Ocugen announced that upon recommendation from the FDA, it will pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate, Covaxin. The company will no longer pursue an Emergency Use Authorization (EUA) for Covaxin.
The FDA provided feedback to Ocugen regarding the Master File the company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data. Ocugen is in discussions with the FDA to understand the additional information required to support a BLA submission. The company anticipates that data from an additional clinical trial will be required to support the submission.
“Although we were close to finalizing 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. 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,” said Shankar Musunuri, PhD, MBA, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen, said in a company news release.
Ocugen recently announced that it secured exclusive rights to commercialize Covaxin in Canada and has initiated discussions with Health Canada for regulatory approval. The company will pursue expedited authorization for Covaxin under the “Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19” in Canada.
“In clinical trials to date, the emerging safety profile of Covaxin is supportive of it being generally well tolerated with a good safety profile, with Ministry of Health and Family Welfare of Republic of India reporting no potential thromboembolic events following the administration of over 6.7 million doses of Covaxin in that country,” said Dr. Bruce Forrest, Acting Chief Medical Officer and member of the vaccine scientific advisory board of Ocugen.