- Moderna (MRNA, Financial) has submitted an FDA application for its updated COVID-19 vaccine, Spikevax 2025-2026.
- The new formula targets the SARS-CoV-2 LP.8.1 variant, in line with FDA guidelines favoring a monovalent JN.1 lineage.
- The application reflects Moderna's ongoing efforts to adapt its vaccines to emerging viral variants.
Moderna, Inc. (MRNA) has officially filed an application with the U.S. Food and Drug Administration (FDA) for the review of its latest Spikevax 2025-2026 vaccine formula. This updated COVID-19 vaccine is specifically engineered to combat the SARS-CoV-2 LP.8.1 variant, aligning with recent FDA guidance that advises updates to a monovalent JN.1 lineage with a preference for the LP.8.1 variant.
This submission emphasizes Moderna’s commitment to leading advancements in mRNA medicine, a move that underscores the company's strategy to address the evolving nature of the COVID-19 virus. As Moderna continues to spearhead rapid vaccine development, the updated Spikevax formula is anticipated to play a critical role in future immunization campaigns.
Moderna has been at the forefront of mRNA technology, employing it not only for infectious diseases but also extending its innovations to fields such as immuno-oncology, rare diseases, and autoimmune conditions. With its latest application, Moderna is poised to maintain its influential position in the biotechnology sector, efficiently adapting to new challenges in human health.
