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COVID-19 Vaccine Update | Covaxin recipients to be monitored for 3 months after 2nd dose

Covaxin is India's indigenous COVID-19 vaccine developed by Bharat Biotech, in collaboration with the ICMR and the National Institute of Virology.

January 21, 2021 / 11:29 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.


The Indian Council of Medical Research (ICMR) has said that the recipients of Covaxin will be monitored for three months after getting the second dose for any adverse reactions.

The ICMR stated this in a detailed plan, according to which if a serious adverse event is linked to vaccination, then the recipient will be compensated, reported Hindustan Times.

The compensation will be based on the national drug controller’s recommendations after a thorough investigation, said the report.

According to the document, the beneficiaries will have to document their health condition in writing and submit the form to health authorities for seven days after taking each dose of the vaccine.

“Day 1-7: The vaccine recipients will be given an adverse event form to record the adverse events. Day 8-27: The vaccine recipients will inform the vaccination site, if they have encountered any health-related issues or adverse events. The vaccine recipients will return the adverse event form during the visit for the administration of the second dose of vaccine (Day 28),” the report stated citing the document.

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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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After administration of the second dose of Covaxin, the recipients will be given an adverse event form to record the adverse events for the next seven days.

“The vaccine recipients will inform the site, if they have encountered any health-related issues or adverse events. Vaccine recipients will return the filled-in adverse event reporting form after completion of 7 days post-vaccination,” the document said.

The paper further mentioned that “all the vaccine recipients will be followed-up for a period of 3 months after the second dose of vaccination.”

Covaxin is India's totally indigenous COVID-19 vaccine developed in collaboration with the ICMR and the National Institute of Virology. The inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio containment facility, one of its kind in the world.

Also Read | Over 1.12 lakh beneficiaries receive coronavirus vaccine on January 20

In phase 1 and 2 clinical trials, Covaxin has demonstrated the ability to produce antidotes against COVID-19. However, the clinical efficacy of the vaccine is yet to be established and it is still being studied in phase 3 clinical trials.

The central licensing authority has granted permission for the sale or distribution of Covaxin for restricted use in emergency situations in public interest as an abundant caution, in clinical trial mode.

(With inputs from PTI)

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Moneycontrol News
first published: Jan 21, 2021 11:29 am

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