Covaxin recommended for children aged 2-18 years

An expert panel on Tuesday recommended Covaxin for use on children between the ages of two and 18. Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September. “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 emergency situation,” the subject expert panel said in a statement.The made in India vaccine will be administered in two doses, with a gap of 20 days between the first and second dose.

In a statement, Bharat Biotech said the clinical trial data it had submitted was thoroughly reviewed by the Central Drugs Standard Control Organisation (CDSCO) and SEC, who provided their positive recommendations. "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," the vaccine developer said.

The Covaxin vaccine tested on children is the same formulation as used on adults, but separate trials were needed to guarantee safety and efficacy on younger recipients. Data on these trials has not been made public yet, but tests were conducted on 1,000+ children across the country. The panel, however, noted the trial on kids showed similar efficacy rates as that on adults.