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 […]
Vaccines
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 […]
Antibody Response to Omicron…
and Other Virus Variants Effectively Replenished after 3rd and 4th COVID-19 Vaccination 12 / 2022 Two vaccinations with Comirnaty do not lead to adequate antibody […]
Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of an Additional Booster Dose of their COVID-19 Vaccine for Older Adults
Submission based on real-world safety and efficacy data from Israel Data showed rates of confirmed infections were 2 times lower and rates of severe illness […]
BioNTech – Statement on Humanitarian Aid in Ukraine
Ugur Sahin, CEO and Co-Founder of BioNTech: “We at BioNTech are closely following the tragic situation in Ukraine and our thoughts are with everyone affected. […]
WHO Director-General’s opening remarks at announcement “spokes” of mRNA technology transfer hub
Your Excellency President Macron,Excellency President Macky Sall,Excellency President Abdel Fattah Al-Sisi,Excellency President Kenyatta,Excellency President Buhari,Excellency President Saied,Excellency President Michel,Excellency President von der Leyen,Excellencies, dear colleagues, […]
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 […]
COVAX delivers its 1 billionth COVID-19 vaccine dose – with video
On 15 January 2021, a shipment of 1.1 million COVID-19 vaccines to Rwanda included the billionth dose supplied via COVAX. Together with our partners, COVAX […]
WHO Interim statement on COVID-19 vaccines
Interim Statement on COVID-19 vaccines in the context of the circulation of the Omicron SARS-CoV-2 Variant from the WHO Technical Advisory Group on COVID-19 Vaccine […]
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 […]
Definitive Agreement to Acquire Exelead will Strengthen Merck’s CDMO Offering for mRNA
Merck has signed a definitive agreement to acquire Exelead, a biopharmaceutical contract development and manufacturing organization (CDMO), for approximately USD 780 million in cash. Targeted […]
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 […]