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.
As part of our commitment to vigilant safety monitoring of #COVID19 vaccines, FDA updated the public on its ongoing evaluation of adverse event reports of myocarditis & pericarditis following vaccination with Moderna and Pfizer-BioNTech COVID-19 vaccines. https://t.co/xI8nzp1GEm pic.twitter.com/FlmaICfpQY
— U.S. FDA (@US_FDA) June 26, 2021
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.