Novavax, SII files COVID Vax EUA in South Africa

Novavax, Inc. and Serum Institute of India Pvt. Ltd. (SII) announced a regulatory submission to the South African Health Products Regulatory Agency (SAHPRA) for an Emergency Use Authorization (EUA) of the Novavax Recombinant Nanoparticle protein based on COVID-19 vaccine candidate with Matrix-M adjuvant. If licensed, the vaccine will be manufactured and marketed by SII in South Africa under the brand name Covovax.

The submission includes data from two pivotal phases of Phase 3 clinical tests : PREVENT-19, which enrolled approximately 30,000 participants in the United States and Mexico; and a trial with almost 15,000 participants in the UK. In both trials, the vaccine demonstrated a strong efficiency with a reassuring security profile. Serious and serious adverse events were few in number and balanced between vaccine and placebo groups. The most common side effects were headache, nausea or vomiting, myalgia, arthralgia, tenderness / pain at the injection site, fatigue and malaise. Novavax will continue to collect and analyze real world data, including safety monitoring and evaluation of variants, as the vaccine is released.

In total, Novavax’s vaccine has received vaccine authorizations in more than 170 countries, including conditional marketing authorization in the EU and an Emergency Use List (EUL) from the World Organization. health (WHO). The Novavax / SII vaccine (Covovax) recently received EUA in India, Indonesia and the Philippines, as well as EUU from WHO and is also currently under review by several regulatory bodies around the world. This includes submitting its complete chemistry, manufacturing and controls ( CMC ) data packet to the United States FDA end of 2021. The company plans to submit an EUA application for the vaccine in the United States after one month, in accordance with the FDA guidelines for submitting all EUA vaccines.