Pharma major Dr Reddy’s Laboratories Ltd on Friday announced that it has received approval from the Drugs Control General of India (DCGI) to conduct Phase 3 clinical trial for the Sputnik V vaccine in India.
The Phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study in India, the Hyderabad-based company said in a statement.
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.
G.V. Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories, termed this as 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,” he said.
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 last August and became the world’s first registered vaccine against Covid-19 based on the established human adenoviral vector platform.
The vaccine’s efficacy is confirmed 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 while it has been registered in Algeria, Argentina, Belarus, Bolivia and Serbia for inoculation.
