- Bharat Biotech got the permit from DGCI in October to start trials
- The Phase III trials will involve 26,000 volunteers across India
- COVAXIN has been evaluated in 1,000 subjects in Phase I and Phase II tirals
New Delhi: Haryana Health Minister Anil Vij has offered to become the “first volunteer” for Phase-III clinical trial of Bharat Biotech’s COVID-19 vaccine ‘Covaxin’, which will begin in Haryana from November 20. “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,” Mr. Vij tweeted. Volunteers who wish to participate in this trial should be adults over 18 years of age.
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.
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.
Bharat Biotech has partnered with the Indian Council of Medical Research (ICMR) for a country-made COVID-19 vaccine using the virus strain isolated by ICMR’s National Institute of Virology (NIV) based in Pune.
The Phase III trials will involve 26,000 volunteers across India, the company said.
Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned to receive COVAXIN(tm) 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 immunogencity data”.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
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