Emergency Use Nod To Covaxin For 6-12 Year-Olds, Bharat Biotech To Submit Safety Data
Bhubaneswar: The Drugs Controller General of India (DCGI ) has granted restricted emergency use authorisation to Bharat Biotech’s Covaxin for children aged 6 to 12 years amid a surge in cases in schools, ANI news agency reported on Tuesday.
The company has been asked to submit safety data, including that on adverse events, with due analysis every 15 days for the first two months and monthly thereafter for five months, the India Today reported.
Last week, the Subject Expert Committee (SEC) of the DCGI had asked the Hyderabad-based firm for additional data on its vaccine for administering it to children aged between 2 and 12 years.
The DCGI has also granted emergency use authorisation to Corbevax for children between the age of 5 and 12 years, sources told ANI.
The panel had earlier approved Covaxin for emergency use in children above 12 years in December last year. Cadila Health’s ZyCoV-D has also received restricted emergency use authorisation for children above the age of 12 years, the news agency added.