Covaxin gets emergency use nod for children aged 2-18 years
The Subject Expert
Committee (SEC) of the drug regulator has recommended granting an emergency use
authorisation to Covaxin for 2-18 age group.
Bharat Biotech's
Covaxin was granted restricted emergency use approval in 'clinical trial mode'
on January 2.
The Subject Expert
Committee (SEC) of the drug regulator has recommended granting an emergency use
authorisation to Bharat Biotech's Covaxin for children aged between
2-18. The SEC has submitted its recommendation to the Drugs Controller
General of India (DCGI) for final approval.
“After detailed
deliberation, the committee recommended for grant of market authorization of
the vaccine for the age group of 2 to 18 years for restricted use in an
emergency situation," the expert panel said in a statement.
It said that
the emergency use authorisation, however, is subject to four conditions.
"The developer of
Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus
Vaccine the approved clinical trial protocol," SEC added.
Other conditions listed by the expert panel are: The firm should provide updated Prescribing Information/Package Insert (PI), Summary of Product Characteristics (SmPC) and Factsheet; 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; and the firm should submit risk management plan.
Bharat
Biotech had last week submitted Phase 2/3 clinical trials data of
children's trials to the DCGI for its verification and subsequent approval
for emergency use authorisation (EUA) for the jab.
Bharat Biotech, in a statement, said that this represents one of
the first approvals worldwide for COVID-19 vaccines for the 2-18 age group.
"Bharat Biotech sincerely thank the DCGI, Subject Experts
Committee, and CDSCO for their expedited review process. We now await further
regulatory approvals from the CDSCO prior to product launch and market
availability of COVAXIN for Children," it said.
Two doses of Covaxin will be administered to children with a gap
of 28 days. For adults, the government has set a gap of 4-6 weeks between the
two shots.
Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India's ongoing COVID-19 vaccination drive.
This is the second COVID-19 vaccine to get approved for children in India. DGCI had, in August, approved ZyCoV-D for children aged 12 and above as well as adults. However, the rollout has not yet begun.
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