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COVID-19: Dr Reddy's gets DCGI nod to conduct phase 3 clinical trials for Sputnik V vaccine
New Delhi, Jan 15: Dr Reddy's Laboratories on Friday said it has received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine for COVID-19.
The phase 3 study of Sputnik V will be conducted on 1,500 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study in the country, the Hyderabad-based firm said in a regulatory filing.
Earlier this week, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial of the vaccine and recommended the phase 3 recruitment.
In its report, the DSMB had concluded that no safety concerns were identified and the study met the primary endpoints of safety.
"This is an important milestone in the progress of this pivotal clinical trial of the vaccine. We expect to commence the phase III study within this month and will continue to fast-track our efforts to bring in a safe and efficacious vaccine for the Indian population," Dr Reddy's Laboratories Co-chairman and Managing Director G V Prasad said.
In September 2020, the drug major had partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V vaccine and for its distribution rights in India.
