Moderna Says Its COVID-19 Vaccine is 100% Effective, Safe in Adolescents

Moderna’s COVID-19 vaccine met its primary endpoint of non-inferior immunogenicity among adolescents versus the Phase 3 study adult comparator group, the company announced on Tuesday. The Phase 2/3 TeenCOVE study enrolled 3,732 adolescent participants ages 12-17, randomized 2:1 to receive two 100 microgram doses of the vaccine or placebo. 

There were no cases of COVID-19 in adolescent participants who received two doses of the Moderna COVID-19 vaccine. The vaccine was 93% effective in seronegative participants 14 days after the first dose using the Centers for Disease Control and Prevention (CDC)’s secondary case definition of COVID-19, which tested for milder disease.  

According to the company, the vaccine was generally well-tolerated, and the majority of adverse events were mild or moderate in severity. Moderna will monitor all participants for a year after their second dose to assess long-term protection and safety. Moderna plans to submit the data to global regulators in June.