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SEC gives Bharat Biotech's COVAXIN Emergency Use Approval: Report

This candidate does not need to be administered in clinical trial mode as its Phase 3 trial interim data have been accepted, the business channel reported.

March 10, 2021 / 07:23 PM IST

The subject expert committee (SEC), an independent panel of experts set up by the Drug Controller General of India, has granted Bharat Biotech's COVAXIN Emergency Use Approval (EUA), according to a report by CNBC-TV18.

This candidate does not need to be administered in clinical trial mode as its Phase 3 trial interim data have been accepted, the business channel reported.

Bharat Biotech said on March 3 that its Covaxin vaccine was 81 percent effective in preventing COVID-19 after the third round of clinical trials.

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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It demonstrated 81 percent interim efficacy in preventing COVID-19 in those without prior infection after the second dose, the company said in a statement.

Covaxin was given restricted emergency use approval in clinical trial mode by the Drug Controller General of India (DCGI), without phase-3 efficacy data. The approval was based on safety and immunogenicity data of phase-1 and phase-2 trials, and of the hypothesis that the vaccine works on mutant strains, including the UK variant.

However, when the nationwide vaccination drive started on January 16, many beneficiaries refused to take the dose citing a lack of efficacy data.

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first published: Mar 10, 2021 06:55 pm