Biological E Corbevax gets DCGI nod for 12-18 years
The CORBEVAX vaccine is administered through intramuscular route with two doses scheduled 28 days apart.;
Hyderabad: Biological E. Limited has announced that its CORBEVAX vaccine, which is India's first indigenously developed Receptor Binding Domain (RBD) Protein sub-unit vaccine against COVID-19, has received emergency use authorisation (EUA) from India's drug regulator for the 12 to 18-year age group.
The Drugs Controller General of India (DCGI) has already approved CORBEVAX for restricted use in emergency situation among adults on December 28, 2021. 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).
Ms. Mahima Datla, Managing Director, Biological E. Limited, said, "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 more closer to finishing our global fight against the COVID-19 pandemic. 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.''
Read also: CDSCO panel recommends Biological E Corbevax for emergency use among 12 to 18 year olds
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