The Food and Drug Administration on Thursday recommended that pharmaceutical companies develop coronavirus vaccines targeting the KP.2 strain, a descendant of the highly contagious JN.1 variant that began spreading widely in the United States this winter. The announcement comes just one week after an FDA advisory committee unanimously recommended updating COVID-19 vaccines in the fall to target the JN.1 variant or its descendants.
After the vote, there was disagreement between committee members and Dr. Peter Marks, the agency’s top vaccine regulator, over which strain the agency should choose. Most committee members expressed a preference for JN.1, but Dr. Marks favored choosing a newer strain like KP.2. “We’re paying an incredibly high premium for the mRNA vaccines to get the freshest vaccine,” Marks said, likening getting the vaccine to buying milk at the store.
The FDA said it had initially advised drugmakers on June 6 to target the JN.1 variant, but the agency continues to monitor circulating strains and “based on the latest available data and recent increases in COVID-19 cases in areas of the country, the FDA has further determined that the JN.1 lineage is preferred for improved vaccines,” with the KP.2 strain preferred “when possible,” the FDA said.
The JN.1 is hardly in circulation in the United States. Centers for Disease Control and Prevention As of Saturday, KP.2 accounted for 22.5% of new coronavirus cases in the U.S., while its sister variant, KP.3, accounted for 25% of new cases.
The FDA’s decision allows pharmaceutical companies to begin manufacturing and distributing the vaccine, which is expected to be used as part of COVID-19 vaccination campaigns this fall.
Three pharmaceutical companies, Pfizer, Moderna, and Novavax, are producing coronavirus vaccines. Pfizer and Moderna’s vaccines are mRNA-based, while Novavax’s vaccine is protein-based. Because protein-based vaccines take a long time to produce, Novavax has indicated that it will not be able to produce the KP.2 vaccine by the fall. Instead, it plans to distribute the JN.1 vaccine that it has already produced.
This is the third time the vaccine has been updated to target circulating strains. The process of selecting the next vaccine is becoming more routine, similar to the annual influenza vaccination update, with vaccinologists selecting the strains in the spring and then conducting vaccination campaigns in the fall.
At the advisory committee meeting, the pharmaceutical company presented data showing that compared to current vaccines that target the variant XBB.1.5, which is not currently in circulation, the JN.1 vaccine should generate higher levels of antibodies against circulating virus strains.
The committee did not recommend who should get the latest vaccine, leaving that to the CDC, which will be holding its own advisory committee meeting later this month.
Source: www.nbcnews.com
