A number of cases of heart inflammation will lead the FDA to slap a new warning label on two COVID-19 vaccines available in the U.S.—the ones from Pfizer-BioNTech and Moderna.
The news comes as more than 177 million people have received at least one dose of a COVID-19 vaccine in the U.S., according to the CDC. Since April 2021, there have been more than 1,000 reports to the Vaccine Adverse Event Reporting System (VAERS) of heart inflammation, known as myocarditis and pericarditis, after receiving an mRNA COVID-19 vaccine. Both Pfizer and Moderna are mRNA vaccines.
"Based on the available data, a warning statement in the fact sheets for both health care providers and vaccine recipients and caregivers would be warranted in this situation," deputy director of FDA's vaccines division Doran Fink said in a briefing Wednesday.
The CDC and its partners are also reviewing the cases, which occurred mostly in male adolescents and young adults 16 and older. Most people who received care for the issue “responded well to treatment and rest and quickly felt better.”
The warning comes after President Joe Biden announced the nation would fall short of his goal to have 70% of U.S. adults vaccinated by July 4. As of June 23, at least 65.6% of adults have received at least one dose of a vaccine, according to the CDC.
Despite the additional warnings of the rare condition, the CDC still recommends anyone 12 and older receives the vaccine. More than 600,000 Americans have died from or with COVID-19.