The Drugs Controller General of India (DCGI) today gave restricted use authorisation to Bharat Biotech’s Covaxin for children between the age group of 6-12 amid an uptick in the Covid cases in schools.
The approval by the DCGI comes following recommendations by the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation(CDSCO).
The DCGI has directed the vaccine maker to submit the safety data, including the data on the adverse events, with due analysis every 15 days for the first two months. After two months, Bharat Biotech has been asked to submit the data monthly for up to 5 months.
Covaxin was granted Emergency Use Listing by the DCGI for the age group of 12 to 18 years on December 24, 2021.
Further, the DCGI also granted emergency use authorisation to Corbevax for children between the age of 5-12 years. The Corbevax is currently being administered to children in the age group of 12-14.
Covid-19 vaccinations for adolescents in the age group of 15-18 years commenced on January 3 this year. The drive was later expanded to include children aged above 12 years last month.