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Ocugen to take BLA route for Covaxin in US based on FDA advice; seek emergency use nod for Canada | India News – Times of India


HYDERABAD: Bharat Biotech’s US associate Ocugen has dropped its plans of making use of for an emergency use authorisation (EUA) for indigenously developed Covaxin and will likely be pursuing the biologics license utility (BLA) route based on the advice of the US drug regulator.
However, for the Canadian market Ocugen will likely be in search of authorization beneath Interim Order for use of Covaxin, it stated in a regulatory submitting to the Securities & Exchange Commission (SEC).
“…upon recommendation from the US 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,” it stated in the submitting.
Ocugen stated the FDA offered suggestions concerning the grasp file the corporate had beforehand submitted and beneficial that Ocugen pursue a BLA submission as an alternative of an EUA utility for its vaccine candidate and requested extra info and information.
“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 stated. “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 stated.
“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.
Meanwhile, Bharat Biotech stated that with herd immunity and vital share of the inhabitants vaccinated, the pandemic is lowering in the United States.
“The USFDA had earlier communicated that no new EUA’s will be approved for Covid vaccines. All applications have to follow the biological license application process, with is the standard process for vaccines,” Bharat Biotech stated.
“Data from an additional clinical trial will be required to support the marketing application submission for Covaxin, which has received EUA’s from 14 countries with more than 50 countries in process,” it added.
According to Bharat Biotech, no vaccine manufactured or developed from India has ever acquired EUA or full licensure from USFDA so when the vaccine is authorized it will likely be a fantastic leap ahead for vaccines innovation and manufacturing from India.



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