Currently, 40,000 volunteers are taking element in Phase III of Sputnik V clinical trials, out of which more than 22,000 have been vaccinated with the initially dose and far more than 19,000 with each the initially and second doses of the vaccine.
Dr.Reddys Laboratories Ltd. and the Russian Direct Investment Fund (RDIF) on Tuesday announced commencement of adaptive phase 2/3 clinical trials for COVID-19 vaccine Sputnik V in India right after getting vital clearance from the Central Drugs Laboratory, Kasauli in Himachal Pradesh. The Indian drug maker, in a release, mentioned this will be a multicenter and randomized controlled study, which will contain security and immunogenicity study. The clinical trials are getting carried out by JSS Medical Research as the clinical study companion.
Further, Dr.Reddys has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology for advisory assistance and to use BIRAC’s clinical trial centres for the vaccine, it mentioned. Recently, RDIF announced the second interim evaluation of clinical trial information, which showed 91.4 per cent efficacy for the vaccine on day 28 right after the initially dose and vaccine efficacy of more than 95 per cent 42 days right after the initially dose. Currently, 40,000 volunteers are taking element in Phase III of Sputnik V clinical trials, out of which more than 22,000 have been vaccinated with the initially dose and far more than 19,000 with each the initially and second doses of the vaccine.
G V Prasad, Co-chairman and Managing Director, Dr.Reddys Laboratories mentioned, “This is another significant step as we continue to collaborate with multiple 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.Reddys and RDIF entered into a partnership to conduct clinical trials of the Sputnik V vaccine and the rights for distribution of the initially one hundred million doses in India. On August 11, 2020, the Sputnik V vaccine created by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the Worlds initially registered vaccine against COVID-19 primarily based on the human adenoviral vector platform.