Former FDA commissioners raise alarm over new vaccine policy

Rachel Cohrs Zhang, Bloomberg News on Dec 3, 2025

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The U.S. Food and Drug Administration’s new vaccine approval philosophy upends established regulatory practices and could put the health and safety of Americans at risk, according to an article written by a dozen of the agency’s former leaders.

The revamped framework was described in an internal email written by Vinay Prasad, the FDA’s top vaccine regulator, last week. Prasad said the agency will impose stricter standards for immunizations after he claimed — without evidence — that a review found 10 children died because they received a Covid vaccine. He also suggested that agency employees should quit if they disagreed with him.

“These measures, and the unilateral way they are being imposed, undermine the public interest,” wrote the former commissioners, who served under presidents from both political parties stretching back more than three decades, in the New England Journal of Medicine. “They are the latest in a series of troubling changes at the FDA, including substantial departures of FDA staff, that could diminish both the FDA’s strength and Americans’ health and safety.”

The new paradigm would make it difficult to update vaccines to protect the public against rapidly evolving respiratory viruses, they wrote in a scathing criticism of changes at the agency during President Donald Trump’s second term.

In a statement Wednesday night, an FDA spokesperson said the agency would soon release documents laying out the new framework as well as data “confirming how the Covid-19 vaccine resulted in children’s deaths that previous leadership failed to properly investigate.”

“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,” the spokesperson said. “The American people deserve evidence-based science.”

It’s not feasible to repeat large-scale clinical trials to test the effectiveness of established immunizations against each new strain of vaccine-preventable disease, especially those that evolve quickly, the former leaders wrote in the article. Requiring long, expensive studies would delay the development of shots best matched to circulating illnesses. They also questioned whether alleged safety signals in Covid vaccines for children warrant upending vaccine access for vulnerable populations, including those with weakened immune systems and older adults.

The authors include former Senate-confirmed and acting commissioners dating back to the 1990s, including Robert Califf, Brett Giroir, Scott Gottlieb, Margaret Hamburg, David Kessler, Stephen Ostroff and Mark McClellan. They served in the administration of former President George H.W. Bush and include officials appointed during the first Trump administration. Stephen Hahn, Trump’s FDA commissioner when the Covid pandemic hit in 2020, wasn’t included.

Prasad’s memo is the latest in a series of actions the Trump administration has taken to upend vaccine policy under Health Secretary Robert F. Kennedy Jr.’s leadership. Officials have unilaterally changed recommendations for Covid vaccines, demanded additional studies when they approve immunizations, fired expert advisers and discussed changing how routine childhood shots are administered.

“The proposed new directives are not small adjustments or coherent policy updates,” the former commissioners wrote. “They represent a major shift in the FDA’s understanding of its job.”

Shares of vaccine makers including Moderna Inc., BioNTech SE, Novavax Inc. and Vaxcyte Inc. dropped after Prasad’s memo became public.

The former leaders also voiced concern that major policy changes were made without normal input from the public or agency officials. Prasad’s demand that agency employees resign if they disagreed with his ideas is counterproductive to developing a culture where agency staff are free to openly challenge leadership and engage with external scientists, they wrote.

Prasad’s tenure has been polarizing. He departed the agency over the summer — and was re-hired two weeks later — amid blowback over his handling of safety concerns related to a rare disease drug.