Corbevax for 5-11 years: Panel seeks nod for emergency use

According to sources, the Drugs Controller General of India (DCGI) will take up the recommendation for formal approval in the next few days.

If approved, Corbevax will become the first Covid-19 vaccine for this age group in India. The US and the UK have been administering Pfizer’s mRNA vaccine for children aged five and above.

Currently, India is only administering Covid-19 vaccines to those above 12 years — Corbevax is given to those in the 12-14 years age group, and Covaxin to those in the 15-18 years group. According to official data, 2.53 crore beneficiaries in the 12-14 years group have  been given the first dose of Corbevax, and 12,47,298 are fully vaccinated.

Corbevax is India’s first indigenously developed Receptor Binding Domain (RBD) Protein sub-unit vaccine against Covid-19, administered through the intramuscular route with two doses scheduled 28 days apart. It can be stored at 2-8 degrees Celsius, which is best suited for India’s requirements.

It is built on the traditional subunit vaccine platform: instead of using the whole virus, the platform triggers an immune response by using fragments, like the spike protein.

Corbevax includes an antigen developed by Texas Children’s Hospital Centre for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialisation team.The centre has already made an advance payment of Rs 1,500 crore to reserve 30 crore doses of Corbevax.

On February 21, Corbevax got emergency use authorisation from India’s drug regulator for the 12-18 years age group. Biological E. had earlier announced that it would manufacture 75 million doses of the vaccine per month, anticipating 100-plus million doses per month from February 2022.

Last September, Biological E. received approval to conduct Phase II/III clinical trial in children and adolescents aged 5-18 years. Based on the no-objection certificate, the company initiated clinical studies in October 2021.