(RTTNews) - Biotechnology company Moderna, Inc., (MRNA) announced Thursday 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 submission is based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 in the U.S.
In May, 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. In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine.
The vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 100% in the Phase 3 COVE study in adults. The study enrolled 3,732 participants ages 12 to less than 18 years in the U.S.
The Moderna COVID-19 vaccine was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adults.
The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein.
Moderna COVID-19 Vaccine is authorized for use under an EUA for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
The company has recently filed for authorization with Health Canada and the European Medicines Agency and will file with regulatory agencies around the world for this important younger age population.
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