INDIA – Soon after Ocugen hit a major bump after FDA rejected emergency use authorisation (EUA) for Covaxin, Hyderabad-based Bharat Biotech has said that the USFDA had earlier communicated that no new Emergency Use Authorization (EUA) will be approved for Covid vaccines.
The Pennsylvania-based eye disease company has had to change its application from an Emergency Use Authorization to a full Biologics License Applications (BLA) approval. Bharat Biotech said biological license application process is the standard process for vaccines
This is setback that will potentially delay the launch of Bharat Biotech’s COVID-19 vaccine Covaxin in USA. So far, Covaxin has received EUA’s from 14 countries with more than 50 countries in process.
The company has said that an additional clinical trial will be required to support the marketing application submission for 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 said.
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.
Reacting to the FDA”s regulation, the pharmaceutical manufacturer added that no vaccine manufactured or developed in India has ever received Emergency Use Authorization or full licensure form the USFDA, therefore, when approved, it will be a “great leap forward” for vaccines innovation and manufacturing from India.
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 the vaccine under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in Canada.
Ocugen has appointed Michael Shine as Senior Vice President, Commercial. Michael Shine is a pharmaceutical and biotechnology executive with nearly 35 years of industry experience.
Over the course of his career, Mr. Shine has held leadership positions within large pharmaceutical companies, including Novapharm Therapeutics, Colgate Oral Pharmaceutical, and Pfizer Vaccines (formerly Wyeth). He also served as Chief Marketing Officer with Thomas Reuters and spent more than eight years in the start-up pharmaceutical space.
“We are thrilled to welcome Mike to the Ocugen team as we take steps towards readiness for potential commercialization of COVAXIN in the US and Canada. As an established marketing and sales biopharma leader, Mike’s experience and commercial expertise will be instrumental to our market launches for Ocugen’s vaccine and ophthalmologic product pipelines, in each case if approved,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.