Former FDA Commissioner Dr. Scott Gottlieb expressed significant concerns regarding a recent decision by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) to alter the Hepatitis B vaccination policy for newborns. During an interview on December 7, 2025, on “Face the Nation,” Gottlieb highlighted the implications of delaying the Hepatitis B vaccine from within 24 hours of birth to two months of age.
The American Academy of Pediatrics voiced alarm over the ACIP’s 8-3 vote, which represents a departure from a three-decade-long practice aimed at protecting infants from Hepatitis B, a virus that can lead to severe health issues, including chronic infection, liver disease, and even death. Gottlieb emphasized that 90% of newborns infected with Hepatitis B during delivery will likely develop chronic infections, underscoring the urgency of immediate vaccination.
In the interview, Gottlieb explained that while older children might clear the infection more easily, infants are particularly vulnerable. The risk of chronic infection significantly increases for newborns if they are not vaccinated right away. He noted that the change could lead to an estimated 1,400 new cases of Hepatitis B in the first year alone, with roughly 25% of those infants potentially facing life-threatening consequences.
Gottlieb criticized the narrative presented by the current administration, which downplays the transmission risk of Hepatitis B. He argued that the assertion that the virus is only transmitted sexually or through contaminated needles misrepresents the reality of how newborns can become infected during delivery.
Another facet of the discussion centered around the composition of the ACIP. Gottlieb expressed concern that some members of the committee may hold anti-vaccine sentiments, suggesting that their influence could shift the body’s credibility and effectiveness in guiding public health policy. He pointed out that significant changes in state legislation, with approximately 17 states already indicating they will disregard ACIP recommendations, could further erode public trust in the organization.
Impacts on Vaccine Development and Public Trust
The interview also touched on recent developments within the FDA, particularly concerning vaccine approval processes. Gottlieb noted a troubling trend where the FDA has indicated it will require new studies for vaccine approval, a shift that could hinder the development of future vaccines. He referenced a memo from Dr. Vinay Prasad, the head of the FDA’s vaccine division, which proposed moving away from established practices that allow for faster approval based on immunogenicity data rather than full-scale outcome studies.
Gottlieb emphasized that such changes could stifle innovation in vaccine development, making it more challenging to update vaccines annually to combat circulating strains of viruses. This shift in policy comes at a time when public confidence in vaccines is already under scrutiny, as highlighted by a sell-off in biotech stocks following reports of these changes.
The interview concluded with Gottlieb urging transparency from the FDA regarding any adverse event data linked to vaccines, particularly in light of claims regarding deaths post-vaccination. He called for rigorous analysis and public disclosure to restore confidence in regulatory processes and ensure that decisions are grounded in sound science.
As the landscape of U.S. public health policy continues to evolve, the impacts of these changes on vaccination strategies and public perception remain critical concerns for health professionals and families alike.
