Covaxin found safe, with no major adverse events in 2 phases of trials: Bharat Biotech

The phase-3 trial of Covaxin will be conducted across 25 sites in about 10-12 states and cover 25,000-26,000 volunteers.

Bharat Biotech recently received approval from the Drugs Controller General of India (DCGI) 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.

Now, the company has shared the preliminary results of its first two stages of trials of Covaxin with IANS.

Sai Prasad, Executive Director, Bharat Biotech International Limited (BBIL) told the news agency that Covaxin was found to be safe without any major adverse events in the first two stages of the trials involving about 1,000 participants.

"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-I trials began in July while Phase-2 trials started in September.

Recruitment of volunteers for phase-3trial to begin this month

Jointly developed Bharat Biotech, the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Covaxin is 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.

The volunteers will be given a dose of 0.5 ml on day 0 and 28, according to reports. Recruitment of volunteers is planned to begin this month.

Bharat Biotech hopes 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.

GlobalCOVID-19 vaccine race: Where India stands?

About 182 COVID-19 vaccine candidates are in pre-clinical or clinical-trial stages across the globe. Of these, nine are in final human-trial stage. India is also picking up the pace, with two vaccines already in Phase-II trials and one in Phase-III.

Besides Covaxin, another indigenously developed vaccine candidate by Zydus Cadila Ltd is in the phase-2 of the human clinical trials. The company has completed enrolment and dosing of 1,000 volunteers in phase-2 clinical trials of its potential Covid-19 vaccine, called ZyCoV-D. It plans to submit the data to the Drug Controller General of India (DCGI) this month and begin phase-3 in December. The company plans to test the ZyCoV-D vaccine on about 15,000-20,000 people in Phase-3 and have final data by March-April 2021. It is hopeful of launching it in the first half of 2021.

Meanwhile, Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is conducting Phase 2 and 3 human clinical trials of the candidate in India.