The companies announce plans to submit a Biologics License Agreement for the mRNA-based vaccine.
The first COVID-19 vaccine to receive an Emergency Use Authorization (EUA) might be the first to garner full US Food and Drug Administration (FDA) approval in the US.
Pfizer-BioNTech announced on May 7 they are initiating the submission process for a Biologics License Application (BLA) for their COVID-19 vaccine.
"We are proud of the tremendous progress we've made since December in delivering vaccines to millions of Americans, in collaboration with the US government," Chairman and CEO of Pfizer Albert Bourla, said in a statement. "We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months."
While the vaccine has been available for 6 months due to the EUA, this move to apply for the BLA solidifies the standing of the vaccine and would be the official government approval of the vaccine.
According to the FDA, a “BLA is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA.”
In order to complete the process, companies need to have applicant information, product/manufacturing information, pre-clinical studies, clinical studies, and labeling.
The timetable for the approval is open-ended but is expected to take months to complete as regulators will analyze data and other aspects of the application.