The US Food and Drug Administration is adding a warning that notes a link between a rare inflammatory heart condition among teens and young adults and the Pfizer-BioNTech and Moderna SARS-CoV-2 vaccines, Reuters reports.
It says that an advisory panel to the Centers for Disease Control and Prevention found there was a "likely association" between the mRNA-based vaccines and the condition but that the benefits of vaccination still outweigh the risks. According to CNBC, there have been about 1,200 cases of myocarditis or pericarditis among people 30 years old or younger who received the Pfizer-BioNTech or Moderna SARS-CoV-2 vaccines, noting that 300 million doses have been administered.
"This is still a rare event," Tom Shimabukuro, deputy director of the CDC's Immunization Safety Office, said during the meeting of the CDC's Advisory Committee on Immunization Practices, according to CNBC.
The CDC notes that individuals who develop the inflammation typically recover, Reuters says. It further reports that Pfizer says it has not observed a higher-than-expected rate of inflammation and that Moderna says it is aware of the reports and is working with regulators and public health officials.