Covaxin gets emergency approval for kids aged 2-18 years by Subject Expert Committee
New Delhi: In a major gain, India’s indigenous COVID vaccine — Covaxin — has been approved for children aged 2-18 years by the Subject Expert Committee (SEC) this noon.
Covaxin has overall efficacy of 77.8 percent against COVID and 65.2 percent protection against the new Delta variant.
The trials are taking place on 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and submitted the trial data to the Drugs and Comptroller General of India (DCGI) at the start of this month. The latest trials revealed that COVAXIN displayed similar safety and immunogenicity in children as it did in its adult subjects.
“After detailed deliberation, the Committee recommended the grant of market authorisation of the vaccine for the age group of plus 2,” a media release said this noon. The made in India vaccine will be administered in two doses.
This is the second COVID-19 vaccine to get approved for children in India. The drugs regulator had earlier approved ZyCoV-D for children aged 12 and above as well as adults. However, the rollout has not yet begun.
A third potential vaccine for kids is Serum Institute’s Novavax, for which the DCGI last month cleared trials for children between seven and 11 years.
The emergency use authorisation, however, is subject to certain conditions. The developer of Covaxin will continue the study as per ‘Whole Virion – Inactivated Coronavirus Vaccine,’ the approved clinical trial protocol.
It will have to provide updated prescribing information/package Insert (PI), Summary of Product Characteristics (SmPC) and factsheet. Moreover, the firm should submit safety data including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter and also as per requirement of New Drugs & Clinical Trials Rules, 2019, it said.
Covaxin is supplied to the Centre at Rs. 215 and at Rs. 1,410 at private hospitals for a 2-dose regimen.
Meanwhile, the World Health Organisation (WHO) is yet to grant emergency use authorisation to Covaxin. Bharat Biotech had reportedly submitted all documents required for the listing to the World Health Organisation by July 9 and the WHO review process, which takes close to six weeks, had commenced the same by July-end.