Russia reaches out to Indian firms to make Sputnik V
Russia has reached out to India to seek collaboration of Indian companies in manufacturing vaccines against Covid-19 and also whether phase 3 or bridging studies could be done here.
The Centre said there has been significant movement on both the fronts. Outreach has been extended to many companies and several have agreed. The regulator will also facilitate phase 3 or bridging studies on Indian patients for the Russian vaccine. India is working to start large-scale manufacturing as well as phase 3 clinical trials locally for Sputnik V — the Covid-19 vaccine developed by Russia.
Chairman of the National Covid-19 Vaccine Administration Taskforce V K Paul on Tuesday said India attached great importance to the Russian offer of manufacturing of the vaccine by Indian firms as well as phase 3 trials or bridging studies, as might be required to establish the efficacy of the vaccine. The government has reached out to several firms for manufacturing of the Russian candidate and around three firms have already shown interest while many other are evaluating the opportunity.
“Russia approached India through appropriate channels on two counts — one is the manufacturing of Sputnik V through the network of Indian firms to achieve a scale of production that is the best in the world; the second is the possibility of conducting phase 3 human clinical trials in India as phase 1 and phase 2 trials on the vaccine have concluded and the results have been published in The Lancet recently,” Paul said. “The Indian government attaches great importance to these offers from Russia and there have been key movements on both these fronts,” he said.
Last week, Lancet published the first peer-reviewed data on the vaccine from early phase 1 and 2 studies showing that the vaccine induced an antibody response in all participants in early trials and has shown a good safety profile with no serious adverse effects. The government said it is a “win-win situation” for India given large production capacities that Indian firms have. Serum Institute alone has the capacity to make up to 100 million vaccine doses in a month.
“The phase 3 or bridging studies would be facilitated by the regulator. We can consider the same model (similar to Serum) for the Russian candidate who will then undergo Phase 3 trials on Indian volunteers,” said Paul.