The US Food and Drug Administration (FDA) plans to add a “black box” warning to COVID-19 vaccines, CNN reported, citing two people familiar with the decision.
A boxed warning—the FDA’s most serious alert—highlights risks such as death or life-threatening or disabling reactions that must be weighed against a medication’s benefits.
The move to add boxed warnings to COVID-19 vaccines is being led by Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, the report added.
The plan is not yet final and could still change. It’s unclear whether the proposed warnings—expected by year-end—would apply only to mRNA vaccines or to all COVID-19 vaccines, and whether they would affect every age group. Of the three FDA-approved Covid vaccines in the U.S., two—Pfizer (PFE) and Moderna (MRNA) —use mRNA technology, which has been a central focus for the administration.
Moderna (MRNA) co-founder and chairman Noubar Afeyan recently defended mRNA vaccines amid an FDA probe into potential vaccine-related deaths, emphasizing that extensive studies show strong safety data and that the shots are estimated to have prevented nearly 20 million deaths globally in their first year — more than a million in the U.S. He urged regulators to focus on “facts and evidence.”
The FDA is “doing a thorough investigation, across multiple age groups, of deaths potentially related to Covid vaccines,” an agency spokesperson told Bloomberg earlier this month.
Bloomberg also reported that the FDA is examining safety data for RSV shots in infants. Sanofi’s (SNY) Beyfortus (nirsevimab) and Merck’s (MRK) Enflonsia (clesrovimab) are approved for this population.