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

Drugs Controller General of India (DCGI) on Thursday declared that  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 vaccine test, however, date and time of test will be decided by company, according to a Russian news ncy report.

news ncy quoted organisation as saying that vaccine will be tested in second phase of its clinical trials before moving on to phase 3. expert committee of DCGI h 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, Sputnik V vaccine is a human eviral vector vaccine that fights against coronavirus.

On August 11, Sputnik V vaccine candidate developed jointly by RDIF and Gamaleya National Research Center of Epidemiology and Microbiology was registered by Ministry of Health of Russia. It became 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 pharma company would submit safety and immugenicity data of phase 2, it would be analysed by expert panel, and n y can proceed with phase 3 trial, official ded.

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 Russian COVID-19 vaccine. It can be also recalled that on October 5, Subject Expert Committee (SEC) h done a thorough evaluation of previous application submitted by Dr. Reddy's lab. Following which  SEC h directed pharma company to apply with a revised protocol along with more information. Dr. Reddy's lab has joined hands with Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V vaccine as well as its distribution. As per 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 Indian government and drug manufacturers of India regarding localisation of production of its Sputnik V vaccine in India. Furrmore, a prestigious medical journal ' Lancet' h published results of clinical trials of Phase I-II of Russian vaccine demonstrating its safety and efficacy.

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(With ANI inputs)