COVID-19 vaccine | DCGI approves Phase II/III clinical trial of Covaxin on 2-18 year-olds

The Drugs Controller General of India (DCGI) has approved Phase II/III clinical trial of Covaxin in the age group of 2 to 18 years.

Moneycontrol News
May 13, 2021 / 11:38 AM IST

Covaxin (Representative image)

The Drugs Controller General of India (DCGI) has approved Phase II/III clinical trial of Covaxin, Hyderabad-based Bharat Biotech's COVID-19 vaccine, in the age group of 2 to 18 years.

"The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on 12.05.2021," the Ministry of Health and Family Welfare said in a statement.

The ministry on May 13 said Bharat Biotech will conduct the trial on 525 healthy volunteers. The vaccine will be administered by the intramuscular route, in two doses given at day 0 and day 28.

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"As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) (COVID-19) on 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions," the ministry said.

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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Covaxin, an inactivated vaccine against COVID-19, has been developed by Bharat Biotech in collaboration with the ICMR's National Institute of Virology (NIV).

Bharat Biotech had on April 24 said the Phase 3 study of Covaxin showed 78 percent overall efficacy against COVID-19 and 100 percent overall efficacy against severe disease and hospitalisation.

 

(This is a developing story. Please check back for updates.)
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TAGS: #Bharat Biotech #coronavirus #Current Affairs #India
first published: May 13, 2021 11:01 am