Novavax and Serum Institute of India Announce Full Product Registration in South Africa of Novavax COVID-19 Vaccine as a Primary Series for Adults Aged 18 and Older

Novavax, Inc. and Serum Institute of India Pvt. Ltd. (SII) 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.

“We are pleased to work with the Serum Institute to offer our protein-based vaccine to the people of South Africa and to support expanded access to an area of the world where vaccination rates are well below public health targets,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “As COVID-19 continues to evolve, having a choice of vaccines is critical to improving vaccination rates.”

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).