Moderna has requested an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the use of its COVID-19 vaccine in adolescents, according to a news release from the company.
In the company’s Phase 2/3 TeenCOVE study of its COVID-19 vaccine in adolescents, 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 (CDC) case definition of COVID-19, which tested for milder disease. The study enrolled 3,732 participants 12-18 years old in the United States.
