FDA to add warning about rare heart inflammation to Moderna, Pfizer vaccine fact sheets – POLITICO
The CDC meeting follows an FDA advisory committee discussion earlier this month about cases of myocarditis and pericarditis seen in a small number of patients who received either of the two available mRNA shots. Health officials are particularly focused on cases seen in people 30 and younger.
FDA wanted to hear from the CDC committee before finalizing the language, Fink said. The FDA warning likely will note that there may be a risk of developing myocarditis or pericarditis within a week after receiving a second dose of either the Pfizer or Moderna shots, and that most cases appear to resolve themselves, he said. Long-term effects, however, are still unclear.
The scope of the problem: The conditions are rare, with more than 1,200 cases under investigation as of June 11 among more th...