DCGI provides EUA for Biological E’s Covid-19 vaccine for use in adolescents
DCGI provides EUA for Biological E’s Covid-19 vaccine for use in adolescents

DCGI provides EUA for Biological E’s Covid-19 vaccine for use in adolescents

Drug Controller General of India (DCGI) has given Emergency Use Permit (EUA) for Biological E.’s (BE) Covid-19 vaccine, CORBEVAX, for persons aged 12 to 18 years.

CORBEVAX is the country’s first domestically developed receptor-binding domain (RBD) protein subunit vaccine against SARS-CoV-2 virus and is adjuvanted with alum and CpG 1018 from Dynavax.

The indicated dose is a two-dose regimen of the vaccine given intramuscularly at 28-day intervals.

Last December, the Drug Regulator approved the vaccine for limited use in adults in emergencies.

The latest approval for use in adolescents is based on preliminary data from the ongoing Phase II / III clinical trial of the vaccine.

In September last year, the company obtained approval to carry out the phase II / III trial of the vaccine for children and young people aged five to 18 years.

BE started the trial in October after receiving the no-objection certificate. In assessing the available safety and immunogenicity data from the ongoing trial, the CORBEVAX vaccine was found to be safe and immunogenic.

The company also performed Phase I / II, II / III vaccine trials in adults as well as a Phase III active comparative trial to analyze its superiority over another Covid-19 vaccine, Covishield.

Biological E. CEO Mahima Datla said: “We are pleased with this significant development which is helping to extend the range 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 ending our global fight against the Covid-19 pandemic. Once fully vaccinated, children can resume their activities and educational activities in schools and colleges without any worries. “

Related companies



Leave a Reply

Your email address will not be published.