1 min read.Updated: 17 Nov 2020, 06:43 AM IST Edited By Sangeeta Ojha
Covaxin phase-3 trials: Volunteers who wish to participate in this trial should be adults over 18 years of age
Covaxin is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio containment facility
Bharat Biotech said it has begun the phase 3 trials of its Covid-19 vaccine candidate, Covaxin, in India. The phase-3 clinical trials will involve 26,000 participants across 22 sites in the country. The trial will be conducted in partnership with the Indian Council of Medical Research (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 coronavirus vaccine. The trial has been registered with the clinical trials registry of India, and approved by the Drugs Controller General of India (DCGI).
Covaxin phase-3 clinical trials in India: All you need to know
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.
Volunteers who wish to participate in this trial should be adults over 18 years of age.
Covaxin, India’s indigenous Covid-19 vaccine, by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio containment facility. Covaxin is a highly purified and inactivated vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied.
Suchitra Ella, joint managing director of Bharat Biotech said, "The development and clinical evaluation of Covaxin marks a significant milestone for vaccinology in India".