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Last Updated : Oct 17, 2020 03:57 PM IST | Source: Reuters

Russia receives renewed approval for COVID-19 vaccine trials in India: RDIF

Large-scale trials of the Sputnik V vaccine in India were first announced and then knocked back by Indian regulators, who said the scale of Phase I and II trials conducted in Russia earlier this year was too small, requesting that they be repeated.

Reuters
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The Russian Direct Investment Fund (RDIF) and Dr Reddy's Laboratories Ltd have received renewed approval to conduct late-stage clinical trials in India of the Russian COVID-19 vaccine, the sovereign wealth fund said on Saturday.

Large-scale trials of the Sputnik V vaccine in India were first announced and then knocked back by Indian regulators, who said the scale of Phase I and II trials conducted in Russia earlier this year was too small, requesting that they be repeated.

Following a new agreement, India will now carry out an adaptive phase II and III human clinical trial involving 1,500 participants, RDIF, which is marketing the vaccine abroad, said on Saturday. Under the deal, Dr Reddy's will conduct the clinical trials and, subject to approval, distribute the finished vaccine in India. RDIF will supply 100 million doses to Dr Reddy's.

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Russia, the first country to grant regulatory approval for a novel coronavirus vaccine, is also conducting Phase III trials of Sputnik V in Belarus, Venezuela and the United Arab Emirates. RDIF has reached agreements with Indian manufacturers to produce 300 million doses of the shot.

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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A Phase III trial involving 40,000 participants is currently underway in Moscow, with 16,000 people having already received the first dose of the two-shot vaccine.

Interim results are expected to be published in early November.

Indian regulators have agreed to incorporate data, provided by Russia on a weekly basis, from the Moscow trial, a source close to the deal told Reuters.

Russia has also reached an agreement with the biotechnology department of India's Science and Technology Ministry to use its laboratories as a base for the Indian clinical trial, the source said.
First Published on Oct 17, 2020 03:57 pm
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