Hyderabad-based pharmaceuticals and biologics major Biological E Ltd on Wednesday expressed confidence over getting emergency use authorisation for use of its Corbevax anti-COVID vaccine in children in the age group of 5-12 years.

The company's Corbevax vaccine is being used for the inoculation of children in the age group of 12 to 14 years, which started on Wednesday.

Biological E said its multiple manufacturing units in Hyderabad are fully qualified to enable production of around 1 billion dosages of Corbevax annually and it is geared up to meet any increase in demand.

As on date, the company has produced 30 crore vaccines as part of its commitment made to the Government of India, with 5 crore dosages already supplied.

Addressing a press conference, Biological E Managing Director Mahima Datla said, "We have achieved a capacity to produce over 100 million doses per month in order to ensure adequate supply and we are able to respond to any increasing demand too, should the need arise."

She said in order to keep it simple for vaccinations to be carried out across age groups, the company has not made any difference in the protein and drug substances used in Corbevax for children and the adult population.

In a presentation, Biological E Executive Vice-President Technical Operations Vikram Paradkar said at present the company is conducting clinical trials of Corbevax among children in the age group of 5-12 years and it is almost nearing completion.

Stating that the interim report has been submitted to the relevant authority, he said, "We are confident of getting emergency use authorisation (EUA) for that age group as well."

A company official said the intent is to develop the COVID-19 vaccine even for babies all the way down to six months old.

Datla said the company has been able to prove superiority of Corbevax over Covishield, which was a pre-condition for getting the approval.

"In clinical trials, Corbevax induced immune response demonstrated consistent neutralisation of the ancestral SARS-COV-2 strain as well as the variants of concern such as Beta, Delta and Omicron," she added.

Biological E said Corbevax vaccination generates antibody response that is "highly persistent for more than 6 months post vaccination".

While Corbevax is the first indigenous vaccine to get emergency use authorisation (EUA) for vaccinating the Indian population between the age group of 12 to 80 years, the government programme is currently focussed on vaccination of 12-14 years age group, Datla said.

She further said Corbevax has been priced at Rs 990 (inclusive of taxes and vaccine administration charges) in the private market, while for the government vaccination programme it is priced at Rs 145.

The company has also commenced clinical trials to use Corbevax as a booster dose over Covishield and Covaxin around two months back.

Biological E had collaborated with the Texas Children's Hospital and the Baylor College in the development of the Corbevax vaccine.

US-based Dynavax Inc supported the programme by providing the adjuvant and THSTI Delhi conducted key immunogenicity testing as part of a comprehensive clinical trial development plan.

BIRAC (a division of the Department of Biotechnology), Bill & Melinda Gates Foundation and Coalition for Epidemic Prevention and Innovation (CEPI) provided partial funding during clinical development, the company said.