The authorities of SEC have officially recommended the Drugs Controller General of India (DCGI), which will approve the EUA making it the second vaccine approved for children.
Previously, Zydus-Cadila had received EUA for administering their ZyCov-D Covid-19 vaccine for children in the 12 to 18 years group. Covaxin is the first vaccine in the country for children below 12 years old.
The firm Bharat Biotech said that it had submitted full data from the Phase 2/3 clinical trials in the 2-18 years age group for Covaxin (BBV152) to the Central Drugs Standard Control Organisation (CDSCO).
The data submitted had been minutely reviewed by the officials of CDSCO and SEC, and so they provided their positive recommendations.
A Bharat Biotech statement said, “We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children."
This will be a two-dose vaccine that will be administered with a gap of 28 days. Nearly one thousand children across the country were involved in the trials.
As per information, two more Covid-19 vaccines for children are in the midst of clinical trials. It is informed that the Serum Institute of India’s Novavax is carrying out trials for children aged 7-11 years while the Biological E’s Corbevax trials are for children aged 5-18 years.
The authorities from World Health Organization (WHO) are scheduled to meet this week to carry out a risk and benefit assessment and will come to a final decision whether to grant emergency use listing to Covaxin. The firm has been submitting data to WHO and also the additional information sought by the WHO in September.
Till Tuesday, in India authorities and health officials have administered 96.34 crore Covid vaccine doses out of which 11.08 crore Covaxin doses were from Bharat Biotech.