(RTTNews) – Dr. Reddy’s Laboratories Ltd. (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 or DCGI to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India. This will be a multi-center and randomized controlled study, which will include safety and immunogenicity study.
Earlier in September, Dr. Reddy’s and RDIF agreed to cooperate on clinical trials and distribution of Sputnik V vaccine in India. Upon regulatory approval in India, RDIF shall supply to Dr. Reddy’s 100 million doses of the vaccine. Deliveries could potentially begin in late 2020.
The Sputnik V vaccine, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, is the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform.
G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories, said “This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic.”