SOUTH AFRICA – The South African Health Products Regulatory Authority (SAHPRA) has authorized the use of Novavax’ protein-based vaccine as a two-dose primary series for active immunization to prevent COVID-19 in adults aged 18 and older.
The South African Health Products Regulatory Authority said that the product registration of Novavax’ protein-based vaccine dubbed NVX-CoV2373 was based on the totality of preclinical, manufacturing, and clinical trial data submitted for review.
The product registration involves two pivotal Phase 3 clinical trials namely PREVENT-19 in the United States and Mexico as well as a United Kingdom-based trial with almost 15,000 adult participants, both published in the New England Journal of Medicine (NEJM).
Novavax Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases and Serum Institute of India Pvt. Ltd. (SII) announced that the Novavax vaccine is marketed in South Africa under the brand name Covovax™.
Novavax Inc. revealed that in both trials, the vaccine demonstrated efficacy with a reassuring safety and tolerability profile, adding that serious and severe adverse events were low in number and balanced between vaccine and placebo groups.
The biotechnology company further disclosed that the most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness or pain, fatigue, and malaise.
Furthermore, NVX-CoV2373 has received authorization for use in adults aged 18 and older from more than 43 countries, including the United States, and from the World Health Organization (WHO).
The pharma giant cautioned that Novavax’ protein-based vaccine is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients, adding that the efficacy of NVX-CoV2373 may be lower in immunosuppressed individuals.
According to Novavax Inc, vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection while administration of NVX-CoV2373 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.
“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.
Novavax President further said that as COVID-19 continues to evolve, having a choice of vaccines is critical to improving vaccination rates while commenting on SAHPRA’s authorization for Novavax’ protein-based vaccine.
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