DGCI green signal for Phase 3 trial of Sputnik V in India

HYDERABAD:  The Hyderabad-based Dr Reddy’s Laboratories has received the approval from Drugs Control General of India (DCGI) to conduct Phase 3 clinical trial for the Russian Covid-19 vaccine, Sputnik V, in India. The company announced this on Friday and also said that the Phase 3 clinical trial will be conducted on 1,500 subjects in India, “as part of the randomised, double-blind, parallel-group, placebo-controlled study.”

Earlier, the independent Data and Safety Monitoring Board (DSMB) had reviewed the safety data from the Phase 2 clinical trial of the vaccine and recommended it for Phase 3 clinical trial. In its report, the DSMB had concluded that no safety concerns were identified and the study met the primary endpoints of safety.

GV Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories said, “We expect to commence the Phase 3 study within this month and will continue to fast-track our efforts to bring in a safe and efficacious vaccine for the Indian population.”

Partnership
It was in September 2020, when Dr Reddy’s partnered with Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V vaccine in India and for its distribution rights in the country. The makers of Sputnik V claim that the vaccine’s efficacy at 91.4 per cent based on data analysis of the final control point of clinical trials in Russia. Currently, the vaccine’s clinical trials are underway in the UAE, Egypt, Venezuela, and Belarus.