DCGI grants EUA to Biological E.’s Covid-19 vaccine for use in adolescents

The Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) to Biological E.’s (BE) Covid-19 vaccine, CORBEVAX, for people aged 12 to 18 years. CORBEVAX is the country’s first domestically developed receptor-binding domain (RBD) protein sub-unit vaccine against the SARS-CoV-2 virus and is adjuvanted with alum and CpG 1018 of Dynavax. The indicated dosage is a two-dose regimen of the vaccine given intramuscularly at a gap of 28 days. In December last year, the drug regulator granted approval to the vaccine for restricted use in adults during emergencies. The latest approval for usage in adolescents is based on interim data from the ongoing Phase II/III clinical trial of the vaccine.