Covaxin, is developed in collaboration with the ICMR and the National Institute of Virology (NIV). This indigenous, inactivated vaccine is manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio containment facility. The highly purified and inactivated vaccine is manufactured in a vero cell manufacturing platform with an superior safety track record of more than 300 million doses supplied.The phase-3 clinical trials will involve 26,000 participants across 22 sites in the country. It is the largest and the first phase 3 efficacy study conducted for a COVID-19 vaccine in India. The trial has been registered with the clinical trials registry of India, and approved by the Drugs Controller General of India (DCGI).
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 the trial should be adults over 18 years of age.
Suchitra Ella, joint managing director of Bharat Biotech said, “The development and clinical evaluation of Covaxin marks a significant milestone for vaccinology in India”.