India, Nov. 17 — Bharat Biotech on Monday said it has begun the phase 3 clinical trials of its coronavirus disease (Covid-19) vaccine candidate, Covaxin, in India, with 26,000 participants across 22 sites in the country.
The trial will be conducted in partnership with the Indian Council of Medical Research (ICMR), the Hyderabad-based drugmaker said in a statement.
“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.
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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Trial volunteers 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. Covaxin has been evaluated in 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogencity data,” the company statement read. Volunteers are those above the age of 18.
Covaxin, India’s indigenous Covid-19 vaccine, is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio containment facility.
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The development and clinical evaluation of Covaxin marks a significant milestone for vaccinology in India for a novel vaccine. It is important for Indian companies to innovate and develop indigenous vaccines, especially during a pandemic,” said Suchitra Ella, joint managing director, Bharat Biotech.
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