Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in India
December 28, 2021 at 09:29 am EST
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Novavax, Inc. and Serum Institute of India Pvt. Ltd. announced that the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. The vaccine will be manufactured and marketed in India by SII under the brand name Covovax. Because the vaccine is stored with standard refrigeration at 2° to 8° Celsius, it may be transported and stored using existing vaccine supply chain, potentially increasing access in hard-to-reach areas. The Novavax/SII vaccine recently received EUA in Indonesia and the Philippines, as well as Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax was also granted Conditional Marketing Authorization by the European Commission and EUL with the WHO for its vaccine, which will be marketed by Novavax as NuvaxovidTM. Novavax has also announced regulatory filings for its vaccine in multiple countries worldwide, while partners SK bioscience and Takeda have submitted regulatory filings in South Korea and Japan, respectively. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.
Novavax, Inc. is a biotechnology company, which discovers, develops and commercializes vaccines to prevent serious infectious diseases. The Company offers a differentiated vaccine platform that combines a recombinant protein approach, advanced nanoparticle technology and its patented Matrix-M adjuvant to enhance the immune response. It has one commercial program, for vaccines to prevent COVID-19, which includes Nuvaxovid prototype COVID-19 vaccine (NVX-CoV2373 or prototype vaccine) and Nuvaxovid updated COVID-19 vaccine (NVX-CoV2601 or updated vaccine) (collectively, COVID-19 Vaccine). The Company is advancing the development of other vaccine candidates, including its COVID19-Influenza Combination (CIC) vaccine candidate and additional vaccine candidates. Its COVID-19 Vaccine and its other vaccine candidates incorporate the Companyâs proprietary Matrix-M adjuvant to enhance the immune response and stimulate higher levels of functional antibodies and induce a cellular immune response.