US-based Ocugen Inc, a clinical-stage biopharmaceutical company, has the licence for Covaxin from Bharat Biotech for the US and Canada.
Ocugen Inc on Friday said the US Food and Drug Administration (USFDA) has declined to grant EUA to Covaxin for use in the 2-18 age group in the country.
US-based Ocugen Inc, a clinical-stage biopharmaceutical company, has the licence for Covaxin from Bharat Biotech for the US and Canada.
Ocugen said it intends to continue working with the USFDA to evaluate the regulatory pathway for the paediatric use of Covaxin.
Ocugen and Bharat Biotech were co-developing Bharat Biotech’s Covaxin for use in the US and Canadian markets. The company had applied for emergency use authorisation (EUA) in November 2021 from the USFDA for paediatric use of Covaxin.
Bharat Biotech’s Covaxin has got an EUA from the World Health Organization (WHO) and has been authorised under emergency use in 20 countries.
India has administered 29.18 crore doses of Covaxin and this includes 8.53 crore doses given to 15-17 year olds.