Biopharmaceutical company, Ocugen, has announced that recommendation from the U.S. Food and Drug Administration (FDA), the company 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.
COVAXIN, India's COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a Vero cell manufacturing platform.
“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 Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.
Ocugen stated that the FDA provided feedback to the company regarding the Master File it had previously submitted and recommended that Ocugen pursue a BLA submission instead of a 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.
“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.
Recently, Ocugen announced that it secured exclusive rights to commercialize COVAXIN in Canada.
Thus, the company 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.
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