Amid Rising Cases, FDA Recommends KP.2 Lineage for Fall COVID-19 Vaccines

COVID-19 cases across the Nation
COVID-19 cases across the Nation. Credit | Adobe Stock

United States: The US Food and Drug Administration (FDA) recently pivoted from its prior endorsement of the JN.1 variant, advocating instead for vaccine manufacturers to concentrate on the KP.2 lineage for the forthcoming fall inoculations.

As per CIDRAP, this adjustment, prompted by recent epidemiological trends and an uptick in national case counts, was publicized yesterday.

Advisory Committee’s Initial Recommendations

On June 5, the FDA’s vaccine advisory panel initially endorsed the JN.1 variant. However, they refrained from recommending the KP.2 offshoot, citing uncertainties regarding the evolutionary trajectory of SARS-CoV-2 strains and concerns over the production timeline of Novavax, a protein-based vaccine that would struggle to rapidly adapt to the KP.2 lineage.

Monitoring and Adaptation

In alignment with the advisors’ counsel, the FDA accepted the JN.1 recommendation but committed to ongoing surveillance of vaccine safety, efficacy, and viral evolution. The Centers for Disease Control and Prevention (CDC) subsequently reported an escalation in KP.3 cases, alongside a steady increase in KP.2 and a decline in the JN.1 parent lineage.

Aligning with Current Strains

The emergent KP.2 and KP.3 variants possess mutations that likely confer increased resistance to immunity derived from prior infections or vaccinations. The FDA’s recent statement underscored that the KP.2 lineage, given the latest data and rising COVID-19 activity in specific regions, should supplant JN.1 to better align 2024-25 vaccines with circulating strains, according to CIDRAP News.

Production Timelines and Efficacy

The FDA assured that transitioning to KP.2 should not delay vaccine availability in the US. mRNA vaccines, with their shorter production cycles, are well-suited for this switch. Novavax has emphasized that its vaccine maintains broad cross-neutralization against various JN.1 descendant viruses, including KP.2 and KP.3, and elicits conserved T-cell responses against these variants.

Commercial Availability

Novavax aims for a commercial rollout of the updated vaccine by September, pending FDA authorization. The company highlighted the broad-spectrum efficacy of its technology against multiple variant strains, including newer forward drift variants.

Regional COVID-19 Trends

The CDC’s latest updates reveal a slight increase in positive test percentages, especially pronounced in the western US, encompassing Arizona, California, Hawaii, and Nevada. Emergency department visits due to COVID-19 have risen modestly, with Hawaii experiencing the highest and is classified as moderate, while other states remain at minimal levels or lack sufficient data, CIDRAP mentioned.

Vigilance in Hawaii

The Hawaii State Department of Health has advised heightened vigilance due to elevated COVID-19 levels, which surpass historical trends. They emphasized the importance of adhering to recommended precautions to mitigate risk.

National Trends

The CDC’s respiratory virus illness snapshot indicates a potential rise in COVID-19 levels across 34 states or territories, with only one state seeing a decline and 14 with uncertain trends. The agency noted an increasing prevalence of KP.3 and LB.1 variants, with LB.1 being another JN.1 offshoot.

Recommendations for Public Health

Hawaii’s health department has urged residents, particularly seniors, to stay current with vaccinations, remain at home when ill, adopt additional household precautions, wear well-fitted masks indoors, and undergo testing if symptomatic.

Wastewater Surveillance Insights

CDC wastewater tracking reflects overall low levels of COVID-19, yet with significant increases in the West. Data from WastewaterSCAN, a nationwide monitoring system managed by Stanford University and Emory University, suggests high COVID levels nationally and in the South and Northeast, with medium levels trending upwards in the past three weeks in the Midwest and West.