FDA Drafts Black‑Box Warning Amid Safety Review The U.S. Food and Drug Administration announced a draft plan to add a black‑box warning—the most serious label—to COVID‑19 vaccines, with a possible final release by the end of 2025. Dr. Vinay Prasad, the agency’s chief medical and scientific officer, is directing the proposal. The warning remains provisional and may be altered before finalization[1].

Scope of Warning Unclear for Vaccine Types and Ages The FDA has not specified whether the warning will cover only Pfizer‑BioNTech and Moderna mRNA products or extend to all FDA‑approved COVID‑19 vaccines. It also has not indicated which age groups, if any, will be subject to the label change. This ambiguity leaves clinicians and patients without clear guidance[1].

Manufacturers Reaffirm Vaccine Safety Despite Warning Proposal In September, Moderna and Pfizer issued statements asserting that their COVID‑19 vaccines continue to be safe and effective, citing ongoing monitoring that has not identified new safety signals in children or pregnant women. Both companies emphasized that the data support continued use across all authorized populations. Their positions contrast with the FDA’s pending warning but rely on the same surveillance systems[1].

Investigation Probes Reported Vaccine‑Related Deaths Across Ages The FDA is conducting an investigation into reports of deaths potentially linked to COVID‑19 vaccination, following a memo from Dr. Prasad that referenced at least ten pediatric fatalities. No detailed data have been released to substantiate these claims, and the investigation’s scope includes multiple age cohorts. The probe is part of the broader safety review prompting the black‑box consideration[1].

Experts Demand Transparent Evidence Before Label Change Former federal officials and public‑health experts have publicly urged the FDA to base any black‑box warning on rigorous, independent analysis rather than political pressure. They argue that without transparent data, the warning could undermine public confidence in vaccines. These calls highlight tension between regulatory caution and the need for clear, evidence‑based communication[1].