More than a dozen former leaders from the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have expressed concerns about proposed changes to federal vaccine policy. Their comments come as the CDC’s Advisory Committee on Immunization Practices (ACIP) begins its final meeting of 2025, where several vaccine recommendations, including those related to the hepatitis B birth dose, are under review.
In an editorial published Wednesday in the New England Journal of Medicine, twelve former FDA commissioners stated they are “deeply concerned by 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.” The group was led by former commissioners Robert Califf and Janet Woodcock.
The editorial points to a memo from Vinay Prasad, chief of the Center for Biologics and Evaluation Research. According to the authors, Prasad’s memo would “upend” longstanding policies around vaccine development in a “unilateral” way. One significant change highlighted is the rejection of immunobridging studies by the FDA. These studies use immunological markers such as neutralizing antibody titers to compare updated vaccines with previous versions, helping infer effectiveness—especially important for frequently mutating viruses like COVID-19 and influenza that require seasonal updates.
On Wednesday, another editorial appeared in the Journal of the American Medical Association. It was authored by three infectious disease specialists and epidemiologists led by former CDC chief Rochelle Walensky. They focused on potential changes to CDC policies regarding hepatitis B vaccination at birth—a key topic at ACIP’s December meeting.
The JAMA editorial included contributions from Michael Abers of Albert Einstein College of Medicine in New York and Angela Ulrich from the University of Minnesota. The authors estimated that delaying administration of the hepatitis B vaccine from birth to one month could increase cases by 8%. Restricting vaccination only to infants born to mothers who test positive for hepatitis B could result in a 63%-76% rise in perinatal infections.
While acknowledging that revisiting routine vaccine recommendations is important as new data becomes available, they cautioned: “delaying the first hepatitis B vaccine dose beyond the newborn period introduces risks that have lifelong detrimental consequences and no measurable health benefit.”
