Dr Reddy's Gets DCGI Nod To Conduct Stage 2/3 Human Trials For Russia's Sputnik V Covid-19 Vaccine

Sputnik V, an adenovirus vector-based vaccine, was developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology, along with the Russian Direct Investment Fund.

(Image: AFP)

New Delhi: After turning down the first proposal, the Drug Controller General of India (DCGI) has finally given nod to Dr. Reddy’s Laboratories to conduct mid to late stage clinical human trials of the Russian vaccine candidate Sputnik V. Sputnik V is the Covid-19 vaccine, making Russia the first in the race of vaccine development. Sputnik V, an adenovirus vector-based vaccine, was developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology, along with the Russian Direct Investment Fund and registered on August 11. In September 2020, Dr. Reddy’s Lab and RDIF entered into partnership to conduct clinical trials and distribute the vaccine in the country. As part of the agreement the RDIF will supply 100 million doses of the Vaccine to the country upon approval. “This will be a multi-center and randomized controlled study, which will include safety and immunogenicity study,” Dr Reddy’s told the Bombay Stock Exchange in a filing on Saturday evening. Even though statements are being issued by both the parties regarding the trial and distributions of the vaccine, but it is unclear till now that how many participants will be enrolled and how many sites will be studying the vaccine’s safety and ability of developing the immune response against the corona virus. After the testing is complete and the vaccine is approved, the RDIF will be supplying 100 million doses of Sputnik V to Dr. Reddy’s lab. As Sputnik V is a two-dose vaccine, the RDIF spokesperson made it clear in a statement that, 100 million doses are meant for 100 million people. As the Sputnik V contains two shots of different common cold Adenovirus. In Russia around 40,000 subjects are going through phase three clinical trials of the Sputnik V vaccine and the UAE also started the phase 3 clinical trials of the vaccine last week.