FDA adds warning about heart inflammation to Pfizer, Moderna COVID vaccines

The U.S. drug regulator on Friday added a warning to the literature that accompanies Pfizer/BioNTech and Moderna COVID vaccines to indicate the risk of heart inflammation after inoculation.

For each vaccine, the fact sheets for healthcare providers have been revised to include a warning that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly after the second dose and with onset of symptoms within a few days after vaccination, the FDA said.

The cases appear to be notably higher in males and in the week after the second vaccine dose. The CDC identified 309 hospitalizations from heart inflammation in persons under the age of 30, of which 295 have been discharged.

Health regulators in several countries have been investigating cases of myocarditis and pericarditis, more frequently found in young men, after a shot of Pfizer or Moderna, vaccines that are based on the mRNA technology.

The latest update from FDA follows an extensive review of information and the discussion by CDC’s Advisory Committee on Immunization Practices meeting on Wednesday.

Myocarditis is a chronic disease responsible for up to 45 percent of heart transplants in the U.S.


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Source: https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-finds-myocarditis-caused-by-infection-on-rise-globally/