Clinical Trials of the Russian Sputnik V Vaccine Have Begun in India

02 December 2020

GMP News

Dr. Reddy’s Laboratories Ltd., and Russian Direct Investment Fund (RDIF) announced that they have commenced adaptive phase 2/3 clinical trials for Sputnik V vaccine in India after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli, India. This will be a multicenter and randomized 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, RDIF announced the second interim analysis of clinical trial data, which showed 91.4% efficacy for the vaccine on day 28 after the first dose; vaccine efficacy over 95% 42 days after the first dose.

G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories said, “This is another significant step as we continue to collaborate with multiple entities along with the government bodies to fast-track the process for launching the vaccine in India. We are working towards making the vaccine available with a combination of import and indigenous production model.”

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

Source

Print

Shareholders

Read more

Pipeline

Read more

Media Center

Read more