On Friday, Moderna Inc. (NASDAQ: MRNA) announced that it has submitted an FDA application for review of its Spikevax 2024-2025 formula, which targets the SARS-CoV-2 variant JN.1.
The submission is based on FDA guidance, which advised that COVID-19 vaccines should be updated to a monovalent JN.1 composition for the 2024-2025 season.
JN.1 and its descendants KP.2 and KP.3 are the versions of the virus that are most common in the U.S. right now, according to the US Centers for Disease Control and Prevention.
In its briefing document, the FDA told the advisory committee Wednesday that studies have shown that currently available COVID-19 vaccines appear to be less effective against the variants currently in circulation.
This guidance aligns with the recommendations from the World Health Organization's panel and the European Medicines Agency's Emergency Task Force on the use of a monovalent JN.1 lineage for COVID-19 vaccine antigen composition.
The most common local adverse event for Moderna's updated COVID-19 vaccine was injection site pain. The most common systemic adverse events include headache, fatigue, myalgia, and chills.
Novavax Inc (NASDAQ: NVAX) said it expects to be ready for the commercial delivery of a protein-based JN.1 COVID-19 vaccine in the U.S. in September this fall, pending authorization.
The decision has now moved to the full FDA. If they concur with their advisory committee, the new vaccine will be monovalent, targeting a single coronavirus variant. Previously, some vaccines were bivalent, designed to protect against two variants.
Pfizer Inc (NYSE: PFE)/BioNTech SE (NASDAQ: BNTX) and Moderna also said their updated vaccines will be available this fall ahead of the 2024-2025 flu season.
Price Action: MRNA shares were down 1.23% at $152.78 at the last check on Friday.