New Delhi: The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, has tied up with the Hyderabad-based pharma firm Dr Reddy’s Laboratories Ltd (Dr Reddy’s) to supply 100 million doses of Sputnik V — the Covid vaccine developed by Russian researchers — in India once it has received all the necessary regulatory clearances.
Dr Reddy’s will perform phase 3 clinical trials — where a vaccine is tested on thousands to establish efficacy and safety — for Sputnik V in India, as required by Indian regulatory norms.
“Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India,” the RDIF said in a press statement issued Wednesday.
“The agreement between RDIF and Dr Reddy’s reflects the growing awareness of countries and organizations to have a diversified anti-Covid vaccine portfolio to protect their populations.”
Sputnik V is an adenovirus vector-based vaccine that was registered by the Russian Ministry of Health on 11 August. It is the world’s first registered Covid-19 vaccine, and results of the phase 1 and 2 clinical trials were published in The Lancet earlier this month.
India and Russia have been in touch on Sputnik V
RDIF CEO Kirill Dmitriev noted in the press statement that India is among the nations worst affected by Covid-19, saying Sputnik V will “provide a safe and scientifically validated option” to aid the country’s battle.
“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 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,” he added.
According to Dmitriev, 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”.
The RDIF has been in touch with several pharmaceutical companies in India for the manufacture and clinical trials of the vaccine but this is the first formal agreement it has signed.
The governments of Russia and India have also been in talks on the possibility of the vaccine being manufactured in India, and New Delhi has assured RDIF of cooperation in its efforts to conduct phase III trials and make the vaccines in the country.
G.V. Prasad, Co-Chairman and Managing Director of Dr Reddy’s Laboratories, said “Sputnik V vaccine could provide a credible option in our fight against Covid-19 in India.
“We are pleased to partner with RDIF to bring the vaccine to India. The phase 1 and 2 results have shown promise, and we will be conducting phase III trials in India to meet the requirements of the Indian regulators,” he added.
Three other vaccines are already in various stages of clinical trials in India, including the one developed by researchers at the University of Oxford which is being manufactured by Pune-based Serum Institute. This vaccine is currently in phase 3 trials after a brief halt.
The vaccines by Bharat Biotech and Zydus Cadila are preparing to start phase 2 trials.
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