Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY®
… For Adolescents 12 through 15 Years of Age COMIRNATY® is the first and only COVID-19 vaccine to be granted FDA approval for adolescents 12 […]
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Pfizer and BioNTech Submit a Variation to EMA
…. for the Vaccination of Children Ages 6 Months to less than 5 Years with COMIRNATY® Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: […]
Statement on Patent Infringement Lawsuit in Germany
BioNTech values and respects valid intellectual property rights. BioNTech’s work is original, and we will vigorously defend it against all allegations of patent infringement. However, […]
Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age
In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety […]
BioNTech introduces first modular mRNA manufacturing facility to promote scalable vaccine production in Africa
Developing turnkey solution to enable mRNA-based vaccine production in modular and scalable sites installed by BioNTech Presidents of Ghana, Rwanda, Senegal, the Director-General of the […]
Pfizer and BioNTech Initiate Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request from U.S. FDA
With pediatric COVID-19 cases surpassing 10 million and at the request of the FDA, the companies have submitted available data on the safety and efficacy […]
BioNTech and InstaDeep Developed and Successfully Tested Early Warning System to Detect Potential High-Risk SARS-CoV-2 Variants
Early Warning System combines Spike protein structural modeling with artificial intelligence (AI) to detect and monitor high-risk SARS-CoV-2 variants, identifying >90% of WHO-designated variants on […]
Pfizer and BioNTech Sign New Global Collaboration Agreement to Develop First mRNA-based Shingles Vaccine
Third mRNA vaccine collaboration between the companies aims to accelerate development of an improved vaccine for shingles, a debilitating, disfiguring and painful disease that affects […]
Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older
First emergency use authorization in the United States for a COVID-19 vaccine booster in adolescents 12 through 15 years of age Today’s FDA action also […]
Pfizer and BioNTech Submit Updated Longer-Term Follow-Up Data of COMIRNATY® in Adolescents 12 Through 15 Years of Age to EMA
In the trial, a two-dose series of COMIRNATY (30-µg per dose) was 100% effective (95% confidence interval [CI, 87.5, 100.0]) against COVID-19, measured seven days […]
Pfizer And BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of COMIRNATY® in Adolescents 12 Through 15 Years of Age
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and […]
Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older
PDF Version First emergency use authorization in the United States for a COVID-19 vaccine booster in individuals 16 years and older Pfizer Inc. (NYSE: PFE) […]
Pfizer and BioNTech Provide Update on Omicron Variant
Preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech COVID-19 Vaccine neutralize the Omicron variant (B.1.1.529 lineage), while two doses show significantly reduced neutralization […]
Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 5 to under 12 Years of Age in the European Union
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the […]
Pfizer and BioNTech Submit Request to Amend U.S. FDA Emergency Use Authorization of Their COVID-19 Vaccine Booster to Include All Individuals 18 and Older
Submission is based on efficacy and safety data from a Phase 3 randomized, controlled trial with more than 10,000 participants Data show a favorable safety […]