Twelve former commissioners of the US Food and Drug Administration have rebuked proposed changes to vaccine policy at the agency saying that the measures will impede the development of new products to prevent infectious disease. Led by Robert Califf, the commissioners outlined their concerns in an article in the 3 December 2025 edition of The New England Journal of Medicine. Dr Califf was FDA commissioner until January 2025. Altogether, the group represents more than 35 years of FDA oversight and policymaking.
The article takes aim at a memorandum written by Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research in late November, in which he outlines a new framework for updating vaccines for diseases such as influenza by requiring premarketing, randomised clinical trials for most new products including updated formulations of existing ones. The proposal would upend the current practice by which the FDA uses ‘immunobridging’ studies to update well-understood vaccines in response to the evolution of the viruses and changes in the prevalence of bacterial serotypes.
“The proposed measures will slow the replacement of older products with better ones and will create potentially prohibitive expenses for new market entrants, especially small biotechnology companies,” the authors write.
As justification for the new measures, the memorandum cites the deaths of 10 children allegedly caused by Covid-19 vaccines. The authors question this correlation, saying that there were no explanations for the analyses leading to this conclusion. They add that 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.”
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