Bharat Biotech said it had submitted 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), that the data had been thoroughly reviewed by the CDSCO and SEC, and that they provided their positive recommendations.
The vaccine Subject Expert Committee (SEC) on Tuesday recommended 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 recommended this to the Drugs Controller General of India (DCGI), which will approve the EUA. This is the second vaccine approved 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 first vaccine in the country for children below 12 years.
Bharat Biotech said it had submitted 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), that the data had been thoroughly reviewed by the CDSCO and SEC, and that they provided their positive recommendations. “We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children,” a Bharat Biotech statement said.
This was one of the first approvals worldwide for Covid-19 vaccines for the 2-18 years age group. Bharat Biotech thanked the DCGI, SEC and CDSCO for expediting the review process. The company would be continuing the study, submit a risk management plan and provide data with analysis every 15 days.
This is a two-dose vaccine that is administered with a gap of 28 days. Around 1,000 children across the country were involved in the trials. Health ministry officials have already indicated that adults would remain priority for the national Covid vaccination programme, and when it is approved for children, the first 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 risk/benefit assessment and come to a final decision whether to grant emergency use listing to Covaxin. Bharat Biotech has been submitting data to WHO on a rolling basis and also submitted additional info sought by the WHO in September. India on Tuesday administered 96.34 crore Covid vaccine doses, of which 11.08 crore Covaxin doses were from Bharat Biotech.