Novavax Receives Emergency Use Authorization For COVID-19 Vaccine In India

(RTTNews) - The Drugs Controller General of India has granted emergency use authorization for Novavax Inc's (NVAX) recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. The vaccine will be manufactured and marketed in India by Serum Institute of India Pvt. Ltd or SII under the brand name Covovax, Novavax said in a statement.

Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 microgram will induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above.

The vaccine is stored with standard refrigeration at 2° to 8° Celsius. Therefore, 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 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 Nuvaxovid.

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.

NVX-CoV2373 has not yet been authorized for use in the U.S. and the trade name Nuvaxovid has not yet been approved by the U.S. FDA.