By Lehlohonolo Lehana.
The US Food and Drug Administration (FDA) has added a warning about the risk of heart inflammation to fact sheets for Moderna and Pfizer-BioNTech COVID-19 vaccines.
The warning on Friday noted that reports of adverse events following vaccination – particularly after the second dose – suggest increased risks of myocarditis, or inflammation of the heart muscle, and pericarditis, or inflammation of the tissue surrounding the heart.
The warning update follows an extensive review of information and discussion by the US Centers for Disease Control and Prevention (CDC’s) Advisory Committee on Immunization Practices meeting on Wednesday, 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
At end of the second week of June, more than 1,200 cases of myocarditis or pericarditis have been reported to the US Vaccine Adverse Event Reporting System.
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.
There has been no comment from Pfizer and Moderna yet.