New Delhi: India is considering Russia’s request for conducting phase-3 clinical trial and manufacturing of its COVID-19 vaccine ‘Sputnik V’ by Indian firms, officials said Tuesday. They informed that there has been ‘significant movement’ on both these fronts and specific outcomes are expected soon. Russia had claimed last month that it had discovered a COVID-19 vaccine to fight the disease.
Dr VK Paul, Member (Health) Niti Aayog, who also chairs the national expert group on COVID-19 vaccine administration, said the government attaches ‘great importance to this offer of partnership from a very special friend to this nation’.
Paul said Indian scientists have looked at the data on ‘Sputnik V’, which is in the public domain now, and there would be a need for the phase -3 trial.
“We are paving was for such a phase-3 trial or bridging studies, as per requirements of the regulatory system, to be facilitated by the government of India,” Paul told a press conference here.
“The Russian government has approached the government of India through appropriate channels to consider the manufacturing of ‘Sputnik V’ through Indian companies and also conducting its phase-3 clinical trials here. On both the tracks there has been significant movement,” Paul informed.
Several Indian companies are currently studying the proposal, he said. “The outreach has been extended to several companies in India and a few of them have come forward while others are in discussions with the Russian counterparts and the government is facilitating that process of how that connect can be made. And there may be specific outcomes very soon in that regard,” Paul said.
“It is a ‘win-win situation’ for India and the world. It underlines India’s ability to manufacture high quality vaccine in large and significant quantities. It is good for Russia, good for India, and also excess capacities or specific part of the capacities can be offered to the rest of the world,” Paul asserted.
‘Sputnik V’ has been developed by Russia’s Gamaleya Research Institute of Epidemiology and Microbiology, along with the Russian Direct Investment Fund (RDIF). The vaccine has not been tested in phase-3 or larger clinical trials.
