Covovax EUA 'vital step for India, where more COVID vaccine options needed': Novavax CEO

Biotechnology company Novavax and Serum Institute of India (SII) 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. According to a press release, the vaccine will now be manufactured and marketed in India by SII under the brand name Covovax. It is a two-dose vaccine and is stable at 2 to 8°C refrigerated temperatures. 

Following the DCGI approval, Stanley C. Erck, President and CEO of Novavax, said, “No one is safe until everyone is safe, and today's authorization 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.”

“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,” he added. 

'A significant milestone'

As per the press note, as the Covovax vaccine is stored with standard refrigeration at 2°C to 8°C, it may be transported and stored using the existing vaccine supply chain, potentially increasing access in hard-to-reach areas. In its clinical trials, the Novovax COVID vaccine showed an overall efficacy rate of 89.7%. The vaccine showed an efficacy of 96.4% against severe to mild cases. It has an 86.3% efficacy rate against the Alpha variant. 

"The approval of Covovax in India marks a significant milestone in strengthening our immunization efforts across India and LMICs," said Adar Poonawalla, CEO of SII. "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,” he added.  

The vaccine has already received EUA in Indonesia and the Philippines, as well as Emergency Use Listing (EUL) with the WHO. Moreover, Novavax has also announced regulatory filings for its vaccine in multiple countries worldwide. It expects to submit the complete package to the US FDA by the end of the year. The vaccine uses a novel platform and is produced by creating "engineered baculovirus" containing a gene for a modified SARS-CoV-2 spike protein, the WHO said in a statement.

(Image: Twitter/AP)