The Drug Controller General of India on February 21 gave emergency use approval to Biological E’s coronavirus vaccine Corbevax for use on children aged 15 years and above.
Nearly two months after Corbevax, the COVID-19 vaccine developed by the Hyderabad-based Biological E was approved for adults in the country; the vaccine has now received regulatory approvals for administration in the 12-18-year age group.
In a statement on February 21 that it has received approval from the Drug Controller General of India for restricted use in an emergency in adolescents aged 12 to less than 18 years based on interim results of the ongoing phase 2 3 clinical studies.
This comes nearly a week after the Central Drug Standard Control Organisation’s subject expert committee on COVID-19 had recommended the receptor-binding domain (RBD) protein subunit vaccine for administration in adolescents.
The development comes even as the government has yet to expand the ongoing national immunization campaign against coronavirus for kids and adolescents under 15 years.
Only Covaxin by Bharat Biotech is permitted for the 15-17 age group in India.
Meanwhile, Mahima Datla, managing director of the firm, said that the development would help extend the reach of the vaccine to the age group of 12 to 18 years in the 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.”
Last September, the company had received approval to conduct a phase 2/3 clinical trial of the vaccine for children and adolescents aged 5 to 18 years.
Based on the no-objection certificate, the firm initiated the clinical study in October 2021 and evaluated the available safety and immunogenicity results of the ongoing phase 2/3 study, which indicated that the vaccine is safe and immunogenic, said.
This vaccine is administered through an intramuscular route with two doses scheduled 28 days apart. The company has conducted an additional phase 3 active comparison clinical trial to evaluate superiority over the Covishield vaccine.
The Centre had made an advance payment of Rs 1,500 crore to the company last year and has agreed to procure five crore vaccine doses, but it is yet to be rolled out even for the adults in the country.