Internal FDA guidance and leaked memos have ignited a policy fight over U.S. vaccine approval standards and schedules. CBER leadership outlined proposals that would require randomized trial evidence for more vaccine uses and reconsider timing for routine childhood immunizations, prompting scientists and public‑health groups to push back. A separate, large literature review released days before the Advisory Committee on Immunization Practices (ACIP) vote strongly urged maintaining universal hepatitis B vaccination within 24 hours of birth, citing data from more than 400 studies that show infection reductions exceeding 95 percent. The timing dispute is immediate: ACIP deliberations could alter newborn hep B timing, with modelers warning that even modest delays would increase chronic infections. The episode underscores regulatory uncertainty and political pressure around vaccine policy, with potential implications for immunization programs, pediatric practice and population health outcomes.