Expert panel rejects Serum Institute's request for trials of Covovax vaccine among children

Serum Institute had applied to the Drugs Controller General of India (DCGI) seeking permission for conducting a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites.

Moneycontrol News
July 01, 2021 / 09:34 AM IST

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An expert panel of the central drug authority has recommended against granting permission to the Serum Institute of India (SII) to conduct phase 2 and 3 trials of COVID-19 vaccine Covovax on children aged between two and 17.

Government panel recommends against allowing Serum Institute of India to conduct phase 2 & 3 clinical trials of Covavax #COVID19 vaccine on children of age 2-17 years: Sources pic.twitter.com/loOhzpjyFe


— ANI (@ANI) July 1, 2021

The government panel has asked Serum Institute to complete trials of Covavax COVID-19 vaccine on adults first, ANI reported citing sources.

Serum Institute of India (SII) had applied to DCGI seeking permission to conduct a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites.

As per a PTI report, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) also noted that the vaccine has not been approved in any country.

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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In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with the SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.

Explained: What Novavax data means to India, approval timelines, volumes and price

The vaccine candidate 'NVX-CoV2373' demonstrated 100 percent protection against moderate and severe disease, 90.4 percent efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial, Novavax said in a statement on June 14.

The clinical trials of Covovax on adults began in India in March and the SII hopes to launch it by September.
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TAGS: #coronavirus #COVOVAX #Current Affairs #India #Novavax #Serum Institute of India
first published: Jul 1, 2021 09:08 am