Novavax's COVID-19 Vaccine Candidate

NVX-CoV2373 is a protein-based vaccine candidate developed by Novavax from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was developed using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. The vaccine is formulated with Novavax’s patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 cannot replicate, nor can it cause COVID-19.

According to the manufacturer, the saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect. Matrix-M is composed of 40 nm particles based on saponin (triterpene glycosides) extracted from the Quillaja Saponaria Molina bark together with cholesterol and phospholipid. It stimulates the entry of antigen-presenting cells into the injection site and increases antigen presentation in local lymph nodes. This enhances the immune response.

NVX-CoV2373 is stored and stable at 2 to 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

The company announced that NVX-CoV2373 demonstrated 100 % protection against moderate and severe disease and 90.4 % overall efficacy in the pivotal Phase 3 study, meeting the primary endpoint. PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 with Matrix-M™ adjuvant in 29,960 participants 18 years of age and older in 119 locations in the United States and Mexico, compared with placebo. These clinical results reinforce that NVX-CoV2373 is highly effective and provides complete protection against both moderate and severe COVID-19 infection.

Additional analyses of the trials are ongoing and will be shared via preprint servers and submitted to peer-reviewed journals for publication, according to the company.

The company plans to file for regulatory authorizations in the third quarter once the final phases of process qualification and assay validation required to meet chemistry, manufacturing, and controls (CMC) requirements are completed. Once regulatory approvals are granted, Novavax remains on track to reach a 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.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the UK that demonstrated efficacy of 96.4 % against the original virus strain, 86.3 % against the B.1.1.7 (Alpha) variant and 89.7 % overall; and the PREVENT-19 trial in the US and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 55 % efficacy overall in HIV-negative participants and 48.6 % efficacy against the B.1.351 (Beta) variant, and a Phase 1/2 study in the U.S. and Australia.