Pharma major Dr. Reddy’s Laboratories on Monday said safety data pertaining to phase-2 clinical trial of Russia’s Sputnik-V COVID-19 vaccine candidate has been submitted to the Drugs Controller General of India (DCGI) for review seeking approval to continue phase-3 clinical trials.
The company said this referring to a review carried out by the independent Data and Safety Monitoring Board (DSMB). “The phase 2 study was conducted on 100 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India. The DSMB looked that no safety concerns were identified and the study has met the primary endpoints of safety. Further, the safety data has been submitted to the DCGI for review and approval to continue phase 3 clinical trials.
Co-chairman and managing director GVPrasad said the Indian clinical trial was conducted by Dr. Reddy’s and Russian Direct Investment Fund is an adaptive design phase 2/3 trial. It is a bridging study to the larger global phase-3 study on 31,000 subjects.
He said the “phase-2 study in India showed a very good safety profile. This further reinforces our confidence in the safety of Sputnik V, which has now been administered to more than one million people in Russia and more than 300,000 people in Argentina. We are working closely towards fast-tracking the launch of the Sputnik V vaccine in India. “
RDIF CEO Kirill Dmitriev said safety data from the phase 2 clinical trial from India is “very positive and confirms the safety profile of Sputnik V in the international markets. In September, Dr. Reddy’s and RDIF had entered into a partnership to conduct clinical trials and the rights for distribution for the vaccine in India. Separately, RDIF and Hetero Group had announced a collaboration for producing 100 million doses of the vaccine in the country. Later, there were reports of RDIF planning to produce more doses in India.
Developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, Sputnik-V is based on the human adenoviral vector platform and the world’s first registered vaccine against COVID-19. Its efficacy is confirmed at 91.4% based on data analysis of the final control point of clinical trials in Russia, the release said.
JSS Medical Research is the clinical research partner for the trials in India. Dr. Reddy’s has partnered with the Biotechnology Industry Research Assistance Council for advisory support, THSTI (Translational Health Science and Technology Institute) for further immunogenicity data characterization and to use BIRAC’s clinical trial centers for the vaccine.