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Expert panel suggests regular market authorisation for Covishield, Covaxin

The two COVID-19 vaccines, cumulatively administered to over 90 percent beneficiaries in the country so far, were granted emergency use authorisation in January 2021.

January 20, 2022 / 09:52 IST

Covishield and Covaxin, the two COVID-19 vaccines granted emergency use nod last year, have been recommended for regular market authorisation by a government expert panel.

The recommendation was made by the Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO), whose views are factored-in by the Drug Controller General of India (DCGI) before taking the final decision.

"SEC of CDSCO has recommended for upgrade of Covishield and Covaxin status from restricted use in emergency situations to grant of new drug permission with conditions in adult population. DCGI will evaluate the recommendations and give its decision," CDSCO said.

The SEC recommendation comes a year after Covishield and Covaxin were granted permission for restricted use. They were cleared for emergency use by the DCGI on January 3, 2021. 

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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According to sources who spoke to CNBC TV18, the two jabs, after receiving the regular market authorisation, will be sold at pharmacy stores linked to hospitals and clinics which are registered with CoWIN -- the Centre's portal for COVID-19 vaccination.

Chemists associated with clinics or hospitals will be permitted to sell the vaccines provided the time of administration is keyed in at CoWIN, the news channel learnt from the persons who are familiar with the development.

Companies may not be able to sell the jabs at nearby chemist shops as they will not be able to align with CoWIN, the sources added.

Covishield, manufactured by the Pune-based Serum Institute of India (SII), is same as the Oxford-AstraZeneca vaccine which was developed in the United Kingdom. The Cyrus Poonawalla-led SII is its authorised manufacturer in India, under the Covishield brand.

Covaxin, on the other hand, is India's indigenously developed vaccine. The Hyderabad-based Bharat Biotech is its developer and manufacturer.

While Covishield is administered at a gap of 12-16 weeks, the Covaxin doses are given at an interval of 4-6 weeks. The dosage gap will remain the same even after the regular market authoritisation is granted, the CNBC TV 18 report said.

India's vaccination drive against coronavirus has so far been led by Covishield and Covaxin, with Russia-made Sputnik V being administered to a small fraction of the beneficiaries. The country has so far administered over 1.58 crore doses.

ZyCoV-D, another COVID-19 vaccine indigenously developed by Zydus Cadila, was last month granted emergency authorisation for use on persons aged above 12.

Moneycontrol News
first published: Jan 19, 2022 09:39 pm

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