Bharat Biotech Seeks Approval For Trials Of Covaxin Booster Dose For 2-18 Years Age Group
Hyderabad-based pharma company Bharat Biotech, the makers of the first indigenous COVID-19 vaccine, Covaxin has reportedly sought permission from the Drugs Controller General of India (DCGI) to conduct trials of booster dose in the 2-18 age group.
"The Hyderabad-based firm had on April 29 submitted an application to DCGI seeking permission to conduct phase 2/3 trial to evaluate the safety, reactogenicity and immunogenicity of Covaxin as a booster dose in healthy volunteers aged 2 to 18 years," a source told PTI.
Study to be conducted in six states
According to reports, Bharat Biotech had applied for permission a week ago. It has already conducted trials in the age group of 2-18 for two doses of Covaxin.
The study is likely to be conducted at six sites, including AIIMS Delhi and Patna.
Recently, Bharat Biotech has also received an Emergency Use Authorisation (EUA) approval for 6-12 years old children for two doses.
Bharat Biotech has also applied for the EUA for the 2-5 years old but Subject Expert Committee (SEC) has asked for more data.
First for 2-18 age group
Bharat Biotech is the first company in India who had applied for permission from DCGI to conduct trials of a booster dose in the 2-18 age group.
Currently, the Covaxin is under the national COVID vaccination programme for the above 15-18 age group for two doses and above 18 years old for a precaution dose.
Children aged 12 to 14 years are vaccinated with Biological E's intramuscular vaccine Corbevax, while those in the 15-18 age group are being administered Covaxin at government vaccination centres.?
The trials for Bharat Biotech's intranasal booster on a heterologous group are under trial, according to the sources data collection process is over for the age group above 18 years.
India's booster dose rollout
India began administering precaution doses of vaccines to the healthcare and frontline workers and those aged 60 and above with comorbidities on January 10 this year.
The comorbidity clause was removed in March making all people aged above 60 eligible for the precaution dose of COVID-19 vaccine.
India expanded the ambit of the precaution doses of COVID-19 vaccines and on April 10 began administering the jabs to all aged above 18 years at private vaccination centres.
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