Hyderabad, January 11, 2021: Dr. Reddy’s Laboratories Ltd. introduced right this moment that the unbiased Data and Safety Monitoring Board (DSMB) has reviewed the security knowledge from the part 2 scientific trial of the Sputnik V vaccine and beneficial the part three recruitment and proceed the scientific trial with none modifications.
The part 2 examine of Sputnik V was carried out on 100 topics as a part of the randomized, double-blind, parallel-group, placebo-controlled examine in India. The DSMB concluded that no security issues had been recognized and the examine has met the first endpoints of security. Further, the protection knowledge has been submitted to the Drugs Controller General of India (DCGI) for evaluation and approval to proceed part three scientific trials.
G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories stated, “The Indian clinical trial being conducted by Dr. Reddy’s and RDIF 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 the Russian Direct Investment Fund, stated, “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. The Sputnik V consistently shows safety and high efficacy in international clinical trials as it is based on safe human adenoviral vector platform.”
The scientific trials are being carried out by JSS Medical Research because the scientific analysis accomplice in India. Dr. Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory help, THSTI (Translational Health Science and Technology Institute) for additional immunogenicity knowledge characterisation, and to make use of BIRAC’s scientific trial centres for the vaccine.