FDA to add heart inflammation warning to Moderna, Pfizer vaccine fact sheets

The U.S. Food and Drug Administration said Wednesday it plans to add a warning to the Moderna and Pfizer COVID-19 vaccines, saying that some people have experienced heart inflammation after getting the vaccination.

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The announcement of the warning came after a Centers for Disease Control and Prevention’s vaccine safety group reported there is a “likely link” between certain COVID-19 vaccines and a rare heart inflammation.

“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,” Doran Fink, deputy director of FDA’s vaccines division, said during a CDC advisory committee meeting on COVID-19 vaccines.

The CDC Vaccine Safety Technical (VaST) Work Group said Wednesday that it had reviewed nearly 500 reports of myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the membrane surrounding the heart, in vaccinated adults under age 30. The group also said that incidents of myocarditis were notably higher after the second dose and higher in males.

The CDC has tracked more than 1,200 cases of myocarditis and pericarditis through June 11. More than 820 of those cases occurred after the second dose of an mRNA vaccine, and 65% of the cases were linked to the Pfizer vaccine.

The greatest number of the cases occurred in men under the age of 24, according to the report.

Pfizer’s vaccine has been authorized for use for people age 12 and up, while Moderna’s vaccine is available only to those over age 18.

After the FDA’s decision was announced, the US Department of Health And Human Services issued a statement saying vaccines are safe and effective and that cases of myocarditis and pericarditis are “extremely rare.”

“We strongly encourage everyone age 12 and older who are eligible to receive the vaccine under Emergency Use Authorization to get vaccinated,” the agency said.

The 1,200 documented cases represent 0.000008% of the more than 150 million people who have been vaccinated with either the Moderna or the Pfizer vaccine.

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

Myocarditis and pericarditis can both happen after a person gets some sort of viral infection, including the COVID-19 infection.

Symptoms of myocarditis include pain in the chest, heart palpitations and shortness of breath.

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