Phase 2 and 3 clinical trials for Sputnik vaccine commence

New Delhi, Dec 1 : Dr. Reddys Laboratories Ltd. and Russian Direct Investment Fund (RDIF) announced on Tuesday that they have commenced adaptive Phase 2 and 3 clinical trials for Sputnik V vaccine in India for Covid-19 after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli.
This will be a multicentre and randomised controlled study, which will include safety and immunogenicity study.
The clinical trials are being conducted by JSS Medical Research as the clinical research partner.
Further, Dr. Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT), for advisory support and to use BIRAC’s clinical trial centres for the vaccine.
Recently, the RDIF announced the second interim analysis of clinical trial data, which showed 91.4 per cent efficacy for the vaccine on day 28 after the first dose; and vaccine efficacy of over 95 per cent 42 days after the first dose.
Currently, 40,000 volunteers are taking part in Phase III of Sputnik V clinical trials, out of which over 22,000 have been vaccinated with the first dose of the vaccine and more than 19,000 — with both the first and second doses of the vaccine.