Bharat Biotech has been asked to submit safety data alongwith the data on adverse event with due analysis, every 15 days for the first two months and after that monthly data for up to five months
DCGI approves Bharat Biotech’s Covaxin for restricted emergency use in children aged 6-12 years – ANI
The Drugs Controller General of India (DCGI) has on Tuesday given restricted emergency-use authorisation to Bharat Biotech’s Covaxin for children between the age of 6 and 12.
DGCI has asked the Hyderabad-based vaccine manufacturing company – Bharat Biotech – to submit safety data alongwith the data on adverse event with due analysis, every 15 days for the first two months and after that monthly data for up to five months.
The no objection certificate was granted to Bharat Biotech after two-month long deliberations on the recommendation given by the Subject Expert Committee (SEC) on COVID-19 last week.
On 21 April, the SEC of DGCI had asked Bharat Biotech to provide additional data on administration of Covaxin for children among children between 2 and 12 years.
For the unversed, in December 2021, the panel had approved Covaxin for emergency use in children above 12 years.
Earlier in March, the Centre told the Delhi High Court that it will be filing a status report regarding the COVID-19 vaccination among children below 12 years of age.
DCGI has also granted emergency use authorisation to Corbevax for children between the age of 5-12 years.
Inputs from agencies
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