The Drug Control General of India (DCGI) approved Dr Reddy’s Laboratories and Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund to conduct an adaptive phase 2/3 human clinical trials for Sputnik V vaccine in India on Saturday.
The study will include safety and immunogenicity and is said to be as a multicenter and randomized controlled study.
As part of the partnership, Dr Reddy’s shall receive 100 million doses of the vaccine from RDIF upon regulatory sanction in India. Dr Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India earlier in September 2020.
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Co-chairman and Managing Director of Dr Reddy’s, G V Prasad, says that they are committed to bring in a safe and efficacious vaccine to combat the pandemic.
In addition to Indian clinical trial data, they will provide safety and immunogenicity study from the Russian phase 3 clinical trial as well.
The Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology became the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform. The Ministry of Health of Russia registered it on August 11, 2020.
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Phase 3 clinical trial of Sputnik V has commenced in the UAE last week and the vaccine is currently undergoing phase 3 clinical trial in Russia and the proposed number of subjects is 40,000.
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