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.
The company obtained approval in September last year to carry out the Phase II/III trial of the vaccine in children and adolescents of the age five to 18 years.
BE commenced the trial in October following receipt of the no-objection certificate. On assessing the available safety and immunogenicity data from the ongoing trial, the CORBEVAX vaccine was found to be safe and immunogenic.
The company also carried out Phase I/II, II/III trials of the vaccine in adults, as well as a Phase III active comparison trial to analyse its superiority over another Covid-19 vaccine, Covishield.
Biological E. managing director Mahima Datla 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.
“We truly believe that with this approval, we are even closer to finishing our global fight against the Covid-19 pandemic. Once fully vaccinated, children can resume their activities and educational pursuits in schools & colleges without any apprehension.”