FDA Updates COVID-19 Vaccine Guidance to Target New Strain

Coronavirus COVID-19

WASHINGTON, D.C. — The FDA on Thursday updated its recommendations for manufacturers of COVID-19 vaccines for the 2024-2025 season. The agency now advises that vaccines should target the KP.2 strain of the virus, if feasible, to better match circulating variants.

The FDA had initially recommended a monovalent JN.1 vaccine for this period. However, recent data and a rise in COVID-19 cases led to the adjustment. The goal is to ensure vaccines are more effective against the strains currently spreading in the United States.

The decision follows a June 5 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). The committee reviewed data on virus variants, vaccine effectiveness, and immunogenicity. Members voted unanimously for a monovalent JN.1 vaccine and discussed specific strains within that lineage, expressing a preference for JN.1.

However, after further review and monitoring of circulating strains, the FDA determined that the KP.2 strain within the JN.1 lineage would be better suited. This change aims to enhance the vaccine’s match to current virus variants.

Manufacturers have been informed of this new guidance. The FDA does not expect this update to delay vaccine availability for the fall of 2024.

The advisory committee had reviewed comprehensive data, including current vaccine performance and variant circulation. They examined both human and animal immunogenicity data, which measure the immune response generated by the vaccine. The committee also evaluated preliminary data on candidate vaccines targeting updated spike proteins of the virus.

This update is part of ongoing efforts to adapt COVID-19 vaccines to evolving virus strains. By targeting the most prevalent strains, vaccines can offer better protection and help control the spread of COVID-19.

The FDA continues to monitor virus trends and vaccine effectiveness. This proactive approach ensures that vaccine strategies remain aligned with the latest scientific evidence and public health needs.

In summary, the FDA’s updated guidance for the 2024-2025 COVID-19 vaccine formula aims to improve protection by focusing on the KP.2 strain. This decision reflects the agency’s commitment to using the latest data to guide public health strategies.

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