Covaxin given approval for emergency use in children aged 12-18 years: DCGI

Dec. 25: The Drug Controller General of India (DCGI) on December 25 gave nod to Bharat Biotech’s vaccine, Covaxin, for emergency use for kids aged 12-18 years. Covaxin is now the second vaccine in India that has received clearance for use for children. The first one is Zydus Cadila’s three-dose jab which was allowed to be administered on adults as well as kids over 12 years of age in August.

Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of COVID-19 vaccine Covaxin for use in children aged between two and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab in early October. The Subject Expert Committee (SEC) on COVID-19 examined the data and deliberated on the EUA application.

Like most vaccines for adults, children between 12 to 18 years of age will be administered Covaxin in two doses. The interval and dosage are likely to be the same as adults.

In a statement Bharat Biotech stated, “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.”

In an important declaration, Prime Minister Narendra Modi while addressing the nation on the Christmas evening announced that vaccine jabs will now be administered to those between 15 to 18 years in the country. This exercise will begin from 3 January, 2022. He said that this decision will help fight the nation against Covid-19 and will also ease the tension of the parents and guardians whose children study in schools and colleges.

Also Read: Vaccination to start for those between 15-18 years from 3 January, 2022: PM Modi