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COVID Vaccines: US FDA Seeks Panel Vote On New Formulation Targeting JN.1 Variant

 
• By Sue Sutter

But agency wants discussion on considerations for the selection of a specific JN.1 lineage strain, such as the KP.2 subvariant, for the 2024-2025 formulation. Although JN.1 sublineages were predominant in the spring, KP.2 is now the most prevalent circulating strain in the US.

Global
Recent epidemiology in the US could complicate the global drive for alignment on COVID-19 vaccine formulations. • Source: Shutterstock

The US Food and Drug Administration is weighing whether the COVID-19 vaccine formulation for the 2024-2025 season should target the JN.1 variant, as recommended by other international regulators, or whether the KP.2 subvariant that is currently the predominating circulating strain should be the focus.

The Vaccines and Related Biological Products Advisory Committee will meet on 5 June, three weeks later than originally planned, to discuss and make recommendations on the selection of

Key Takeaways

  • WHO's recommendation to target JN.1 was made before JN.1 lineage-derived variants with FLiRT mutations, such as KP.2, became dominant in the US.

  • This change in epidemiology warrants consideration, the FDA said, asking VRBPAC to discuss considerations for selection of a specific JN.1 lineage strain

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