Reports indicate the FDA is considering adding boxed (black‑box) warnings to Covid‑19 vaccine labeling; the move is being driven within the agency’s biologics branch and has ignited criticism from outside experts. Multiple sources told journalists the potential warnings could target specific platforms, age groups or all Covid vaccines, though agency decisions were not final. Public‑health and infectious‑disease specialists cautioned that boxed warnings—rare for vaccines—would be unprecedented and risk sharply reducing uptake despite extensive safety data. Federal spokespeople stressed no formal agency announcement had been made and that evaluations continue.