Covovax gets DCGI nod after Corbevax; India's vaccine kitty expands to seven

In yet another boost for India's vaccination, Novavax-SII's Covovax has been granted emergency authorisation by the Drug Controller General of India (DCGI) on Tuesday night. Welcoming the approval, Novavax CEO Stanley C Erck stated that approval will help India's efforts to control the pandemic. Covovax, jointly produced by Novavax and Serum Institute of India, is yet to get approval in the United States.

Covovax approved by DCGI

"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". Covovax is a recombinant nanoparticle protein-based COVID-19 vaccine.

"The approval of Covovax in India marks a significant milestone in strengthening our immunization 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 favorable safety profile, to our nation". With Covovax's approval, India's vaccine kitty has expanded to Covishield, Covaxin, Sputnik V, Moderna vaccine (mRNA-1273), Janssen vaccine, ZyCoV-D, Corbevax and allowed import of any foreign-based vaccine i.e Pfizer.

About Covovax

Covovax (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the alpha variant of the COVID-19 virus. COvovax was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Covovax contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

It comes in a vial containing ten doses and can be stored at standard refrigeration at 2° to 8° Celsius. The currently assigned shelf-life of the vaccine is 9 months. The vaccine is administered in two doses 21 days apart from each other. The overall efficacy of the vaccine is 89.7% - with  96.4% against severe to mild cases and  86.3% efficacy rate against the Alpha variant. Covovax became the 9th vaccine to get an emergency use listing (EUL) from the World Health Organization after Covishield, Covaxin, Pfizer, Moderna, J&J, Sinovac, Sinopharm, AstraZeneca.