Sputnik V became the world’s first registered Covid vaccine based on a human adenoviral vector platform
Dr. Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) announced on Tuesday the start of adaptive phase 2/3 clinical trials for the COVID-19 Sputnik V vaccine in India after receiving the necessary authorization from the Central Laboratory. of Medicines in Himachal Pradesh.
The Indian drugmaker, in a statement, said this will be a multicenter, randomized controlled study, including a safety and immunogenicity study.
Clinical trials are being conducted by JSS Medical Research as a clinical research partner.
Additionally, Dr. Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), the Department of Biotechnology to provide advice and to utilize BIRAC’s clinical trial centers for the vaccine, he said.
Recently, RDIF announced the second interim analysis of clinical trial data, which showed 91.4% vaccine efficacy on day 28 after the first dose and greater than 95% vaccine efficacy 42 days later. of 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 received the first dose and more than 19,000 with the first and second doses of the vaccine.
GV Prasad, Co-President and Managing Director of Dr Reddy’s Laboratories, 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. Working to make the vaccine is available with a combination of domestic and imported production model. “
In September 2020, Dr. Reddy’s and RDIF partnered to conduct Sputnik V vaccine clinical trials and distribution rights for 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 of Russia was registered by the Russian Ministry of Health and became the world’s first registered vaccine against coronavirus based on the platform of human adenoviral vectors.
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