Moderna seeks FDA emergency use authorization of COVID-19 vaccine for adolescents
Moderna announced this morning that it requested an emergency use authorization for its COVID-19 vaccine in adolescents with the U.S. Food and Drug Administration.
“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,” said Stéphane Bancel, chief executive officer of Moderna.
In May, the company announced that the Phase 2/3 TeenCOVE study of Moderna’s COVID-19 vaccine in adolescents met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition.
The vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 100% when using the same case definition as in the Phase 3 COVE study in adults. In addition, a vaccine efficacy of 93% in seronegative participants was observed starting 14 days after the first dose using the secondary Centers for Disease Control and Prevention case definition of COVID-19, which tested for milder disease.
The study enrolled 3,732 participants ages 12 to less than 18 years in the U.S. Read more about the filing here.