India’s first Covid-19 vaccine candidate by Hyderabad-based Bharat Biotech set for trials

HYDERABAD: India’s first Covid-19 vaccine candidate Covaxin, developed by Hyderabad-based Bharat Biotech in collaboration with the National Institute of Virology (NIV), has received Drug Controller General of India (DCGI) approval for phase I and II human trials.
Human trials for the indigenous, inactivated vaccine will begin across the country next month, Bharat Biotech said.
Pointing out that results from preclinical studies on animals have been promising and show extensive safety and effective immune responses, Bharat Biotech CMD Dr Krishna Ella said the results of trials should be out by October 2020.
“The trials resulted in a safe and immunogenic response from all the animals that were tested,” Ella said. “At the moment, we are not sure how the vaccine is going to perform in humans as clinical trials are about to commence. Based on the success of results of phase I & II, which would be out by October 2020, we will progress to larger clinical trials. Thereafter, the licensure timelines will be set upon receiving regulatory approvals.”
“Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies,” he added.Ella said inactivated viruses have proven safety records and Bharat Biotech has expertise in vero cell culture vaccine manufacturing platform as it has already manufactured rabies, polio, Japanese Encephalitis and Rotavirus vaccines.
The SARS-CoV-2 virus strain was isolated from an asymptomatic Covid-19 patient at NIV, Pune, and transferred to Bharat Biotech, which grew and replicated the virus and developed the vaccine candidate at its BSL-3 (Bio Safety Level-3) high containment manufacturing facility at Genome Valley in Hyderabad, where it will be manufactured.
Apart from Covaxin, Bharat Biotech is partnering with US-based vaccine maker FluGen and virologists at the University of Wisconsin-Madison to develop an intranasal vaccine - CoroFlu. It has also inked an exclusive deal with the Thomas Jefferson University of Philadelphia for the development of a new vaccine candidate for Covid-19, which has been invented at Jefferson using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins.