A group of 12 former commissioners of the US Food and Drug Administration (FDA) have expressed concern about proposed changes to vaccine regulation in the US.
In a comment piece published in the New England Journal of Medicine, the party, which includes the agency’s most recent commissioner Robert Califf, said that plans outlined by current Center for Biologics Evaluation and Research (CBER) director Vinay Prasad “undermine” current regulatory frameworks that ensure safe and effective vaccines are available when needed.
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The article is in direct response to a memo sent by Prasad to FDA staff last week, which puts forward several guidelines that would significantly alter vaccine regulation in the US. If enacted, the proposals would “upend core policies governing vaccine development and updates” and “undermine public interest”, according to the former commissioners. Prasad’s email was first reported by the New York Times.
Chief among Prasad’s visions is a new framework that rejects the agency’s long-standing reliance on “immunobridging” studies for well-understood vaccines with extensive safety data. These studies use immunological markers to infer the effectiveness of a new drug through a surrogate measure of efficacy, helping to expedite access to new vaccines in the event of a public health need. For example, immunobridging studies were extensively employed when evaluating vaccine candidates during the Covid-19 pandemic.
The former commissioners said abandoning this existing framework “will subject vaccines to a substantially higher and more subjective approval bar”.
This will likely slow the rate at which improved vaccines replace older products, along with potentially adding costs to market entrants, especially impacting small biotechnology companies.
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By GlobalDataPrasad’s memo also calls for an internalisation of scientific debates within the agency, charactering those who express concerns about agency processes or decision as acting illegally and unethically.
Califf and the other authors comment that this approach would “evade public transparency”.
The motivation for these sweeping regulatory changes stems from claims by the FDA that Covid-19 vaccines caused the deaths of ten children. The agency has neither revealed full details of the studies it used to identify these deaths nor the analysis it used to ascertain vaccine causation.
Speaking to Fox News, current FDA commissioner Marty Makary said: “This was data that was accumulated during the Biden administration—they did not make it public. We’re going to make that information available.”
Tracy Beth Høeg led an investigation into Covid-19 vaccine safety over mid-2025. Earlier this week, she was appointed director of the FDA’s Center for Drug Evaluation and Research (CDER). She co-authored a paper with Makary on the risks of Covid-19 vaccine boosters for young adults in 2022.
US Health Secretary Robert F Kennedy (RFK) Jr overhauled the Centers for Disease Control and Prevention’s (CDC’s) vaccine committee this year, replacing members with well-known vaccine sceptics and individuals who were critical of both the Covid-19 vaccines and related countermeasures such as lockdowns. These changes were part of a wider initiative from the Trump administration on decreasing reliance on vaccines for respiratory diseases.
In a comment piece published in JAMA in June 2025, 17 former Advisory Committee (AdCom) on Immunization Practices (ACIP) members warned that the American immunisation programme was significantly weakened due to the sweeping regulatory changes.
With the commissioners’ comment article taking aim at the FDA, health leaders under the Trump administration are navigating an intense period of criticism.
“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. It is to insist on open deliberation, solid evidence, and procedures the public can see and trust,” the commissioners concluded in the journal.
