Biological E Limited's Corbevax COVID vaccine, the first indigenously developed in India Receptor Binding Domain (RBD) protein subunit vaccine against the novel virus, has finally acquired emergency use authorisation (EUA) from the nation's drug regulator for the 12 to 18 years age group.
The Drugs Controller General of India (DCGI) provided the official approval to Corbevax for restricted use in emergencies among adults on December 28, 2019.
Emergency Authorisation
BE obtained permission for limited use in an emergency situation in adolescents aged between 12 to less than 18 years, on the basis of interim results of the ongoing phase II/III clinical study.
Biological E. Limited managing director Mahima Datla 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 we are even closer to finishing our global fight against the pandemic with this approval," reported India Today.
She added that children could resume their activities and educational pursuits in schools and colleges without apprehension when fully vaccinated.
Datla also thanked all the participants in the clinical trials, the Biotechnology Industry Research Assistance Council (BIRAC) and Department of Biotechnology, Translational Health Science and Technology Institute (TSTHI), the clinical site staff, and chief investigators who have extended their support over the past few months.
Corbevax Clinical Trials
Back in September last year, BE had obtained the official approval to conduct a Phase II/III clinical trial of Corbevax in adolescents and children aged 5 to 18 years. On the basis of the no-objection certificate, BE started the clinical examination in October 2021 and estimated the available immunogenicity and safety results of the ongoing phase II/III analysis, which showed that the vaccine is safe and immunogenic.
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