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FDA Asks COVID Vaccine Makers To Target KP.2 Strain, If Feasible, For Next Shot

HealthFDA Asks COVID Vaccine Makers To Target KP.2 Strain, If Feasible, For Next Shot

The U.S. Food and Drug Administration (FDA) has revised its strain recommendation for the 2024-25 COVID-19 vaccines, now advising manufacturers to target the KP.2 variant instead of the previously recommended JN.1 lineage. This change, announced on Thursday, comes as both Moderna and Novavax had already submitted applications to update their fall 2024 vaccines with the JN.1 strain.

Novavax, which is currently manufacturing a JN.1 vaccine, stated it could not produce a vaccine targeting a different strain by this fall. The company, which applied for authorization on Friday, reported that its JN.1 shot generated broad cross-neutralizing antibodies against multiple variants, including KP.2 and KP.3, and expects to have its vaccine ready by mid-July. Novavax has not yet commented on the FDA’s updated preference.

This FDA update diverges from recommendations made by its own advisory panel, the European regulator, and the World Health Organization (WHO), all of which recommended targeting the JN.1 strain. However, Peter Marks of the FDA emphasized the importance of providing an option for a KP.2-targeting vaccine, leveraging the rapid adaptability of mRNA technology used by Moderna and Pfizer-BioNTech.

JN.1, which was dominant in the U.S. earlier this year, now accounts for just 3.1% of cases as of early June, according to the Centers for Disease Control and Prevention (CDC). In contrast, the KP.2 variant currently represents about 22.5% of cases, with KP.3 now being the most prevalent at 25%.

Pfizer has indicated ongoing discussions with global regulators, including the FDA, to determine the composition of future COVID vaccine formulations. Moderna has committed to preparing its updated vaccine in time for the fall vaccination campaign, irrespective of the final strain decision.

The FDA’s new guidance has impacted the stock market, with shares of Novavax, Moderna, and BioNTech each closing down by over 3.5% in the U.S.

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