“Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US,” Dr.
Shankar Musunuri, Chairman of the Board, Chief Executive Officer and co-founder of Ocugen said.
“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 US population in the long term,” he added.
Ocugen recently announced that it secured exclusive rights to commercialise Covaxin in Canada and has initiated discussions with Health Canada for regulatory approval.
The company will pursue expedited authorisation for the vaccine under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in Canada.