Phase 3 trial of Covaxin to begin in Haryana on Nov 20, minister Anil Vij offers to be first volunteer

Haryana home minister Anil Vij on Wednesday announced that the third phase trial of Covaxin, Bharat Biotech International Limited’s potential vaccine candidate against the coronavirus disease (Covid-19), will begin on Friday in the state. Vij also offered to be the first volunteer for the vaccine trial.

“Trial for third phase of Covaxin a coronavirus vaccine product of Bhart Biotech to start in Haryana on 20th November. I have offered myself as first volunteer to get vaccinated,” the minister wrote on Twitter.

Bharat Biotech has begun the Phase 3 clinical trials of Covaxin with 26,000 participants across 22 sites in the country, the pharma firm had said on Monday. The Hyderabad-based drug maker is conducting the trial in collaboration with the Indian Council of Medical Research (ICMR).

“The Phase III trials will involve 26,000 volunteers across India, conducted in partnership with ICMR. It is the largest clinical trial conducted for a Covid-19 vaccine in India. This is India’s first phase 3 efficacy study for a Covid-19 vaccine, and the largest phase III efficacy trial ever conducted in India,” Bharat Biotech said in a statement.

The trial has been registered with the clinical trials registry of India and approved by the Drugs Controller General of India (DCGI).

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In Haryana, Pandit Bhagwat Dayal Sharma University of Health Sciences in Rohtak and ESIC hospital in Faridabad have been identified among those sites across the country where trials will be conducted, according to Bharat Biotech’s statement.

Trial volunteers, above the age of 18, will receive two intramuscular injections, about 28 days apart. “Participants will be randomly assigned to receive Covaxin or placebo. The trial is double-blinded, such that the investigators, the participants and the company will not be aware of who is assigned to which group,” the pharma firm said.

Covaxin has been evaluated in 1,000 subjects in phase I and phase II clinical trials, with promising safety and immunogenicity data, the statement added.

(With agency inputs)

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