HYDERABAD: Bharat Biotech’s US partner Ocugen has dropped its plans of applying for an emergency use authorisation (EUA) for indigenously developed Covaxin and will be pursuing the biologics license application (BLA) route based on the recommendation of the US drug regulator. The process is slated to stretch the timelines for launch of the vaccine in the US market.
However, for the Canadian market, Ocugen will be seeking authorization under Interim Order for use of Covaxin, it said in a regulatory filing to the Securities & Exchange Commission (SEC).
“…upon recommendation from the US Food and Drug Administration (FDA), the company will pursue submission of a BLA for its Covid-19 vaccine candidate, Covaxin. The company will no longer pursue an EUA for Covaxin,” Ocugen said in the filing.
Ocugen said the FDA provided feedback 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,” it said. “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,” Dr Shankar Musunuri, chairman of the Board, CEO, and co-founder of Ocugen said in a 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 US population in the long term,” Dr Musunuri added.
Explaining the reasons for the move, Bharat Biotech said that “with a good herd immunity and significant percentage of the population vaccinated, the pandemic is reducing in the United States. On the sidelines of this, the USFDA had earlier communicated that no new EUA would be approved for new Covid-19 vaccines”.
“Our US partner, Ocugen has received a recommendation from the FDA to pursue 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 said.
According to Bharat Biotech, no vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA so when the vaccine is approved it will be a great leap forward for Indian vaccine innovation and manufacturing.
Watch US FDA rejects emergency use authorisation for Covaxin


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