Novavax Provides More COVID-19 Vaccines for US Government

Yesterday, Novavax announced it was continuing its relationship with the US Department of Health and Human Services (HHS), in collaboration with the Department of Defense, to deliver up to 1.5 million doses of the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373). This is a modification to its existing agreement.

"This agreement acknowledges the need to offer the American people a diverse COVID-19 vaccine portfolio and underscores the importance of Novavax' partnership with the US government to ensure continuous access to a protein-based option as part of public health measures," President and Chief Executive Officer of Novavax John C. Jacobs, said in a statement. "We look forward to continuing our collaboration with the US government on the development of our COVID-19 vaccine to meet the requirements of the FDA and our commercial customers for the upcoming 2023/2024 vaccination campaign."

Last summer, Novavax received an FDA Emergency Use Authorization (EUA) for its COVID-19 vaccine for use in adults and the authorization was later expanded to include children aged ≥12 years as a two-dose primary series. The vaccine is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, as well as to people 18 years of age and older who elect to receive the Novavax vaccine because they would otherwise not receive a booster dose of a COVID-19 vaccine.

The initial EUA came from data submitted to FDA was based off of 2 phase 3 clinical trials they conducted with 1 using nearly 30,000 participants that were randomized between December 27, 2020 and February 18, 2021, and the other using nearly 15,000 participants who were randomized between September 28, 2020 to November 28, 2020.

Both studies’ results were published in the New England Journal of Medicine. In the former, which was named the PREVENT-19 trial, they had participants in the US and Mexico and the latter had people from the United Kingdom participating. In the PREVENT-19 trial, the vaccine demonstrated an overall efficacy of 90.4%. In the UK study, the vaccine was found to be 89.7% effective against symptomatic COVID-19 caused by both B117 and non-B117 variants.

The Novavax vaccine differs from the mRNA vaccines (Moderna, Pfizer-BioNTech) in that it is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

According to the company this modified contract with the federal government is supported with previously allocated federal funds from HHS, the Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority, through the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract Number W15QKN-16-9-1002, Project Number MCDC2011-001.