The FDA said it will add a warning to fact sheets for the COVID-19 vaccines from Pfizer and Moderna concerning rare cases of heart inflammation linked to the shots.
The warnings are likely to say that rare cases of a heart condition called myocarditis have been seen in some recipients of the mRNA shots within several days to a week following administration, particularly after the second dose. The announcement came Wednesday after a meeting of an advisory panel to the CDC, where experts said the data suggests a “likely association” between the shots and cases of myocarditis or heart inflammation. The evidence presented at the meeting echoes what health officials in other countries have found: A study from Israel earlier this month found a possible link between the Pfizer jab and myocarditis cases.
The CDC has so far confirmed 323 cases of the condition in people ages 12 through 29, but patients generally recovered from the symptoms and no deaths have been associated with this side effect. Data presented at the advisory meeting estimated that instances of heart inflammation occurred about 12.6 times for every 1 million Pfizer or Moderna second doses administered. Officials say teens and younger men made up the bulk of cases. “Based on the available data, a warning statement in the fact sheets for both health care providers and vaccine recipients and caregivers would be warranted in this situation,” Doran Fink, deputy director of FDA’s vaccines division, said during the advisory meeting.
Still, health officials stress that the vaccinations prevent far worse outcomes. A new CDC report, released immediately after Wednesday’s meeting, estimates that 5,700 COVID-19 cases and as many as 215 hospitalizations are prevented for every million doses administered to boys between 12 and 17.