USFDA Rejects Pediatric Use of India- made Covaxin During Emergency

Mar 06, 2022, 15:15 IST

USFDA Rejects Pediatric Use of India- made Covaxin During Emergency | Ocugen Inc, a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, announced that the U.S. Food and Drug Administration (USFDA), has declined to issue an emergency use authorization (EUA) for Covaxin, the COVID-19 vaccine developed by its Indian partner Bharat Biotech, for use among children and teenagers aged 2 to 18 years in the country.

Ocugen had entered into a deal with Hyderabad-based vaccine maker Bharat Biotech in 2020, under which it would develop, supply, and commercialize Covaxin for the U.S. market.

Covaxin, is one of the two most widely used COVID-19 vaccines apart from AstraZeneca manufactured CoviShield in India and also has an emergency use listing from the World Health Organization. Under the partnership terms, Ocugen said it would have U.S. rights to the vaccine candidate and be responsible for clinical development, registration, and commercialization for the U.S. market.

Ocugen said that they would follow up with the USFDA to evaluate the regulatory process for getting a EUA for the pediatric use of Covaxin, in a press release issued on March 4.

#UPDATE: The U.S. Food and Drug Administration (@US_FDA), at this time, has declined to issue an EUA for our #COVID19 #vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 2 to 18 years of age. For more: https://t.co/PsuvNsY0WH pic.twitter.com/XCtCuW9wuc

— Ocugen (@Ocugen) March 4, 2022