Novavax Seeks DCGI's Approval For Emergency Use Of Its Covid-19 Vaccine In India

United States-based Novavax on Thursday (5 August) said it, along with its partner Serum Institute of India, applied for regulatory approval from Drug Controller General of India (DCGI) for allowing the emergency use of its Covid-19 vaccine in India.

Novavax has signed a vaccine manufacturing pact with the Pune-based Serum Institute of India (SII), the world's largest vaccine producer by volume.

The SII also manufactures the Oxford-AstraZeneca's Covid-19 vaccine, called Covishield, that is currently being used in India's Covid vaccination drive.

Apart from India, the Novavax has asked Indonesia and the Philippines to allow emergency use of its Covid-19 vaccine, called Covovax.

"Today's submission of our recombinant nanoparticle COVID-19 vaccine, the first protein-based option filed with any regulatory agency, represents a major milestone in Novavax' transformation into a commercial global vaccine company," said Stanley C Erck, President and Chief Executive Officer, Novavax.

"This important step toward access to millions of doses of a safe and effective vaccine for countries with an urgent need to control the pandemic was made possible through our strategic partnership with Serum Institute of India, and it demonstrates the power of global collaboration," Erck added.

SII and Novavax have now completed the submission of all modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls data. A Good Manufacturing Practice joint site inspection of SII was successfully completed by DCGI in May 2021, the company said in a statement.

The Novavax two-dose shot is made with lab-grown copies of the spike protein that coats the coronavirus.

In June, Novavax announced the vaccine had proved about 90% effective against symptomatic Covid-19 in a study of nearly 30,000 people in the US and Mexico. It also worked against variants circulating in those countries at the time. Side effects were mostly mild, reports Livemint.

The Novavax Covid-19 vaccine is stored and stable at 2 degree celsius to 8 degree celsius, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials, the company said.