India's COVID-19 Vaccine to Submit Biologics License Application in the USA
Pennsylvania-based Ocugen, Inc. announced on June 10, 2021, that following a recommendation from the U.S. Food and Drug Administration (FDA), it will pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate, COVAXIN™.
Therefore, the Company will no longer pursue an Emergency Use Authorization (EUA) for the Covaxin vaccine developed by India-based Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology.
Covaxin is currently being administered under emergency use authorizations in 13 countries, and applications for emergency use authorization are pending in more than 60 additional countries.
Additionally, the FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and requested additional information and data. The Company anticipates that data from an additional clinical trial will be required to support the BLA submission.
“While this (recommendation) will extend our timelines, we are committed to bringing Covxin to the USA," said Dr. Shankar Musunuri, Chairman of the Board, CEO, and Co-founder of Ocugen, in a press statement.
"This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect the USA population in the long term."
Ocugen recently announced that it secured exclusive rights to commercialize Covaxin in Canada and has initiated discussions with Health Canada for regulatory approval.
Malvern, PA-based Ocugen, Inc. (NASDAQ: OCGN) is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19.