Moderna files to expand authorization of its COVID-19 vaccine for 12-18 year olds

Following positive test results, Moderna, Inc. filed last week with the U.S. Food and Drug Administration (FDA) to expand the scope of its COVID-19 vaccine’s emergency use authorization (EUA) to include adolescents between 12 and 18 years old.

This expansion push follows the results of a Phase 2/3 TeenCOVE study released in May, which showed the mRNA-1273 vaccine to be 100 percent effective among nearly 2,500 fully vaccinated adolescent participants. A 93 percent efficacy rate was observed from 14 days after the first dose among seronegative participants. In all, 3,732 participants were enrolled.

“We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States,” Stéphane Bancel, CEO of Moderna, said. “We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents. We have already filed for authorization with Health Canada and the European Medicines Agency, and we will file with regulatory agencies around the world for this important younger age population. We remain committed to helping to end the COVID-19 pandemic.”

Currently, the mRNA-1273 vaccine is authorized solely for use on adults in the U.S. Other nations around the world, as well as the World Health Organization, have also cleared it for similar use. The U.S. Biomedical Advanced Research and Development Authority (BARDA) is actively supporting the vaccine and will reimburse Moderna all of its allowable costs to pursue its development.

As to the effects on adolescents, the recent study also notably found the vaccine to be well-tolerated and generally safe, in line with the results found on adults. No significant safety concerns emerged during the trial, and most side effects were mild or moderate, from injection site pain to headaches, fatigue, myalgia, and chills. Safety monitoring is ongoing.