Covaxin's COVID-19 vaccine has received restricted emergency use authorization for use in 6 to12 year old kids, from the Drugs Control General of India, reported PTI.
The approval comes just hours after the Subject Expert Committee of the DCGI recommended the vaccine for this age group, while also asking Bharat Biotech to submit additional data supporting Covaxin's safety and efficacy in children between the ages of 2 and 12.
Just last week, Biological E's protein subunit based COVID vaccine Corbevax was recommended by the SEC for use in children between the ages of 5 and 11. Corbevax too has reportedly received an EUA from the DCGI for the same age group.
It must be noted that an EUA doesn't automatically mean that the vaccines will be rolled out for these age groups. They will now need to be approved by the National Technical Advisory Group on Immunisation before they are made available to people.
Covaxin for Kids: What Do We Know?
When the national COVID vaccine drive was extended to children over the age of 15, Covaxin was announced to be the only vaccine to be offered to this age group.
Here are some fast facts to know about Covaxin for children.
The vaccine formula is the same as the one for adults.
For children, it is to be taken in 2 doses with a gap of 28 days.
Although the vaccine was previously approved for kids over 12, and now kids over 6, it has only been rolled out for children over 15 under the national inoculation drive as of now.
What Do We Know About the Clinical Trials?
Applying for an EUA, Bharat Biotech had submitted phases 2 and 3 clinical trial data of their COVID vaccine on children over the age of 2 to the drug's regulatory body for review back in August 2021.
This data has not been made public yet.
A preprint version of the phase 2/3 trials, however, released on 30 December, finds the vaccine to be demonstrating 'robust safety and immunogenicity in 2-18 Volunteers.'
Here are some key points from the phase 2/3 clinical trial.
The phase 2/3 trial was an open-Label, multi-centre Study.
The trials were conducted between June 2021 to September 2021.
525 eligible participants (between the ages of 2 and 18) were enrolled and divided into three groups based on their age, in an age descending way.
As is the practice with trials on children, this study did not have a control arm.
The SEC's recommendation of the vaccine for younger age groups, and the subsequent EUA from the DCGI comes following an analysis of this data.
(Written with inputs from PTI.)