Bharat Biotech begins its the phase 3 trials of its Covid-19 vaccine, Covaxin, in India. The phase-3 clinical trials will involve 26,000 participants across 22 places 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.
Trial volunteers will receive two intramuscular injections about 28 days apart. Participants will be randomly assigned to receive Covaxin or placebo.
Covaxin, is developed in collaboration with 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.