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DCGI grants emergency use approval to Bharat Biotech’s Covaxin for minors aged 12 to 18

Along with the approval, the regulatory process is being streamlined so that children can be registered on the CoWin platform to get the jabs.

The Drugs Controller General of India has approved the Covid vaccine Covaxin for minors aged 12 to 18. According to reports, DCGI has granted emergency use approval for Bharat Biotech to use the made-in-India vaccine to people in the age group 12 years to 18 years.

In October this year, the Subject Expert Committee (SEC) has given a recommendation to the Drugs Controller General of India (DCGI) for the use of Bharat Biotech’s COVID-19 vaccine Covaxin for people aged between 2-18 years. However, the DCGI chose to grant the approval for children in aged between 12-18 years.

Along with the approval, the regulatory process is being streamlined so that children can be registered on the CoWin platform to get the jabs.

“Bharat Biotech has submitted data from clinical trials in the 2-18 years age group for COVAXIN (BBV152) to CDSCO. The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and have provided their positive recommendations,” Bharat Biotech said in a statement.

“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,” the company added.

After a long delay, the World Health Organisation had granted Emergency Use Listing status to Covaxin, making people who received the vaccine eligible for international travel.

Ayodhra Ram Mandir special coverage by OpIndia

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OpIndia Staffhttps://www.opindia.com
Staff reporter at OpIndia

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