The Drugs Controller General of India (DCGI) recently approved Bharat Biotech to conduct phase 3 clinical trials India’s first indigenous coronavirus vaccine, Covaxin.
The Hyderabad-based company had submitted the interim data of phase 1 and 2 clinical trials while seeking the DCGI’s nod for conducting phase-3 clinical trials. However, the vaccine maker was asked to submit complete safety and immunogenicity data of the ongoing phase-2 trial.
The company now has shared the preliminary results of its first two stages of trials of Covaxin with IANS.
“Having received the approval from DCGI after assessing data from Phase I and 2 as well as the results of animal challenge study, we have moved into the last phase of trials,” he was quoted as saying.
While Phase I data for neutralising antibodies had shown good immunogenicity, analysis of Phase-2 data is on, he added.
The Phase-II trials began in September while the Phase I trial was started in July itself.
Volunteers’ recruitment For Phase-3 Trial About to Begin This Month
Bharat Biotech, is Jointly developing with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) Covaxin. The vaccine is being created using the inactivated version of SARS-CoV-2, the virus which causes COVID-19.
The phase-3 trial of the vaccine will be conducted across 25 sites in about 10-12 states and cover 25,000-26,000 volunteers aged 18 years and above, Prasad said.
According to reports, the volunteers will be given a dose of 0.5 ml on day 0 and 28 and recruitment of volunteers is planned to begin this month.
Bharat Biotech is hoping to apply for regulatory approval for the vaccine in the second quarter of 2021.
“The Phase III efficacy data will be available approximately at the end of Q1 in 2021, after which we will apply for regulatory approval for release of the vaccine. We will continue on to phase IV which routinely follows up the participants for a few years,” Prasad told IANS.
Prasad didn’t reveal the timeline for the vaccine launch. But some reports suggest that the company is hoping to launch it by June next year, unless the government decides to give the vaccine an emergency use authorisation before that.