Russia’s sovereign wealth fund said on Wednesday that it had reached an agreement with India’s leading pharmaceutical companies, Dr. Reddy’s Laboratories, to cooperate in clinical trials and distribution of the Sputnik V vaccine for Covid-19 in India.
“Following regulatory approval in India, the RDIF will supply Dr. Reddy’s 100 million doses of the vaccine,” the Russian Direct Investment Fund (RDIF) said in a statement.
“The Sputnik V vaccine, which is based on a 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 the completion of successful trials and registration of the vaccine by regulatory authorities in India, “the statement added.
Russia’s envoy to India Nikolay Kudashev has held talks with Indian officials in recent weeks about cooperation in the development of a vaccine, including the joint development and production of Sputnik V.
The Russian side also formally shared cooperation modalities on the vaccine with Indian authorities who have not yet responded to the matter, people familiar with the developments said on condition of anonymity.
The vaccine is also believed to have featured in discussions during Foreign Minister S Jaishankar’s visit to Moscow last week for a meeting of the foreign ministers of the Shanghai Cooperation Organization (SCO) states.
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RDIF said its agreement with Dr. Reddy’s “reflects the growing awareness of countries and organizations to have a diversified portfolio of anti-Covid vaccines to protect their populations.”
RDIF CEO Kirill Dmitriev said: “We are very pleased to be partnering 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 ”.
“India is among [the] countries most severely affected by Covid-19 and we believe that our human adenovirus dual vector platform will provide a safe and scientifically validated option for India in the battle against Covid-19, “he added.
Dmitriev said that RDIF partners will receive an “effective and safe drug” and that the human adenoviral vector platform, which forms the core of the Russian vaccine, has been “tested in more than 250 clinical studies over decades and shown to it is safe with no possible long-term negative consequences ”.
GV Prasad, Co-Chairman and Managing Director of Dr Reddy’s, said that the Phase I and Phase II results “have shown promise, and we will conduct Phase III trials in India to meet the requirements of Indian regulators.”
The Russian Ministry of Health registered the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology on August 11. A research paper on the results of the Sputnik V phase I and phase II clinical trials published in The Lancet, a leading international medical journal, on September 4 said that it had not shown serious adverse effects and a stable immune response in the 100 percent of the participants.
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Post-registration clinical trials of Sputnik V, involving 40,000 volunteers, are currently ongoing, the RDIF said. More than 55,000 volunteers applied to join the post-registration trials and the first results of these trials are expected to be published in October-November, he added.
The Serum Institute of India is also working with the University of Oxford and AstraZeneca on another Covid-19 vaccine.
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