FDA Intends to Put Most Serious Warning on COVID Vaccines, CNN Reports

The U.S. Food and Drug Administration intends to put a “black box” warning on COVID-19 vaccines, CNN reported on Friday, citing two people familiar with the agency’s plans.

The warning is the most serious type and highlights major risks such as severe side effects and restrictions.

The plan to include the warnings for COVID shots is being orchestrated by Vinay Prasad, the FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, according to the report.

“Unless the FDA announces it, any claim about what it will do is pure speculation,” U.S. Department of Health and Human Services spokesperson Andrew Nixon said about the plans to include the warning.

Following the CNN report, vaccine maker Moderna pointed to a statement it issu