NEW DELHI: Russia has approached India to seek the collaboration of Indian companies in the manufacture of Covid-19 vaccines and also if phase 3 or bridge studies could be conducted here. The Center said there has been significant movement on both fronts.
The disclosure has spread to many companies and several have accepted. The regulator will also facilitate phase 3 or bridging studies in Indian patients for the Russian vaccine. India is working to begin large-scale manufacturing as well as local phase 3 clinical trials for Sputnik V, the Covid-19 vaccine developed by Russia.
The chair of the National Covid-19 Vaccine Administration Task Force, VK Paul, said on Tuesday that India attaches great importance to the Russian supply of vaccine manufacturing by Indian companies, as well as to phase 3 trials or studies. bridge, as might be necessary to establish the efficacy of the vaccine.
The government has approached various companies to manufacture the Russian candidate and around three companies have already shown interest, while many others are evaluating the opportunity.
“Russia approached India through the proper channels for two reasons: one is the manufacture of Sputnik V through the network of Indian companies to achieve a production scale 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 of the vaccine have been completed and the results have recently been published in The Lancet, ”said Paul.
“The Indian government attaches great importance to these offers from Russia and there have been key movements on both fronts,” he said.
Last week, the Lancet published the first peer-reviewed data on the vaccine from the first phase 1 and 2 studies showing that the vaccine induced an antibody response in all participants in the first trials and has shown a good profile. safety without serious adverse effects.
The government said it is a “win-win situation” for India, given the large production capacity that Indian companies have. The Serum Institute alone has the capacity to produce up to 100 million doses of vaccines in a month. “The regulator would facilitate phase 3 or bridging studies. We can consider the same model (similar to serum) for the Russian candidate who will then undergo phase 3 trials in Indian volunteers, ”said Paul.
The disclosure has spread to many companies and several have accepted. The regulator will also facilitate phase 3 or bridging studies in Indian patients for the Russian vaccine. India is working to begin large-scale manufacturing as well as local phase 3 clinical trials for Sputnik V, the Covid-19 vaccine developed by Russia.
The chair of the National Covid-19 Vaccine Administration Task Force, VK Paul, said on Tuesday that India attaches great importance to the Russian supply of vaccine manufacturing by Indian companies, as well as to phase 3 trials or studies. bridge, as might be necessary to establish the efficacy of the vaccine.
The government has approached various companies to manufacture the Russian candidate and around three companies have already shown interest, while many others are evaluating the opportunity.
“Russia approached India through the proper channels for two reasons: one is the manufacture of Sputnik V through the network of Indian companies to achieve a production scale 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 of the vaccine have been completed and the results have recently been published in The Lancet, ”said Paul.
“The Indian government attaches great importance to these offers from Russia and there have been key movements on both fronts,” he said.
Last week, the Lancet published the first peer-reviewed data on the vaccine from the first phase 1 and 2 studies showing that the vaccine induced an antibody response in all participants in the first trials and has shown a good profile. safety without serious adverse effects.
The government said it is a “win-win situation” for India, given the large production capacity that Indian companies have. The Serum Institute alone has the capacity to produce up to 100 million doses of vaccines in a month. “The regulator would facilitate phase 3 or bridging studies. We can consider the same model (similar to serum) for the Russian candidate who will then undergo phase 3 trials in Indian volunteers, ”said Paul.
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