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Dr Reddy's gets DSMB nod to conduct Phase-3 trial of Sputnik Covid-19 vaccine in India

The phase 2 study of Sputnik V was conducted on 100 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study in India. The DSMB concluded that no safety concerns were identified and the study has met the primary endpoints of safety, Dr Reddy's said.

January 12, 2021 / 10:07 AM IST
(Image: Reuters)

(Image: Reuters)

 
 
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Dr. Reddy’s Laboratories on Monday announced that the independent Data and Safety Monitoring Board (DSMB) has reviewed the safety data from the phase 2 clinical trial of the Sputnik V vaccine and recommended the phase 3 recruitment and continue the clinical trial without any modifications.

“The safety data from the phase 2 clinical trial from India is very positive, and confirms the safety profile of Sputnik V in the international markets. The Sputnik V consistently shows safety and high efficacy in international clinical trials as it is based on a safe human adenoviral vector platform,” Dr Reddy's said in a statement.

The phase 2 study of Sputnik V was conducted on 100 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India. The DSMB concluded that no safety concerns were identified and the study has met the primary endpoints of safety, Dr Reddy's said.

“The Indian clinical trial being conducted by Dr. Reddy’s and RDIF is an adaptive design phase 2/3 trial. It is a bridging study to the larger global phase 3 study on 31,000 subjects," said G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s.

"The phase 2 study in India showed a very good safety profile. This further reinforces our confidence in the safety of Sputnik V, which has now been administered to more than 1 million people in Russia and more than 300,000 people in Argentina. We are working closely towards fast-tracking the launch of the Sputnik V vaccine in India,” Prasad added.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, “The safety data from the phase 2 clinical trial from India is very positive, and confirms the safety profile of Sputnik V in the international markets. The Sputnik V consistently shows safety and high efficacy in international clinical trials as it is based on safe human adenoviral vector platform.”

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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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The clinical trials are being conducted by JSS Medical Research as the clinical research partner in India. Dr. Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support, THSTI (Translational Health Science and Technology Institute) for further immunogenicity data characterisation, and to use BIRAC’s clinical trial centres for the vaccine.

In September 2020, Dr. Reddy’s and Russian Direct Investment Fund (RDIF) entered into a partnership to conduct the clinical trials of the Sputnik V vaccine and the rights for distribution in India.

Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the established human adenoviral vector platform.

It currently ranks among the top 10 candidate vaccines approaching the end of clinical trials and the start of mass production on the World Health Organization’s (WHO) list. The vaccine’s efficacy is confirmed at 91.4 percent based on data analysis of the final control point of clinical trials in Russia.

Currently, the vaccine’s clinical trials are underway in the UAE, Egypt, Venezuela, and Belarus while it has been registered in Algeria, Argentina, Belarus, Bolivia, and Serbia for inoculation.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Jan 11, 2021 09:49 pm

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