Multiple outlets reported that FDA officials are considering adding a boxed (boxed/’black‑box’) warning to Covid‑19 vaccine labeling, a move that has drawn immediate criticism from public health experts and vaccine manufacturers. Reports cite internal agency memos and two sources familiar with FDA plans, while public health groups warned the change could reduce uptake despite existing safety data. The coverage includes reporting of a leaked memo attributed to senior FDA officials and statements from industry representatives noting robust global safety monitoring for authorized vaccines. Scientific and policy experts emphasized that boxed warnings are the agency’s most serious labeling tool and urged evidence-based justification before implementation. The debate underscores tensions at the FDA over vaccine communication and regulatory consistency. Clarifier: a boxed warning is the FDA’s most prominent safety notice in prescribing information intended to highlight serious or life‑threatening risk that must be weighed against benefits.