New Delhi: Ocugen Inc., Bharat Biotech’s partner for USA and Canada, has sought approval from the US Food and Drug Administration (FDA) for emergency use authorisation of Covaxin for paediatric use.
The submission is based on results of a Phase 2/3 paediatric 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, Ocugen said in a regulatory filing, reported PTI.
“Filing for emergency use authorisation in the US for paediatric use is a significant step toward our hope to make our vaccine candidate available here and help combat the COVID-19 pandemic,” Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen said.
On November 3, the World Health Organisation gave emergency use licence to Covaxin. Travellers fully vaccinated with Covaxin can now enter the US from November 8, joining travellers fully vaccinated with other shots like Pfizer-BioNTech, Johnson & Johnson, Moderna, Oxford-AstraZeneca, Covishield, Sinopharm and Sinovac.
