The trial is due to enrol 3,000 healthy teenagers in the United States, and is being conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
The current Phase 3 trial for the mRNA vaccine is for adults aged 18+. The primary efficacy analysis of the 30,000 strong trial put vaccine efficacy against COVID-19 as 94.1%.
The randomized, controlled Phase 2/3 study for adolescents will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. Each participant will be assigned to receive a placebo or a 100 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.
Stéphane Bancel, chief executive officer of Moderna, said: “Our goal is to generate data in the spring of 2021 that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year.”
Pfizer’s mRNA Phase 3 trial includes adolescents aged 16+ (as per an expanded trial announced in September); while both AstraZeneca and Johnson & Johnson’s Phase 3 trials cover participants aged 18+.