On February 21, India’s Drug Controller General granted emergency use authorisation to Biological E’s coronavirus vaccine Corbevax for youngsters aged 15 and up.
Corbevax, the COVID-19 vaccine created by Hyderabad-based Biological E, has now acquired regulatory clearances for administration in the 12-18-year age group, about two months after it was approved for adults in the country.
Based on interim results from current phase 2, 3 clinical studies, the business announced in a statement on February 21 that it has gained approval from the Drug Controller General of India for restricted use in an emergency circumstance among adolescents aged 12 to less than 18 years.
This comes nearly a week after the topic expert committee on COVID-19 of the Central Drug Standard Control Organization recommended the receptor-binding domain (RBD) protein subunit vaccination for use in adolescents.
The news comes as the administration debates whether or not to expand the ongoing national coronavirus vaccination campaign for children and adolescents under the age of 15.
In India, only Bharat Biotech’s Covaxin is currently approved for the 15-17 age group.
Meanwhile, the firm’s managing director, Mahima Datla, said in a statement that the development will help extend the vaccine’s reach in the country to children aged 12 to 18.
“With this permission, we feel we are one step closer to completing our global campaign against the COVID-19 pandemic.” Children can resume their hobbies and educational interests in schools and colleges without fear once fully immunised.”
The business gained approval in September to undertake a phase 2/3 clinical trial of the vaccine in children and adolescents aged 5 to 18.
The company began the clinical investigation in October 2021, based on the no-objection certificate, and assessed the available safety and immunogenicity results from the ongoing phase 2/3 study, which revealed that the vaccine is safe and immunogenic, according to the company.
This vaccine is given intramuscularly in two doses 28 days apart, and the business claims to have undertaken an extra phase 3 active comparison clinical trial to see if it is better than the Covishield vaccine.
The government paid the company an advance payment of Rs 1,500 crore last year and has agreed to purchase 5 crore vaccine shots, but it has yet to be rolled out to adults in the country.