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Moderna Files for Emergency Use Authorization for its COVID-19 Vaccine in Adolescents in the United States
Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 in the U.S. CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Moderna, Inc.,
About this update from Moderna, Inc.
[{"type":"text","content":"\nSubmission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 in the U.S.\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nModerna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today 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).\n\n“We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States,” said Stéphane Bancel, Chief Executive Officer of Moderna. “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.”\n\nIn 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 using the primary definition. The vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 100% when using the same case definition as in the Phase 3 COVE study in adults. In addition, a vaccine efficacy of 93% in seronegative participants was observed starting 14 days after the first dose using the secondary Centers for Disease Control and Prevention (CDC) case definition of COVID-19, which tested for milder disease. The study enrolled 3,732 participants ages 12 to less than 18 years in the U.S.\n\nThe Moderna COVID-19 vaccine was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adults. No significant safety concerns have been identified to date. The majority of adverse events were mild or moderate in severity. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second d...