Covaxin, the vaccine candidate developed by Bharat Biotech India Limited (BBIL) in collaboration with Indian Council of Medical Research (ICMR), has received approvals from India’s drug control authority, Drugs Controller General of India (DCGI’s) Expert Committee for the initiation of the final and Phase III clinical trials.
The expert committee met on October 20 to give its nod to Phase III trials and suggested some ‘minor amendments’ in the protocol.
“In continuation of the SEC meeting dated 05.10.2020, the firm presented their data from Phase I and II along with animal challenge data in two species including NHP on the Inactivated Corona Virus Vaccine (BBV152) along with the proposal to conduct event-driven Phase III clinical trial to assess the efficacy of the vaccine,” the expert panel said in a statement on Tuesday.
Earlier in September, Bharat Biotech had informed that Covaxin had proved to be effective in inducing immunity against COVID-19 in animals. The firm had stated that the two-dose vaccination regimen of inactivated SARS-CoV-2 vaccine candidates was administered in 20 rhesus macaques which were divided into four groups equally.
Bharat Biotech, along with Zydus Cadila and Serum Institute of India, which is conducting clinical trials on Oxford University-AstraZeneca vaccine, are some of the frontrunners in Covid-19 vaccine development in India.
(With inputs from agencies)