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Moderna has filed applications with the FDA for its updated Spikevax COVID-19 vaccine targeting the LP.8.1 and JN.1 variants, following guidance for vaccine updates to combat new strains.

The FDA will mandate new clinical trials for annual COVID-19 booster approvals, impacting all vaccine makers, including Moderna, particularly for healthy individuals aged 50 to 64 and young children.

The FDA advisory committee voted to focus on the JN.1 strain for future Covid-19 boosters, but the impact on the approval process and need for new trials is unclear.

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About Moderna, Inc.

Moderna, Inc. engages in the development of transformative medicines based on messenger ribonucleic acid. The firm's product pipeline includes the following modalities: prophylactic vaccines, cancer vaccines, intratumoral immuno-oncology, localized regenerative therapeutics, systemic secreted therapeutics, inhaled pulmonary therapeutics and systemic intracellular therapeutics. It operates through the following geographical segments: United States, Europe, and Rest of World. The company was founded by Noubar B. Afeyan, Robert S. Langer, Jr., Derrick J. Rossi, and Kenneth R. Chien in 2010 and is headquartered in Cambridge, MA.