Ocugen, Inc the US-partner of Bharat Biotech International Ltd, has applied to the US Food and Drug Administration (USFDA) for Emergency Use Authorisation (EUA) of Covaxin for paediatric use. Ocugen had earlier filed for approval for Covaxin for use in adults as well.
The submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children at 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.
A Phase 2/3, open-label, multicenter study was conducted in India from May 2021 to July 2021, to evaluate the safety, reactogenicity and immunogenicity, of the whole-virion inactivated SARS-CoV-2 Vaccine (Covaxin) in healthy volunteers 2-18 years of age.
“Filing for EUA in the US for pediatric use is a significant step towards our hope to make our vaccine candidate available here and help combat the Covid-19 pandemic,” Shankar Musunuri, Chairman of the Board, CEO, and Co-Founder, Ocugen said in statement on Friday.