Haryana Health Minister Anil Vij Volunteers For Phase-III Trial of Covaxin in State

Earlier on Monday, Bharat Biotech announced about the beginning of Phase III trials of COVAXIN that involves 26,000 volunteers across India. Volunteers who wish to participate in this trial should be adults over 18 years of age.

Updated: November 18, 2020 3:09 PM IST

By India.com News Desk | Edited by Rajashree Seal

Haryana Health Minister Anil Vij Volunteers For Phase-III Trial of Covaxin in State
Vij wrote, "Trial for third phase of Covaxin a coronavirus vaccine product of Bharat Biotech to start in Haryana on 20th November. I have offered myself as first volunteer to get vaccinated."

New Delhi: As the third phase of clinical trials for Bharat Biotech’s COVID-19 vaccine, Covaxin, is about to begin in Haryana on  November 20, state Health Minister Anil Vij on Wednesday offered to become the “first volunteer” for the anti-COVID-19 vaccine trial.

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

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

Earlier on Monday, Bharat Biotech announced about the beginning of Phase III trials of COVAXIN that involves 26,000 volunteers across India. Volunteers who wish to participate in this trial should be adults over 18 years of age.

According to a news agency report ANI, the trial has been approved by the Drugs Controller General of India and will be conducted in partnership with the Indian Council of Medical Research (ICMR). It is said to be the largest clinical trial conducted for a country-made COVID-19 vaccine using the virus strain isolated by ICMR’s National Institute of Virology (NIV) based in Pune.

Trial volunteers will receive two intramuscular injections approximately 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.

COVAXIN has been evaluated in 1000 subjects in Phase I and Phase II clinical trials, with “promising safety and immunogenicity data”.

In October, the Drugs Controller General of India (DCGI) gave permission to Bharat Biotech for conducting Phase-III clinical trial for Covaxin.

“The DCGI thoroughly analyzed recommendation of the Subject Expert Committee for Bharat Biotech COVID-19 vaccine. On Friday, the top drug regulator granted approval to the pharma giant to conduct phase III clinical trial in India for Covaxin,” a government official had said.

According to the Subject Expert Committee (SEC), on October 5, the firm presented their data from the 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.

(With ANI inputs)

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