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Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine COMIRNATY ® (also known as BNT162b2) receives conditional marketing authorization from the European Commission; this milestone represents a global joint effort to advance the first authorized mRNA vaccine Pfizer and BioNTech are ready to immediately ship initial doses to the 27 EU member states Pfizer and BioNTech previously announced an agreement with the European Commission to supply 200 million vaccine doses to EU member states; the EU also has an option to purchase an additional 100 million doses in 20...

Pfizer and BioNTech Receive CHMP Positive Opinion for their COVID-19 Vaccine European Commission decision on conditional marketing authorization expected imminently Positive CHMP opinion follows several emergency use authorizations worldwide; committee reviewed totality of scientific evidence, including Phase 3 efficacy and safety data If authorized, BNT162b2 will be the first COVID-19 vaccine available in the European Union Pfizer Inc. and BioNTech SE announced today that the Committee for … European Commission decision on conditional marketing authorization expected imminently Positive...

(2) Analysis of 37 participants immunized with BNT162b2 showed a broad immune response with SARS-CoV-2-specific neutralizing antibodies, T H1 type CD4+ T cells, and strong expansion of CD8+ T cells of the early effector memory phenotype All vaccinated participants demonstrated neutralizing antibody as well as T cell responses. T cell responses were directed against multiple regions of the spike protein, including the RBD, suggesting immune recognition of multiple independent epitopes Data confirm previous findings from the U.S. trial demonstrating a good safety profile and robust induction o...