June 11, 2021 -- Moderna announced it has requested an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine in adolescents.
The submission is based on a phase II/III U.S. study of the messenger RNA (mRNA) vaccine, mRNA-1273, in 2,500 participants ages 12 to younger than 18. Efficacy in 2,500 adolescents who received the Moderna COVID-19 vaccine was 100% when using the same case definition as in a phase III study in adults. In addition, a vaccine efficacy of 93% in seronegative participants was observed starting 14 days after the first dose, according to the company.
The Moderna COVID-19 vaccine was generally well tolerated, with a safety and tolerability profile generally consistent with the phase III study evaluated for EUA in adults. No significant safety concerns have been identified to date, Moderna said.
The company said it has already filed for authorization with Health Canada and the European Medicines Agency and will file with regulatory agencies around the world for the younger age population.