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Last Updated : Sep 22, 2020 07:23 PM IST | Source: Reuters

India trials for Russia's 'Sputnik-V' vaccine may begin in next few weeks: Dr Reddy's

Indian trials of the Sputnik-V vaccine candidate, being developed by Russia's sovereign wealth fund, will enroll 1,000-2,000 participants and be conducted at multiple government and private hospitals across the country, Deepak Sapra, CEO for API and pharmaceutical services at Dr. Reddy's, told Reuters.

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Reddy's Laboratories Ltd could begin late-stage Indian clinical trials of Russia's potential coronavirus vaccine in the next few weeks, an executive at the Indian drugmaker said on Tuesday.

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Indian trials of the Sputnik-V vaccine candidate, being developed by Russia's sovereign wealth fund, will enroll 1,000-2,000 participants and be conducted at multiple government and private hospitals across the country, Deepak Sapra, CEO for API and pharmaceutical services at Dr. Reddy's, told Reuters.

COVID-19 Vaccine

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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.

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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.

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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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"We want to get to the first step - which is the commencement of the clinical trials by getting the necessary approvals from the Indian regulators - within the next few weeks," Sapra said.

The trials are part of a deal between the Russian Direct Investment Fund (RDIF) and Dr Reddy's, in which the Indian firm will conduct Phase III studies in India, pursue local regulatory approvals and, subject to approval, distribute the finished vaccine product in India. RDIF will supply 100 million doses to Dr Reddy's.

The RDIF has also reached agreements with Indian manufacturers to produce 300 million doses of the shot in India. Russia was the first country to grant regulatory approval for a novel coronavirus vaccine.

Sputnik-V doses supplied in India will likely be a combination of Indian- and Russian-made doses, Sapra said, adding that RDIF and Dr Reddy's would soon identify potential manufacturers in India.

The RDIF has said vaccine deliveries to India could begin in late 2020, but Sapra suggested it could take longer. "I think it's going to be several months before we accomplish all the steps in the process," he added.

India, which has a population of more than 1.3 billion, is the world's second worst affected country by COVID-19 behind the United States. For weeks, it has reported the world's highest daily jump in infections, which reached a total of 5.6 million on Tuesday.

First Published on Sep 22, 2020 03:41 pm
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