India to Help Russia’s Sputnik V Vaccine’s Phase 3 Trail & Manufacture
On Tuesday, the Centre confirmed that the vaccine cleared by Russian regulators for public use, Sputnik V vaccine’s Phase 3 clinical trials could be conducted in multiple Indian sites, or could be manufactured in India in partnership with domestic companies.
Member, NITI Aayog and co-chair, National Expert Group on Vaccine Administration for Covid-19, Dr. V K Paul said that three Indian companies have expressed interest in partnering with the Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology after Russia sought for help from India.
He added saying, “Approaching India through appropriate channels, the Russian government has sought help on two counts: First is to consider manufacturing the vaccine through the network of well-known and high-quality vaccine manufacturing companies. The partnership’s first part of the request is to manufacture the vaccine by Indian companies when the scale-up takes place.
Conducting a larger Phase 3 trial in India is the second request from Russia. Phase 1 and 2 trials have been completed already, and now the Phase 3 studies, or any bridging studies to be conducted in India if need be. Finding a suitable partner and the required regulatory processes for
conducting the trial is the second part of the request.Comprehensive data on the vaccine’s safety and efficacy was submitted to Indian authorities by the Gamaleya Research Institute of Epidemiology and Microbiology. The vaccine candidate was shown to trigger a strong immune response, according to the results of Phase 1 and Phase 2 clinical trials on 76 people.
Dr. Paul added, “The Government of India attaches great importance to this offer and partnership and mentioned that there has been significant movement on both tracks. Some companies are in discussion with the Russians while two-three of them have already come forward as the outreach had been extended to many companies in India. The process is being facilitated by the government. For both India and Russia, this is a win-win situation.”
He said, “All the regulatory clearances necessary for larger clinical trials will be facilitated by the Indian government. The Indian scientists have looked at the data, on the regulatory front. The Phase 3 trials or bridging study, if required, will be facilitated by the Indian government as per science and the Indian regulatory system.”
Moscow plans to conduct Phase 3 clinical trials in many countries, including the Philippines, Brazil, UAE, and Saudi Arabia, according to the official Sputnik V website, run by sovereign wealth fund Russian Direct Investment Fund. Vaccine production is anticipated to begin this month.
It also states that at least 20 countries, had expressed interest in obtaining the Sputnik V, countries including India, Mexico, Brazil, the Philippines, Indonesia, UAE, and Saudi Arabia.
Due to the secrecy and speed with which the vaccine candidate from Gamaleya got regulatory approval, western experts have been skeptical about the Russian claim. The Lancet study states that around 40,000 volunteers from different age and risk groups will be involved in Sputnik’s Phase 3 trial.
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India to Help Russia’s Sputnik V Vaccine’s Phase 3 Trail & Manufacture
