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FDA Advises COVID Vaccine Shift to KP.2 Variant for Fall Rollout

FDA Advises COVID Vaccine Shift to KP.2 Variant for Fall Rollout

United States: With the surge of the new variants of COVID-19, health experts have been advised to make new vaccines that will target the new KP.Two variants, a sub-variant of the JN.1 variant, which spread widely last winter.

The statement was released by the US Food and Drug Administration last week. Reportedly, the agency has shifted its recommendation following a unanimous vote by an FDA advisory panel last week. The panel advised that COVID vaccines should now target the older JN.1 variant this upcoming autumn, according to the reports by US News.

After the vote, panel members and Dr Peter Marks, the chief vaccine regulator at the agency, held differing opinions on which variant to prioritize. While most panel members favored JN.1, Marks leaned towards selecting a newer strain like KP.2.

“At this juncture, we are paying a steep premium for mRNA vaccines to ensure we have the most up-to-date options,” Marks remarked during discussions.

Initially advising vaccine manufacturers to focus on JN.1, the FDA has since adjusted its stance based on the latest data and an uptick in COVID cases. Now, the preferred target for updated vaccines is the KP.2 strain, according to the agency.

Reportedly, “The FDA has communicated this change to the manufacturers of licensed and authorized COVID-19 vaccines,” stated the agency. “It is not expected that shifting to KP.2 will cause any delays in vaccine availability in the United States.”

Recent reports from the US Centers for Disease Control and Prevention indicate that JN.1 has largely receded from circulation in the country. Currently, KP.2 constitutes 22.5% of new COVID cases, with its sister variant KP.3 contributing to 25% of new cases.

Three pharmaceutical companies are involved in producing COVID vaccines: Pfizer, Moderna, and Novavax. Pfizer’s and Moderna’s vaccines rely on mRNA technology, while Novavax’s utilizes a protein-based approach. Given the longer production timeline for protein-based vaccines, Novavax has indicated it will not be able to manufacture a KP.2 vaccine in time for the fall, as reported by NBC News. Instead, they plan to distribute a JN.1 vaccine, which has already been in production, according to reports by US News.

The process of selecting the next round of COVID vaccines now mirrors the annual update process for flu shots.

At the FDA advisory committee meeting, vaccine manufacturers presented data suggesting that a JN.1 vaccine could produce higher antibody levels against current virus strains compared to the existing vaccine, which targets XBB.1.5, a variant no longer prevalent.

However, it is to be noted that any recommendation has not been released which has covered the potentially eligible population. The decision will be made by the Centers for Disease Control and Prevention during a meeting, later this month.

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