Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad, M.D., have drawn harsh pushback from 12 former commissioners of the agency.
The proposed changes, as laid out in a leaked memo from Prasad to staffers at the agency’s Center for Biologics Evaluation and Research on Nov. 28, would “disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections,” the 12 former FDA leaders wrote in a Dec. 3 article in The New England Journal of Medicine.
The 12 commissioners collectively guided the FDA for more than 35 years during both Republican and Democratic administrations. The astounding unanimity gathered by the former FDA leaders in such a short turnaround shows the urgency and seriousness of the matter at a time when both U.S. vaccine policies and the FDA itself are undergoing major turbulence.
The former commissioners said they are “deeply concerned” by the proposed policies, along with Prasad’s invitation for staff members who disagree with his regulatory approach to “submit your resignation letters.”
“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 commissioners wrote.
In the memo, Prasad linked “no fewer than 10” deaths of children to the use of COVID vaccines, going on to suggest that the shots may not offer absolute benefits in reducing severe disease and death. The FDA, in approving the shots, “may have harmed more children than we saved,” the official concluded.
The death cases were drawn from the Vaccine Adverse Event Reporting System, which serves to flag potential safety signals. But, in their article, the former commissioners wrote that data from the system must “be evaluated in carefully designed investigations” because it collects unverified reports. Prasad’s memo did not include detailed information on how a causal relationship was drawn between the deaths and the vaccines.
Previously, the FDA had carefully reviewed all the adverse events cases and reached different conclusions, the former commissioners wrote. “The memo offered no explanation of the process and analyses that were used to reach the new retrospective judgment, nor did it indicate why that assessment should justify wholesale rewriting of vaccine regulation,” they wrote.
Going forward, the FDA will require more definitive data before authorizing vaccines for pregnant women, Prasad said in the memo.
Prasad, who, besides overseeing the FDA’s review of vaccines also serves as the agency’s chief medical and scientific officer, also teased other upcoming policy changes such as rejecting immunogenicity data as an acceptable way to expand indicated populations of existing vaccines and requiring large studies before vaccines can be promoted as safe to administer together.
“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.”
Seasonal updates to existing vaccines such as those for influenza typically rely on antibody level data rather than an examination of hard clinical endpoints such as hospitalizations. It’s not completely clear whether Prasad’s rejection of immunogenicity data as approvable for “most new products” would apply to seasonal vaccines. But he did call the existing annual flu shot framework “an evidence-based catastrophe.”
The former commissioners argued that forgoing the immunogenicity pathway would slow the replacement of older products with better ones and harm competition because outcomes studies that Prasad wants are long and expensive.
What’s more, the former FDA leaders took issue with “the unilateral way” the proposed measure are being imposed.
“[C]hanges of this magnitude should be developed by guidance or regulation, with broad consultation within the agency, meaningful opportunity for public comment, and often public advisory-committee input,” the former commissioners wrote.
In his memo, Prasad said he’s open to debate on the topics but said these discussions should be internal until the agency is ready to go public. Those who do not agree with these “core principles and operating principles” should “submit your resignation letters,” he added.
“Demands for ideological alignment as a condition of employment are irreconcilable with an agency whose strength is the pluralism of its expert views,” the former commissioners wrote in their article. “Americans’ safety depends on a culture in which evidence is reviewed openly and staff can surface concerns, challenge leadership, and engage with external scientists without fear of reprisal.”
The 12 former FDA commissioners include Scott Gottlieb, M.D., who spent two years leading the FDA under the first Trump administration. One notable absence from the co-authors of the article is Gottlieb’s successor Stephen Hahn, M.D., who until recently worked as a CEO-partner of Flagship Pioneering, the venture capital firm that launched COVID vaccine maker Moderna. He was named the CEO of CDMO Nucleus RadioPharma in August.
Editor's Note: The story was updated to reflect Stephen Hahn's current role.