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Covaxin Cleared For Children Above 12 By Drug Regulator

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Covaxin is only the second vaccine approved for use in children in India

Bharat Biotech’s Covaxin COVID-19 vaccine has been approved by the Drugs Controller General of India (DCGI) for emergency use in children aged 12-18. India will begin rolling out vaccines for children ages 15-18 on January 3, PM Modi said in a speech tonight.

Bharat Biotech had previously submitted clinical trial data for Covaxin (BBV152) in the 2-18 age group to the Central Drugs Standard Control Organization (CDSCO). After discussing Bharat Biotech’s EUA application on October 12, the CDSCO’s Committee of Experts for COVID-19 recommended that Covaxin be granted emergency approval for use in the 12 to 18 age group under certain conditions.

“The recommendations of the SEC experts have been considered by this directorate. Accordingly, based on the recommendations of the SEC experts and the submission of additional safety data, at this point in time, this directorate has no objection to the additional indication of the Whole Virion-inactivated coronavirus vaccine for use in of the age group from 12 to 18 years for the limited use in an emergency situation “, it says in the DCGI letter to Bharat Biotech.

According to the DCGI nick, Bharat Biotech said in an official statement, “Covaxin is formulated so that the same dose can be given to adults and children. It has proven itself for the original variant in terms of safety and efficacy in adults and subsequent variants. “

Covaxin is only the second vaccine approved for use in children in India; in August, Zydus Cadila’s three-dose DNA vaccination was allowed to be used in adults and children over 12 years of age.

A third potential vaccine for children is Novavax from the Serum Institute, which the DCGI approved studies for children between the ages of seven and eleven last month. A fourth is Corbevax from Biological E, which has been approved for advanced studies in children over the age of five. In July, it had given the Serum Institute of India (SII) permission to conduct phase 2/3 studies of Covovax in children ages 2 to 17 with certain conditions.

India is slowly shifting its focus to vaccinating children against the coronavirus after giving adults over 100 crore doses.

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