Covaxin phase 3 trial will begin in Haryana on November 20, Minister Anil Vij offers to be the first volunteer
Haryana Interior Minister Anil Vij announced on Wednesday that the third phase of testing of Covaxin, Bharat Biotech International Limited’s potential candidate vaccine against the coronavirus disease (Covid-19), will begin on Friday in the state. Vij also volunteered to be the first volunteer for the vaccine trial.
“The third phase trial of Covaxin, a Bhart Biotech coronavirus vaccine product, will begin in Haryana on November 20. I volunteered as the first volunteer to get vaccinated, ”the minister wrote on Twitter.
Bharat Biotech has begun phase 3 clinical trials of Covaxin with 26,000 participants at 22 sites across the country, the pharmaceutical firm said Monday. The Hyderabad-based drug maker is conducting the trial in collaboration with the Indian Council for 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 in the Indian Clinical Trials Registry and approved by the Comptroller General of Medicines of India (DCGI).
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In Haryana, the Pandit Bhagwat Dayal Sharma University of Health Sciences in Rohtak and the ESIC hospital in Faridabad have been identified among the sites across the country where the trials will take place, according to the statement from Bharat Biotech.
Trial volunteers, 18 years of age and older, will receive two intramuscular injections, approximately 28 days apart. “Participants will be randomly assigned to receive Covaxin or placebo. The trial is double-blind, so researchers, participants and the company will not know who is assigned to which group, “said the pharmaceutical firm.
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 contributions from the agency)