Hyderabad-based Dr. Reddy’s Laboratories Ltd and Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, on Saturday announced that they have received approval from the Drug Control General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trials for Sputnik V vaccine in India. It will be a multi-centre and randomised controlled study, during which safety and immunogenicity will also be examined.
In September 2020, Dr. Reddy’s and RDIF entered into an agreement 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.
Dr Reddy’s Laboratories CMD G.V. Prasad said: “This is a significant development that allows us to commence the clinical trials in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic.”
RDIF CEO Kirill Dmitriev said, “We are pleased to collaborate with the Indian regulators and in addition to Indian clinical trial data, we will provide safety and immunogenicity study from the Russian phase 3 clinical trial. This data will further strengthen the clinical development of Sputnik V vaccine 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 authorities in Russia and became the world’s first registered vaccine against Covid-19 based on the human adenoviral vectors platform.
Currently, Sputnik V is undergoing phase 3 clinical trial in Russia and the proposed number of subjects is 40,000. Last week, phase 3 clinical trial of the vaccine has commenced in the UAE.