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DCGIs asks Bharat Biotech to submit protocol for administering COVID-19 vaccine under clinical trial mode

The clinical trial mode means, that everyone will consent for the vaccine, there will be no placebo arm and the recipients will be closely monitored, said ICMR's Balram Bhargava.

January 05, 2021 / 10:49 PM IST
Krishna Ella, Chairman and Managing Director of Bharat Biotech.

Krishna Ella, Chairman and Managing Director of Bharat Biotech.

Balram Bhargava, Director General of the Indian Council of Medical Research (ICMR), on January 5 said Bharat Biotech has been asked by the Drugs Controller General of India (DCGI) to provide the SOPs (standard operating protcols) for administering its COVID-19 vaccine candidate under clinical trial mode.

"The clinical trial mode means, that everyone will consent for the vaccine, there will be no placebo arm and the recipients will be closely monitored," Bhargava told media.

Bharat Biotech's COVID-19 vaccine has been granted restricted emegency use permission in “clinical trial mode”, to have more options for vaccinations, especially in cases of infection by mutant strains.

But the use of clinical trial mode has raised questions.

Unfair to accuse us of inexperience, Covaxin Phase-3 efficacy data by March: Bharat Biotech Chairman Krishna Ella

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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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Krishna Ella, Chairman and Managing Director of Bharat Biotech, on January 4 said he didn't know what the regulator meant when it accorded approval under ‘clinical trial mode’, the first such approval.

He said he was in the process of getting more clarity from the drug regulator.

Bhargava hasn't provided clarity, on whether those who may suffer from serious adverse event due to vaccine are eligible for getting compensation, like participants of clinical trials.
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: Jan 5, 2021 07:11 pm

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