Moderna Seeks Authorization to Immunize Adolescents
Massachusetts-based Moderna, Inc. announced that it has requested an emergency use authorization (EUA) for its COVID-19 vaccine in adolescents with the U.S. Food and Drug Administration (FDA).
The Moderna COVID-19 Vaccine is currently Authorized for use under a EUA for active immunization to prevent COVID-19 caused by the SARS-CoV-2 beta coronavirus in individuals 18 years of age and older.
In May 2021, the Company announced that the Phase 2/3 TeenCOVE study of Moderna’s COVID-19 vaccine in adolescents met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. However, the Moderna COVID-19 Vaccine may not protect all vaccine recipients.
Stéphane Bancel, CEO of Moderna, stated in a press release issued on June 10, 2021, “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.”
The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center.
Cambridge, MA-based Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology, and manufacturing and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases.