Drug regulator approves phase 3 trials for Russian vaccine candidate

Sputnik V is the world’s first vaccine to be registered


Russia’s vaccine candidate, Sputnik V, will undergo phase two/three trials in India. Though the announcement for the trials was made last month, the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund and Dr Reddy’s Laboratories limited said on Saturday that an approval to conduct phase three trials had been received from the central drugs standard control authority. Sputnik V is the world’s first vaccine to be registered. 

“This will be a multi-centre and randomised controlled study, including safety and immunogenicity study,” the RDIF said in a statement. 

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 will supply 100 million doses of the vaccine to Dr Reddy’s upon regulatory approval in India.

Sputnik V is currently undergoing phase three clinical trial in Russia and the proposed number of subjects is 40,000. Additionally, phase three clinical trial of the vaccine has commenced in the UAE, last week. Sputnik V is also being tested in phase three trials in Belarus and Venezuela.

GV Prasad, co- chairman and managing director, Dr Reddy’s laboratories said, “We acknowledge DCGI’s scientific rigour and guidance in the entire process. 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.”

Kirill Dmitriev, RDIF CEO said that in addition to Indian clinical trial data, we will provide safety and immunogenicity study from the Russian phase three clinical trial. “This data will further strengthen the clinical development of Sputnik V vaccine in India,” he said. 

On August 11, 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.

Currently in India, the OxfordAstraZeneca vaccine is also undergoing phase three trials, the results of which are expected in the November, according to Dr VK Paul, member, Niti Aayog. India is also considering emergency use authorisation for a Covid-19 vaccine, the union health minister Dr Harsh Vardhan has said.