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FDA to add warning about rare heart inflammation to Moderna, Pfizer vaccine fact sheets - POLITICO
Jun 23, 2021 1 min, 23 secs

A CDC safety panel has determined there is a "likely association" between the Pfizer and Moderna shots and cases of myocarditis and pericarditis in vaccine recipients.

A CDC safety panel has determined there is a "likely association" between the Pfizer and Moderna shots, which both use mRNA technology, and cases of myocarditis and pericarditis in vaccine recipients, according to an analysis presented at the meeting Wednesday.

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.

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.

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.

In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.".

Keeping watch: If a link is established between the mRNA vaccines and the heart conditions, particularly among youths, the number of cases reported is likely to rise.

The CDC plans to recommend that patients who develop myocarditis after their first mRNA Covid shot delay their second dose until more data is collected on the condition's link to Covid-19 vaccines, said Sara Oliver of the agency's National Center for Immunization and Respiratory Diseases

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