Hyderabad: Ocugen, which has commercialisation rights for Covaxin (developed by Bharat Biotech) in the US, upon recommendation from the US Food and Drug Administration (FDA), said it will pursue submission of a biologics license application (BLA) for the Covid-19 vaccine.
The company said it will no longer pursue an Emergency Use Authorization (EUA) for Covaxin. The FDA provided feedback to Ocugen regarding the Master File Ocugen had previously submitted and recommended that the company 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 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. 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, CEO and co-founder of Ocugen.
“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.
Bharat Biotech in its statement clarified, “With good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the United States (US). On the sidelines of this, the USFDA had earlier communicated that no new emergency use authorization (EUA) would be approved for new Covid-19 vaccines.”
“Our US partner, Ocugen, has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for Covaxin, which is full approval. All applications have to follow the BLA process, which is the standard process for vaccines. Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for Covaxin. This process will extend our timelines,” Bharat Biotech added.
Covaxin received EUAs from 14 countries, with over 50 countries in the process. “No vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA. Thus, it will be a great leap forward for vaccine innovation and manufacturing from India when (BLA is) approved,” the Hyderabad vaccine maker said.
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