Malvern-based Ocugen has submitted a request to the Food and Drug Administration for Emergency Use Authorization (EUA) of its COVID-19 vaccine candidate for children.

The vaccine candidate BBV152, also known as COVAXIN, was developed by the biopharmaceutical company’s partner, Bharat Biotech. It has already been studied in an immuno-bridging clinical trial in India with children aged two to 18.

COVAXIN — a whole-virion, inactivated vaccine — is produced using a Vero Cell manufacturing platform. This methodology has been used in the manufacturing of the inactivated polio vaccine for more than three decades, as well as for other traditional childhood vaccines.

The EUA submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech. The study involved 526 children between two and 18 years of age in the May and July timeframes. It bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in approximately 25,800 adults.

The results of the trial showed that the neutralizing antibody responses against wild-type strains among children were equivalent to those seen in adults in the large Phase 3 efficacy and safety trial.

This indicates that children between two and 18 years are protected in the same way as adults.