Dr Reddy's, RDIF receive approval to conduct clinical trial for Sputnik V vaccine

Dr Reddy’s Laboratories Ltd and Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, today 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 randomized controlled study, which will include safety and immunogenicity study.

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

G V Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories, in a statement 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 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.”

On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia. It became the world’s first registered vaccine against Covid-19 based on the human adenoviral vectors platform.

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 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’s management company is based in Moscow. Currently, RDIF has experience of the successful joint implementation of more than 80 projects with foreign partners totalling more than RUB1.9 tn and covering 95% of the regions of the Russian Federation. RDIF portfolio companies employ more than 800,000 people and generate revenues which equate to more than 6% of Russia’s GDP. RDIF has established joint strategic partnerships with leading international co-investors from more than 18 countries that total more than $40 bn.