Russia seeks India's help for Sputnik vaccine Phase-3 trial, production

The Russian government has sought India's help in manufacturing the Sputnik V vaccine and also to conduct Phase-3 trials or bridging studies in the country, a top official said on Tuesday.

Sputnik V, an adenovirus vector-based vaccine, was developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology, along with the Russian Direct Investment Fund and was registered on August 11.

"The Russian government approached the Indian government through appropriate channels and sought help on two counts - to consider its manufacturing through our network of companies that are well-known for vaccine manufacturing of high quality. The second request was, if need be, Phase-3 or any bridging studies be conducted in India," said NITI Aayog member, Dr. V.K. Paul.

The Indian government attaches great importance to this offer of partnership from a very special friend of this nation, and on both the tracks there has been significant movement, he added.

Calling it a "win-win" situation for India, Paul said: "India can manufacture that vaccine in large and significant quantities, which is good for Russia and India and the specific part of that quantity can also be provided to the world."

The NITI Aayog member said that Indian scientists have looked at the data of their vaccine and there would be a need for a Phase-3 trial. "We are working in partnership with this vaccine candidate for manufacturing, trial, and regulatory facilitation in the spirit of partnership, science, and humanity."

Outreach has been extended to several companies in India and four of them have already come forward, Paul said, adding that others are in discussion with their Russian counterpart and the government is facilitating the process of how that connection can be made.

Meanwhile, in India, three vaccines are in advanced stages. There are two indigenous vaccines being developed by Zydus Cadila and Bharat Biotech in collaboration with the Indian Council of Medical Research. The Serum Institute of India has also partnered with AstraZeneca for manufacturing the Covid-19 vaccine candidate developed by the University of Oxford.

"Bharat Biotech-ICMR's Phase-1 is completed and enrollment for Phase-2 has started today. Zydus Cadila's Phase-2 is progressing nicely. Manufacturing capacity of Serum Institute is unimaginable - 75 to 100 million doses per month. The Phase-3 trials in 17 sites on 1,600 people will start soon," Paul added.

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