Today, the full results from PREVENT-19, Novavax’ pivotal Phase 3 clinical trial of NVX-CoV2373, a recombinant protein nanoparticle vaccine against COVID-19, were published in the New England Journal of Medicine. The paper, ‘Efficacy and Safety of NVX-CoV2373 in Adults in the U.S. and Mexico,’ may be accessed here.
PREVENT-19 achieved its endpoint of efficacy in preventing polymerase chain reaction (PCR)-confirmed, symptomatic mild, moderate or severe COVID-19 with onset at least 7 days after the second dose. The trial demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulating variants of concern and variants of interest, and 90.4% efficacy against COVID-19 of any severity during the time period evaluated. Solicited adverse events were predominantly mild-to-moderate and transient. Severe reactions were infrequent and there were no safety concerns related to vaccination.
PREVENT-19 evaluated the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M™ adjuvant in nearly 30,000 participants 18 years of age and older at 119 locations in the United States and Mexico. The trial included a blinded ‘crossover,’ ensuring all participants received NVX-CoV2373 without compromising Food and Drug Administration (FDA)-required safety follow-up.
Novavax expects to submit its complete CMC package to FDA for review by the end of 2021.
The manuscript was previously posted to the medRxiv preprint server in October 2021. Initial findings from the study were shared in June.