Published 19 hours ago • loading... • Updated 19 hours ago

'Black Box' Explained as Covid Vaccine 'to Get FDA’s Strongest Warning'

On MONDAY, Dec. 15, 2025 the U.S. Food and Drug Administration is reportedly weighing a boxed safety alert for COVID-19 vaccines, the agency's most serious label, but the proposal remains under review.
Boxed warnings are typically used for serious risks, with COVID vaccine labels already noting myocarditis and pericarditis, especially in males ages 12 to 24, though the FDA has not clarified if all vaccines are covered.
The U.S. Centers for Disease Control and Prevention reported vaccinated children had fewer COVID-related emergency visits, a 2022 study estimated nearly 20 million deaths were prevented, and Pfizer and Moderna emphasized close monitoring this year.
The reported plan has alarmed many outside health experts who see no scientific basis for a black box, while HHS cautioned claims are speculative until FDA announces a decision, Andrew Nixon said.
Three COVID vaccines are approved in the U.S., two use mRNA technology, and Coverage warned that a future dose could carry a serious safety warning, potentially affecting public perception; Dr. Aaron Kesselheim, Harvard University, expressed concern about the unclear decision process.

Insights by Ground AI