Dr. Reddy’s gets DCGI nod to conduct phase-3 trial of Sputnik V vaccine in India
Hyderabad: While India all set to launch the world’s largest COVID-19 vaccination drive from Saturday, the Indian drug regulator- the Drugs Control General of India (DCGI) has permitted Dr. Reddy’s Laboratories to conduct phase-3 clinical trial of Russian vaccine ‘Sputnik V’ in India.
“The phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomized, doubleblind, parallel-group, placebo-controlled study in India” Dr. Reddy’s said.
Earlier, 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 concluded that no safety concerns were identified and the study met the primary endpoints of safety.
Earleir in the month, the Indian drug regulator had granted emergency use approvals to two vaccines- the Covishield, being manufactured by the Serum Institute and Bharat Biotech’s Covaxin.
“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” : G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories
In September 2020, Dr. Reddy’s partnered with Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V vaccine and for its distribution rights in India.
Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the established human adenoviral vector platform.