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    Bharat Biotech gets permission to conduct Phase- II and III trials for its vaccine for age group of two to 18

    Published on May 13, 2021

    Bharat Biotech has been granted permission to conduct Phase- II and III trials of COVID vaccine Covaxin for the age group of two to 18 years. The expert panel of the Central Drugs Standard Control Organisation has recommended the conduct of trials. The Drugs Controller General of India has accepted the recommendation of Subject Expert Committee, SEC. The trial will be conducted in 525 healthy volunteers.During the trial, the two doses of vaccine will be administered to the volunteers. The gap between the first and second dose will be 28 days.

    Earlier, the Subject Expert Committee of Central Drugs Standard Control Organisation deliberated upon Bharat Biotech application seeking permission to conduct Phase-II and III trials to evaluate the safety and immunogenicity of Covaxin vaccine in Children aged between two and 18 years.

    Covaxin has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research. This vaccine is currently being used in the nationwide vaccination drive for the vaccination of people aged above 18 years