(1) 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.
Pfizer, BioNTech seek full FDA approval of COVID vaccine
Updated 8:10 AM;
Pfizer and BioNTech now seek full approval from the U.S. Food and Drug Administration for their coronavirus vaccine, the companies announced Friday.
The companies’ mRNA vaccine is currently available in the United States through the emergency use authorization the FDA granted them on Dec. 11, 2020. Since then, more than 170 million doses of the Pfizer-BioNTech vaccine have been delivered across the U.S., according to a statement from the companies.
The process to get full approval from the FDA starts with the initiation of a biologics license application with the federal government. Data to support the BLA will be submitted by Pfizer and BioNTech on a rolling basis over the coming weeks, with a request for priority review, the statement said.
The Pfizer-BioNTech COVID-19 vaccine may not protect all vaccine recipients.
In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%).
Severe allergic reactions, including anaphylaxis, have been reported following the Pfizer-BioNTech COVID-19 vaccine during mass vaccination outside of clinical trials.
Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 vaccine.
Available data on Pfizer-BioNTech COVID-19 vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
Kadmon Provides Business Update and Reports First Quarter 2021 Financial Results
ACCESSWIRE
07 May 2021, 06:19 GMT+10
NEW YORK, NY / ACCESSWIRE / May 6, 2021 / Kadmon Holdings, Inc. (NASDAQ:KDMN) today provided a business update and reported financial and operational results for the first quarter of 2021. We continue to ramp up commercial launch preparation activities for belumosudil in anticipation of the PDUFA goal date of August 30, 2021. Labeling discussions with the FDA are progressing and we believe that belumosudil, if approved, will serve a critical, unmet need for patients with cGVHD, said Harlan W. Waksal, M.D., President and CEO of Kadmon. In addition, we are exploring the therapeutic potential of belumosudil in systemic sclerosis, a disease with similar manifestations to cGVHD. We continue to enroll patients in two separate Phase 2 studies in this indication and expect to present initial data from the open-label study by year-end 2021. In parallel, we are advancing
BioNTech SE: Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of their COVID-19 Vaccine
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Pfizer Disclosure Notice
The information contained in this release is as of May 7, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, a rolling submission of a Biologics License Application (BLA) with the FDA for BNT162b2, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distributio