Approval

Biological E Receives DCGI Approval For Administration Of Corbevax In Children Aged 12 To 18 Years

February 22,2022 09:59 AM
- By Admin

Corbevax is India's first indigenously developed Receptor Binding Domain (RBD) Protein subunit vaccine against COVID-19. The vaccine had already received approval for restricted use in emergency situations among adults. 

Biological E. Limited (BE) today received Emergency Use Authorisation (EUA) from the Drugs Controller General of India (DCGI) for the administration of its Corbevax vaccine in children aged 12 to 18 years. The approval for restricted use in an emergency situation by the Indian drug regulator was granted on the basis of interim results of the ongoing phase II/III clinical study. Corbevax is India's first indigenously developed Receptor Binding Domain (RBD) Protein subunit vaccine against COVID-19. The vaccine had already received approval for restricted use in emergency situations among adults on December 28, 2020. Highlighting the benefits of expanding the vaccine to children, Mahima Datla, Managing Director, Biological E. Limited, said, “We are pleased with this 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. 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. The Centre had placed an order of five crore Corbevax doses earlier this month, which the pharma company plans to meet with the production of over 100 million Covid vaccine doses per month. Each dose of the Corbevax vaccine was sold to the government for Rs 145 excluding taxes.The company also aims to deliver over one billion doses to countries across the globe. The Corbevax vaccine is administered through the intramuscular route with two primary doses scheduled 28 days apart from each other. The vaccine is stored at 2 to 8 degrees’ Celsius temperature and is available in the capacity of 0.5 ml (single dose), 5 ml (10 doses) vial and 10 mL (20 doses) vial pack. Hyderabad-based Biological E had received approval to conduct a Phase II/III

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