Covaxin gets approval for 6-12 age group
The Drugs Controller General of India (DCGI) has given emergency use authorisation to Bharat Biotech’s Covaxin for children between the age group of 6-12.
The approval on Tuesday by the DCGI comes following recommendations by the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO).
Monthly data to be submitted
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. Thereafter, Bharat Biotech has been asked to submit the data monthly for up to 5 months, reports NDTV.
The DCGI approval has come amid increase in Covid cases in schools recently.
Covaxin was granted Emergency Use Listing by the DCGI for the age group of 12 to 18 years on December 24, 2021. It’s currently being administered to those in the 15-18 age group.
The DCGI has also granted emergency use authorisation to Corbevax for children between the age of 5-12 years. The vaccine is currently being administered to those in the age group of 12-14.
Zydus Cadila’s vaccine, ZycovD, has also been approved for children above the age of 12 years for a two-dose regimen.
Union Health Minister Mansukh Mandaviya tweeted said India’s fight against Covid has become stronger with the recent approvals.