FDA to add heart risk warning to mRNA vaccines

The FDA on Wednesday said it will add a warning about rare cases of heart inflammation in teens and young adults to fact sheets for the Pfizer/BioNTech and Moderna COVID-19 vaccines – but that the benefits greatly outweigh the risks - and are still recommending the vaccine for all Americans over 12 years old.

CDC advisory groups found the risk of the heart condition in adolescents and young adults is likely linked to the mRNA vaccines… And that the risk is notably higher after the second dose and in males.

Doctors and hospitals have been warned by the CDC to watch for symptoms of myocarditis or pericarditis, and the FDA warning will further raise awareness.

But in a Wednesday meeting, advisors said the benefits of the mRNA vaccines appeared to clearly outweigh the risk.

In a separate report, the CDC said that the patients with heart inflammation following vaccination generally recover from the symptoms and do well.

The cases are extremely rare. Data from the CDC suggests heart inflammation is seen at a rate of about 13 cases per million in the three weeks after the second shot in 12- to 39-year-olds.

HHS - along with leading U.S. doctors groups and public health officials - issued a statement urging all eligible Americans to still get vaccinated.