Pfizer and BioNTech Receive CHMP Positive Opinion for COVID-19 Vaccine Booster in the European Union
October 04, 2021 12:10 ET
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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)...
Pfizer und BioNTech geben positive Ergebnisse aus Zulassungsstudie für COVID-19-Impfstoff bei Kindern im Alter von 5 bis 11 Jahren bekannt
September 20, 2021 06:45 ET
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BioNTech SE
Die Ergebnisse sind die ersten Daten aus einer Zulassungsstudie für einen COVID-19-Impfstoff bei Kindern unter 12 JahrenDer Impfstoff zeigte bei Studienteilnehmern im Alter von 5 bis 11 Jahren ein...
Pfizer and BioNTech Announce Positive Topline Results from Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years
September 20, 2021 06:45 ET
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BioNTech SE
Results are the first from a pivotal trial of any COVID-19 vaccine in children under 12 years of ageIn participants 5 to 11 years of age, the vaccine was safe, well tolerated and showed robust...
FDA-Beratungsausschuss unterstützt einstimmig Notfallzulassung für COMIRNATY®-Auffrischungsimpfung bei Personen ab 65 Jahren und bestimmten Risikogruppen
September 18, 2021 03:40 ET
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BioNTech SE
Der FDA-Beratungsausschuss prüfte klinische Daten zu einer Auffrischungsimpfung mit COMIRNATY®, die hohe neutralisierende Antikörpertiter gegen SARS-CoV-2 und alle bisher untersuchten Varianten...
FDA Advisory Committee Votes Unanimously in Favor of COMIRNATY® Booster for Emergency Use in People 65 and Older and Certain High-Risk Populations
September 18, 2021 03:40 ET
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BioNTech SE
Committee reviewed clinical data showing a booster dose of COMIRNATY® elicits high neutralization titers against SARS-CoV-2 and all currently tested variants Reactogenicity profile within seven days...
Association of American Physicians and Surgeons (AAPS) Asks Pima County Supervisors to Reject COVID-19 Vaccine Mandate
September 03, 2021 17:59 ET
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Association of American Physicians and Surgeons
TUCSON, Ariz., Sept. 03, 2021 (GLOBE NEWSWIRE) -- On Sept 7, the Pima County Board of Supervisors will consider a proposal to mandate that all healthcare workers in Pima County licensed by the State...
Association of American Physicians and Surgeons (AAPS) Asks Employers to Rescind COVID-19 Vaccine Mandates
August 31, 2021 17:48 ET
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Association of American Physicians and Surgeons
TUCSON, Ariz., Aug. 31, 2021 (GLOBE NEWSWIRE) -- As employers continue to impose COVID-19 vaccine mandates, with the support of more than 50 healthcare-related organizations, the Association of...
Pfizer und BioNTech leiten den Einreichungsprozess einer ergänzenden Biologics License Application bei der FDA für die Zulassung einer Auffrischungsimpfung mit COMIRNATY ® bei Personen ab 16 Jahren ein
August 25, 2021 12:10 ET
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BioNTech SE
Neue Daten der Phase-3-Studie zeigen, dass eine Auffrischungsimpfung (dritte Dosis) mit dem COVID-19-Impfstoff von Pfizer und BioNTech signifikante neutralisierende Antikörpertiter gegen SARS-CoV-2...
Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of COMIRNATY® in Individuals 16 and Older
August 25, 2021 12:10 ET
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BioNTech SE
New Phase 3 data show booster (third) dose of COMIRNATY induces significant SARS-CoV-2 neutralizing antibody titers and demonstrated a favorable safety and tolerability profileSARS-CoV-2 neutralizing...
Association of American Physicians and Surgeons (AAPS) Releases Statement on FDA ‘Approval Letter’ for COVID-19 Vaccine
August 25, 2021 10:42 ET
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Association of American Physicians and Surgeons
TUCSON, Ariz., Aug. 25, 2021 (GLOBE NEWSWIRE) -- The expected FDA “approval letter” for the Pfizer COVID-19 vaccine was issued on Aug 23, and the Biden Administration immediately called on companies...