Hyderabad-based Dr Reddy's Laboratories said that the Phase 3 trials of Russian coronavirus vaccine, Sputnik V are expected to be completed by March 2021-end depending on approvals and data accuracy. The pharma giant, which has received DCGI nod to conduct clinical trials of Sputnik V, said that the phase 2 trials of the vaccine were expected to be completed by December.
"Phase-3, we should finish somewhere by March and then of course it depends on the ability to compile the data, obtain the approvals etc. It can be as early as end of March or April/May and beyond. It depends on the results. It's a combination of phase-2, global phase-3 and phase-3 in India," Dr Reddy's CEO Erez Israeli was quoted by news agency PTI as saying. Israeli added company required 100 and 1,400 volunteers for Phase 2 and 3 trials respectively.
Dr Reddy's and Russian Direct Investment Fund (RDIF) joined hands to carry out clinical trials and distribute 100 million doses of Sputnik V vaccine across India. A joint statement issued by both the companies stated distribution of the vaccine was expected to begin by late 2020 depending entirely on the completion of trials and registration of the vaccine by the authorities.
Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Russian Health Ministry and went onto become the world's first registered COVID-19 vaccine based on the human adenoviral platform. Phase-3 trials of Sputnik V are currently underway in Russia and the proposed number of subjects is 40,000.
As COVID-19 cases continue to rise across the world, India continues to remain the second most affected nation with a total of 80, 40,203 cases and 73,15,989 recoveries.
Source: Business Today