To curb the pandemic situation in South Africa, Novavax, a biotechnology firm focused on manufacturing and commercializing advanced vaccines for high-risk infectious diseases, along with the Serum Institute of India (SII), have reportedly declared a regulatory submission for emergency use authorization of COVID-19 vaccine to the South African Health Products Regulatory Agency (SAHPRA).
As per sources, the vaccine is Novavax’s recombinant nanoparticle protein-centric COVID-19 jab candidate with Matrix-M adjuvant.
Novavax commented that upon authorization, the vaccine named NVX-CoV2373, will be produced and commercialized by SII under the name Covovax in South Africa.
Stanley C Erck, Chief Executive Officer and President of Novavax stated that the firm is elated thankful for the long-standing history of alliance in South Africa to modernize the vaccines. He added that the country’s crucial role in the Phase 2b booster study and clinical trial of the protein-centric COVID-19 vaccine is an example of the support.
Erck continued that Serum Institute and Novavax are committed to delivering COVID-19 vaccine developed on well-understood technology.
As per credible sources, Novavax has received the authorization of vaccines from over 170 countries, which also includes emergency use listing (EUL) from the World Health Organization (WHO) and conditional marketing authorization for the vaccine in the European Union.
Reportedly, the Novavax/SII vaccine has received a EUA from Indonesia, India, and the Philippines along with WHO EUL, and is also under review by various supervisory firms across the world. This includes the submission of full chemistry, manufacturing, and controls (CMC) information to the US Food and Drug Administration (FDA) by the end of 2021.
It has been speculated that the firm expects to submit a request for EUA for vaccines across the US after one month under supervision from the FDA, about the submission of all EUA vaccine doses.