 
A Clinical Trial with India’s first indigenous COVID-19 Vaccine is currently ongoing at Mahatma Gandhi Medical College and Research Institute, Pondicherry. MGMCRI in collaboration with the Indian Council of Medical Research and Bharat Biotech Limited is the first Medical facility to start human trials for India’s own COVID-19 Vaccine in the region of Puducherry.
The trial is currently ongoing across 21 centres in India and based on the results of the trial, the vaccine might be licensed commercially in 2021. The study is an endpoint-driven, randomized, double-blind, placebo-controlled study in which participating adults will be randomized to receive 2 doses of Vaccine Candidate or a control normal saline plus aluminum hydroxide on Month 0 and Month 1. Participants will be followed for efficacy and safety.
The purpose of this Phase 3 study in MGMCRI SITE is to evaluate the protective efficacy and safety of the whole-virion inactivated SARS-CoV-2 vaccine, BBV152B.The trial was started in December 2020 after due approval from the DCGI, ICMR and the Institutional Human Ethics Committee. The trial had enrolled 916 healthy human volunteers and is currently in the follow up phase.
The interim analysis of the trial from across the sites had demonstrated an efficacy of 82.3% for the vaccine. At MGMCRI Site, there has been no incidence of serious adverse events related to the investigational product. The trial is currently monitored by a dedicated team under the department of Pulmonary Medicine.
