COVID vaccine companies told to focus on KP.2 variant for fall shots, per FDA announcement

The U.S. Food and Drug Administration (FDA) has recommended that COVID vaccine manufacturers update their formulas for fall doses, in an attempt to target the KP.2 strain of the JN.1 variant.

The Thursday announcement came just a week after the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend a “monovalent JN.1-lineage vaccine” at its June 5 meeting.

As of the end of March 2024, the KP.2 variant was responsible for just 4% of infections in the U.S., according to the COVID Data Tracker from the Centers for Disease Control and Prevention (CDC).

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Meanwhile, over 50% of infections at that time were attributed to its parental strain, JN.1.

Just a few weeks later, KP.2 is now the cause of around 28% of infections, while the JN.1 variants have largely dropped in prevalence, the tracker shows.

The U.S. Food and Drug Administration has recommended that COVID vaccine manufacturers update their formulas for fall doses, in an attempt to target the KP.2 strain of the JN.1 variant. (iStock)

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, recently spoke with Dr. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration, about the new vaccine formulations.

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“It makes sense to target the KP.2 strain because it is becoming the predominant strain — it is surging in California and will spread across the country,” Siegel told Fox News Digital.

KP.2 is now the cause of around 28% of infections, while the JN.1 variants have largely dropped in prevalence, CDC Tracker data shows. (iStock)

The KP.2 strain is “highly immunoevasive,” the doctor warned — which means that immunity from previous variants and subvariants don’t offer much protection.

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“On the other hand, the vaccine will cause a production of immune cells and antibodies that will continue to protect you against previous variants and subvariants,” Siegel added.

The updated vaccine is especially important for high-risk groups, those who have chronic illnesses, the elderly and anyone who comes in contact with them, according to doctors. (iStock)

It is especially important for high-risk groups, those who have chronic illnesses, the elderly and anyone who comes in contact with them, according to the doctor.

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In a statement to Fox News Digital, vaccine maker Novavax — which makes protein-based vaccines — said the company “just filed” its application for a JN.1 COVID vaccine. 

A vial of the Phase 3 Novavax coronavirus vaccine is seen ready for use in the trial at St. George’s University hospital in London, on Oct. 7, 2020. (AP Photo/Alastair Grant, File)

“Novavax’s updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3,” the company said in a press release.

“The submission is in line with guidance from the U.S. FDA, European Medicines Agency (EMA) and the World Health Organization (WHO) to target the JN.1 lineage this fall.”

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Fox News Digital reached out to Pfizer and Moderna — both of which produce mRNA-based vaccines — requesting comment on their plans for fall formulations.