Dr. Reddy’s gets nod for Sputnik V trials
Pharma major Dr. Reddy’s Laboratories and Russia’s sovereign wealth fund RDIF have received approval from the Drugs Controller General of India to conduct an adaptive phase 2/3 human clinical trial for the Sputnik V vaccine in India. It is the world’s first registered vaccine against COVID-19.
This will be a multicentre and randomised controlled study, which will include safety and immunogenicity study.
Developed by Gamaleya National Research Institute of Epidemiology and Microbiology, Russia, Sputnik V vaccine is based on the human adenoviral vectors platform. The vaccine was registered by Russia’s Health Ministry in August.
The DCGI approval “is a significant development that allows us to commence the clinical trial in India. We are committed to bringing in a safe and efficacious vaccine to combat the pandemic,” Dr. Reddy’s Co-chairman and Managing Director G.V. Prasad said in a statement issued by the company and RDIF.
Russian Direct Investment Fund (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.”