Former US public health officials are raising alarms about significant shifts in 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 led by Robert F. Kennedy Jr. and a panel of recently appointed advisers are jeopardizing public health with a disorganized approach to vaccine science, reports BritPanorama.
Last week, Dr. Vinay Prasad, the FDA’s chief medical and scientific officer, stated 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.
However, in a letter published Wednesday in the New England Journal of Medicine, a dozen former FDA commissioners cautioned that these proposed changes would “upend core policies governing vaccine development and updates” and “undermine the public interest.”
The former commissioners noted that the changes were prompted by unfounded assertions about the dangers of vaccines.
“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. This group consists of agency leaders from both Democratic and Republican administrations, collectively possessing over 35 years of oversight experience.
While acknowledging the need for flexibility in policy, they cautioned that scientific debate must occur through established forums designed to facilitate rigorous and transparent discussions.
Current FDA leadership, they argue, is bypassing these essential principles, offering “no explanation of the process and analyses” related to the pediatric deaths associated with the proposed changes, nor any justification for “wholesale rewriting of vaccine regulation.”
They also warned that adjustments to the approval process—particularly changes to the evidence and studies required for vaccines to reach the market—would reject long-standing safety standards while imposing unnecessary burdens, thereby “suppressing innovation and competition.” Such delays in development could potentially cost lives, especially if vaccine manufacturers cannot respond swiftly to the evolution of respiratory viruses or bacteria changes.
“The proposed guidelines would dramatically change vaccine regulation based on a reinterpretation of selective evidence, deviating sharply from the norms that have anchored the FDA’s globally respected scientific integrity,” the former FDA commissioners asserted.
“If the goal is to rebuild confidence, the answer is not to discard the basic rules of science, stifle argument and oversight, or replace expert scientific inquiry with unilateral decisions by a few individuals,” they added. “It is to insist on open deliberation, solid evidence, and procedures the public can see and trust.”
The FDA did not immediately respond to requests for comment.
Key CDC meeting this week
This letter coincides with an important meeting of the committee advising 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 raised concerns among many public health experts.
In an opinion piece published Wednesday in Stat, three former CDC leaders who resigned in protest after the ousting of former director Dr. Susan Monarez expressed that ACIP “appears poised to raise vaccine risks while burying their benefits.”
They highlighted troubling trends from the ACIP meetings in June and September, where data presentations “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 stated, warning that “loosely defined sessions” for this week’s meeting could invite misapplied risk framing.
They cautioned that simply raising dangerous hypotheticals in an official setting might significantly impact 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 warned. “Misguided discussions don’t remain theoretical. They shape public perception, influence future votes, and trigger ripple effects in vaccine supply and coverage.”
In response, HHS stated that it “continues to promote transparency in vaccine safety data and to communicate clearly about both risks and benefits.”
The statement continued, emphasizing that “Secretary Kennedy reconstituted ACIP to strengthen its independence and to end past practices that favored established corporate interests over open scientific review.” The meeting this week aims to evaluate the full body of data and issue recommendations grounded in evidence-based scientific standards.
These concerns are not the first public warnings regarding policy changes under Kennedy. In September, nine former CDC directors expressed in a New York Times opinion piece that Kennedy is “endangering every American’s health” amid a “raging fire” of upheaval. Additionally, over 1,000 current and former HHS employees sent a letter to Kennedy demanding his resignation.
