Covaxin Can Be Given For Children Aged 2-18 Years
The Subject Expert Committee (SEC) on Covid-19 gave emergency use approval to Covaxin developed by Hyderabad based Bharat Biotech for children in the 2 to 18 years age group. The vaccine developer had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and submitted the trial data to the Drugs and Comptroller General of India in October. Covaxin will be administered in two doses, with a gap of 20 days between the first and second dose.
Bharat Biotech said that the Central Drugs Standard Control Organisation (CDSCO) and SEC have studied the clinical trial data it had submitted. CDSCO and SEC have provided their positive recommendations.
Bharat Biotech added that, “This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thank the DCGI, Subject Experts Committee, and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children.”
A few days ago, India had also granted emergency use approval to ZyCov-D’s Covid-19 vaccine for children between the ages of 12 to 18. ZyCov-D’s Covid-19 vaccine is developed by pharmaceutical firm Zydus Cadila and is the first DNA vaccine to be approved in the world.