The vaccine Subject Expert Committee (SEC) on Tuesday suggested granting of emergency use authorisation (EUA) for vaccine maker Bharat Biotech’s Covid-19-vaccine, Covaxin, for children in the 2-18 years age group. The SEC has suggested this to the Drugs Controller General of India (DCGI), which will approve the EUA. This is the second vaccine authorized for children. Earlier, 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 initially vaccine in the nation for children beneath 12 years.
Bharat Biotech mentioned it had submitted information 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), that the information had been completely reviewed by the CDSCO and SEC, and that they offered their positive suggestions. “We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children,” a Bharat Biotech statement mentioned.
This was one of the initially approvals worldwide for Covid-19 vaccines for the 2-18 years age group. Bharat Biotech thanked the DCGI, SEC and CDSCO for expediting the evaluation approach. The enterprise would be continuing the study, submit a danger management program and provide information with evaluation each and every 15 days.
This is a two-dose vaccine that is administered with a gap of 28 days. Around 1,000 children across the nation have been involved in the trials. Health ministry officials have currently indicated that adults would stay priority for the national Covid vaccination programme, and when it is authorized for children, the initially priority would be children with comorbidities. There are two more Covid-19 vaccines for children that are in the midst of clinical trials. Serum Institute of India’s Novavax is carrying out trials for children aged 7-11 years. Biological E’s Corbevax trials are for children aged 5-18 years.
The World Health Organizaiton (WHO) is scheduled to meet this week to carry out a danger/advantage assessment and come to a final selection no matter if to grant emergency use listing to Covaxin. Bharat Biotech has been submitting information to WHO on a rolling basis and also submitted further information sought by the WHO in September. India on Tuesday administered 96.34 crore Covid vaccine doses, of which 11.08 crore Covaxin doses have been from Bharat Biotech.