A day after Serum Institute of India (SII) sought the Drugs Controller General of India’s approval to conduct a small domestic trial of the Novavax coronavirus vaccine, its Chief Executive Officer Adar Poonawalla on Saturday the company is hopeful of launching the vaccine by June this year.
The vaccine will be launched under the local brand Covovax.
Poonawalla said that SII’s partnership with Novavax, a vaccine undergoing trials for effectiveness against the novel coronavirus, has published ‘excellent efficacy results’.
“Our partnership for a COVID-19 vaccine with @Novavax has also published excellent efficacy results. We have also applied to start trials in India. Hope to launch #COVOVAX by June 2021!” he said in a tweet.
Pune-based SII, the world’s largest vaccine manufacturer, and the Indian Council of Medical Research have a tie-up with the company and bridging studies will be done once the regulators give the approval.
SII’s application with the DCGI is being examined. A bridging trial is a supplementary trial performed in a new region or country to get more clinical data on efficacy, safety and dose regimen.
Earlier, Dr Umesh Shaligram, executive director of SII, told News18 that the company is keen on starting the bridging trials in the country and that SII would be in a position to start the trials by February once the approvals come through. “Data of protection against the new variants is promising. The good thing is that the new strain in South Africa emerged as the trials of the vaccine were going on in the country,” he said.
In September 2020, Novavax had announced its deal with Serum Institute to produce 2 billion doses of the Covid-19 vaccines. In India, the vaccine will be called Covovax, developed by Novavax and upscaled by the SII.