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Covaxin final approval for 2-18 years old under expert opinion and evaluation: Report

The vaccine, developed by Hyderabad-based Bharat Biotech, was granted clearance by the Subject Expert Committee (SEC) of the drug regulator on October 12.

October 14, 2021 / 05:07 PM IST
Representative image

Representative image

The final approval for emergency use of COVID-19 vaccine Covaxin on children aged between 2 and 18 is "under expert opinion and evaluation", news agency ANI reported on October 14 citing government sources.

The vaccine, developed by Hyderabad-based Bharat Biotech, was recommended for emergency use on minors by the Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI) on October 12.

The final nod from the DCGI is, however, awaited. With the drug regulator's clearance, Covaxin would become the first vaccine in India to be granted emergency use authorisation for use on children.

The government sources also told ANI that pharmaceutical firm Biological E will submit final data related to its COVID-19 vaccine Corbevax by November-end.

The vaccine, last month, received DCGI's approval to conduct phase 2/3 study to evaluate the “safety, reactogenicity, tolerability and immunogenicity” of Corbevax in children and adolescents.


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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Biological E had also received approval for phase 3 comparator safety and immunogenicity trial in adults after a review of phase 1 and 2 clinical trials data by a subject expert committee, the Ministry of Science and Technology said on September 3.

On September 2, Niti Aayog member (health) Dr VK Paul said that results of Phase 3 trials of Corbevax were awaited and the company had committed to supply a significant quantity of the vaccine by the end of the year, ANI had reported.

“Stockpile is being produced. We should wait for the results. We hope it’ll be in the next month or two. They’ve made a broad commitment that they’ll supply a significant amount by year-end,” Dr Paul had said.
Moneycontrol News
first published: Oct 14, 2021 04:42 pm

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