'Covovax authorisation is a vital step in India, where additional vaccine options are needed'

Gaithersburg/Pune (Maryland/Maharashtra): Novavax a biotechnology company dedicated to developing and commercialising next-generation vaccines for serious infectious diseases, and Serum Institute of India (SII), the world's largest vaccine manufacturer by volume, on Tuesday, announced that the Drugs Controller General of India (DCGI) has granted emergency use authorisation (EUA) for Novavax's 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.

"No one is safe until everyone is safe, and today's authorisation marks a vital step for India, where additional vaccine options and millions of doses are needed in the country's ongoing efforts to control the pandemic," said Stanley C Erck, President and Chief Executive Officer, Novavax.

"Novavax and SII will not rest in our partnership to deliver our vaccine to those in India and across the globe, as we work to protect the health of people everywhere."

Because the vaccine is stored with standard refrigeration at 2° to 8° Celsius, it may be transported and stored using the existing vaccine supply chain, potentially increasing access in hard-to-reach areas.

"The approval of Covovax in India marks a significant milestone in strengthening our immunisation efforts across India and LMICs," said Adar Poonawalla, Chief Executive Officer, Serum Institute of India.

"We are proud to deliver a protein-based COVID-19 vaccine, based on Phase 3 clinical data demonstrating more than 90% efficacy and a favourable safety profile, to our nation."
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.

The Drugs Controller General of India (DCGI) has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above.