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Former FDA, CDC leaders warn that US vaccine policy is under threat

By CNN Newsource

Published December 3, 2025 2:08 PM

By Deidre McPhillips, CNN

(CNN) — Former US public health officials are sounding alarms about significant changes being made to the country’s vaccine policy under the Trump administration. Two public letters this week — one from former commissioners of the US Food and Drug Administration and one from former leaders at the US Centers for Disease Control and Prevention — warn that health leadership spearheaded by Robert F. Kennedy Jr. and a panel of recently appointed advisers are putting the public’s health at risk with a haphazard approach to vaccine science.

Last week, Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, said in an internal memo that the FDA would be changing its vaccine approval process, alleging that Covid-19 vaccination resulted in the deaths of 10 children.

But in a letter published Wednesday in the New England Journal of Medicine, a dozen former FDA commissioners warned that the proposed changes would “upend core policies governing vaccine development and updates” and “undermine the public interest.”

The proposed changes were motivated by unjustified assertions about the dangers of vaccines, the former commissioners wrote.

“We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe, effective, and available when the public needs them most,” they wrote. The group consists of agency leaders who served under both Democratic and Republican administrations, with more than 35 years of combined oversight.

In the letter, the former commissioners noted the importance of willingness to re-examine standards when warranted — but they caution that scientific debate must happen in well-established forums that were established to encourage rigorous discussion in a transparent way.

They say current FDA leadership is skirting these core principles of the agency, offering “no explanation of the process and analyses” used to re-examine the 10 pediatric deaths that were at the core of proposed changes, nor an explanation that would “justify wholesale rewriting of vaccine regulation.”

They also warn that proposed changes to the approval process — namely changes to the types of studies and evidence needed for vaccines to come to market — rejects longstanding safety standards and adds undue burden, which would “suppress innovation and competition.” The changes could cause delays in development that may cost lives if vaccine manufacturers can’t adapt quickly enough to “keep up with the natural evolution of respiratory viruses” or changes in bacteria.

“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,” the former FDA commissioners wrote.

“If the goal is to rebuild confidence, the answer is not to toss aside the basic rules of science, stifle argument and oversight, or supplant expert scientific inquiry for the unilateral decision making of a few individuals,” they wrote. “It is to insist on open deliberation, solid evidence, and procedures the public can see and trust.”

The FDA did not immediately respond to CNN’s request for comment.

Key CDC meeting this week

The letter comes on the eve of a pivotal meeting of a committee that advises the CDC on vaccine policy. Earlier this year, Kennedy, secretary of the US Department of Health and Human Services, completely overhauled the Advisory Committee on Immunization Practices, or ACIP.

The committee may vote this week to make a major change to the childhood vaccine schedule, potentially delaying a dose of the hepatitis B vaccine given to newborns by weeks or even years — a possibility that has concerned many public health experts.

In an opinion piece published Wednesday in Stat, three former CDC leaders who resigned in protest this summer after former director Dr. Susan Monarez was ousted said ACIP “appears poised to raise vaccine risks while burying their benefits.”

They say the ACIP meetings in June and September show concerning signs of a “committee losing its footing,” with data presentations that “lacked substantial evidence or peer review.”

“When a scientific body stops following its own procedures, rigor and transparency both slip, and public trust erodes,” they wrote. And “loosely defined sessions” for this week’s meeting “could invite misapplied risk framing.”

They caution that simply raising dangerous hypotheticals in a setting like this can have a significant effects on public health.

“Even if the committee takes no drastic action, raising fringe concerns in an official forum can legitimize their ideological questions, an increasingly common tactic among newer members,” the former CDC leaders wrote. “Misguided discussions don’t remain theoretical. They shape public perception, influence future votes, and trigger ripple effects in vaccine supply and coverage.”

HHS said in a statement that it “continues to promote transparency in vaccine safety data and to communicate clearly about both risks and benefits.”

“Secretary Kennedy reconstituted ACIP to strengthen its independence and to end past practices that favored established corporate interests over open scientific review,” the statement said. “ACIP will evaluate the full body of data at its meeting this week and will issue recommendations grounded in evidence-based and clear scientific standards.”

These aren’t the first public warnings public health leaders have raised about policy changes under Kennedy. In September, nine former CDC directors said in a New York Times opinion piece that Kennedy is “endangering every American’s health” in a “raging fire” of upheaval. More than 1,000 current and former HHS employees also sent a letter to Kennedy in September demanding his resignation.