The Drug Controller General of India (DCGI) granted emergency authorisation to Novavax-Covovax SII’s on Tuesday night, providing a major reprieve.
The Drug Controller General of India (DCGI) granted emergency authorisation to Novavax-Covovax SII’s on Tuesday night, providing yet another boost to India’s vaccination efforts. Novavax CEO Stanley C Erck expressed his delight at the approval, saying that it will aid India’s efforts to contain the pandemic. Covovax, a joint venture between Novavax and the Serum Institute of India, is still awaiting FDA approval in the United States.
DCGI has given their approval to Covovax.
“No one is safe until everyone is safe,” Stanley C Erck, President and Chief Executive Officer of Novavax, said. “Today’s authorization marks a critical step for India, where additional vaccine options and millions of doses are needed in the country’s ongoing efforts to control the pandemic.” “As we work to protect people’s health around the world, Novavax and SII will not rest in our partnership to deliver our vaccine to those in India and around the world.” Covovax is a COVID-19 vaccine made from recombinant nanoparticle proteins.
“The approval of Covovax in India is a significant step forward in strengthening our immunisation efforts in India and LMICs,” said Adar Poonawalla, CEO of Serum Institute of India. “We are proud to present our country with a protein-based COVID-19 vaccine based on Phase 3 clinical data demonstrating over 90% efficacy and a favourable safety profile.” With the approval of Covovax, India’s vaccine portfolio has grown to include Covishield, Covaxin, Sputnik V, Moderna vaccine (mRNA-1273), Janssen vaccine, ZyCoV-D, and Corbevax, as well as the ability to import any foreign-based vaccine, such as Pfizer.
Covovax (NVX-CoV2373) is a protein-based vaccine based on the genetic sequence of the COVID-19 virus’s alpha variant. COvovax is formulated with Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralising antibodies. It was developed using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. Covovax is a virus that contains purified protein antigen but cannot replicate or cause COVID-19.
It comes in a vial with ten doses and can be stored at 2° to 8° Celsius in standard refrigeration. The vaccine’s current shelf life is set at 9 months. The vaccine is given in two doses, one after the other, 21 days apart. The vaccine’s overall efficacy is 89.7%, with 96.4 percent efficacy against severe to mild cases and 86.3 percent efficacy against the Alpha variant. After Covishield, Covaxin, Pfizer, Moderna, J&J, Sinovac, Sinopharm, and AstraZeneca, Covovax became the 9th vaccine to receive an emergency use listing (EUL) from the World Health Organization.