DCGI grants EUA to Biological E's COVID-19 vaccine Corbevax for 12-18 age group

India's drug regulator has granted emergency use authorisation (EUA) to Corbevax, India's first indigenously developed Receptor Binding Domain (RBD) protein sub-unit vaccine against COVID-19, for 12-18 years age group, Biological E Limited said on Monday. 
 
The Drugs Controller General of India (DCGI) had already approved Corbevax for restricted use in emergency situation among adults on December 28, 2021. The vaccine 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.  
 
"This significant development 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 closer to finishing our global fight against the COVID-19 pandemic," Biological E Managing Director Mahima Datla said. 

"Once fully vaccinated, children can resume their activities and educational pursuits in schools and colleges without any apprehension," she said while thanking the participants of the clinical trials, Biotechnology Industry Research Assistance Council (BIRAC) and Department of Biotechnology, Government of India, Translational Health Science and Technology Institute (TSTHI) and principal investigators and clinical site staff who extended their support. 
 
In September 2021, Biological E received approval to conduct phase II/III clinical trial on Corbevax in children and adolescents aged 5 to 18 years. Based on the no-objection certificate, Biological E 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.  

The Corbevax vaccine is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees Celsius temperature and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial and 10 mL (20 doses) vial pack. Biological E had conducted phase I/II, II/III clinical trials of Corbevax vaccine for adults in the country. In addition, it conducted a phase III active comparison clinical trial to evaluate superiority over Covishield vaccine. 
 
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