Policy & Regulation
Dr. Reddy's and RDIF start Sputnik V trials in India
1 December 2020 -

Indian pharmaceutical company Dr. Reddy's Laboratories Ltd (BSE:500124) (NSE:DRREDDY) (NYSE:RDY) and the Russian Direct Investment Fund (RDIF) announced on Tuesday the launch of adaptive phase 2/3 clinical trials for the Sputnik V COVID-19 vaccine in India.

India's Central Drugs Laboratory has approved the multicentre and randomised controlled trial, which will include safety and immunogenicity study.

RDIF recently announced the second interim analysis of clinical trial data, which showed 91.4% efficacy for the vaccine on day 28 after the first dose and efficacy over 95% 42 days after the first dose.

Approximately 40,000 volunteers are currently taking part in Phase III clinical trials of Sputnik V, of whom 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.

Dr. Reddy's and RDIF entered into a partnership in September 2020 to conduct clinical trials of the Sputnik V vaccine and the rights for distribution of the first 100 million doses in India.