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COVID-19 vaccine | Beneficiaries hesitant to sign Bharat Biotech’s Covaxin consent form: States tell Centre

At least three states administering Bharat Biotech's Covaxin told the central government that they faced hesitation from beneficiaries who had to sign the consent form, according to a report.

January 18, 2021 / 10:15 AM IST
File image: A healthcare worker performs a trial run of COVID-19 vaccine delivery system in New Delhi, India. (Image: AP Photo/Altaf Qadri, File)

File image: A healthcare worker performs a trial run of COVID-19 vaccine delivery system in New Delhi, India. (Image: AP Photo/Altaf Qadri, File)


At least three states that administered Bharat Biotech’s Covaxin on January 16 have said that beneficiaries were reluctant to sign the consent form, according to a report by The Economic Times. This resulted in less than 50 percent strike rate – Bihar, Tamil Nadu and Telangana – on the first day of what is being called as the “world’s largest” COVID-19 vaccination exercise.

The issue was raised by the states in the coordination meeting chaired by Union Health Minister Dr. Harsh Vardhan later on January 16.

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Tamil Nadu was able to administer just 99 Covaxin doses out of the planned 600 on the first day of the vaccination drive. The following day, it had administered 90 more doses till 2.00 pm, the report suggests.

All 11 states, which agreed to administer Covaxin doses, have dedicated six vaccination centres as part of the drive. All of these centres are restricted to government hospitals.

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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.

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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.

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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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However, the news report suggests that beneficiaries in Rajasthan saw hesitation. The state administered 314 Covaxin doses out of the planned 600. No adverse event was reported from the vaccine in the state. Rajasthan’s National Health Mission director Naresh Thakral told the newspaper that translating the consent form to Hindi may have helped.

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This comes at a time when some experts and politicians have raised concerns regarding the efficacy of Covaxin, which is currently under phase-3 clinical trials.

Bharat Biotech's COVID-19 vaccine Covaxin, developed in collaboration with the Indian Council of Medical Research (ICMR), was granted restricted emergency use approval under the clinical trial mode. This means that people who receive the doses will have to sign a three-page informed consent form, and will also be monitored for any serious side effects. This was the first such approval given to a vaccine in India.

Read: What is informed consent form for Covaxin, what information is sought and other questions answered

A total of 2.24 lakh beneficiaries were inoculated with the COVID-19 vaccine so far in India. Of these, a total of 447 adverse events were reported following immunisation (AEFI), the Union Health Ministry said on day two of the nationwide vaccination drive on January 17.

Besides Covaxin, the Drugs Controller General of India (DCGI) had also approved Covishield produced by the Serum Institute of India (SII).

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Moneycontrol News
first published: Jan 18, 2021 10:15 am

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