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Corbevax gets EUA approval
Corbevax gets EUA approval
Becomes 2nd Covid vaccine for children in India
Hyderabad: Vaccine manufacturer Biological E Ltd on Monday announced that its Covid-19 vaccine Corbevax has received emergency use authorisation (EUA) from India's drug regulator for the 12 to 18-year age group.
According to the Hyderabad-based firm, Corbevax is India's first indigenously developed Receptor Binding Domain (RBD) protein sub-unit vaccine against Covid-19.
The Drugs Controller General of India (DCGI) had already approved Corbevax for restricted use in emergency situation among adults on December 28, 2019. 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 2/3 clinical study).
Biological E Managing Director Mahima Datla said the development would help extend the reach of the vaccine to the age group of 12 to 18 years. "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 and colleges without any apprehension," she said. She thanked all the participants in the clinical trials, the Biotechnology Industry Research Assistance Council (BIRAC) and the Centre's Department of Biotechnology, the 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.
