Moderna has filed an application with the US Food and Drug Administration (FDA) to review its updated Spikevax formula, designed to combat the SARS-CoV-2 variant JN.1, for the 2024 to 2025 season.

The move follows guidance from the FDA recommending an update to Covid-19 vaccines to include the monovalent JN.1 composition.

The recommendation was unanimously supported by the Vaccines and Related Biological Products Advisory Committee during a meeting held on 5 June 2024.

It aligns with the guidance from the World Health Organization Technical Advisory Group on Covid-19 Vaccine Composition and the European Medicines Agency’s Emergency Task Force on the use of Covid-19 vaccines targeting the JN.1 variant.

The most common local adverse event linked to the updated Covid-19 vaccine of Moderna was pain at the injection site.

Systemic adverse events reported include headache, fatigue, myalgia and chills.

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These findings are critical as Moderna aims to secure global regulatory approval and supply the vaccine in time for the next vaccination season.

While the updated Spikevax vaccine for the 2024 to 2025 season is under review, the current 2023 to 2024 formula has been authorised for emergency use in individuals aged six months to 11 years.

The Spikevax vaccine is indicated for active immunisation against Covid-19 in individuals aged 12 years and above.

Moderna CEO Stéphane Bancel stated: “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.

“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 latest submission comes on the heels of Moderna’s recent success in securing FDA approval for its mRNA-based respiratory syncytial virus (RSV) vaccine, mRESVIA, for adults aged 60 and above.