Moderna says the Food and Drug Administration has decided to delay its ruling on authorizing the drugmaker\u2019s coronavirus vaccine for children ages 12 to 17 so it can further study any connection to heart inflammation.<\/p>\n
The FDA may take until January to analyze results from studies on the risks of developing myocarditis \u2014 a type of heart inflammation \u2014 after vaccination, Moderna\u00a0said in a statement Sunday<\/a>.<\/p>\n 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.<\/p>\n The cases of myocarditis, while very rare and mild, were more acute in young men and adolescents, Moderna said.<\/p>\n Nevertheless, the company said that data from the 1.5 million adolescents who\u2019ve received its vaccine \u201cdoes not suggest an increased risk of myocarditis.\u201d<\/p>\n \u201cThe safety of vaccine recipients is of paramount importance to Moderna,\u201d the company said in a statement. \u201cThe company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence.<\/p>\n