Covaxin gets green light for human clinical trials in the United States
After a long wait, Bharat Biotech’s Covaxin has finally received the green light from the US Food and Drug Administration (USFDA) to conduct human clinical trials for its Covid-19 vaccine Covaxin.
The development means a lot to the Hyderabad-based vaccine maker, one of the first companies in the world to release a Covid-19 vaccine.
Although it has obtained the emergency use license from many countries and the World Health Organization (WHO), the company has not been able to access the lucrative markets of the United States and Canada.
“Covaxin will be evaluated as a Covid-19 vaccine candidate in the United States,” Bharat Biotech said.
“The USFDA has lifted its clinical hold on the company’s Investigational New Drug (IND) application to evaluate the Covid-19 vaccine candidate BBV152 (Covaxin),” Ocugen Inc., which is co-developing Covaxin with Bharat Biotech for the North American markets, mentioned.
“We now have clearance to begin human clinical trials for Covaxin in the United States,” a source from Bharat Biotech said.
In a filing with the U.S. Securities and Exchange Commission (SEC), Ocugen said the IND had been filed with the FDA for a Phase III bridging study in support of a BLA submission ( Biologics License Application). (A BLA is used to request permission to introduce or deliver a biological product in interstate commerce.)
“A full response has been submitted to Health Canada (a Canadian department responsible for national health policy) against the notices of deficiencies. A letter of intent has also been signed with Liminal BioSciences for the acquisition of a new manufacturing facility based in Canada,” he said.
The American firm said it had selected a manufacturing partner. “Bharat Biotech’s technology transfer is ongoing. We are aiming for 100 million doses per year,” he said in the filing.
February 19, 2022