BioNTech SE: BioNTech Announces First Quarter 2021 Financial Results and Corporate Update
More than 450 million doses of BNT162b2 supplied to 91 countries or territories worldwide as of May 6, 2021
Signed agreements for over 1.8 billion doses of BNT162b2 in 2021 and first contracts signed for periods 2022 and beyond
Announced planned expansion of global footprint to Asia with establishment of first regional headquarters for south east Asia in Singapore, including a fully-integrated and state-of-the art mRNA manufacturing facility
In oncology, a first-in-human Phase 1 trial started for the neoantigen-targeting T cell therapy, BNT221. The development of BioNTech s oncology pipeline has continued to accelerate with 14 product candidates now in 15 ongoing trials
(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.
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.
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
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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine
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.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “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.”