FDA Actions Pose More Threats to The Availability of Life-Saving Vaccines

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RM Califf et al. N Engl J Med 2026;394:4-6. A Threat to Evidence-Based Vaccine Policy and Public Health Security at the FDA

This editorial by 12 former FDA commissioners of both Democratic and Republican administrations is sharply critical of recent policy changes at the FDA which threaten the supply of life-saving vaccines.

Here is an excerpt:

“The existing regulatory model builds public trust by encouraging open information exchange and rigorous, transparent scientific debate. Yet a memo sent last week to FDA staff will upend core policies governing vaccine development and updates…

The memo (available at https://www.biocentury.com/article/657740) was written by Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), who also serves as the agency’s chief scientific officer, chief medical officer, and acting head of CBER’s office of biostatistics, as well as overseeing the division responsible for vaccine review and approval. His memo characterizes the actions of FDA scientists who express concerns about agency processes or decisions to outside parties as “unethical” and “illegal.” It calls for scientific debates to be kept within the agency “until they are ready to be made public,” and instructs staff members who disagree with the new framework to “submit your resignation letters.”..

If enacted, the framework would impede the ability to update vaccines to keep up with the natural evolution of respiratory viruses or changes in the prevalence of bacterial serotypes…

The new framework rejects the agency’s long-standing reliance on “immunobridging” studies for well-understood vaccines with extensive safety data. Using this approach, once a reliable correlation with effectiveness has been established, a vaccine’s ability to stimulate the immune system to produce protective antibodies can serve as a surrogate for its efficacy in helping patients avoid infections and complications from rapidly evolving viruses such as SARS-CoV-2 and influenza. Because these viruses change frequently, repeating large-scale efficacy trials for every new seasonal strain is not feasible within the time needed to update the vaccines…

Abandoning the existing methods won’t “elevate vaccine science,” as the memo asserts. It will subject vaccines to a substantially higher and more subjective approval bar. The proposed measures will slow the replacement of older products with better ones and will create potentially prohibitive expenses for new market entrants…Moreover, insisting on long, expensive outcomes studies for every updated formulation would delay the arrival of better-matched vaccines when new outbreaks emerge or when additional groups of patients could benefit…

The new approach would also evade public transparency, including long-standing statutory and regulatory mechanisms that enable disagreements about benefit–risk balance, clinical trial end points, trial design, and data analysis to be aired in public…

The benefits and risks of many established vaccines are well understood, and imposing the new approval requirements without meaningful new evidence could make it impossible to keep up with evolving infectious threats.

The memo asserts, incorrectly, that “we do not have reliable data” on the benefits of Covid vaccination in children. Reasonable scientists should engage in open debate about how best to shape recommendations for children at lower risk for Covid-19, but substantial evidence shows that vaccination can reduce the risk of severe disease and hospitalization in many children and adolescents…

 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.

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In a nearby neighborhood, my wife and I went walking and came across a “free art” stand which looked similar to a “free little library” stand. We picked out this small piece (about 5 inches on each side).

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