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Investegate |BioNTech SE Announcements | BioNTech SE: Pfizer and BioNTech to Supply the European Union with up to 1.8 Billion Additional Doses of COMIRNATY®

BioNTech SE
Pfizer and BioNTech to Supply the European Union with up to 1.8 Billion Additional Doses of COMIRNATY®
Pfizer and BioNTech to Supply the European Union with up to 1.8 Billion Additional Doses of COMIRNATY®
New agreement to supply 900 million doses to the European Commission (EC), with option to request up to an additional 900 million doses
Additional dose deliveries beginning December 2021 through 2023
Pfizer and BioNTech have now committed a total of up to 2.4 billion doses of COMIRNATY® to the EC since the beginning of the pandemic
NEW YORK AND MAINZ, GERMANY, May 20, 2021 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a new agreement with the European Commission (EC) to supply 900 million doses of COMIRNATY ....

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BioNTech SE: Pfizer and BioNTech Submit Request to Expand Conditional Marketing Authorization of COMIRNATY in the EU to Adolescents

BioNTech SE: Pfizer and BioNTech Submit Request to Expand Conditional Marketing Authorization of COMIRNATY in the EU to Adolescents
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(Nasdaq: BNTX) today announced they have submitted a variation to the Conditional Marketing Authorization (CMA) in the European Union (EU) to the European Medicines Agency (EMA) for the Pfizer-BioNTech vaccine COMIRNATY
(BNT162b2) to request an extension of the indication for use in adolescents 12 to 15 years of age. If EMA approves the variation, the amended CMA will be valid in all 27 member states of the EU. The companies have already submitted a similar request to the U.S. Food and Drug Administration (FDA) for the Emergency Use Authorization (EUA) and plan to request additional amendments with other regulatory authorities worldwide. ....

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Hasselback-Kartoffeln aus dem Ofen: Mit diesem leckeren Rezept gelingt's!

Hasselback-Kartoffeln aus dem Ofen: Mit diesem leckeren Rezept gelingt's!
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Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine

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Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine
NEW BRUNSWICK, N.J., April 21, 2021 – Johnson & Johnson (the Company) today announced publication in the New England Journal of Medicine of primary data from the Phase 3 ENSEMBLE clinical trial for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The publication of the primary analysis follows the topline efficacy and safety data announced in January, showing the trial met all primary and key secondary endpoints, and found that the Johnson & Johnson single-dose COVID-19 vaccine prevented hospitalization and death across all study participants 28 days after vaccination. ....

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Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) Review | More News

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EMA Confirms Overall Benefit-Risk Profile Remains Positive
Company to update the COVID-19 Vaccine Janssen Summary of Product Characteristics and Package Leaflet to include important information on very rare adverse event
Johnson & Johnson remains committed to supplying 200 million doses of its COVID-19 vaccine to the European Union, Norway and Iceland
NEW BRUNSWICK, NJ, USA I April 20, 2021 I Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the European Medicines Agency s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has provided updated guidance for use of the Company s COVID-19 vaccine and confirmed the overall benefit-risk profile remains positive. The guidance follows PRAC review of a small number of cases of a very rare adverse event involving blood clots in combination with low platelet counts that can occur within approximately one to three weeks following injection with the Company s COVID-19 vaccine. ....

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