FDA recommends COVID jab manufacturers update formulas to combat new strain

A new strain of COVID has prompted recommendations for vaccine companies to update their formulas in anticipation of cases in the fall.

The U.S. Food and Drug Administration (FDA) announced Thursday that manufacturers of the COVID vaccines should focus on the KP.2 strain of the JN.1 variant.

This update came after first advising to target the JN.1 variant.

“Based on the totality of the evidence, on June 6, 2024, FDA initially advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 Formula) for use in the United States beginning in fall 2024 should be monovalent JN.1 vaccines,” the FDA noted.

This announcement came after a committee meeting in which the panel expressed a preference for JN.1, in opposition to the FDA’s Dr. Peter Marks who preferred focusing on a newer strain, like KP.2.

“We are paying an incredibly high premium for mRNA vaccines to be able to have the freshest vaccines,” said Marks, the director of the Center for Biologics Evaluation and Research (CBER) at the FDA.

“FDA has continued to monitor the circulating strains of SARS-CoV-2. Based on the most current available data, along with the recent rise in cases of COVID-19 in areas of the country, the agency has further determined that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 Formula) is the KP.2 strain, if feasible,” the agency updated.

“This change is intended to ensure that the COVID-19 vaccines (2024-2025 Formula) more closely match circulating SARS-CoV-2 strains,” the FDA noted, adding that vaccine manufacturers were notified of the change.

“JN.1 has largely fallen out of circulation in the U.S., according to the Centers for Disease Control and Prevention. As of Saturday, KP.2 accounts for 22.5% of new Covid cases in the U.S. KP.3, a sister variant, accounts for 25% of new cases,” NBC News reported.

Pfizer’s and Moderna’s vaccines are mRNA-based while a third company, Novavax, uses protein-based vaccines.

Novavax told Fox News Digital that they “just filed” an application for a JN.1 COVID vaccine.

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

“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,” Fox News medical contributor Marc Siegel told Fox News Digital.

Siegel, a clinical professor of medicine at NYU Langone Medical Center, warned that the KP.2 strain is “highly immunoevasive.”

“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,” he added.

Frieda Powers


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