Pune - Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume, and Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, receive emergency use authorization (EUA) for Novavax' 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 Bharat by SII under the brand name COVOVAX™.
Sharing his views, Adar Poonawalla, Chief Executive Officer, Serum Institute of India (SII), said, “The approval of COVOVAX by DCGI is a significant milestone in strengthening our immunization efforts across Bharat and LMICs. We are proud to deliver a highly-effective protein-based COVID-19 vaccine of more than 90% efficacy rate, based on clinical data demonstrating a favorable safety profile. We are certain that as the repertoire of the COVID-19 vaccine increases, we will be poised strongly to save the lives of millions of people against the pandemic.”
“We expect the authorization of our vaccine to serve a vital need in Bharat, helping to increase the vaccination rate in a country where a significant number of doses is needed to control the pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “Novavax and our partner, Serum Institute of India, continue to increase our forward momentum, and we will not rest in our work to deliver our vaccine to those in Bharat and across the globe, as we work to protect the health of people everywhere.”
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. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.
Authorized Use of Novavax’ Covid-19 Vaccine in Bharat
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.
Important Safety Information
COVOVAX is contraindicated in persons who have hypersensitivity to the active substance or to any of the excipients of this vaccine.