No major mutation in Covid-19 virus in India, confirms PMO

India gives nod to clinical trial of Russia's Sputnik V vaccine

Prior to this, Dr.Reddys Laboratories Ltd. and Russian Direct Investment Fund (the official sponsor of the vaccine candidate) had entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India.

The study also revealed that the USA, the United Kingdom and India are the top three nations with a geometric mean of 3.27 per cent, 3.59 per cent, and 5.39 per cent, respectively, of mutation similarity score with other 72 countries.

India's drug regulatory authority has approved a clinical trial of Russia's Sputnik V vaccine candidate against the novel coronavirus disease on healthy Indian volunteers, setting the stage for the country's fourth Covid-19 vaccine trial.

This will be a multi-centre and randomized controlled study, which will include safety and immunogenicity study, it said.

While Sputnik V is now undergoing Phase-3 clinical trials involving 40,000 volunteers in Russian Federation, a Phase-3 clinical trial of the vaccine has also commenced in the UAE last week.

Co-chairman and Managing Director of Dr Reddy's Laboratories, G. V. Prasad, has applauded the controller's approval of the trials in India.

"India is heading fast towards vaccine development as two manufacturers are already in phase-3 trial and one in the phase-2 trial, while more players are joining the race", the Indian Express quoted Jadhav as saying.

Dr. Jadhav said, "We can produce 700-800 million vaccine doses every year once things are streamlined". Around 40,000 volunteers are expected to receive Sputnik V during the phase 3 trial now underway in Russian Federation.

In addition, the RDIF, together with its partners, is conducting Sputnik V clinical trials in Belarus, the United Arab Emirates, and Venezuela.

The SEC had on October 5 asked the firm to re-apply stating it will have to conduct both phase 2 and 3 clinical trials and can not directly hold phase 3 trial for the vaccine in India.

African countries are facing a dual challenge, given the high procurement costs and the small number of companies worldwide that have the capability to develop vaccines, the World Health Organization official added.

Now two indigenously developed vaccine candidates, one by Bharat Biotech in collaboration with ICMR and another one by Zydus Cadila Ltd are in the phase 2 ofthe human clinical trials.



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