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Dr Reddy's begins process to obtain emergency use authorisation for Sputnik V

Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of phase 3 clinical trial, which included data on 19,866 volunteers in Russia, the statement said.

February 19, 2021 / 06:30 PM IST
(Image: Reuters)

(Image: Reuters)

 
 
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Dr Reddy's Laboratories on Friday said it has approached drugs regulator DCGI for emergency use authorisation (EUA) for COVID-19 vaccine Sputnik V.

As part of the review process, the drug major will present the safety profile of phase 2 study, and interim data of phase 3 trial, which is expected to be complete by February 21, 2021, Dr Reddy's said in a statement.

In September last year, the Hyderabad-based firm partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of Sputnik V and for its distribution rights in India.

The vaccine is undergoing phase 3 clinical trial in India. The Drugs Controller General of India (DCGI) has already given the EUA nod for two COVID-19 vaccines – Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca , being manufactured by Serum Institute of India in Pune.

The vaccines are being administered to frontline workers across the country. Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of phase 3 clinical trial, which included data on 19,866 volunteers in Russia, the statement said.

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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 vaccine also maintained a consistent efficacy at 91.8 per cent even among the group of 2,144 volunteers over 60 years old. "The efficacy of Sputnik V was reported to be 91.6 per cent by the Lancet, which is an impressive development in the fight against COVID-19. The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India," Dr Reddy's Laboratories Co-chairman and Managing Director G V Prasad said.

Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia on August 11, 2020 and became the world's first registered vaccine against COVID-19 based on the human adenoviral vector platform. Sputnik V has already receivedapproval in 26 countries and has been administered to more than 2 million people worldwide.

Follow our full coverage of the coronavirus pandemic here.
PTI
first published: Feb 19, 2021 06:30 pm

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