The Drug Regulatory Authority's Subject Matter Expert Committee (SEC) has recommended that Bharat Biotech give Covaxin emergency clearance for children ages 2 to 18. The SEC has submitted its recommendation to the Drugs Controller General of India (DCGI) for final approval.
“After detailed deliberation, the committee recommended the 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.
However, four conditions are attached to the emergency permit. "The developer of Covaxin will continue the study as per Whole Virion, Inactivated CoronaVirus Vaccine the approved clinical trial protocol," SEC added. The other conditions mentioned by the expert group are: The company must provide an information sheet (PI), a summary of product characteristics (SPC) and an up-to-date information sheet;
The company must provide safety data every 14 days for the first two months and monthly thereafter, including data from AEFI and AESI, with appropriate analysis and in accordance with the requirements of the New Drugs & Clinical Trials Rules, 2019; and the company must provide a risk management plan.
Bharat Biotech submitted data from Phase 2/3 clinical trials to DCGI for review and subsequent emergency clearance (EUA) for vaccination last weekBharat Biotech said in a statement that this would be one of the first global approvals of COVID-19 vaccines for ages 2 to 18.
"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.Children receive two doses of Covaxin 28 days apart. For adults, the government has set an interval of 4 to 6 weeks between the two injections.
Covaxin, developed locally by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR), is being used in adults as part of the ongoing COVID-19 vaccination campaign in India.This is the second COVID-19 vaccine approved for children in India. In August, the DGCI approved ZyCoV-D for children 12 years and older and for adults. However, the rollout has not yet started.
Sources:- Money control
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