Moderna Confirms FDA Delayed Covid-19 Vaccine in Adolescents to Review Myocarditis Risk

The Food and Drug Administration is delaying a decision on Moderna Inc.’s MRNA application to authorize use of its Covid-19 vaccine in adolescents to assess whether the shot leads to a heightened risk of myocarditis, the company said. The FDA notified Moderna on Friday evening that an analysis may not be completed until January of next year while the agency reviews recent international data on the risk of myocarditis after vaccination, the company said Sunday. The Wall Street Journal reported earlier this month that the FDA was delaying a decision on Moderna’s application for authorization in 12- to 17-year-olds after several Nordic countries limited use due to myocarditis reports.