Former FDA and CDC Leaders Warn Against Proposed Vaccine Policy Changes Amid ACIP Deliberations
Key Insights
More than a dozen former FDA commissioners published a warning in the New England Journal of Medicine opposing proposed changes to vaccine approval standards by current FDA biologics chief Vinay Prasad.
The former officials argue that rejecting immunobridging studies would undermine the regulatory framework for vaccines that require frequent updates, particularly COVID-19 (search) and influenza (search) vaccines.
Former CDC (search) director Rochelle Walensky and colleagues published analysis in JAMA showing that delaying hepatitis B (search) birth dose vaccination could increase perinatal infections by 8% to 76%.
More than a dozen former FDA and CDC (search) officials have issued stark warnings about potential changes to federal vaccine policy through dual editorials published in prominent medical journals, as the CDC's Advisory Committee on Immunization Practices convenes for its final 2025 meeting.
Former FDA Commissioners Challenge Regulatory Changes
In a New England Journal of Medicine editorial published Wednesday, twelve former FDA commissioners expressed deep concern over "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."
Led by former commissioners Robert Califf and Janet Woodcock, the officials specifically criticized a memo from Center for Biologics and Evaluation Research (search) chief Vinay Prasad that would "upend" longstanding vaccine development policies in a "unilateral" manner.
The former commissioners highlighted particular concern over Prasad's memo "rejecting" the FDA's use of immunobridging studies, which serve as "a reliable correlation with effectiveness" for well-understood vaccines with existing safety data. These studies are especially critical for viruses that mutate frequently, such as COVID-19 (search) and influenza (search), which require seasonally updated vaccines.
Epidemiologists rely on immunobridging studies to compare updated vaccines to previous iterations, using immunological markers like neutralizing antibody titers to infer effectiveness without requiring lengthy new clinical trials.
Hepatitis B Vaccination Policy Under Scrutiny
Simultaneously, three infectious disease specialists and epidemiologists, led by former CDC (search) chief Rochelle Walensky, published an editorial in the Journal of the American Medical Association warning of risks associated with changing CDC policies around birth dose hepatitis B (search) vaccination.
The authors, including Michael Abers from Albert Einstein College of Medicine and Angela Ulrich from the University of Minnesota, conducted analysis estimating the impact of revised guidelines on perinatal infections.
According to their calculations, pushing the birth dose of hepatitis B (search) from newborn administration to one month post-birth would immediately increase hepatitis cases by 8%. More restrictive changes under ACIP discussion—limiting the birth dose only to infants born to mothers testing positive for hepatitis B—would raise perinatal cases by 63% to 76%.
Clinical Impact and Public Health Concerns
The JAMA authors acknowledged they "applaud" revisiting routine vaccine recommendations as new data emerges, but warned that "delaying the first hepatitis B vaccine dose beyond the newborn period introduces risks that have lifelong detrimental consequences and no measurable health benefit."
These policy debates are occurring as ACIP deliberates changes to hepatitis B (search) vaccination protocols during its December meeting, with birth dose vaccination serving as a primary topic for the first day of discussions.
The former FDA commissioners warned that the proposed regulatory changes could suppress innovation, slow vaccine updates for emerging diseases, create higher expenses for new market entrants, and ultimately risk Americans' health and safety. They emphasized that requiring new studies could delay the arrival of vaccines better matched to new outbreaks or patient populations, potentially hindering timely public health responses.