Dr. Reddy’s Laboratories has secured the go-ahead from the Drugs Control General of India (DCGI) to begin phase 3 clinical trial for the Russian Covid-19 vaccine Sputnik V in India.
The Indian pharma company plans to hold the phase 3 study on 1500 volunteers as part of the randomized, double-blind, parallel-group, placebo-controlled study.
G V Prasad – Co-chairman and Managing Director of Dr. Reddy’s Laboratories said: “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 bringing in a safe and efficacious vaccine for the Indian population.”
Earlier this month, Dr. Reddy’s Laboratories said that the Sputnik V Covid-19 vaccine met the primary endpoint of safety in a phase 2 trial in India. Subsequently, an independent data and safety monitoring board (DSMB) examined the safety data from the phase 2 clinical trial of the Sputnik V Covid-19 vaccine and recommended the phase 3 enrollment.
In its report, the DSMB reported that no safety concerns were noted and the phase 2 clinical trial met the primary endpoints of safety.
Dr. Reddy’s Laboratories has a partnership with the Russian Direct Investment Fund (RDIF) for bringing the Russian Covid-19 vaccine Sputnik V to India.