WASHINGTON, D.C. (CNN) – The U.S. Food and Drug Administration is weighing the addition of a black box warning to COVID-19 vaccines, based on information from two people familiar with the agency’s planning, indicating this possibility is under active consideration.
Black box warnings appear at the top of a drug’s labeling. They represent the FDA’s most serious cautions, designed to alert patients and providers to risks such as death, life-threatening reactions, or disability that must be weighed against the drug’s benefits.
It isn’t immediately clear whether the warning for COVID-19 vaccines would apply to vaccines that use messenger RNA technology, extend to all COVID-19 vaccines, or be limited to certain age groups.
The agency’s plan has not been finalized yet, but sources say it is expected to be disclosed by the end of the year.
