DRL gets DCGI nod for phase 2/3 human trials of Sputnik V Covid vaccine
19 Oct 2020
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Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and Dr Reddy’s Laboratories Ltd on Saturday announced that they have received approval from the Drug Control General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India.
This will be a multi-centre and randomised controlled study, which will include safety and immunogenicity study.
Earlier, in September, 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 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.
“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,” G V Prasad, co-chairman and managing director, Dr Reddy’s Laboratories, 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,” Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said.
Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, became the first vaccine to be developed for vaccination against Covid-19 vaccine after it was registered by Russia’s ministry of health on 11 August 2020.
Sputnik V, which is based on the human adenoviral vectors platform, is currently undergoing phase 3 clinical trial in Russia with proposed trials on 40,000 volunteers. Additionally, phase 3 clinical trial of the vaccine has commenced in the UAE last week.
Russian Direct Investment Fund (RDIF) is Russia's sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors. RDIF acts as a catalyst for direct investment in the Russian economy. RDIF has successful implemented more than 80 joint projects with foreign partners totaling more than RUB1.9 tn and covering 95 per cent of the regions of the Russian Federation.
With investments in 18 countries, RDIF portfolio companies employ more than 800,000 people and generate revenues which equate to more than 6 per cent of Russia’s GDP.
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