'Made in India' Covaxin gets emergency use approval for children aged 2-18 years

Hyderabad-based Bharat Biotech had finished the Phase-2 and Phase-3 trials on 1,000 beneficiaries aged below 18, last month.

Published on:

10 Dec 2021, 12:00 am

2 min read

In a notable moment for India's vaccination program, Bharat Biotech's COVAXIN has received emergency use approval for being administered to children. As per reports, the Subject Expert Committee on COVID-19 has sanctioned the use of Covaxin for kids aged between 2-18. The current decision was taken after extensive deliberations, wherein the authorities studied the various parameters related to trials and vaccine usage.

Two doses to be administered at a gap of 20 days

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Reportedly, Hyderabad-based Bharat Biotech had finished the Phase-2 and Phase-3 trials on 1,000 beneficiaries aged below 18, last month. The date and reports related to the trials were submitted to the DCGI earlier this month. While the approved gap between the two doses of Covaxin for adults is 28 days, reports state that children will be given the second dose after 20 days.

Currently placed under the emergency-use category, the vaccine is expected to receive final approval from the Drug Controller General of India, stated reports. While children with severe co-morbidities will be prioritised, healthier kids are likely to be immunised later.

Emergency use of Covaxin subject to certain conditions

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The emergency use sanction comes with certain predefined conditions. According to these conditions, manufacturers of Covaxin must continue the study in line with the approved clinical trial protocol for Inactivated Corona Virus Vaccine. Moreover, the developers will have to offer comprehensive information about the vaccine administration and trial process, on a timely basis.

In August, ZyCov-D's Covid-19 vaccine was given emergency use approval for children between the ages of 12 to 18. With the reopening of schools across the country, experts have been expressing concern over the possibility of children being infected. After the current approval, the nation is all set to witness the vaccination of children in large numbers.

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