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Dr Reddy’s Laboratories Ltd and the Russian Direct Investment Fund (RDIF) announced on December 1 the commencement of elastic phase 2/3 clinical trials for COVID-19 vaccine Sputnik V in India after receiving mandatory clearance from the Central Drugs Laboratory, Kasauli in Himachal Pradesh.
The Indian drug maker said this will be a multi-centre and randomised controlled study, which will consist of safety and immunogenicity study.
The clinical trials are being conducted by JSS Medical Research, the clinical study partner.
Further, Dr Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology for advisory support and to use BIRAC’s clinical trial centres for the vaccine,” it said.
Recently, RDIF declared the second interim analysis of clinical trial data, which showed 91.4 percent efficacy for the vaccine on day 28 after the first dose and vaccine efficacy of over 95 percent 42 days after the initial dose.
Currently, 40,000 volunteers are taking part in Stage III of Sputnik V clinical trials, from which over 22,000 have been vaccinated with the first dose and over 19,000 with both the first and second doses of the vaccine.
GV Prasad, co-chairman and managing director, Dr Reddy’s Laboratories stated,”This is another significant step as we continue to collaborate with numerous entities along with the government bodies to fast-track the process for launching the vaccine in India.
We are working towards making the vaccine available with a combination of import and indigenous production model.”
In September 2020, Dr Reddy’s and RDIF entered into a partnership to conduct clinical trials of the Sputnik V vaccine and the rights for distribution of the initial 100 million doses in India.
On August 11, 2020, the Sputnik V vaccine developed from the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the Worlds first documented vaccine against COVID-19 based on the individual adenoviral vector platform.