Moderna Files FDA Application for the JN.1 Targeting COVID-19 Vaccine

Manufacturing is underway.

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Moderna today announced that it has submitted an application to the FDA for review of its Spikevax 2024-2025 formula, targeting the SARS-CoV-2 variant JN.1.

Manufacturing is underway and doses of Moderna's Spikevax 2024-2025 formula will be ready to ship as early as August, pending regulatory approval.

"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.

The most common solicited local adverse event for Moderna's updated COVID-19 vaccine was injection site pain. The most common solicited systemic adverse events include headache, fatigue, myalgia and chills.

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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