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Dr.Reddys Laboratories Ltd. and Russian Direct Investment Fund, Russias autonomous wealth fund, on Saturday announced they have received approval from the Drug Control General of India to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India.
The city-based drug maker said in a press release that this will be a multi-center and randomised controlled study,which will consist of safety and immunogenicity study.
Earlier in September 2020, Dr.Reddys and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of this partnership, RDIF shall provide 100 million doses of the vaccine to Dr.Reddys upon regulatory approval in India.
G V Prasad, Co-chairman and Managing Director, Dr.Reddy, said,”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, CEO of the Russian Direct Investment Fund, said,”We are very happy to collaborate with the Indian regulators and along with Indian clinical trial information, we’ll offer safety and immunogenicity study from the Russian stage 3 clinical trial. This data will further strengthen the clinical development of Sputnik V vaccine in India.”
On August 11, 2020, the Sputnik V vaccine developed from the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the worlds first registered vaccine against COVID-19 depending on the individual adenoviral vectors platform. Sputnik V is currently undergoing Phase 3 clinical trials in Russia and the projected number of topics is 40,000.
Furthermore, Phase 3 clinical trial of the vaccine commenced in the UAE last week.