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COVID-19 Vaccine: India yet to decide on giving indemnity to vaccine makers

India’s drug regulator had recently approved two COVID-19 vaccines, Oxford's Covishield manufactured by SII in the country and Bharat Biotech's Covaxin, for restricted emergency use.

January 13, 2021 / 12:01 PM IST

The government is yet to firm up its view on providing indemnity to the two COVID-19 vaccine makers -- Serum Institute of India (SII) and Bharat Biotech International -- against claims and lawsuits for damages in case of side effects.

India’s drug regulator had recently approved two COVID-19 vaccines, Oxford's Covishield manufactured by SII in the country and Bharat Biotech's Covaxin, for restricted emergency use.

As the approval came, both the vaccine makers had requested indemnity in case there are health complications after the vaccination. However, the government has not yet decided on the matter, reported Mint citing people familiar with the development.

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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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“We have discussed indemnity with several companies, including Serum and Bharat Biotech, and also the regulator and other stakeholders, but have not yet decided on the matter," a government official was quoted as saying.

The government is waiting for data on whether side effects are observed after the mass inoculation drive begins in the country, said the report citing an industry official.

Also read | Check legal options for vaccine recipients having severe side effects

An indemnity is a comprehensive form of insurance compensation for damages or loss. Here, it means a form of insurance for legal claims made by vaccine recipients if they have serious adverse events (SAEs) after receiving a COVID-19 shot, the report suggested.

India will launch its COVID-19 vaccination drive from January 16 in what Prime Minister Narendra Modi has called the world's largest inoculation programme with priority to be given to nearly three crore healthcare and frontline workers.

Also read | India's COVID-19 vaccine: Who'll get it, when and how - All you need to know

According to the COVID-19 Vaccine Operational Guidelines, the shots will be offered first to an estimated one crore healthcare workers, and around two crore frontline workers, and then to persons above 50 years of age, followed by persons younger than 50 years of age with associated comorbidities based on evolving pandemic situation.

(With inputs from PTI)

Follow our full coverage on COVID-19 here.
Moneycontrol News
first published: Jan 13, 2021 09:06 am

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