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BioNTech SE (// BY-on-tek; short for Biopharmaceutical New Technologies) is a German biotechnology company based in Mainz that develops and manufactures active immunotherapies for patient-specific approaches to the treatment of diseases. It develops pharmaceutical candidates based on messenger ribonucleic acid (mRNA) for use as individualized cancer immunotherapies, as vaccines against infectious diseases and as protein replacement therapies for rare diseases, and also engineered cell therapy, novel antibodies and small molecule immunomodulators as treatment options for cancer.
The company has developed an mRNA-based human therapeutic for intravenous administration to bring individualized mRNA-based cancer immunotherapy to clinical trials and to establish its own manufacturing process.
In 2020 BioNTech developed, in conjunction with Pfizer, the RNA vaccine BNT162b2 for preventing COVID-19 infections, which offers a 95% efficacy. On 2 December 2020, temporary HMR authorization was granted by the United Kingdom government for BNT162b2 vaccinations within the UK. It was the first mRNA vaccine ever authorized. Some days later the vaccine got also an emergency approval in the United States, Canada, and Switzerland. On 21 December 2020, the European Commission approved BioNTech/Pfizer’s coronavirus vaccine in accordance with the positive recommendation of the European Medicines Agency (EMA).