Twelve former FDA commissioners publicly condemned proposed vaccine-policy changes and accused the agency’s biologics chief of threatening longstanding regulatory standards, publishing their critique in a major medical forum. Their rebuke focused on plans to require longer and larger studies for updated vaccines, arguing the move risks undermining timely vaccine updates and public trust. Amid that backlash, the FDA named Tracy Beth Høeg, M.D., Ph.D.—a physician involved in recent vaccine-safety investigations—as acting director of the Center for Drug Evaluation and Research (CDER). The appointment comes during rapid turnover at senior FDA posts and follows intense internal and external scrutiny of vaccine policy proposals. The confluence of a high-profile public rebuke and a leadership change heightens uncertainty about the agency’s regulatory posture on vaccines and therapeutics. Biotech companies and investors should expect continued debate on evidentiary standards, potential shifts in review timelines, and reputational fallout affecting FDA interactions and guidance.