The Indian Wire » Business » Dr Reddy’s Agrees To Perform Clinical Trials And Dispense 100Million Doses Of Russian Sputnik V COVID-19 Vaccine In India
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Dr Reddy’s Agrees To Perform Clinical Trials And Dispense 100Million Doses Of Russian Sputnik V COVID-19 Vaccine In India

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The Russian Direct Investment Fund (RDIF) and Dr Reddy’s have agreed to perform clinical trials and dispense 100 million doses of Russia’s Sputnik V Covid-19 vaccine in India.

The Russian Direct Investment Fund (RDIF) is Russia’s sovereign wealth fund established by the Russian government in 2011 for the purpose of investing in the biggest high-growth companies from sectors of the Russian economy. Its authorization is to co-invest alongside the world’s largest institutional investors — direct investment funds, sovereign wealth funds and leading companies.

The RDIF will begin the supply of 100 million doses of the vaccine to Dr Reddy’s, once they get regulatory approval in India said Dr Reddy’s in a statement.

The Sputnik V Vaccine based on human adenoviral vector platform is currently undergoing clinical trials.

The authorities could potentially start the deliveries by the end of 2020, depending on the completion of successful trials and registration of vaccine by regulatory authorities in India.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, “We are very pleased to partner with Dr Reddy’s in India. India is amongst most severely impacted countries from COVID 19 and we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to India in the battle against COVID 19. RDIF partners will receive an effective and safe drug to fight the coronavirus. The platform of human adenoviral vectors, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and it has been found safe with no potential negative long-term consequences.”

She also said, the partnership between Dr Reddy’s and the RDIF indicates the growing concern of countries and organizations to have a diversified anti-COVID vaccine portfolio to protect their populations.

G V Prasad, Co-Chairman & MD of Dr Reddy’s Laboratories said, “We are pleased to partner with RDIF to bring the vaccine to India. Phase I and II clinical trials have shown promising results. We will be conducting Phase-III trials in India to ensure safety and efficacy for the Indian population and to meet the requirements of the Indian regulators. Sputnik V vaccine could provide a credible option in our fight against COVID-19 in India.”

Prof Sergey Tsarenko, Deputy Chief Physician for Anesthesiology and Reanimation at Hospital No. 52 in Moscow, said, “The main criteria for evaluating a vaccine are safety and efficacy. In Sputnik V, safety is ensured by the use of human adenoviral vectors, which we repeatedly encounter throughout our lives. Efficacy is achieved by using two different human adenoviruses sequentially, which differentiates this platform.”

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

The nucleus of the Russian vaccine, the outlet of human adenoviral vectors has been tested in more than 250 clinical studies over decades, and it has been found safe with no probable negative long-term impacts.

A research paper on the results of Phase I and Phase II clinical trials of the Sputnik V vaccine was published On September 4 in The Lancet, one of the leading international medical journals, indicating no serious unfavorable effects and a safe immune response in 100 percent of partaker.

Currently, the authorities are conducting post-registration clinical trials of the Sputnik V vaccine which involves more than 40,000 volunteers. Over 55,000 volunteers applied to participate in the post-registration trials. The early results of these trials are expected to be published in October-November 2020.

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