Bharat Biotech's COVID-19 vaccine, Covaxin, has received emergency authorisation for use in children over the age of 12 by the Drugs Controller General of India (DCGI), the company announced on Saturday, 26 December.
Covaxin becomes the second COVID-19 vaccine to be approved for kids in India after Zydus Cadila's vaccine, which received an EUA back in August.
Bharat Biotech made the announcement on Twitter, saying "we have documented excellent safety and immunogenicity data readouts in children."
Minutes before the official announcement came, Prime Minister Narendra Modi, in an address to the nation declared that COVID-19 vaccination for kids between the ages of 15 and 18 would begin in the country from 3 January 2022 onwards.
What Do We Know About Covaxin for Children?
Covaxin for kids is essentially the same vaccine that is being administered to adults, but also tested for its safety and efficacy in children.
The company had reportedly submitted the results of phase 3 clinical trials on 2 to 18 year old kids to the DCGI in August for review, based on which a subject expert committee recommended rolling out the vaccine for the same age group in October.
The DCGI's final decision in favour of approving the vaccine for children over the age of 12 comes nearly 2 months after the recommendation.
It must be noted that the results of the clinical trials conducted by Bharat Biotech have not yet been released for peer review, and the data from the study has not been made public.
It is also unknown why the DCGI decided to keep 12 years as the cut off age while granting the EUA.
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.
Another COVID vaccine candidate in India that has been cleared for clinical trials is Serum Institute's Covovax, which earlier this month, was added to WHO's list of approved COVID vaccines.
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