(WTNH) — Thursday morning Moderna, Inc. announced that the company has requested an emergency use authorization (EUA) for its COVID-19 vaccine in adolescents with the U.S. Food and Drug Administration (FDA).
Stéphane Bancel, Chief Executive Officer of Moderna stated:
…We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents. We have already filed for authorization with Health Canada and the European Medicines Agency and we will file with regulatory agencies around the world for this important younger age population. We remain committed to helping to end the COVID-19 pandemic.”
A study of 3,732 participants ages 12 to less than 18 years in the U.S. were tested using the vaccine. This Phase 2/3 TeenCOVE study showed no cases of COVID-19 with participants who had both doses of Moderna’s COVID-19 vaccine, said Moderna.
There have been no reported safety concerns as of now. The participants will be monitored for the next twelve months to determine long-term effects. Data reported may change based on this ongoing study.