Will Russia be allowed to conduct trials of its controversial COVID-19 vaccine ‘Sputnik V’ in India?

Russia plans to conduct phase 3 clinical trials of its controversial COVID-19 vaccine 'Sputnik V' in different countries, including Saudi Arabia, UAE, Brazil, and India.

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Written By: Longjam Dineshwori | Updated : August 13, 2020 11:59 AM IST

Russia on Tuesday announced that it had approved the world's first COVID-19 vaccine, but experts around the world are sceptical over the safety of the vaccine that has been tested in just 76 people. The vaccine dubbed "Sputnik V" is jointly developed by Moscow's Gamaleya Institute of Epidemiology and Microbiology and Russia Defence ministry. The first clinical trials of the vaccine had begun only on June 17 but it is yet to complete the crucial last stage human trials. On Tuesday, Russian President Vladimir Putin announced the approval of the vaccine for use and that its mass production will start next month. The vaccine is expected to be available for public use by October.

The Russian Direct Investment Fund (RDIF), which is financing the production of Sputnik V, also declared on its official website that it "sees strong global interest in the vaccine and plans to conduct phase 3 clinical trials in different countries, including Saudi Arabia, UAE, Brazil, India and the Philippines, and start mass production in other countries in partnership with local sovereign wealth funds, including India, South Korea and Brazil, as well as, in Saudi Arabia, Turkey and Cuba."

It plans to ramp up the vaccine production to 200 million doses by the end of 2020 including 30 million doses in Russia.

RDIF added that at least 20 countries had expressed interest in obtaining the Sputnik V, including UAE, Saudi Arabia, Indonesia, Philippines, Brazil, Mexico and India.

Russia plans to conduct phase 3 clinical trials of Sputnik V in India

While Russia claimed that phase 3 clinical trials of Sputnik V, which it launched on Tuesday, will also be conducted in India, officials in the Union Health Ministry denied having any talk about such collaboration so far.

Launching of phase 3 trials for any vaccine requires appropriate regulatory approvals by the Drug Controller General of India. But a senior official of the Health Ministry told a leading Indian newspaper that there is no movement on that front yet. The official also noted that they have not received any data from phase 1 and 2 trials of the Russian vaccine yet.

A senior official in the Indian Council of Medical Research has also denied any information on the matter, the newspaper reported.

Meanwhile, some reports say that Russia has approached Hyderabad-based Bharat Biotech to produce its vaccine in large quantities, but the firm hasn't yet announced anything about this collaboration yet.

India has the capacity for mass production of Sputnik V: AIIMS Director

Dr Randeep Guleria, Director, All India Institute for Medical Sciences (AIIMS) has also expressed concern over the safety and efficacy of the controversial Russian vaccine.

In an interview with a leading newspaper, he said that India has the capacity for mass production of the Russian vaccine candidate, but cautioned that it is crucial to check its safety and efficacy.

There should not be any side effects of the vaccine and it should provide good immunity and protection- Dr Guleria added.

However, Russia has so far not published any documents or research papers of its vaccine trials, except sharing the results of its successful completion of Phase I trials with the public. According to reports, 76 volunteers were administered with the vaccine candidate in phase I clinical trials of 'Sputnik V' that had started on June 17.

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