clinical endpoints such as prevention of disease for most new products, and requiring pneumonia vaccine manufacturers to prove their products reduce pneumonia instead of merely showing they trigger antibodies, he said.

Califf and the other former commissioners said that the changes “represent a major shift in the FDA’s understanding of its job” and wrongly reject the agency’s long-standing practice of allowing updated vaccines based on immunobridging studies that rely on antibody data.

The updates “will subject vaccines to a substantially higher and more subjective approval bar” and “slow the replacement of older products with better ones and will create potentially prohibitive expenses for new market entrants, especially small biotechnology companies,” they wrote.

Califf reported several competing interests, including holding stock in the laboratory American Health Associates. Nine other former commissioners listed current or recent relationships with at least one pharmaceutical company, including Dr. Scott Gottlieb, who sits on the board of vaccine maker Pfizer, and Dr. Stephen Ostroff, who was a Pfizer consultant until January.

“The fact these criticisms are coming from former FDA officials who opposed raising the bar for vaccine science confirms we are on the right track,” a spokesperson for the Department of Health and Human Services, the FDA’s parent agency, told The Epoch Times in a Dec. 4 email. “Unfortunately, these former officials lowered standards to the point where pneumonia vaccines didn’t lower the rate of pneumonia and millions of Americans skipped the annual flu vaccine due to uncertain effectiveness year-to-year.”

The spokesperson added: “The American people deserve evidence-based science. Dr. Prasad’s email lays out a philosophical framework that points us toward that higher standard.”

Officials plan to soon release documents outlining the new position on vaccines as well as the probe into child deaths following COVID-19 vaccination. A specific date has not been designated for the release.