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HYDERABAD: Indigenously developed Covid-19 vaccine Covaxin has received approval from the Drugs Controller General of India (DCGI) for emergency use in children aged between 12-18 years.
The drug regulator’s nod comes over two months after the Subject Expert Committee (SEC), that advises the DCGI, recommended emergency use approval for vaccinating kids in the 2-18 years age group.
Covaxin’s developer Bharat Biotech on Saturday confirmed that it had received the drug regulator’s approval for emergency use of the vaccine on kids in the 12-18 years age bracket.
“Covaxin is formulated uniquely such that the same dosage can be administered to adults and children. Covaxin has established a proven record for safety and efficacy in adults for the original variant and subsequent variants,” Bharat Biotech said in a statement.
“We have documented excellent safety and immunogenicity data readouts in children. We look forward for Covaxin to provide similar levels of protection for adults and children alike,” the company said while lauding the authorities for their “diligent review of all data and for their fastidious approval process”.
Covaxin was granted EUA nod on January 3 this year and since then over 15.25 crore doses of the vaccine have been administered so far to those aged 18 years and above as part of the national Covid-19 immunisation drive.
The drug regulator’s nod comes over two months after the Subject Expert Committee (SEC), that advises the DCGI, recommended emergency use approval for vaccinating kids in the 2-18 years age group.
Covaxin’s developer Bharat Biotech on Saturday confirmed that it had received the drug regulator’s approval for emergency use of the vaccine on kids in the 12-18 years age bracket.
“Covaxin is formulated uniquely such that the same dosage can be administered to adults and children. Covaxin has established a proven record for safety and efficacy in adults for the original variant and subsequent variants,” Bharat Biotech said in a statement.
“We have documented excellent safety and immunogenicity data readouts in children. We look forward for Covaxin to provide similar levels of protection for adults and children alike,” the company said while lauding the authorities for their “diligent review of all data and for their fastidious approval process”.
Covaxin was granted EUA nod on January 3 this year and since then over 15.25 crore doses of the vaccine have been administered so far to those aged 18 years and above as part of the national Covid-19 immunisation drive.
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