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Last Updated : Oct 03, 2020 08:30 AM IST | Source: PTI

Dr Reddy's seeks DCGI nod to conduct phase-3 clinical trial of Russian COVID-19 vaccine Sputnik V

The Indian pharma giant has collaborated with The Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V as well as its distribution.

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The Hyderabad-based Dr Reddy's Laboratories has applied to the Drugs Controller General of India for permission to conduct phase-3 human clinical trials of the Russian vaccine Sputnik V against COVID-19 in India, sources said.

The Indian pharma giant has collaborated with The Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V as well as its distribution.

Upon regulatory approval in India, RDIF will supply to drugmaker Dr Reddy's 100 million doses of the vaccine, the firm said last month.

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"The Dr Reddy's Laboratories has applied to the DCGI seeking permission to conduct phase-3 human clinical trials of the Sputnik V vaccine against COVID-19 developed by Russia. The DCGI will carry out a technical evaluation of the application before giving its approval," a source told PTI.

COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Sources said it would be multi-centre, observer-blind, randomised controlled study.

The phase-3 trial of Sputnik V is underway in Russia since September 1 on around 40,000 subjects, they added.

Sputnik V has been developed by Gamaleya National Research Centre of Epidemiology and Microbiology and RDIF.

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

The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19vaccinecandidate, is also conducting phase 2 and 3 human clinical trials in India.
First Published on Oct 2, 2020 10:47 pm
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