Reports indicate the U.S. Food and Drug Administration is weighing a boxed (black‑box) warning for COVID‑19 vaccines, a regulatory step that outside experts say would be unprecedented for broadly used vaccines and could sharply reduce uptake. Sources described internal deliberations at the FDA and memos from agency officials prompting debate inside public health circles. Public health and infectious‑disease clinicians told reporters that the available real‑world safety data do not support adding the agency’s most serious warning to COVID‑19 vaccines, and that such a label could worsen vaccine hesitancy. The reports quote agency insiders and HHS spokespeople and note ongoing reviews of pediatric safety analyses. Regulators have not finalized any labeling change; the accounts underscore widening tensions between the FDA’s staff analysts, senior officials and outside experts over how to communicate rare safety signals while preserving vaccine confidence.