India is Considering Russias Request for Conducting Phase-3 Trial and Manufacturing of Vaccine Sputnik V

09 September 2020

GMP News

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 (September 8), noting 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.

“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,” 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.

Several Indian companies are currently studying the proposal, he 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.

“We are working in partnership with this vaccine candidate for manufacture for phase-3 trial as well as regulatory facilitation in the spirit of partnership and in the spirit of science for humanity,” Paul said.

As far as vaccine development in India is concerned, he said, three candidates are in different stages of clinical trials.

Currently two indigenously developed vaccine candidates – one by Bharat Biotech in collaboration with the ICMR and the other by Zydus Cadila Ltd – have completed phase 1 of the human clinical trial and moved to phase-2.

The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, has also started the process of conducting Phase-2 and 3 human clinical trials of the candidate.

The SII has the capacity to produce 75 to 100 million doses per month, he said.

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