Biological E. Limited (BE), on Monday, February 21 announced that its Corbevax vaccine has received emergency use authorisation (EUA) from India's drug regulator for the 12 to 18-year age group. 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 Il/III clinical study).
Last September, BE received approval to conduct a Phase 1/III clinical trial on Corbevax in children and adolescents aged 5 to 18 years. 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.
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.
An expert panel of India's central drug authority on January 31 had recommended granting restricted emergency use authorisation to Corbevax for age group 12 to 18 years subject to certain conditions.
The government has still not not taken a decision on vaccinating those aged below 15 years. NITI Aayog member (Health) V K Paul at a press conference recently said that the additional need for vaccination and inclusion of population for vaccination is examined constantly.
Mahima Data, Managing Director, Biological E. Limited, 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. Once fully vaccinated, children can resume their activities and educational pursuits in schools & colleges without any apprehension."
With PTI inputs