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Phase 2/3 Trials of Covid-19 Sputnik V Vaccine Begin in India | India News


HYDERABAD: Dr Reddy’s Laboratories Ltd and Russia’s sovereign wealth fund Russian Direct Investment Fund (RDIF) said on Tuesday they began phase 2/3 adaptive clinical trials for Sputnik V vaccine in India after receiving the necessary authorization from the Central Laboratory of Drugs, Kasauli.
The clinical trials, which are being conducted by JSS Medical Research as a clinical research partner, will be a multicenter, randomized controlled study that will include safety and immunogenicity studies.
Dr. Reddy’s said he has also partnered with the Biotechnology Industry Research Assistance Council (BIRAC) of the Department of Biotechnology (DBT) to provide advice and to utilize the BIRAC clinical trial centers for the vaccine. .
Commenting on the developingDr Reddy’s Laboratories Co-Chairman and Managing Director GV Prasad said: “This is another important step as we continue to collaborate with multiple entities alongside government agencies to accelerate the vaccine launch process in India. We are working to make the vaccine available with a combination of a national and imported production model ”.
On Monday, Dr. Reddy’s top brass, including Prasad and company president Satish Reddy, had a virtual meeting with Prime Minister Narendra Modi and updated him on vaccine development.
Recently, RDIF announced the second interim analysis of clinical trial data, which showed a 91.4% efficacy of the vaccine on day 28 after the first dose and more than 95% efficacy 42 days after the first dose.
Currently, 40,000 volunteers are participating in Phase III of the Sputnik V clinical trials, of which more than 22,000 have been vaccinated with the first dose of the vaccine and more than 19,000, with both the first and second doses of the vaccine. vaccine.
In September 2020, Dr. Reddy’s and RDIF had signed an agreement to conduct clinical trials of Sputnik V and the distribution of the first 100 million doses in India.
On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Russian Ministry of Health and became the world’s first registered vaccine against Covid-19 based on the platform of human adenoviral vectors.

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