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DCGI drops 'clinical trial mode' condition for Bharat Biotech's Covaxin

Currently, those receiving Bharat Biotech’s Covaxin are asked to sign a consent form before being vaccinated.

March 11, 2021 / 06:59 PM 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.

The Drugs Controller General of India (DCGI) on March 11 amended its emergency use approval to Bharat Biotech's COVID-19 vaccine Covaxin by dropping the 'Clinical Trial Mode' label.

Based on the recommendations of the Subject Expert Committee (SEC), the DCGI said the permision is amended to read as "this permission is for restricted use in emergency situation in public interest."

The DCGI asked Bharat Biotech to continue ongoing Phase III clinical trial as per approved clinical trial protocol and submit a revised summary of product characteristics, prescribing information, and the fact sheet.

On Wednesday, an expert panel had recommended the removal of the “clinical trial mode” label attached to the emergency authorisation of Covaxin.

The SEC noted that the firm has carried out interim analysis after 43 cases of symptomatic RT-PCR positive COVID-19 have been reported out of which 36 were in the placebo arm and seven in the vaccine arm. As per interim data from late-stage clinical trials, Covaxin had an efficacy of 80.6 percent.

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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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After detailed deliberation, the SEC has recommended the omission of the clinical trial mode label restriction.

The DCGI amendment would mean that the vaccine can be administered with less stringent conditions and might lead to an increase in the uptake of the vaccine.

Currently, those receiving Bharat Biotech’s Covaxin are asked to sign a consent form before being vaccinated. The screening and consent form adds that compensation for serious adverse events will be paid by the company if it is proven to be causally related to the vaccine.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Mar 11, 2021 06:59 pm

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