U.S. Produced COVID-19 Vaccine Found Effective and Safe

Maryland-based Novavax, Inc. announced that NVX-CoV2373, 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 29,960 participants across 119 sites in the U.S. and Mexico to evaluate the efficacy, safety, and immunogenicity, emphasizing recruiting a representative population of communities and demographic groups most impacted by the disease.

The placebo-controlled portion of PREVENT-19 continues in adolescents from 12 to less than 18 years of age, which recently completed enrollment with 2,248 participants.

The company confirmed it 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 requirements.

In March 2021, the European Medicine Agency started a rolling review of NVX-CoV2373 developed by Novavax CZ AS (a subsidiary of Novavax, Inc.).

Upon regulatory approvals, Novavax remains on track to reach a manufacturing capacity of 100 million doses per month by the end of the 3Q21 and 150 million doses per month by the end of the 4th quarter of 2021.

"PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile," stated Gregory M. Glenn, M.D., President of Research and Development, Novavax, in a press release.

"These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the coronavirus."

"Our vaccine will be a critical part of the solution to COVID-19, and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government."

Located in Gaithersburg, MD, Novavax, Inc. (NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.