Moderna says the Food and Drug Administration has decided to delay its ruling on authorizing the drugmaker’s coronavirus vaccine for children ages 12 to 17 so it can further study any connection to heart inflammation.
The FDA may take until January to analyze results from studies on the risks of developing myocarditis — a type of heart inflammation — after vaccination, Moderna said in a statement Sunday.
The Centers for Disease Control and Prevention has logged hundreds of cases of heart inflammation occurring after a person got either of the two-dose Moderna or Pfizer/BioNTech vaccines.
The cases of myocarditis, while very rare and mild, were more acute in young men and adolescents, Moderna said.
Nevertheless, the company said that data from the 1.5 million adolescents who’ve received its vaccine “does not suggest an increased risk of myocarditis.”
“The safety of vaccine recipients is of paramount importance to Moderna,” the company said in a statement. “The company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence.