Ocugen Inc., Bharat Biotech's partner for USA and Canada for COVID-19 vaccine Covaxin on Friday said it has submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the jab for paediatric use.
Covaxin (BBV152) is a whole-virion, inactivated vaccine, manufactured using a Vero Cell manufacturing platform, as has been used in the production of the inactivated polio vaccine for the past 35 years, as well as of other traditional childhood vaccines.
The submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India.