FDA Recommends Vaccine Companies Focus on KP.2 Variant Amid Rising COVID-19 Cases
ICARO Media Group
In response to the recent surge in COVID-19 cases across the United States, the Food and Drug Administration (FDA) has urged vaccine companies to prioritize the KP.2 lineage for their updated shots. This recommendation comes after the FDA previously suggested a switch to the JN.1 variant for fall vaccinations.
The FDA's vaccine advisory group initially recommended the JN.1 variant on June 5, but did not include the KP.2 offshoot due to uncertainties surrounding the evolution of SARS-CoV-2 strains. Additionally, concerns were raised about the availability of the Novavax protein-based vaccine, which has a longer production timeline and cannot easily switch to the more specific KP.2 lineage.
However, recent data from the Centers for Disease Control and Prevention (CDC) revealed a significant increase in KP.2 viruses, along with a rise in KP.3 proportions and a decline in the JN.1 parent lineage. These rising offshoots possess mutations that are believed to make them more evasive to immunity from prior infection or vaccination.
Based on these findings, the FDA now recommends vaccine companies prioritize the KP.2 lineage to ensure that future COVID-19 vaccines closely match the circulating strains. The agency reassures that this switch is not expected to cause any delays in the availability of vaccines for the United States, particularly mRNA vaccines, which have a shorter production timeline.
Novavax, the producer of a protein-based vaccine, has stated that its product provides broad cross-neutralization against a range of JN.1 descendant viruses, including KP.2 and KP.3. The company also highlights conserved T-cell responses against various JN.1 offshoots. Pending FDA authorization, Novavax expects to have their vaccine ready for commercial delivery in September.
In the midst of these developments, Hawaii has emerged as a COVID-19 hot spot within the United States. The CDC's latest data reveals an increase in early COVID indicators, including a rise in positive test results, with the highest rates seen in the western region comprising Arizona, California, Hawaii, and Nevada.
Due to the high COVID-19 levels in the state, the Hawaii State Department of Health has urged the public to remain vigilant and emphasized the importance of recommended precautions to reduce the risk of transmission.
According to the CDC's respiratory virus illness snapshot, COVID-19 levels are projected to be growing or likely growing in 34 states or territories, declining in one, and with an uncertain trend in 14. The agency notes that an increasing proportion of the variants causing COVID-19 are expected to be KP.3 and LB.1, another JN.1 offshoot with rising proportions.
To combat the rising cases, Hawaii's health department is urging people to ensure they are up to date with their recommended vaccine doses, especially for seniors. They are also advising individuals to stay home when sick, take extra precautions within households, wear well-fitted masks indoors with others, and get tested if experiencing symptoms.
Wastewater tracking conducted by the CDC has shown low overall COVID-19 levels, but a sharp increase in the West. However, data from WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, indicates that COVID-19 levels are in the high category nationally and in the South and Northeast regions, with medium concentrations and an upward trend over the past three weeks in the Midwest and the West.
As the nation continues to grapple with the ongoing pandemic, the FDA's recommendation to prioritize the KP.2 variant aims to ensure that future COVID-19 vaccines provide effective protection against the evolving strains of the virus.