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COVID-19: Drug regulator CDSCO to evaluate Covaxin's phase 3 trial data

The government approved Bharat Biotech's Covaxin for restricted emergency use under clinical trial mode.

March 05, 2021 / 09:03 AM IST
Bharat Biotech's Covaxin was granted restricted emegency use approval in 'clinical trial mode' on January 2.

Bharat Biotech's Covaxin was granted restricted emegency use approval in 'clinical trial mode' on January 2.


India's first indigenously developed COVID-19 vaccine, Covaxin, will undergo strict evaluation in the wake of the Phase 3 trial data. Bharat Biotech, which developed the vaccine, announced on March 3 that Covaxin was 81 percent effective in preventing the infection after the third round of clinical trials.

The firm will submit the Phase 3 clinical trial data to the government in the coming days for review, LiveMint reported, citing a senior official at Central Drugs Standard Control Organisation (CDSCO).

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"Bharat Biotech is expected to submit the clinical trial data in 2-3 days. After the company submits the data, the Subject Expert Committee (SEC) will review and evaluate the data for granting it emergency use authorization, which is currently restricted to clinical trial mode," the official said, as per the report.

The government had approved Covaxin for restricted emergency use under clinical trial mode. Put simply, clinical trial mode means that a person will receive the vaccine after providing written consent and is followed up to see if the vaccine has caused any side-effects.

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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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EXPLAINED | Covaxin shows 81% efficacy, here's how it stacks up against Covishield

"There is a rigorous assessment of laboratory and clinical trial data, including data on quality, safety, production of protective antibodies and efficacy, before emergency use authorization—which is aligned with global guidelines—is granted," the official said.

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

Covishield vs Covaxin: A comparison of COVID-19 vaccines administering in India

“Data from 25,800 participants received a vaccine or placebo in a 1:1 ratio showed that the vaccine candidate was well-tolerated,” the company said in a statement.

Krishna Ella, chairman and managing director of Bharat Biotech, said that the vaccine demonstrated significant immunogenicity against the rapidly emerging variants.

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first published: Mar 5, 2021 09:03 am

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