Russia’s Sputnik V vaccine to be tested on 100 Indian volunteers during its phase-2 trials

The Drugs Controller General of India (DCGI) on Thursday declared that the Russian Sputnik V vaccine against COVID-19 will be tested in India on 100 volunteers. DCGI has granted permission to pharmaceutical giant Dr. Reddy's Laboratories for conducting the vaccine test, however, the date and time of the test will be decided by the company, according to a Russian news agency report.

The news agency quoted the organisation as saying that the vaccine will be tested in the second phase of its clinical trials before moving on to phase 3. The expert committee of DCGI had last week recommended granting permission to Dr. Reddy's Laboratories for conducting phase 2 clinical trials of Russian COVID-19 vaccine candidate, Sputnik V, in India. According to Russian researchers, the Sputnik V vaccine is a human adenoviral vector vaccine that fights against coronavirus.

On August 11, the Sputnik V vaccine candidate developed jointly by RDIF and the Gamaleya National Research Center of Epidemiology and Microbiology was registered by the Ministry of Health of Russia. It became the world's first registered vaccine against COVID-19.

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Phase 2 clinical trial to include 100 subjects

According to a government official, Dr. Reddy's Lab has stated that in phase 2 clinical trial it would include 100 subjects and for phase 3, it would take 1400 subjects. Moreover, once the pharma company would submit the safety and immunogenicity data of phase 2, it would be analysed by the expert panel, and then they can proceed with the phase 3 trial, the official added.

Dr. Reddy's Laboratories re-applies fresh protocol to DCGI

Last week on October 13, Dr. Reddy's Laboratories re-applied fresh protocol to DCGI in order to seek its approval for conducting phase 2 and 3 clinical trials of the Russian COVID-19 vaccine. It can be also recalled that on October 5, the Subject Expert Committee (SEC) had done a thorough evaluation of the previous application submitted by Dr. Reddy's lab. Following which the SEC had directed the pharma company to apply with a revised protocol along with more information. Dr. Reddy's lab has joined hands with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution. As per the RDIF agreement, it will supply 100 million doses of its potential COVID-19 vaccine to India drug company Dr. Reddy's Lab.

In September, Kirill Dmitriev, CEO, RDIF, informed that Russia is in close dialogue with the Indian government and drug manufacturers of India regarding localisation of production of its Sputnik V vaccine in India. Furthermore, a prestigious medical journal 'The Lancet' had published the results of clinical trials of Phase I-II of the Russian vaccine demonstrating its safety and efficacy.

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(With ANI inputs)