SII, Novavax report full product registration in South Africa of COVID jab NVX-CoV2373 for adults aged 18 and older
Gaithersburg: Novavax, Inc., a biotechnology company and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, have 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.
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.
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.
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).
Serum Institute of India Pvt, Ltd. is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses), supplying the world's least expensive and WHO-accredited vaccines to as many as 170 countries.
