The U.S. Food and Drug Administration intends to place a black box warning on COVID-19 vaccines, CNN reported, citing sources.
Black box warnings appear at the top of prescribing information for medicines. They are the FDA’s most serious warnings, intended to alert the public to risks such as death or life-threatening reactions that should be weighed against the benefits.
The plan has not been finalized and may still change. It is expected to be unveiled by the end of the year.
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The move follows the FDA’s requirement for updated warning labels on mRNA COVID-19 vaccines regarding myocarditis and pericarditis. The vaccines have been associated with a rare risk of myocarditis, which causes damage to heart muscle cells.
Earlier this week, Stanford University released a study showing that mRNA-based COVID-19 vaccines cause myocarditis in about one in every 140,000 recipients after the first dose. That rate rises to one in 32,000 after the second dose. Males under age 30 face the highest risk.
The study, however, found that COVID-19 itself is 10 times more likely to cause myocarditis than the vaccine.
“The mRNA vaccines have done a tremendous job mitigating the COVID pandemic,” said Dr. Joseph Wu, director of the Stanford Cardiovascular Institute. “Without these vaccines, more people would have gotten sick, more people would have had severe effects and more people would have died.”
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According to a 2023 National Library of Medicine report, more than 400 medications have boxed warnings.
“Medications with boxed warnings associated with them may have adverse financial consequences as these warnings can affect the marketability of the drug and generate negative news reports,” the report said. “Clinicians must use their clinical judgment on whether to prescribe medications with these warnings. Boxed warnings are not meant to be absolute contraindications, but instead to draw attention to potential severe side effects.”
