(CNN) — Former US public health officials are sounding the alarm over major changes being made to the country’s vaccine policy under the Trump administration. Two public letters this week — one from former commissioners of the U.S. Food and Drug Administration and one from former leaders of the U.S. Centers for Disease Control and Prevention — warn that health care leadership led by Robert F. Kennedy Jr. and a panel of recently appointed advisors are endangering public health 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, in an internal memo that the FDA would change the vaccine approval process, claiming that vaccination against Covid-19 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 “undermine core policies on vaccine development and updates” and “undermine the public interest.”
The proposed changes were motivated by unwarranted claims about the dangers of vaccines, the former commissioners wrote.
“We are deeply concerned by the FDA’s sweeping new claims about vaccine safety and by proposals that would undermine a regulatory model designed to ensure vaccines are safe, effective, and available when the public needs them most,” they wrote. The group is made up of agency leaders who served under both Democratic and Republican administrations, with more than 35 years of joint oversight.
In the letter, the former commissioners noted the importance of a willingness to re-examine standards when warranted – but they cautioned that scientific debate must take place in established forums established to encourage rigorous discussions in a transparent manner.
They say current FDA leadership is sidestepping these core agency principles and offering “no explanation of the process and analyses” used to re-examine the 10 child deaths that were at the heart of the proposed changes, nor an explanation that would “justify a wholesale rewrite of vaccine regulations.”
They also warn that proposed changes to the approval process — namely changes to the types of studies and evidence needed to bring vaccines to market — overturn long-standing safety standards and add unnecessary burdens that would “stifle innovation and competition.” The changes could cause development delays that could cost lives if vaccine makers cannot adapt quickly enough to “keep up with the natural evolution of respiratory viruses” or changes in bacteria.
“The proposed guidance would dramatically change vaccine regulation based on a reinterpretation of selective evidence and through a process that sharply breaks with the norms that have anchored the FDA’s globally respected scientific integrity,” the former FDA commissioners wrote.
“If the goal is to rebuild trust, the answer is not to override the basic rules of science, suppress arguments and oversight, or crowd out expert scientific research for the unilateral decision-making of a few individuals,” they wrote. “It is an insistence on open deliberation, solid evidence and procedures that the public can see and trust.”
The FDA did not immediately respond to CNN’s request for comment.
Important CDC meeting this week
The letter comes on the eve of a crucial meeting of a committee that advises the CDC on vaccine policy. Earlier this year, Kennedy, secretary of the U.S. Department of Health and Human Services, completely overhauled the Advisory Committee on Immunization Practices (ACIP).
The committee could vote this week to make a major change to the childhood vaccine schedule, potentially delaying the doses of hepatitis B vaccine given to newborns by weeks or even years — a possibility that worries many public health experts.
In one op-ed Published Wednesday in Stat, three former CDC leaders who resigned in protest this summer after former director Dr. Susan Monarez was impeached that ACIP “appears poised to increase vaccine risks while burying its benefits.”
They say the ACIP meetings in June and September show signs of a “committee losing its footing,” with data presentations that “lack substantial evidence or peer review.”
“When a scientific body stops following its own procedures, accuracy and transparency disappear and public trust erodes,” they wrote. And “loosely defined sessions” for this week’s meeting “may give rise to misapplied risk framing.”
They warn that simply advancing dangerous hypotheses in a situation like this could have significant public health consequences.
“Even if the committee doesn’t take drastic action, voicing fringe concerns in an official forum can legitimize their ideological questions, a tactic increasingly used among newer members,” the former CDC leaders wrote. “Misguided discussions do not remain theoretical. They shape public perception, influence future votes and cause ripple effects in vaccine supply and coverage.”
HHS said in a statement that it “continues to promote transparency in vaccine safety data and clearly communicate both risks and benefits.”
“Secretary Kennedy re-established ACIP to strengthen its independence and end past practices that favored vested corporate interests over open scientific review,” the statement said. “ACIP will review the full body of data at its meeting this week and make recommendations based on evidence-based and clear scientific standards.”
These are not the first public warnings public health leaders have issued about policy changes under Kennedy. In September, nine former CDC directors said in a New York Times op-ed that Kennedy was “endangering the health of every American” in a “raging fire” of unrest. More than 1,000 current and former HHS employees also sent a letter to Kennedy in September demanding his resignation.
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