Moderna files FDA application for JN.1 targeting COVID vaccine
Cambridge: Moderna, Inc. has announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2024-2025 formula, targeting the SARS-CoV-2 variant JN.1.
"For four years, Moderna has consistently delivered vaccines that offer protection against COVID-19, and work is well underway to provide a vaccine targeting JN.1," said Stéphane Bancel, CEO of Moderna. "Staying up to date with your COVID-19 vaccine remains one of the best ways to protect yourself during the upcoming respiratory illness season."
The submission is based on guidance from the U.S. FDA, which advised that COVID-19 vaccines should be updated to a monovalent JN.1 composition for the 2024-2025 season. This guidance aligns with the recommendations from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) and the European Medicines Agency's Emergency Task Force (ETF) on the use of a monovalent JN.1 lineage for COVID-19 vaccine antigen composition.
Moderna is submitting data to regulators worldwide to support registration and supply of the 2024-2025 formula of Spikevax in time for the upcoming vaccination season.
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AUTHORIZED USE IN THE U.S.
Emergency uses of the Moderna COVID-19 Vaccine (2023-2024 Formula) have not been approved or licensed by the FDA, but have been authorized by the FDA, under an Emergency Use Authorization (EUA) for use in individuals 6 months through 11 years of age.
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INDICATION (U.S.)
SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
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