
Moderna yesterday announced promising preliminary immunogenicity data for its 2025-26 formulation of Spikevax COVID-19 vaccine, which targets the LP.8.1 variant.
In a press release, the company said the data are from an ongoing phase 4 clinical trial to gauge the safety, tolerability, and immune response to the updated Spikevax vaccine. The findings come ahead of a September 19 Centers for Disease Control and Prevention (CDC) meeting of the Advisory Committee on Immunization Practices, which is slated to discuss and vote on vaccine recommendations.
Spikevax prompted a greater than eight-fold increase in neutralizing antibodies against LP.8.1 in people ages 12 through 64 years with at least one underlying condition that puts them at high risk for severe COVID complications, as well as adults aged 65 and older.
Pfizer and BioNTech last week announced strong phase 3 clinical data for their updated COVID vaccine.
Safety profile consistent with earlier studies
Moderna said the safety profile is consistent with that of earlier studies, with findings revealing no new safety concerns.
Recent CDC data show that that wastewater SARS-CoV-2 detections are high and that LP.8.1 and related strains XFG and NB.1.8.1 continue to dominate. “This preliminary analysis confirms Moderna's updated COVID-19 vaccine is a strong match to today's top circulating strains in the U.S.,” the company said.
The latest clinical findings support preclinical data that supported the Food and Drug Administration (FDA) approval of the updated Spikevax formulation.