INDIA: Bharat Biotech’s Covaxin was given restricted emergency-use authorization by the Drugs Controller General of India (DCGI) on Tuesday for children aged 6 to 12.
The DGCI has directed Bharat Biotech, a vaccine production business situated in Hyderabad, to report safety data, as well as data on adverse events, every 15 days for the first two months, and then monthly data for up to five months.
Bharat Biotech received the no-objection certificate after a two-month deliberation on the recommendation made by the Subject Expert Committee (SEC) on COVID-19 last week.
On April 21, the DGCI’s SEC requested that Bharat Biotech produce further data on the administration of Covaxin to children aged 2 to 12.
The panel approved Covaxin for emergency usage in children over the age of 12 in December 2021.
The Centre had previously informed the Delhi High Court that it will be presenting a status report on the COVID-19 vaccine among children under the age of 12. Corbevax has also been given emergency use authorization by DCGI for children aged 5 to 12.
On 28 December last year, the Drugs Controller General of India (DCGI) approved Covovax for limited use in crises in adults, and on 9 March this year, the DCGI approved it for limited use in emergencies in children aged 12 to 17 years, subject to specific criteria.
Children aged 12 to 14 years are being inoculated against COVID-19 using Biological E’s Corbevax. On December 24, 2021, the DCGI issued Covaxin Emergency Use Listing (EUL) for the age group of 12 to 18 years.
“The CDSCO’s Subject Expert Committee on COVID-19, which debated on Biological E’s EUA application, has recommended granting emergency use authorization for Corbevax in the age group of five to eleven years,” according to a source. On March 16, India began immunizing youngsters aged 12 to 14.
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