PFIZER AND BIONTECH INITIATE ROLLING SUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR U.S. FDA APPROVAL OF THEIR COVID 19 VACCINEhttps://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-biologicsNEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency.
The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process.
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Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.
Pfizer and BioNTech also have submitted an application to expand the current EUA for their COVID-19 vaccine to include individuals 12 to 15 years of age. The companies intend to submit a supplemental BLA to support licensure of the vaccine in this age group once the required data six months after the second vaccine dose are available.
There are two pieces of news in this.
First, in plain English, BioNTech and Pfizer have initiated the process that if successful will result in full approval of their vaccine.
Second, BioNTech and Pfizer have also applied for an EUA allowing use of their vaccine with youths ages 12-15, and plan 6 months later to initiate the process of including those youths in their BLA.
Speaking speculatively, it seems likely that Moderna will also soon start the BLA process. I hope
LIEden's crew aren't stupid enough to try to arm-twist Pfizer and Moderna over their patents:
"Nice vaccine you got there, it'd be a shame if you defended your patent and something happened to your BLAs."