New Delhi, Apr 26: The Drugs Controller General of India (DCGI) has granted restricted emergency-use authorisation to Bharat Biotech’s Covaxin for children in the 6 to 12 years age group.
The regulator has asked Bharat Biotech to submit safety data, including the data on adverse event with due analysis, every 15 days for the first two months and monthly thereafter up to five months.
The no objection certificate was granted to Bharat Biotech on April 25 after two-month-long deliberations on the recommendation given by the Subject Expert Committee on COVID-19 last week.
The move on the expansion of the COVID vaccine will now depend on the health ministry or the COVID working group of the National Technical Advisory Group on Immunisation.
As of now, all above 12 years of age are eligible for COVID vaccination in India but the government has permitted only Corbevax for the 12-14-year age group under the nationwide COVID vaccination programme.
