Pfizer and BioNTech
Pfizer and BioNTech Announce Updated COVID-19 Vaccine Data Supporting Efficacy in Children 6 Months through 4 Years of Age
August 23, 2022 06:45 ET | BioNTech SE
Updated analysis from 34 cases occurring at least seven days following a three-dose regimen showed 73.2% vaccine efficacy among children ages 6 months through 4 yearsThe vaccine efficacy remained...
Pfizer und BioNTech
Pfizer und BioNTech reichen Antrag für Notfallzulassung eines angepassten bivalenten COVID-19-Impfstoffs für Omikron-Varianten BA.4/BA.5 bei der FDA ein
August 22, 2022 10:30 ET | BioNTech SE
Die Daten stützen Antrag auf Notfallzulassung einer 30-µg-Auffrischungsdosis eines an Omikron BA.4/BA.5 angepassten bivalenten COVID-19-Impfstoffs für Personen ab 12 JahrenDie Unternehmen haben die...
Pfizer and BioNTech
Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine
August 22, 2022 10:30 ET | BioNTech SE
Data support request for Emergency Use Authorization of a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and olderCompanies have rapidly...
Pfizer-BioNTech COVI
Pfizer-BioNTech COVID-19-Impfstoff zeigt bei Kindern im Alter von 6 Monaten bis unter 5 Jahren nach drei Dosen starke Immunantworten, hohe Wirksamkeit und vorteilhaftes Sicherheitsprofil
May 23, 2022 06:45 ET | BioNTech SE
Basierend auf den ersten Studiendaten erfüllen drei Dosen des Pfizer-BioNTech COVID-19-Impfstoffs alle für die US-Notfallzulassung notwendigen Immunobridging-Kriterien (Vergleich der...
Pfizer-BioNTech COVI
Pfizer-BioNTech COVID-19 Vaccine Demonstrates Strong Immune Response, High Efficacy and Favorable Safety in Children 6 Months to Under 5 Years of Age Following Third Dose
May 23, 2022 06:45 ET | BioNTech SE
Based on topline data, three doses of the Pfizer-BioNTech COVID-19 Vaccine met all immunobridging criteria required for Emergency Use AuthorizationThe third 3-µg dose was well-tolerated among 1,678...
Pfizer and BioNTech
Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of an Additional Booster Dose of their COVID-19 Vaccine for Older Adults
March 15, 2022 18:00 ET | BioNTech SE
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 were 4 times lower among individuals who...
Pfizer und BioNTech
Pfizer und BioNTech erhalten positive CHMP-Empfehlung für COMIRNATY® bei Kindern von 5 bis unter 12 Jahren in der Europäischen Union
November 25, 2021 07:30 ET | BioNTech SE
NEW YORK, USA und MAINZ, Deutschland, 25. November 2021—Pfizer Inc. (NYSE: PFE, „Pfizer“) und BioNTech SE (Nasdaq: BNTX, „BioNTech“) gaben heute bekannt, dass der Ausschuss für Humanarzneimittel...
Pfizer and BioNTech
Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 5 to under 12 Years of Age in the European Union
November 25, 2021 07:30 ET | BioNTech SE
NEW YORK and MAINZ, Germany, November 25, 2021—Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use...
FDA Recommends COVID Vaccine for Children; Association of American Physicians and Surgeons (AAPS) Urges Caution
October 28, 2021 18:01 ET | Association of American Physicians and Surgeons
TUCSON, Ariz., Oct. 28, 2021 (GLOBE NEWSWIRE) -- A committee of experts advising the Food and Drug Administration met on Oct 26 and voted 17 to 0, with one abstention, to recommend authorizing the...
Pfizer and BioNTech
Pfizer and BioNTech Receive CHMP Positive Opinion for COVID-19 Vaccine Booster in the European Union
October 04, 2021 12:10 ET | BioNTech SE
NEW YORK and MAINZ, Germany, October 4, 2021—Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP)...