A year into Robert F. Kennedy Jr.'s leadership at HHS, the agency has enacted sweeping personnel and policy changes that critics say have disrupted established scientific norms. The tenure included a reduction in recommended childhood vaccines and staff departures across federal health agencies, prompting debate about long‑term effects on public health infrastructure. Concurrently, controversy around Vinay Prasad, head of the FDA office overseeing vaccines and biologics, intensified after his leadership decision to refuse Moderna’s flu vaccine submission. Allegations about management style and decision‑making have fueled industry concern about shifting regulatory expectations and the potential for unpredictable review outcomes. Biotech companies and policy observers are recalibrating regulatory risk assessments, noting that both HHS and FDA leadership choices now factor heavily into clinical strategy and market planning.