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COVID-19 Vaccine Update: Covaxin yet to get DCGI's nod for emergency use in children

Covaxin received a recommendation Subject Expert Committee (SEC) on COVID-19 for granting emergency use authorization earlier this week.

October 16, 2021 / 11:23 AM IST
If approved by the drugs regulator, Bharat Biotech's Covaxin will be the second COVID-19 vaccine after Zydus Cadila's needle-free ZyCoV-D to receive EUA for use in those below 18 years.

If approved by the drugs regulator, Bharat Biotech's Covaxin will be the second COVID-19 vaccine after Zydus Cadila's needle-free ZyCoV-D to receive EUA for use in those below 18 years.

Bharat Biotech's COVID-19 vaccine Covaxin is yet to get approval by the Drugs Controller General of India (DCGI) for emergency use authorisation in children and adolescents in the two to 18 years age group, as it is seeking additional technical opinion on it, reported Hindustan Times citing sources.

The vaccine received a recommendation Subject Expert Committee (SEC) on COVID-19 for granting emergency use authorisation earlier this week.

“The drugs controller general of India (DCGI) is taking more technical opinion on vaccinating children even though the expert panel has recommended its use,” a senior official in the union health ministry told the publication.

The official further noted, “We will have to be extremely careful when talking about COVID-19 vaccination in children as even the developed countries that have begun vaccinating their children, are treading cautiously. The whole world is watching and we cannot afford to slip.”

If approved by the drugs regulator, it will be the second COVID-19 vaccine after Zydus Cadila's needle-free ZyCoV-D to receive EUA for use in those below 18 years.

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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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Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of COVID-19 vaccine Covaxin for use in children aged between two and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab in the beginning of this month. The Subject Expert Committee (SEC) on COVID-19 examined the data and deliberated on the EUA application.

The committee noted that the interim safety data of the phase 2/3 clinical trial was reviewed in a meeting on August 26, sources said. The overall geometric mean titre (GMT) for the paediatric population is comparable with GMT of the adult population in phase -3 efficacy study, the recommendations stated.

Also read | India records 15,981 COVID-19 cases, 166 fatalities in a day

After detailed deliberation, the committee recommended the grant of market authorisation of the vaccine for the two to 18 years age group for restricted use in emergency situations subject to certain conditions, they stated. According to the conditions, the firm should continue the study as per the approved clinical trial protocol and provide updated prescribing information/package Insert (Pl), Summary of Product Characteristics (SmPC) and Factsheet.
Moneycontrol News
first published: Oct 16, 2021 11:23 am

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