On March 2, Novavax Pharmaceuticals shared an extended analysis of its pivotal Phase 3 clinical trial conducted in the UK, demonstrating that its protein-based COVID-19 vaccine, NVX-CoV2373, maintained high efficacy over a six-month surveillance period. Furthermore, the analysis showed that the vaccine was 82.5% effective (95% CI: 75.0, 87.7) in preventing all COVID-19 infections (symptomatic and asymptomatic), measured by PCR+ or anti-N seroconversion.

This data builds upon the final analysis of the UK Phase 3 trial published in the New England Journal of Medicine in June 2021, which was part of Novavax's global regulatory submission for NVX-CoV2373 and demonstrated vaccine efficacy of 89.7% (95% CI: 80.2, 94.6) with cases collected over a period exceeding three months (median surveillance of 55 days).

During an extended data collection window, vaccine efficacy was evaluated over a six-month period from November 10, 2020, to May 10, 2021 (median surveillance of 101 days). NVX-CoV2373 continued to exhibit a reassuring safety profile during this window, with adverse events balanced between the vaccine and placebo groups. Additionally, the trial showed sustained protection, with an overall vaccine efficacy of 82.7% (95% CI: 73.3, 88.8). Throughout the six-month efficacy collection window, the vaccine was 100% effective against severe disease (95% CI: 17.9, 100), consistent with the preliminary analysis.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19. NVX-CoV2373 is manufactured using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein and incorporates Novavax’s patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19.

The Novavax COVID-19 vaccine is packaged as a ready-to-use liquid formulation in vials containing ten doses. The vaccination regimen requires two intramuscular injections administered 21 days apart, each 0.5 ml (5 mcg antigen and 50 mcg Matrix-M adjuvant). The vaccine is stored at temperatures between 2 and 8 degrees Celsius and can utilize existing vaccine supply and冷链channels. The use of the vaccine should be in accordance with official recommendations.

Novavax has established manufacturing, commercialization, and distribution partnerships for NVX-CoV2373 globally. Existing authorizations leverage Novavax's manufacturing partnership with the Serum Institute of India (SII), the world's largest vaccine manufacturer by volume. This will subsequently be supplemented by data from other manufacturing sites within Novavax's global supply chain.

About the Matrix-M™ Adjuvant

Novavax's patented saponin-based Matrix-M™ adjuvant has been shown to be effective and well-tolerated, enhancing the immune response by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes.