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Serum Institute of India seeks full marketing authorisation for Covishield currently meant for emergency use only

If the authorisation is granted, Covishield will become the second Covid vaccine in the world to receive such an approval after Pfizer-BioNTech's got a nod from the US.

December 31, 2021 / 01:22 PM IST
In a tweet, Serum Institute's CEO Adar Poonawalla said that the Centre now has enough data for full market authorisation

In a tweet, Serum Institute's CEO Adar Poonawalla said that the Centre now has enough data for full market authorisation


Having supplied over 125 crore doses of Covishield in the country, the Serum Institute of India (SII) has sought full market authorisation for its Covid vaccine currently meant for emergency use only.

Chief executive Adar Poonawalla today said that the Centre has enough data for full market authorisation.

If the regular marketing authorisation is granted, Covishield will become the second Covid vaccine in the world to receive such an approval after Pfizer-BioNTech's got a nod in the US.

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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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SII had earlier also sought regular marketing approval in October after it supplied 100 crore doses in India and many other countries.

Also read | Covovax better booster for Covishield-vaccinated people: Virologist

Emergency use approval to Covishield was granted on January 3, the vaccine playing a crucial role in pandemic control and becoming the mainstay of India's Covid inoculation drive.

 
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