Federal vaccine policy is in flux after internal CBER memos and agency planning signalled a stricter evidentiary bar for vaccine approvals, prompting public debate and scrutiny. FDA leadership has proposed requiring randomized clinical data across intended populations rather than relying on surrogate endpoints or extrapolation. The proposal, outlined in an internal memo from CBER leadership and covered in STAT and industry outlets, has drawn criticism and concern from clinicians and vaccine experts who warn changes could delay access to routine childhood respiratory vaccines. Agency documents and reporting indicate the move is pitched as strengthening safety and benefit demonstration but will reshape trial design, timelines and manufacturer obligations.