FDA plans to "move rapidly" to add a warning to fact sheets for Pfizer and Moderna's Covid-19 vaccines about the rare risk of developing inflammatory heart conditions, an agency official said Wednesday.
"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 vaccines.
The scope of the problem: The conditions are rare, with more than 1,200 cases under investigation as of June 11 among more than 150 million people who have received either the Pfizer or Moderna vaccine. CDC has found more cases occurring after the second shot of an mRNA vaccine. More cases have been reported among Pfizer vaccine recipients, which may be due to the fact that the shot is authorized for people age 12 and up, while Moderna's shot is only authorized for adults.
The "mRNA vaccines may be a new trigger for myocarditis," said Matthew Oster of the CDC. The condition can also occur after viral infection, including Covid-19.