The FDA wants an update of the shots.
The U.S. Food and Drug Administration (FDA) has revised its recommendation for COVID-19 vaccine updates, now advising manufacturers to target the KP.2 variant, a descendant of the earlier JN.1 variant that was prevalent last winter. This decision contrasts with an earlier FDA advisory panel vote, where there was unanimous support for targeting the JN.1 variant for fall vaccinations. However, Dr. Peter Marks, the FDA’s lead vaccine regulator, favored focusing on newer strains like KP.2, citing the importance of having the most current vaccines available.
Recent data, along with an increase in COVID-19 cases, influenced the FDA’s shift towards recommending the KP.2 variant as the preferred target for updated vaccines. The agency has communicated this change to vaccine manufacturers and expects no delay in the availability of these updated vaccines for the U.S. market.
In the United States, the JN.1 variant has significantly declined, according to the Centers for Disease Control and Prevention (CDC), while the KP.2 variant now represents 22.5% of new COVID-19 cases. Another related variant, KP.3, is responsible for 25% of new cases.
Among the major vaccine manufacturers—Pfizer, Moderna, and Novavax—Pfizer and Moderna produce mRNA-based vaccines, while Novavax uses a protein-based approach. Due to longer production times for protein-based vaccines, Novavax plans to continue manufacturing a vaccine targeting the JN.1 variant for the upcoming fall season, as it cannot produce a KP.2 vaccine in time.
The process of updating COVID-19 vaccines mirrors the annual updates seen with influenza vaccines, adapting to address emerging virus variants. While vaccine makers have presented data showing the efficacy of a JN.1 vaccine against current strains compared to the older XBB.1.5 variant, which is no longer circulating, decisions on vaccine distribution and administration will be made by the CDC during its upcoming advisory committee meeting on vaccines later this month.
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