FDA Delays Authorizing Moderna COVID-19 Shot in Adolescents

The FDA is taking more time to review Moderna’s COVID-19 vaccine in adolescents age 12 to 17 years over concerns the messenger RNA (mRNA)-based shot may be associated with increased risk of myocarditis, a type of heart inflammation.

The FDA said its review might not be finished before January 2022 and said it will be examining global data analyses on the rare risk of myocarditis following the inoculation.

The agency’s extended review will likely include data from Scandinavian countries, which in October advised men under 30 not to get the Moderna shot, citing concerns that cases of myocarditis were higher in this population.

A Centers for Disease Control and Prevention (CDC) expert panel concluded in late June that a probable link exists between heart inflammation and receiving an mRNA COVID-19 shot, but the CDC and the World Health Organization have found the risk of myocarditis following vaccination with an mRNA vaccine to be rare and usually mild (DID, Aug. 23).

Based on its own global analysis, Moderna said the rate of myocarditis in people younger than 18 years old “does not suggest an increased risk of myocarditis,” but pledged that it is “committed to working closely with the FDA to support their review.”

Because of the FDA’s delay, the drugmaker noted it will temporarily hold off on filing for FDA Emergency Use Authorization (EUA) of its shot in children.

On Friday, the agency granted Pfizer/BioNTech an updated EUA allowing its mRNA COVID-19 vaccine in children age five to 11 years. The Pfizer/BioNTech jab, which is now fully approved in people 16 years and older, previously won FDA authorization in May for adolescents (DID, Nov. 1). ― Jason Scott