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Corbevax, Biological E Ltd’s (BE) Covid vaccine, has received emergency-use authorisation (EUA) from the Drug Controller General of India (DCGI). Hyderabad-based BE received the approval for restricted use in an emergency situation in adolescents aged 12 to 18 years, based on interim results of the ongoing Phase II/III clinical study, said the company on Monday. The DCGI had approved Corbevax for restricted use in emergency situation in adults on December 28, 2019. “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,’‘ said Mahima Datla, Managing Director, Biological E Limited, in a release. “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.’‘ Last September, BE received approval to conduct a Phase II/III clinical trial on Corbevax in children and adolescents aged 5 to 18 years.
Safety results
Based on the no-objection certificate, BE 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”, according to the release. The vaccine is administered through an 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. BE has conducted Phase I/II, II/III clinical trials of its vaccine for adults in the country. In addition, it conducted a Phase III active comparison clinical trial to evaluate superiority over Covishield. Corbevax is India’s first indigenously developed protein sub-unit vaccine against Covid. It has been developed by Biological E jointly with Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine (Baylor) in Houston, Texas.
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