The Serum Institute of India (SII) and Novavax, Inc have received an Emergency Use Authorisation (EUA) for Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant by the Drugs Controller General of India (DCGI). The vaccine will be manufactured and marketed in India by SII under the brand name Covovax, the companies said in a joint statement.
Speaking in this regard, Adar Poonawalla, Chief Executive Officer, SII, said, “The approval of Covovax by DCGI is a significant milestone in strengthening our immunisation efforts across India and LMICs. ….deliver a highly-effective protein-based COVID-19 vaccine of more than 90 per cent efficacy rate, based on clinical data demonstrating a favourable safety profile….”
According to the statement, the Novavax/SII vaccine recently received Emergency Use Listing (EUL) with the World Health Organization (WHO), EUA in Indonesia and the Philippines. Novavax also announced regulatory filings for its vaccine in Australia, Canada, the European Union, New Zealand, the United Kingdom, and with the WHO. Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) submission in South Korea. It expects to submit the complete package to the US Food and Drug Administration (FDA) by the end of the year.