On Tuesday night, the Drug Controller General of India (DCGI) granted emergency approval to Novavax-Covovax SIIs, granting a significant reprieve.
On Tuesday night, the Drug Controller General of India (DCGI) granted emergency approval to Novavax-Covovax SII vaccines, giving India’s vaccination efforts a boost. The decision pleased Novavax CEO Stanley C Erck, who said it will help India’s attempts to curb the pandemic. In the United States, Covovax, a joint venture between Novavax and the Serum Institute of India, is still pending FDA approval.
Covovax has received approval from DCGI.
Stanley C Erck, President and Chief Executive Officer of Novavax, stated, “No one is secure until everyone is protected.” “Today’s approval is a significant step forward for India, which requires additional vaccination alternatives and millions of doses in order to combat the pandemic.” “As we seek to defend people’s health around the world, Novavax and SII will not stop working together to get our vaccine to India and the rest of the world.” Covovax is a recombinant nanoparticle protein-based COVID-19 vaccine.
“The approval of Covovax in India is a big step forward in enhancing our vaccination efforts in India and LMICs,” Serum Institute of India CEO Adar Poonawalla stated. “We are pleased to provide a protein-based COVID-19 vaccine to our country, which is based on Phase 3 clinical data exhibiting over 90% efficacy and a favourable safety profile.” India’s vaccine portfolio now includes Covishield, Covaxin, Sputnik V, Moderna vaccine (mRNA-1273), Janssen vaccine, ZyCoV-D, and Corbevax, as well as the capacity to import any foreign-based vaccine, such as Pfizer.
Covovax (NVX-CoV2373) is a protein-based vaccination based on the COVID-19 virus’s alpha variant’s genomic sequence. COvovax is prepared with Novavax’s unique saponin-based Matrix-M adjuvant to boost immune response and boost neutralising antibody levels. Antigen generated from the coronavirus spike (S) protein was created using Novavax’s recombinant nanoparticle technology. Covovax is a virus with pure protein antigen but no ability to replicate or induce COVID-19.
It comes in a vial with ten doses and can be stored in regular refrigeration at 2° to 8° Celsius. The vaccine currently has a 9-month shelf life. The vaccination is administered in two doses, 21 days apart, one following the other. Overall, the vaccination has an efficacy of 89.7%, with 96.4 percent efficacy against severe to mild cases and 86.3 percent against the Alpha form. Covovax received the 9th vaccination to earn an emergency use listing (EUL) from the World Health Organization, following Covishield, Covaxin, Pfizer, Moderna, J&J, Sinovac, Sinopharm, and AstraZeneca.