Thursday, December 10, Moderna Inc. had dosed the first participants in a mid-to-late study testing the coronavirus vaccine in adolescents aged 12 to less than 18.
Moderna has submitted applications seeking emergency use authorization (EUA) in the United States and EU after full results from a late-stage study showed the vaccine was 94.1% effective in adults with no serious safety concerns.
The trial will enroll 3,000 healthy participants in the United States and will assess the safety and effectiveness of two doses of the company’s vaccine candidate, mRNA-1273, given 28 days apart.
Moderna’s adolescents’ study is being conducted in collaboration with the Biomedical Advanced Research and Development Authority, a part of the U.S. Department of Health and Human Services.
“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,” Chief Executive Officer Stephane Bancel said in a statement.