FDA to Add Warning Label for Heart Inflammation on Pfizer’s Covid Vaccine

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The U.S. Food and Drug Administration said Wednesday it would add a new label on the Covid-19 vaccine developed by Pfizer/BioNTech warning that rare cases of heart inflammation could occur in patients after taking it.

“The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination,” health officials including Dr. Rochelle Walensky  said in a statement accompanying the announcement. “Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment.”

The statement came after the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices found more than 1,200 cases of pericarditis or myocarditis had occurred in people who took the Pfizer/BioNTech vaccine. The conditions cause heart pain, especially during physical exertion, and are sometimes fatal.

As of June 11, a total of 267 cases had been reported after the first dose of the vaccine, and 827 reported after the second dose. Men under 30 comprised the bulk of complainants. Age may account for the fact that Pfizer has been the subject of more complaints than its competitors, Moderna and Johnson & Johnson. Pfizer’s vaccine is the only one approved for use in those aged 12 to 18.

“We know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe,” the health officials added in their statement. “We strongly encourage everyone age 12 and older who are eligible to receive the vaccine … to get vaccinated, as the benefits of vaccination far outweigh any harm.”