New Delhi: The Drug Controller General of India (DGCI) has approved Bharat Biotech’s anti-COVID-19 vaccine Covaxin for emergency use for adolescents above 12 years of age with certain conditions. Officials gave this information on Saturday. It is the second vaccine to receive regulatory approval for use among children and adolescents under 18 years of age, after Zydus Cadila, the non-needle anti-Covid-19 vaccine, Zycov-D.
At night, Prime Minister Narendra Modi announced that the anti-COVID-19 vaccination for teens aged 15 to 18 would begin on January 3. The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on COVID-19, after considering the application for emergency use of Bharat Biotech on 11 October, after considering the applications for children and adolescents in the age group of 2-18 years with certain conditions. for emergency use of Covaccine.
“The recommendations of the SEC were evaluated by another expert committee, following which DCGI sought additional data from the vaccine maker,” an official said. The DCGI gave its approval on Friday, the official said. The DCGI’s approval order said there is no objection to allowing the vaccine for adolescents aged 12 to 18 years based on the additional safety data provided and the recommendation of SEC experts.
Hyderabad-based vaccine maker Bharat Biotech has completed Phase II-III trials for the use of the Covaxin vaccine among children aged 2 to 18 years. The company then submitted the data to CDSCO in early October for verification and emergency use approval.
Commenting on the development, Bharat Biotech said in a statement, “Covaxin has been designed to provide the same dosage for adults and children. Covaxin has shown a proven record for safety and efficacy in adults for both the original form and later forms of COVID-19. We have documented excellent safety and immunity data in children. We look forward to providing an equal level of protection for adults and children with Covaccine.”
