The Pfizer and Moderna COVID vaccines are both linked to heart inflammation. In May, the U.S. Food and Drug Administration authorized Pfizer’s vaccine for 12- to 17-year-olds, but the agency is delaying its decision on authorizing Moderna’s vaccine for adolescents while it assesses whether the shot could increase the risk of myocarditis.
The U.S. Food and Drug Administration (FDA) said on Oct. 15 it was delaying a decision on authorizing Moderna’s COVID vaccine for adolescents while the agency assesses whether the shot could increase the risk of myocarditis, a heart inflammatory condition, the Wall Street Journal reported.
In June, the FDA added a warning to the literature accompanying Pfizer and Moderna mRNA COVID vaccines, to indicate an increased risk of myocarditis. However in May, a few weeks before the FDA added the warning, the agency authorized Pfizer’s COVID vaccine for ages 12 to 17, despite the known increased risk of myocarditis.
It was also in June that Moderna filed for authorization in the U.S. of its vaccine for adolescents 12 through 17 years old.
The FDA’s review of Moderna’s application is ongoing, an FDA spokesperson told Reuters, adding that while the agency cannot predict how long the process may take, it is evaluating the data as expeditiously as possible.