DCGI Approved Corbevax Vaccine for 5 to 12 Years Age Group, Covaxin Vaccine for 6-12 Age Groups: The Drugs Controller General of India (DCGI) has granted restricted emergency use authorisation (EUA) to Covaxin for use in 6 to 12 years old children. The national drug regulator has asked Covaxin manufacturer Bharat Biotech to submit safety data. It has also asked for the data on adverse events with due analysis, every 15 days for the first two months and monthly thereafter up to five months. Bharat Biotech had applied for approval of Covaxin for use in 6 to 12 year old age groups. Corbevax has also been approved for those between five to 12 years of age.
The no objection certificate was granted to Bharat Biotech on April 25 based on the recommendations of the Subject Expert Committee (SEC) on COVID-19 last week following two-month-long deliberations. The union health ministry or the COVID working group of the National Technical Advisory Group (NTAG) on Immunisation will further decide on the expansion of the COVID vaccine. All above 12 years of age are eligible for COVID vaccination in India as of today.
The government has permitted only Corbevax for use in the 12 to 14 years age group under the nationwide COVID vaccination programme. The DCGI had earlier last year on December 25 approved Bharat Biotech Covaxin for EUA in the 12 to18 age group.
Bharat Biotech completed the phase 2/3 trials of Covaxin. Following this it had submitted the data to the DCGI for subsequent approval for EUA in October.
It had presented its proposal for grant of market authorisation of its Whole Virion, Inactivated coronavirus Vaccine (BBV152) in the 2 to 18 years age group for restricted use in emergency situation along with the interim safety and immunogenicity data of phase 2/3 clinical trial conducted. Zydus Cadila’s Covid -19 vaccine ZyCoV-D had got EUA approval from the DCGI in the month of August, 2021.