The Drug Controller General of India (DCGI) has granted Bharat Biotech’s Covaxin a limited emergency use authorization for children aged 6 to 12 years. The regulator has required Bharat Biotech to submit safety data, including appropriately analyzed adverse event data, every 15 days for the first two months and monthly for up to five months.

Bharat Biotech granted Bharat Biotech a no-objection certificate on April 25 after two months of deliberation on the recommendations made by the COVID-19 subject matter expert committee last week. Initiatives to expand the COVID vaccine will now depend on the Ministry of Health or the National Immunization Technical Advisory Group’s COVID task force.

All people in India above the age of 12 are eligible for the COVID vaccine. Still, under the national COVID vaccination program, the government has only allowed Corbevax to be used by those in the 12-14 age group.
Bharat Biotech has applied for approval of its vaccine for the 2-12 age group, but the Central Drug Standards Control Organization’s SEC recommendation currently only approves the 6-12 age group.