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Wednesday, September 23, 2020

Russia seeks India help for Sputnik Phase 3 trials, manufacture

As first reported by The Indian Express on Monday, the Gamaleya Research Institute of Epidemiology and Microbiology has submitted “comprehensive data” on the vaccine's safety and efficacy to Indian authorities.

Written by Kaunain Sheriff M | New Delhi | Updated: September 9, 2020 9:00:07 am
Russia seeks India help for Sputnik Phase 3 trials, manufactureRussia's second request is to hold larger Phase 3 trials in India. (AP Photo)

THE CENTRE confirmed on Tuesday that the Sputnik V vaccine — cleared by Russian regulators for public use — could be either manufactured in India in partnership with domestic companies, or its Phase 3 clinical trials could be conducted in multiple Indian sites. Dr V K Paul, Member, NITI Aayog and co-chair, National Expert Group on Vaccine Administration for Covid-19, said Russia has “sought help on (these) two counts”, and three Indian companies have expressed interest in partnering with the Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology.

“The Russian vaccine has been under consideration. The Russian government approached India through appropriate channels and sought help on two counts. One, to consider manufacturing through our network of companies that are well known for manufacturing vaccines of high quality, and of a size, volume and capacity which 12q2is perhaps the very best in the world. The intent was: can this vaccine be manufactured by Indian companies when the scale-up takes place. This is the first part of the request for partnership,” said Dr Paul.

Russia’s second request is to hold larger Phase 3 trials in India. “The Russians have done Phase 1 and 2, (the results) were published in the Lancet last week; if need be, Phase 3 studies, or any bridging studies, be conducted in India. Which means regulatory processes and finding a suitable partner for conducting the trial. This is the second part of the request,” he said.

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As first reported by The Indian Express on Monday, the Gamaleya Research Institute of Epidemiology and Microbiology has submitted “comprehensive data” on the vaccine’s safety and efficacy to Indian authorities. According to the results of Phase 1 and Phase 2 clinical trials on 76 people, the vaccine candidate triggered a “strong” immune response.

Dr Paul confirmed that “several” Indian companies have sought to partner Russia. “The Government of India attaches great importance to this offer and partnership of a very special friend. And on both tracks, there has been significant movement. The outreach has been extended to several companies in India, and two-three of them have already come forward. Others are in discussion with the Russians. The government is facilitating the process. There will be specific outcomes very soon in that regard. This is a win-win situation for both India and Russia,” he said.

Dr Paul said the Indian government would “facilitate” all the regulatory clearances required for larger clinical trials. “On the regulatory front, the Indian scientists have looked at the data. Yes, there will be a need for Phase 3 trials in the normal course of things, and, if that is required, we are paving the way so that such Phase 3 trials or bridging study, as per science and the Indian regulatory system, will be facilitated by the Indian government,” Dr Paul said.

According to the official Sputnik V website, run by sovereign wealth fund Russian Direct Investment Fund, Moscow plans to conduct Phase 3 clinical trials in many countries, including Saudi Arabia, UAE, Brazil and the Philippines. The production of the vaccine is expected to start this month.

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Significantly, it states that at least 20 countries, including India, “had expressed interest in obtaining the Sputnik V”; these countries include the UAE, Saudi Arabia, Indonesia, the Philippines, Brazil and Mexico.

Western experts have been sceptical about the Russian claim given the speed and secrecy with which the Gamaleya candidate got regulatory approval. The Lancet study states that Sputnik’s Phase 3 trial will involve 40,000 volunteers from different age and risk groups.

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