Writing in separate editorials in The New England Journal of Medicine and The Journal of the American Medical Association, former chiefs of federal scientific agencies issued warnings about the changes being proposed to vaccine frameworks by current officials.
More than a dozen former FDA and CDC officials warned of potential changes to federal vaccine policy in dual editorials published in two prominent medical journals on Wednesday.
The warnings come as the final 2025 meeting of the CDC’s Advisory Committee on Immunization Practices gets underway, where a number of changes, including to the birth dose of the hepatitis B vaccine, are set to be debated.
In an editorial in the New England Journal of Medicine published Wednesday, a dozen former FDA commissioners wrote that 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.”
Led by former commissioners Robert Califf and Janet Woodcock, the officials warned that proposed changes in a memo sent by Center for Biologics and Evaluation Research chief Vinay Prasad would “upend” in a “unilateral” manner longstanding policies around vaccine development and updates.
Among a series of changes, Prasad’s memo, according to the writers, “rejects” the FDA’s use of immunobridging studies, which serve as “a reliable correlation with effectiveness” for well-understood vaccines with existing safety data, particularly for viruses that mutate frequently, like COVID-19 and influenza, and need seasonally updated vaccines.
Epidemiologists use immunobridging studies to compare updated vaccines to previous iterations, using immunological markers like neutralizing antibody titers to infer effectiveness.
Also on Wednesday, three infectious disease specialists and epidemiologists, led by former CDC chief Rochelle Walensky, published an editorial in the Journal of the American Medical Association, warning of the risks of changing the CDC’s policies around birth dose hepatitis B vaccination, the topic of the first day of ACIP’s December meeting.
In their JAMA piece, the authors, including Michael Abers, an infectious disease doctor at the Albert Einstein College of Medicine in New York and Angela Ulrich, an epidemiologist at the University of Minnesota, estimated the number of perinatal infections that occur under the revised guidelines.
Pushing the birth dose of hepatitis B, given to newborn infants, to one month post-birth would immediately increase hepatitis cases 8%, according to an analysis done by the authors. Further restricting the birth dose only to infants born to mothers testing positive for hepatitis B—another potential change under discussion at ACIP—would raise perinatal cases by 63%-76%.
While the authors said that they “applaud” revisiting routine vaccine recommendations as new data emerges, they 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.”
