Hyderabad: Corbevax, India's first indigenously developed Receptor Binding Domain (RBD) Protein sub-unit vaccine against COVID-19, manufactured by Biological E (BE) Limited has received emergency use authorization for the 12 to 18 year age group in India by the Drugs Controller General of India (DCGI), subject to certain condition, official sources said. This is the third vaccine to receive emergency use authorization from DCGI for the age group of 12 to 18 years after ZyCoV-D of Zydus Cadila and Covaxin of Biotech. Currently, Covaxin is being used in India for those in the age group of 15 to 18 years.
"BE received the approval for restricted use in an emergency situation in adolescents aged 12 to less than 18 years based on interim results (of the ongoing phase II/III clinical study)," the manufacturer of Corbevax Biological E Limited (BE) stated in a release on Monday. Mahima Datla, the Managing Director of BE said that they believe that with the approval, the goal of finishing the fight against the Covid-19 pandemic has come closer.
"We are pleased with this significant development, which helps extend the reach of our vaccine to the age group of 12 to 18 years in our country. We truly believe that with this approval, we are even closer to finishing our global fight against the COVID-19 pandemic," stated Datla. She also said that once fully vaccinated children can resume their usual activities and educational pursuits without any apprehension.
"Once fully vaccinated, children can resume their activities and educational pursuits in schools & colleges without any apprehension. We thank all the participants in the clinical trials, Biotechnology Industry Research Assistance Council (BIRAC) and Department of Biotechnology, Govt of India, Translational Health Science and Technology Institute (TSTHI), and the principal investigators and clinical site staff who have extended their support during the last several months,’’ stated Datla.
"Last September, BE received approval to conduct a Phase II/III clinical trial on CORBEVAXTM in children and adolescents aged 5 to 18 years. Based on the no-objection certificate, BE initiated the clinical study in October 2021 and evaluated the available safety and immunogenicity results of the ongoing phase II/III study, which indicated that the vaccine is safe and immunogenic," stated the release.
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