Biological E's Corbevax vaccine approved for children aged 12-18 years
The Drugs Controller General of India (DCGI) has granted an emergency use authorization (EUA) to Corbevax—a COVID-19 vaccine developed by Hyderabad-based Biological E—for use in children aged between 12 and 18 years. The development comes nearly a week after a subject expert committee of the Central Drug Standard Control Organisation (CDSCO) recommended the vaccine for use in adolescents.
- The approval makes Corbevax the second coronavirus vaccine to be available for the below-18 age group in India.
- So far, India has been administering Bharat Biotech-developed COVAXIN to the population aged 15-18 years.
- The country had started inoculation for that cohort from January 3. Since then, more than 7.6 crore children have been vaccinated against COVID-19.
"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)," Biological E said in a statement on Monday.
Corbevax is touted as India's first indigenous receptor-binding domain (RBD) protein subunit vaccine against the coronavirus SARS-CoV-2. It had already been approved for restricted use in an emergency situation for adults. That nod had come from the DCGI in December 2021. In August last year, the central government had placed an order for 30 crore doses of Corbevax.
Corbevax is administered through the intramuscular route with two doses scheduled 28 days apart. It is stored at temperatures ranging from 2-8°C. It comes in 0.5 ml, 5 ml, and 10 ml vial packs, Biological E 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," Biological E's Managing Director Mahima Datla said in a statement. "We truly believe that with this approval, we are even closer to finishing our global fight against the COVID-19 pandemic." Datla added.
