The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans, the latest move by President Donald Trump’s health officials to undermine a vaccine that was a standout victory of his first term. The plan shocked outside experts, who said there was no basis for the warning.
A boxed warning, which appears at the top of prescribing information for medicines, is the agency’s most serious, designed to warn about risks such as death or life-threatening or disabling reactions that should be weighed against the intervention’s benefits. They can also be used when a risk might be lowered by using a medicine in a targeted way, such as only in certain groups.
Boxed warnings on opioids, for example, warn about risks of abuse, addiction, overdose and death. The acne medication Accutane carried a warning about the risks of birth defects when used during pregnancy. ACAM2000, a smallpox and mpox vaccine, has a warning about complications such as heart inflammation and encephalitis.
The plan to install the warnings for Covid-19 vaccines is being orchestrated by Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, according to one person, who declined to be named because they weren’t authorized to share the information publicly.
The plan has not been finalized and may still change. It wasn’t immediately clear whether the plans for the warnings, expected to be unveiled by the end of the year, would be applied only to mRNA vaccines or to all Covid-19 vaccines, or whether they would apply to all age groups. Three vaccines are approved by the FDA for use in the US, and two of them — from Pfizer and Moderna – use mRNA technology, which has been a key focus of the administration.
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