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Last Updated : Oct 17, 2020 05:25 PM IST | Source: PTI

DRL gets DCGI s nod to conduct COVID-19 vaccine phase 2/3 human trials

The city-based drug maker said in a press release that this will be a multi-center and randomised controlled study,which will include safety and immunogenicity study.

PTI
Representative image
Representative image

Dr.Reddys Laboratories Ltd. and Russian Direct Investment Fund, Russias sovereign wealth fund, on Saturday announced that they have received approval from the Drug Control General of India to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India.

The city-based drug maker said in a press release that this will be a multi-center and randomised controlled study,which will include safety and immunogenicity study.

Earlier in September 2020, Dr.Reddys and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr.Reddys upon regulatory approval in India.

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G V Prasad, Co-chairman and Managing Director, Dr.Reddy, said, "This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic."

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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Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, "We are pleased to collaborate with the Indian regulators and in addition to Indian clinical trial data, we will provide safety and immunogenicity study from the Russian phase 3 clinical trial. This data will further strengthen the clinical development of Sputnik V vaccine in India."

On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the worlds first registered vaccine against COVID-19 based on the human adenoviral vectors platform. Sputnik V is currently undergoing Phase 3 clinical trials in Russia and the proposed number of subjects is 40,000.

Additionally, Phase 3 clinical trial of the vaccine commenced in the UAE last week.
First Published on Oct 17, 2020 05:08 pm
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