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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

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.

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”