Dr Reddy’s receives DCGI approval to conduct phase 2/3 trials of Sputnik V vaccine in India

A view of a vial of Russia's experimental Sputnik V coronavirus vaccine. (Photo: AP)

In a significant move towards India potentially getting a Covid-19 vaccine by the end of this year, the country’s top drug regulator has approved a request by Dr Reddy’s Laboratories to conduct mid- to late-stage human trials for the Russian Sputnik V vaccine candidate.

The Hyderabad-headquartered firm, which had entered into an agreement with the Russian Direct Investment Fund (RDIF) last month to help receive approvals for the candidate in India, will now move ahead with an adaptive phase 2/3 clinical trial of the candidate here.

“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.

It is unclear at this stage how many participants will be enrolled in this trial and how many sites will be studying the vaccine’s safety and ability to help develop an immune response against Covid-19.

Once testing is completed and if approvals are granted, RDIF will be supplying around 100 million doses of Sputnik V to Dr Reddy’s. Unlike other two-dose vaccines, this would mean 100 million people in India would get the vaccine, as each “dose” contains two shots of different common cold adenoviruses, according to an RDIF spokesperson.

The vaccine is also currently undergoing phase 3 clinical trials in Russia with a proposed number of 40,000 subjects. Additionally, phase 3 clinical trials of the vaccine also commenced in the UAE last week.

“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,” said G V Prasad, Co-chairman and Managing Director of Dr Reddy’s Laboratories.

“This data will further strengthen the clinical development of Sputnik V vaccine in India,” Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said.

Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia on August 11 and was touted to be the world’s “first” registered vaccine against Covid-19.

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