Moderna has filed for FDA emergency use authorization for use of its COVID-19 vaccine in adolescents aged 12 through 17.
Moderna has filed for FDA emergency use authorization (EUA) for use of its COVID-19 vaccine in adolescents aged 12 through 17, the company announced on Thursday.
If granted authorization for this use, Moderna’s vaccine mRNA-1273 will be the second COVID-19 vaccine authorized for adolescents. In May, the FDA expanded the EUA for Pfizer-BioNTech’s COVID-19 vaccine to include individuals aged 12 to 15 years.
Moderna previously announced positive results from its phase 2/3 TeenCOVE study, which evaluated the immunogenicity and safety of mRNA-1273 in adolescents. The study, which involved 3732 adolescents, showed no cases of COVID-19 in participants who received 2 doses of the vaccine. Vaccine efficacy was observed to be 100% when using the same case definition as in the phase 3 COVE study in adults, according to Moderna. The results also showed vaccine efficacy of 93% in seronegative participants starting 14 days after the first dose.
The vaccine safety profile was similar to what was seen with adults, with no major safety concerns identified. Most adverse effects (AE) were mild or moderate in severity. The most common local AE was pain at the injection site. After the second dose, the most common systemic AEs were fatigue, chills, myalgia, and headache.
“We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents,” said Stéphane Bancel, chief executive officer of Moderna. “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.”
Moderna also recently announced it has initiated the rolling submission process for the biologics license application for mRNA-1273 for full approval of the vaccine in adults.
1. Moderna Files for Emergency Use Authorization for its COVID-19 Vaccine in Adolescents in the United States. News release. Moderna; June 10, 2021. Accessed June 11, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-files-emergency-use-authorization-its-covid-19-vaccine