NEW DELHI: India is considering Russia’s request to conduct a phase 3 clinical trial and the manufacture of its Covid-19 Sputnik V vaccine by Indian companies, officials said Tuesday, noting there has been “significant movement” on both fronts. and specific results are expected. soon.
Dr VK Paul, Member (Health) Niti Aayog, who also chairs the national group of experts on the administration of the Covid-19 vaccine, said that the government attaches “great importance to this partnership offer from a very special friend to this nation. ”
He said that Indian scientists have analyzed Sputnik V data, which is now in the public domain, and that phase -3 testing would be necessary.
“We are paving was for a phase 3 trial or bridge studies, as per the requirements of the regulatory system, which will be facilitated by the government of India,” he told a press conference here.
The Russian government has approached the government of India through the appropriate channels to consider manufacturing Sputnik V through Indian companies and also to conduct its phase 3 clinical trials here, Paul said.
“On both tracks there has been significant movement,” he said.
Several Indian companies are currently studying the proposal, he said.
“The scope has been extended to various companies in India and some of them have come forward while others are in discussions with the Russian counterparts and the government is facilitating that process of how that connection can be made. And there may be very specific results. soon in that sense, “said Paul.
It is a “win-win situation” for India and the world, he said, and underscores the county’s ability to manufacture high-quality vaccines in large and significant quantities.
It’s good for Russia, good for India, and excess capabilities or a specific part of the capabilities can also be offered to the rest of the world, he said.
Sputnik V has been developed by the Gamaleya Research Institute of Epidemiology and Microbiology of Russia, together with the Russian Direct Investment Fund (RDIF). The vaccine has not been tested in phase 3 or larger clinical trials.
“We are working in partnership with this candidate vaccine for the fabrication of a phase 3 trial, as well as for regulatory facilitation in the spirit of partnership and in the spirit of science for humanity,” Paul said.
When it comes to vaccine development in India, he said, three candidates are in different stages of clinical trials.
Currently, two indigenously developed candidate vaccines, one from Bharat Biotech in collaboration with the ICMR and the other from Zydus Cadila Ltd, have completed phase 1 of the human clinical trial and have moved on to phase 2.
The Pune-based Serum Institute of India, which has partnered with AstraZeneca to manufacture the candidate Oxford Covid-19 vaccine, has also started the process of conducting Phase 2 and 3 human clinical trials of the candidate.
IBS has the capacity to produce 75 to 100 million doses a month, he said.
Dr VK Paul, Member (Health) Niti Aayog, who also chairs the national group of experts on the administration of the Covid-19 vaccine, said that the government attaches “great importance to this partnership offer from a very special friend to this nation. ”
He said that Indian scientists have analyzed Sputnik V data, which is now in the public domain, and that phase -3 testing would be necessary.
“We are paving was for a phase 3 trial or bridge studies, as per the requirements of the regulatory system, which will be facilitated by the government of India,” he told a press conference here.
The Russian government has approached the government of India through the appropriate channels to consider manufacturing Sputnik V through Indian companies and also to conduct its phase 3 clinical trials here, Paul said.
“On both tracks there has been significant movement,” he said.
Several Indian companies are currently studying the proposal, he said.
“The scope has been extended to various companies in India and some of them have come forward while others are in discussions with the Russian counterparts and the government is facilitating that process of how that connection can be made. And there may be very specific results. soon in that sense, “said Paul.
It is a “win-win situation” for India and the world, he said, and underscores the county’s ability to manufacture high-quality vaccines in large and significant quantities.
It’s good for Russia, good for India, and excess capabilities or a specific part of the capabilities can also be offered to the rest of the world, he said.
Sputnik V has been developed by the Gamaleya Research Institute of Epidemiology and Microbiology of Russia, together with the Russian Direct Investment Fund (RDIF). The vaccine has not been tested in phase 3 or larger clinical trials.
“We are working in partnership with this candidate vaccine for the fabrication of a phase 3 trial, as well as for regulatory facilitation in the spirit of partnership and in the spirit of science for humanity,” Paul said.
When it comes to vaccine development in India, he said, three candidates are in different stages of clinical trials.
Currently, two indigenously developed candidate vaccines, one from Bharat Biotech in collaboration with the ICMR and the other from Zydus Cadila Ltd, have completed phase 1 of the human clinical trial and have moved on to phase 2.
The Pune-based Serum Institute of India, which has partnered with AstraZeneca to manufacture the candidate Oxford Covid-19 vaccine, has also started the process of conducting Phase 2 and 3 human clinical trials of the candidate.
IBS has the capacity to produce 75 to 100 million doses a month, he said.
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