CNN – The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination.
The vaccines’ previous labels warned about the risk of a heart condition called myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the lining outside the heart, which the US Centers for Disease Control and Prevention website says is rare but possible after vaccination.
The new labels will expand that warning to certain age groups.
Research has consistently shown that the mRNA Covid-19 vaccines are safe and effective, and millions of people have gotten them without serious incident.
Some studies have found that Covid-19 infection itself carries a higher risk of myocarditis or pericarditis than the vaccine does.
The CDC last month told its independent vaccine advisers that research showed Covid-19 vaccinations from 2020 through 2022 showed a statistically significant increased risk of myocarditis.
The incidents were rare, however, and “there is no increased risk observed with the doses administered in subsequent years,” the agency said.
In the rare case that someone did develop heart inflammation after vaccination, the CDC told the advisers, acute myocarditis typically resolves quickly.
The vaccines already carried warnings that the highest risk of these heart problems was observed in males between ages 18 and 24 for the Moderna vaccine and 12 to 17 for Pfizer’s; the new warnings for both vaccines will be for males age 16 to 25.
In letters to Pfizer and Moderna that were dated April 17 and are now posted online, the agency says analysis of commercial health insurance claims data shows that there were eight cases of myocarditis and/or pericarditis per million vaccine doses given to people ages 6 months through 64 years …
