Dr. Reddy’s and RDIF Received Approval to Conduct Clinical Trial for Sputnik V Vaccine in India
News Desk, News Nation 360 : Dr Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) and Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, announced that they have received approval from the Drug Control General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India. This will be a multi-centre and randomized controlled study, which will include safety and immunogenicity study. On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform. Sputnik V is currently undergoing phase 3 clinical trial in Russia and the proposed number of subjects is 40,000. Additionally, phase 3 clinical trial of the vaccine has commenced in the UAE last week. G V Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories, said that this is a significant development that allows them to commence the clinical trial in India and they are committed to bringing in a safe and efficacious vaccine to combat the pandemic. Earlier in September 2020, Dr Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr Reddy’s upon regulatory approval in India.
Report : Anustup Kundu