Covid-19 vaccine developed and manufactured by India will run through its phase-3 trials in India. Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio containment facility.
The Phase-3 trials, which involve 26,000 volunteers across India, are being conducted in partnership with the Indian Council of Medical Research (ICMR). The eligibility for the trial is that the volunteer should be adults of 18 years of age. 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 about 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity data.
This is India’s first Phase-3 efficacy study for a Covid-19 vaccine, and the largest Phase-3 efficacy trial ever conducted in India, the Hyderabad-based company said.
