FDA Chief Questions Universal Hepatitis B Newborn Vaccination Policy

FDA Commissioner Dr. Marty Makary has publicly questioned the CDC’s longstanding policy of universal hepatitis B vaccination for newborns, citing a lack of solid evidence to support administering the vaccine at birth to all infants. This challenge comes as the CDC’s vaccine advisory panel, recently reshaped under Health Secretary Robert F. Kennedy Jr., considers revising or eliminating the birth dose requirement amid concerns about political interference in vaccine policy. The original universal vaccination policy, adopted in the early 1990s after epidemiologists found many hepatitis B cases lacked identifiable risk factors, led to a 99% decline in cases among children and teens. Critics warn that delaying or removing the birth dose could jeopardize decades of progress in preventing hepatitis B, liver disease, and cancer, especially since maternal infection status is not always known at birth. While Makary supports vaccines generally, he argues for a more nuanced, risk-based approach, suggesting that vaccination might be deferred unless the mother is hepatitis B positive. Public health experts caution that such changes could increase infection risks, emphasizing the importance of maintaining evidence-based vaccination schedules to protect infant health.