The Food and Drug Administration is delaying its review of Moderna’s coronavirus vaccine for 12-to-17-year-olds due to a possible risk of myocarditis, an inflammation of the heart muscle, the company said Sunday.
The FDA told Moderna that it may have to push the approval back until early 2022.
Moderna said in a statement Sunday that "the company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence."
The Centers for Disease Control and Prevention has reported that myocarditis cases have usually occurred a few days after getting either the Pfizer or Moderna coronavirus vaccine, mostly among young adults and male teenagers and mostly after the second shot, the Hill reports.
Moderna also stated that "it is estimated that over 1.5 million adolescents have received the Moderna COVID-19 vaccine. To date, the observed rate of myocarditis reports in those less than 18 years of age in Moderna’s global safety database does not suggest an increased risk of myocarditis in this population. Moderna is committed to conducting its own careful review of new external analyses as they become available."
The company filed for emergency use authorization for its vaccine to be used for teenagers in June.
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