India is considering Russia’s proposal for conducting third phase of clinical trials and manufacturing of its coronavirus disease (Covid-19) vaccine Sputnik V by firms in the country, Niti Aayog member Vinod Paul said on Tuesday, adding that specific outcomes of the deal are expected very soon.
“Indian scientists have looked at data and we are paving the way for phase 3 trials or bridging studies as per science and the requirements of regulatory system of India. We are working in partnership with this vaccine candidate for manufacture, trials and regulatory facilitation,” Paul said at a briefing.
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Sputnik V received regulatory clearance from Russia on August 11, making it the world’s first Covid-19 vaccine to be approved by a government. Russian scientists published the results of Phase 1 and Phase 2 of trials in The Lancet last week that demonstrated Sputnik V was safe and induced a satisfactory antibody response in all participants within 21 days. Phase 3 trials of the vaccine began last week.
“The government of Russia approached the government of India and sought help on two counts. One, to consider manufacturing through our network of companies for manufacturing high quality vaccines, as the size, volumes and capacity is perhaps the best in the world… And whether, if need be, phase 3 or bridging studies can be conducted in India, which means support in regulatory processes and finding suitable partners for trials,” said Paul. On both counts, there has been significant movement, he said. “The outreach has been extended to several companies in India and three to four have already come forward, and the others are in discussion with their Russian counterparts and the government is facilitating the process of how the connect can be made. There may be specific outcomes very soon,” he added.
{{/usCountry}}“The government of Russia approached the government of India and sought help on two counts. One, to consider manufacturing through our network of companies for manufacturing high quality vaccines, as the size, volumes and capacity is perhaps the best in the world… And whether, if need be, phase 3 or bridging studies can be conducted in India, which means support in regulatory processes and finding suitable partners for trials,” said Paul. On both counts, there has been significant movement, he said. “The outreach has been extended to several companies in India and three to four have already come forward, and the others are in discussion with their Russian counterparts and the government is facilitating the process of how the connect can be made. There may be specific outcomes very soon,” he added.
{{/usCountry}}Dr K VijayRaghavan, principal scientific adviser to the government, said: “The Department of Biotechnology and its agencies have put in place collaborative processes... They will then decide if the next steps, which are clinical trials at the appropriate phase, are to be taken.”