Bharat Biotech’s Covaxin is yet to receive final approval for emergency use for children aged 2-18 years. Official sources said the Drug Controller General of India (DCGI) would approve Covaxin for children aged 2 to 18 years after evaluating the data. Bharat Biotech has submitted the clinical trial data for the age group of 2-18 years to the Central Drugs Standard Control Organization (CDSCO) after getting approval from the expert committee.
An expert panel of the Central Drugs Authority of India has recommended emergency use of Covaccine for children aged 2 to 18 years with certain conditions. Let us tell you that this Made in India vaccine will be given in two doses. There will be an interval of 20 days between the first and second doses.
Recommendation for approval with certain conditions
If approved by the Drugs Controller General of India (DCGI), it will be the second vaccine after Zydus Cadila’s needleless Xycov-D to receive Emergency Use Approval (EUA) to be administered to people below the age of 18 years. In its recommendations, the SEC said, “The committee, after detailed deliberations, recommended the approval of the vaccine for limited use in the market for limited use in the age group of two years to 18 years in emergency situations, subject to certain conditions.” ‘s.
Phase II-III trials of Covaccine have been completed
Hyderabad-based Bharat Biotech has completed Phase II-III trials of Covaccine, an anti-Covid-19 vaccine, for use in children and adolescents between the ages of two and 18 years. The company had submitted the data to the Central Drugs Standard Control Organization (CDSCO) earlier this month for its verification and approval for emergency use.