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The Subject Expert Committee (SEC) of CDSCO has granted emergency use approval (EUA) to Covaxin for children in the 2-18 years age group. Covaxin is developed by Hyderabad based Bharat Biotech.
Caovaxin had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and submitted the trial data to the Drugs Controller General of India (DCGI) at the start of this month.
After detailed deliberation, the committee recommended the grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations, as per sources the subject expert panel said. This vaccine will be given in two shots in twenty days of time period.
Yet, WHO has not approved emergency use authorisation to Covaxin. Bharat Biotech had submitted all documents required for the listing to the WHO by July. In August, CDSCO had also approved EUA to Zydus Cadila's ZyCov-D, Covid-19 vaccine for children between the ages of 12 to 18 which is the first DNA vaccine to be approved in the world.
Schools are re-opened in many parts of the country and concerns were raised by many over possibilities of a spike in COVID-19 infection amongst the children. Now, production, availability and vaccination of children will be important aspect.
