Novavax Claims 90% Efficacy in Covid Vaccine Trial

Gaithersburg, MD-based Novavax has announced that its recombinant nanoparticle protein-based Covid-19 vaccine demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. The study enrolled almost 30,000 participants across 119 sites in the U.S. and Mexico to evaluate efficacy, safety and immunogenicity, the company says.

“The company intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements,” a news release says. It expects to be able to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.