In a setback to Bharat Biotech’s COVID-19 vaccine Covaxin, the US Meals and Drug Administration has “recommended” Ocugen Inc, the US associate of the Indian vaccine maker, to go for Biologics Licence Software (BLA) route with extra information, nixing hopes of Emergency Use Authorisation.
Ocugen in a press release on Thursday introduced that as really helpful by the US FDA, it is going to pursue submission of a biologics licence software (BLA) for Covaxin.
Biologics Licence Software or BLA, is a “full approval” mechanism by the FDA for medicine and vaccines.
“The company will no longer pursue an Emergency Use Authorisation (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 stated.
The event might delay the Covaxin launch within the US, Ocugen stated.
Ocugen is in discussions with the FDA to grasp the extra info required to assist a BLA submission.
The corporate anticipates that information from an extra medical trial can be required to assist the submission.
“Although we were close to finalising our Emergency Use Authorisation 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, Chief Government Officer 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,” he added.
Ocugen just lately introduced that it secured unique rights to commercialise Covaxin in Canada and has initiated discussions with Well being Canada for regulatory approval.
The corporate will pursue expedited authorisation for the vaccine beneath the Interim Order Respecting the Importation, Sale and Promoting of Medicine for Use in Relation to COVID-19 in Canada.
In a press release issued by Bharat Biotech, the corporate stated that “The USFDA had earlier communicated that no new Emergency Use Authorisation 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 additional acknowledged that “Covaxin has received EUA’s 14 countries with more than 50 countries in process,” including that “No vaccine manufactured or developed from India has ever received Emergency Use Authorisation or full licensure from USFDA. When approved, it will be a great leap forward for vaccines Innovation and manufacturing from India.”