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Covovax approval to strengthen immunization efforts in India, lower & middle income countries: SII

“The approval of Covovax by DCGI is a significant milestone in strengthening our immunization efforts across India and LMICs. We are proud to deliver a highly-effective protein-based COVID-19 vaccine of more than 90 per cent efficacy rate, based on clinical data demonstrating a favorable safety profile.

December 28, 2021 / 02:22 PM IST
Representative image/AFP

Representative image/AFP


Vaccine major Serum Institute of India (SII) on Tuesday said the approval for the COVID-19 vaccine ‘Covovax’ would strengthen immunization initiatives across India and various lower and middle income countries (LMICs) across the world.

“The approval of Covovax by DCGI is a significant milestone in strengthening our immunization efforts across India and LMICs. We are proud to deliver a highly-effective protein-based COVID-19 vaccine of more than 90 per cent efficacy rate, based on clinical data demonstrating a favorable safety profile.


“We are certain that as the repertoire of the COVID-19 vaccine increases, we will be poised strongly to save the lives of millions of people against the pandemic,” SII CEO Adar Poonawalla said in a statement.

He was responding to Union Health Minister Mansukh Mandaviya’s announcement that the Central Drug Authority, the Central Drugs Standard Control Organisation (CDSCO), has approved the SII’s vaccine Covovax for restricted use in emergency situations.

Covovax is produced by Pune-based SII under licence from US-based vaccine maker Novavax Inc.

In August 2020, Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.

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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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Poonawalla also thanked Mandaviya for the approval.

“Thank you Shri Hon. @mansukhmandviya for granting Emergency Use Authorization for COVOVAX in India. This is a highly effective vaccine and is a big step in India’s fight against COVID-19,” he tweeted.


The Covovax/Novavax vaccine has recently received Emergency Use Listing (EUL) with the World Health Organisation (WHO), Emergency Use Authorization (EUA) in Indonesia and the Philippines.

Novavax also announced regulatory filings for its vaccine in Australia, Canada, the European Union, New Zealand and the United Kingdom.

Additionally, Novavax and SK bioscience have announced a Biologics License Application (BLA) submission in South Korea.


Novavax expects to submit the complete package to the United States Food and Drug Administration (USFDA) by the end of the year.

“We expect the authorisation of our vaccine to serve a vital need in India, helping to increase the vaccination rate in a country where a significant number of doses is needed to control the pandemic,” Novavax President and Chief Executive Officer Stanley C Erck said.

Novavax and SII continue to increase forward momentum, and the entities would carry on with their objective to deliver vaccines to those in India and across the globe, he added.
PTI
first published: Dec 28, 2021 02:24 pm
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