Summary :
After a long wait, Bharat Biotech’s Covaxin has finally got the nod from the US Food and Drug Administration (USFDA) to conduct clinical trials in humans for its Covid-19 vaccine Covaxin.
This development means a lot for the Hyderabad-based vaccine maker, one of the first companies in the world to come out with a vaccine for Covid-19.
COVID-19
Though it got the Emergency Use licence from scores of countries and the World Health Organisation (WHO), the firm could not access the lucrative markets of the US and Canada.
“Covaxin will be evaluated as a Covid-19 vaccine candidate in the United States,” Bharat Biotech has said.
“The USFDA has lifted its clinical hold on the company’s investigational New Drug application (IND) to evaluate the Covid-19 vaccine candidate BBV152 (Covaxin),” Ocugen Inc., which is co-developing Covaxin with Bharat Biotech for the North American markets, said.
“We now have permission to start human clinical trials for Covaxin in the United States,” a source in Bharat Biotech has said.
In a filing to the US Securities and Exchange Commission (SEC), Ocugen indicated that IND had been filed with FDA for Phase-iii bridging study in support of a BLA (Biologics License Application) submission. (A BLA is used to request permission to introduce or deliver a biologic product into interstate commerce.)
“A comprehensive response has been submitted to Health Canada (a Canadian department responsible for national health policy) against notice of deficiencies. A Letter of Intent has also been signed with Liminal BioSciences for acquisition of a new Canada-based manufacturing facility,” it said.
The US firm said that it had selected a manufacturing partner. “Transfer of technology from Bharat Biotech is in progress. We are targetting 100 million doses a year,” it said in the filing.