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Highlights

  • Moderna files FDA application for updated Spikevax vaccine targeting LP.8.1 variant
  • Submission aligns with FDA guidance to update COVID-19 vaccines to monovalent JN.1 lineage
  • Spikevax 2025-2026 formula aims to address evolving SARS-CoV-2 variant landscape

Moderna, Inc. (NASDAQ: MRNA) has submitted an application to the U.S. Food and Drug Administration (FDA) seeking review and authorization for its updated COVID-19 vaccine formula, Spikevax 2025-2026. The new formulation is designed specifically to target the SARS-CoV-2 variant LP.8.1.

This submission follows FDA guidance recommending that COVID-19 vaccines be updated to a monovalent formulation based on the JN.1 lineage, with a preference for targeting the LP.8.1 variant. Moderna’s application reflects its response to evolving viral strains and regulatory direction aimed at improving vaccine effectiveness against circulating variants.

The proposed Spikevax update represents Moderna’s continued efforts to adapt its mRNA vaccine platform to address the dynamic nature of the SARS-CoV-2 virus. By focusing on the LP.8.1 variant, the company aims to keep pace with the latest viral mutations identified by health authorities.

Moderna’s mRNA technology platform underpins its vaccine development capabilities, allowing for relatively rapid reformulation in response to new viral threats. Since its initial COVID-19 vaccine authorization, Moderna has applied its mRNA expertise to create vaccine candidates targeting multiple infectious diseases, as well as treatments for various other medical conditions.

The FDA’s review process will evaluate the updated Spikevax formula for safety and efficacy in protecting against the LP.8.1 variant. This review is a critical step in Moderna’s ongoing vaccine strategy for the upcoming 2025-2026 period, aligning with public health goals to manage COVID-19 through vaccination.

Moderna’s regulatory submission highlights the ongoing adaptation efforts within the pharmaceutical industry to respond to the shifting landscape of SARS-CoV-2 and COVID-19 prevention.