Hyderabad-based pharma major Bharat Biotech’s US partner Ocugen has sought the Emergency Use Authorisation (EUA) from the US FDA for Covaxin to be administered in children aged two to 18 years. Ocugen said that it has submitted a request in this regard. 

“The submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children two-18 years of age, which bridged immunogenicity data, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India,” it said in a statement. Covaxin uses the same Vero Cell manufacturing platform as other childhood vaccines, including the inactivated polio vaccine.