Dr. Reddy’s, RDIF get DCGI nod for Sputnik V clinical trial

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Phase 3 trials of the vaccine are already underway in Russia and UAE.

Pharma major Dr. Reddy’s Laboratories and Russia’s sovereign wealth fund RDIF have received approval from the Drugs Controller General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in the country.

This will be a multi-centre 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 the world’s first registered vaccine against COVID-19 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.”

Dr. Reddy’s and Russian Direct Investment Fund (RDIF) had last month announced a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. Under the partnership, RDIF will be supplying 100 million doses of the vaccine to Dr. Reddy’s upon regulatory approval in India.

Sputnik V is currently undergoing phase 3 clinical trial in Russia and the proposed number of subjects is 40,000. Additionally, phase 3 clinical trial of the vaccine has commenced in the UAE last week, the release on Saturday said.

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