Russia to supply 100 mn doses of COVID-19 vaccine Sputnik V to India; Dr Reddy’s, RDIF join hands for clinical trials

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Deliveries of the Russian COVID-19 vaccine likely to commence later this year subject to completion of successful trials and registration of the vaccine by regulatory authorities in India

The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and pharma major Dr Reddy’s Laboratories Ltd (Dr Reddy’s) agreed to cooperate on clinical trials and distribution of COVID-19 vaccine Sputnik V in India, the companies said in a joint statement on Wednesday.

Upon regulatory approval in India, RDIF will supply 100 million doses of the vaccine to Dr Reddy’s.

The Sputnik V vaccine, which is based on well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India, the statement said.

Dr Reddy’s also confirmed the pact through a tweet, which said that RDIF and Dr Reddy’s to cooperate on clinical trials and supply of 100 million doses of Sputnik V vaccine to India.

The agreement between RDIF and Dr Reddy’s reflects the growing awareness of countries and organisations to have a diversified anti-COVID vaccine portfolio to protect their populations.

Kirill Dmitriev, CEO of the RDOF, said, “We are very pleased to partner with Dr Reddy’s in India. Dr Reddy’s has had a very well-established and respected presence in Russia for over 25 years and is one of the leading pharmaceutical companies in India.”

He further said that 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 added.

G V Prasad, co-Chairman & Managing Director at Dr Reddy’s, said, “We are pleased to partner with RDIF to bring the vaccine to India. The 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.”

Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered on August 11 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.

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 of 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.

Apart from Sputnik V, Pune-based Serum Institute of India (SII) is also conducting human trials of another COVID-19 vaccine in collaboration with British-Swedish biopharmaceutical giant AstraZeneca and the Oxford University.

Two more domestic pharma firms, Bharat Biotech International and Zydus Cadila, reportedly completed first phase of the clinical trials for their respective COVID-19 vaccine candidates.

Image credit: Moneycontrol

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