Bharat Biotech's COVID-19 Vaccine Covaxin has been recommended for an emergency use authorisation for use in children between the ages of 2 and 18 years.
The Subject Expert Committee has made the recommendation to India's drugs regulation authority, Drugs Controller General of India (DCGI) to grant an EUA to India's first home grown vaccine on the basis of data submitted by the company.
A formal DCGI approval is likely to follow soon.
It was reported back in August that Bharat Biotech was submitting data from phase 3 clinical trials involving children to the DGCI for review.
It must be noted that the results of the clinical trials conducted by Bharat biotech have not yet been released for peer review.
Here's what we know about Covaxin's COVID-19 vaccine for kids.
Covaxin for Kids
“After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation."Subject Expert Committee's expert panel in a Statement, quoted by Moneycontrol
The DCGI had granted Bharat biotech permission to conduct phases 2 and 3 trials of it's COVID-19 vaccine on kids, back in May.
In June, AIIMS had announced that they were screening children aged 6-12 years for the trials, and that they were also planning trials for kids aged 2 to 6 years of age as well.
These clinical trials were said to be conducted on around a thousand children, in 525 centres.
In September, Bharat Biotech announced that they had completed Phase 2 and Phase 3 trials of Covaxin on children below 18 years of age.
The data from the study, submitted to the DCGI is yet to be released by the company, and the safety and efficacy information of the vaccine in kids is yet unknown.
The COVID vaccine for kids is said to be administered in two doses much like the one for adults, but with a gap of 20 days.
The approval from the DCGI falls in line with the government's plans to start rolling out COVID vaccines for kids with comorbidities by the end of October.
Other COVID Vaccines for Kids in India
Apart from covaxin, other vaccine manufacturers in the country also have COVID-19 vaccine for kids in the pipeline, including Serum Institute of India's Covovax.
The Drug Controller General of India (DCGI), in August, had given Gujarat-based pharmaceutical company Zydus Cadila’s three-dose COVID-19 vaccine emergency use authorisation for use in both adults as well as children above the age of 12 years.
When it does, Covaxin will likely become the first COVID-19 vaccine in the country to receive an EUA for children below the age of 12.
In the meantime, Covaxin's COVID-19 vaccine for adults is awaiting WHO's decision on adding it to its' COVID vaccine EUL (Emergancy Use Listing).
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