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COVID Vaccines: US FDA Changes Course, Wants New Formulas To Target KP.2 Subvariant ‘If Feasible’

 
• By Sue Sutter

Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’

Changing course
FDA quickly changed course on its COVID vaccine formulation recommendations for 2024-2025. • Source: Shutterstock

The US Food and Drug Administration’s change of mind on the preferred COVID-19 vaccine formulation for 2024-2025 means there will be at least one JN.1 variant-targeted vaccine on the market come fall despite the agency’s new recommendation for a KP.2 subvariant formulation.

On 13 June, the agency announced it had advised manufacturers to use the KP.2 strain of the JN.1-lineage virus “if feasible” in vaccines for the coming year.

Key Takeaways

  • Despite initial guidance to manufacturers for a monovalent JN.1 variant formulation, the FDA now says vaccines should target the KP.2 subvariant "if feasible."

  • Change...

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