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Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®


Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®
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®, bringing total doses to 600 million for 27 EU member states
All doses expected to be delivered in 2021 
BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY
®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021. This announcement is a result of the European Commission’s (EC) decision to exercise its option to purchase an additional 100 million doses under its expanded Advanced Purchase Agreement signed on
1. This brings the total number of doses to be delivered to the EU to 600 million. ....

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Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis


Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis
Pfizer Inc. today announced that the U.S. Food and Drug Administration has extended the priority review period for the New Drug Application for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act goal date has been extended three months to early Q3 2021. The FDA has also extended the review period for the Supplemental New Drug …
Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has extended the priority review period for the New Drug Application (NDA) for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) goal date has been extended three months to early Q3 2021. ....

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Pfizer Inc.: Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study


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Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates BNT162b2 is highly effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to six months after the second dose
Vaccine was 100% effective in preventing severe disease as defined by the U.S. Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration
Vaccine was 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage is prevalent
Vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose ....

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