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.