On Sept. 13, 2022, Novavax and Serum Institute of India, the world’s largest vaccine manufacturer by volume, announced that the South African Health Products Regulatory Authority has granted full product registration with conditions for Novavax’ protein-based vaccine, NVX-CoV2373, as a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults aged 18 and older. The Novavax vaccine is marketed in South Africa under the brand name Covovax.

The product registration was based on the totality of preclinical, manufacturing, and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled 29,960 participants aged 18 years and older in the U.S. and Mexico and was published in the New England Journal of Medicine (NEJM); and a UK-based trial with almost 15,000 adult participants, also published in NEJM.

In both trials, the vaccine demonstrated efficacy with a reassuring safety and tolerability profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.

NVX-CoV2373 has received authorization for use in adults aged 18 and older from more than 43 countries, including the U.S., and from the World Health Organization (WHO).

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 disease. 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. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

NVX-CoV2373 is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization, and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with SII, the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain.