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India gives go ahead for trials of Russia's Sputnik vaccine

India's drug controller has given a go ahead to Dr Reddys Laboratories and Russian Direct Investment Fund for the phase 2 and 3 human clinical trial for Russia's Sputnik V Covid vaccine&nbsp;

India's drug controller has given a go ahead to Dr Reddys Laboratories and Russian Direct Investment Fund for the phase 2 and 3 human clinical trial for Russia's Sputnik V Covid vaccine in India. The Hyderabad-based drug maker said in a press release that this will be a multi-center and randomised controlled study. Earlier in September, Dr&nbsp;Reddys and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr.Reddys upon regulatory approval in India.

India's drug controller has given a go ahead to Dr Reddys Laboratories and Russian Direct Investment Fund for the phase 2 and 3 human clinical trial for Russia's Sputnik V Covid vaccine in India. The Hyderabad-based drug maker said in a press release that this will be a multi-center and randomised controlled study, which will include safety and immunogenicity study. Earlier in September, Dr&nbsp;Reddys and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr.Reddys upon regulatory approval in India.

Russian vaccine: India ready for human trials & production

Russia has approached India for conducting phase-3 clinical trial and manufacturing of its Covid-19 vaccine Sputnik V by Indian firms

Russia has approached India for conducting phase-3 clinical trial and manufacturing of its Covid-19 vaccine Sputnik V by Indian firms. The Indian govt has said that it is working to facilitate Moscow's request. Niti Aayog member Dr V K Paul, who also chairs the national expert group on Covid-19 vaccine administration, has said that 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. Dr Kaul said that that there has been considerable movement on Russia's request and several Indian companies are currently studying the proposal.

New Delhi, PTI: 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. There has been "significant movement" on both these fronts and specific outcomes are expected soon.
Dr V K 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".
He said that 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.
&ldquo;We are paving way for such a phase-3 trial or bridging studies, as per requirements of the regulatory system, to be facilitated by the government of India," he 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, Paul said.
"On both the tracks there has been significant movement,&rdquo; he said.
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, he said, underlining the county'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, he said.
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.

Russia releases first batch of Sputnik V into public

Russia releases first batch of Covid-19 vaccine Sputnik V into public, regional deliveries being planned.

Russia releases first batch of Sputnik V to public
Covid-19 vaccine registered by Russia on Aug 11
Regional deliveries are being planned by Russia
Officials hope to vaccinate Moscow residents first

The first batch of Sputnik V vaccine against coronavirus, developed by Russia's Gamaleya National Research Center of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) has been released into civil circulation, and regional deliveries are planned in the near future, the Russian Health Ministry has said.
The Russian health ministry registered the first vaccine against Covid-19, named Sputnik V, on August 11.
Moscow Mayor&nbsp;on Sunday said that the majority of Moscow residents will be vaccinated against the coronavirus within the next few months.

rdif

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