Federal regulators on June 25 updated labels for the Pfizer-BioNTech and Moderna COVID-19 vaccines to expand warnings regarding heart inflammation.
The updated labels state that myocarditis, inflammation, and a related condition called pericarditis have occurred following receipt of one of the shots “most commonly in males 12 years through 24 years of age.”
The Food and Drug Administration said in letters to the vaccine manufacturers earlier this year that they should update warnings on the inflammation to reflect available information.
The previous labels said that the highest observed risk of myocarditis after Pfizer vaccination was in males aged 12 to 17 while the highest observed risk following Moderna vaccination was in males aged 18 to 24….