Dr Reddy's Laboratories has received the Drugs Controller General of India (DCGI) approval for conducting phase 3 trials of the Russian COVID-19 vaccine Sputnik V across India. Phase-3 trials will be carried out on 1,500 subjects as part of the double-blind, parallel-group, placebo-controlled study, Dr Reddy's stated in a regulatory filing.
The Data and Safety Monitoring Board (DSMB) had reviewed the safety data from phase 2 trials of the vaccine and stated that there were no safety concerns attached to the jab earlier this week, following which it recommended the recruitment of volunteers for phase 3 trials.
Dr Reddy's Laboratories Co-chairman and Managing Director GV Prasad told PTI, "This is an important milestone in the progress of this pivotal clinical trial of the vaccine. 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."
The Hyderabad-based pharma giant teamed up with the Russian Direct Investment Fund (RDIF) for carrying out clinical trials and distribution of the Sputnik V vaccine across India. The vaccine's efficacy is touted to be 91.4 per cent based on the data from Russia.
Globally, the trials of this vaccine are currently underway in Belarus, Egypt, UAE and Venezuela while it is registered in Algeria, Argentina, Bolivia, Belarus and Serbia for inoculation.