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Dr Reddy’s Laboratories has announced that the independent Data and Safety Monitoring Board (DSMB) has reviewed the safety data from the phase 2 clinical trial of the Russian Sputnik V Covid-19 vaccine and has recommended the phase 3 recruitment and to continue the clinical trial without any modifications.
The phase 2 study of Sputnik V was conducted on 100 subjects as part of a randomised, double-blind, parallel-group, placebo-controlled study in India. The DSMB concluded that no safety concerns were identified and the study has met the primary endpoints of safety. Further, the safety data has been submitted to the Drugs Controller General of India for review and approval to continue phase 3 clinical trials.
GV Prasad, Co-chairman and Managing Director, Dr. Reddy’s, said: “The Indian clinical trial being conducted by Dr. Reddy’s and RDIF (Russian Direct Investment Fund) is an adaptive design phase 2/3 trial. It is a bridging study to the larger global phase 3 study on 31,000 subjects. The phase 2 study in India showed a very good safety profile. This further reinforces our confidence in the safety of Sputnik V, which has now been administered to more than 1 million people in Russia and more than 300,000 people in Argentina. We are working closely towards fast-tracking the launch of the Sputnik V vaccine in India.”
Kirill Dmitriev, CEO of RDIF, said: “The safety data from the phase 2 clinical trial from India is very positive, and confirms the safety profile of Sputnik V in the international markets. Sputnik V consistently shows safety and high efficacy in international clinical trials as it is based on safe human adenoviral vector platform.”
Research partners
The clinical trials are being conducted by JSS Medical Research as the clinical research partner in India. Dr. Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology for advisory support, Translational Health Science and Technology Institute (THSTI) for further immunogenicity data characterisation, and to use BIRAC’s clinical trial centres for the vaccine.
In September 2020, Dr Reddy’s and RDIF entered into a partnership to conduct the clinical trials of the Sputnik V vaccine and the rights for distribution in India.
Sputnik V was developed by the Gamaleya National Research Institute of Epidemiology and Microbiology in Russia.
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