Clinical trial of Sputnik V vaccine against COVID-19 to begin in India

COVID-19 vaccine trails are taking place across the globe and India too is doing their bit to get a vaccine out soon to curb the spread of coronavirus. In the latest development, the Sputnik V vaccine vaccine trail will begin in India. After suffering a setback with the first proposal being rejected by the Drug Controller General of India has allowed Dr.Reddy to conduct the vaccine trial in the country.

The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund which acts as a catalyst for direct investment in the Russian economy and Dr. Reddy’s Laboratories Ltd. an integrated pharmaceutical company join hands for the COVID-29 vaccine trial. The collaboration has 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-center and randomized controlled study, which will include safety and immunogenicity study.

Dr. Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India in September this year. As part of the partnership, RDIF is expectd to supply 100 million doses of the vaccine to Dr. Reddy’s upon regulatory approval in India.

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

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 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.” Said Kirill Dmitriev, CEO of the Russian Direct Investment Fund.

The Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered on August 11th 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 has commenced in the UAE last week.

 

 

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