Guwahati: Bharat Biotech’s Covaxin has been given restricted use authorisation by the Drugs Controller General of India (DCGI) for children between the age group of 6-12.
The DCGI gave its clearance following recommendations from the Central Drugs Standard Control Organisation’s Subject Expert Committee (SEC) on Covid-19 (CDSCO).
For the first two months, the DCGI has asked the vaccine maker to submit safety data, including data on adverse occurrences, with due analysis every 15 days. Following that, Bharat Biotech will be required to report data on a monthly basis for up to five months.
On December 24, 2021, the DCGI issued Covaxin an Emergency Use Listing (EUL) for children aged 12 to 18. It is now being given to people between the ages of 15 and 18.
It may be mentioned that Corbevax has also been given emergency use authorization by the DCGI for children aged 5 to 12.