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Russia to sell 100 million Sputnik V Covid-19 vaccine doses to Dr. Reddy's

After the vaccine certification for human usage, DRL would be distributing Sputnik V for supply in India
Last Updated 17 September 2020, 06:10 IST

The phase-3 clinical trials of Sputnik V, the world’s first registered Covid-19 vaccine developed in Russia, would be conducted in collaboration with Hyderabad-based Dr Reddy’s Laboratories.

Speaking to DH, G V Prasad, Co-Chairman, and Managing Director of DRL said that post the vaccine certification for human consumption, DRL would be distributing Sputnik V for supply in India and other countries.

On Wednesday, the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and Dr Reddy’s Labs announced a collaboration on the clinical trials and distribution of Sputnik V vaccine in the country.

Upon the regulatory approval i.e., of the Drug Controller General of India post the clinical trials, RDIF would supply 100 million doses of the vaccine to Dr Reddy’s.

“The trials, also to be approved by the regulator, would be on a much smaller scale,” Prasad told DH.

The Sputnik V vaccine, based on a human adenoviral vector platform, is undergoing clinical trials to counter SARS-CoV-2.

“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,” Prasad said.

“Not sure, yet. We have just started the process,” Prasad said when asked as when the trials are expected to begin.

Vaccine deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India, a joint press statement from RDIF and DRL said.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, “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,” Dmitriev further said.

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 Covid-19 vaccine.

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

Post-registration clinical trials of the Sputnik V vaccine involving 40,000 volunteers are currently ongoing. More than 55,000 volunteers have applied to take part in post-registration trials. The first results of these trials are expected to be published in October-November 2020, RDIF and DRL stated.

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(Published 16 September 2020, 10:23 IST)

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