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/**
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Grünes Licht für Biontech-Pfizer-Impfstoff › gesundheitsnews.at
Pfizer und BioNTech erhalten EU-Zulassung für COVID-19-Impfstoff. Die Europäische Arzneimittelbehörde (EMA) hat am 21.12.20 den Einsatz des Covid-19-Impfstoffs genehmigt.
Pfizer Inc. (NYSE: PFE) und BioNTech SE (Nasdaq: BNTX) gaben heute bekannt, dass die Europäische Kommission (EK) eine bedingte Marktzulassung für Pfizers und BioNTechs COMIRNATY® (bekannt als BNT162b2) erteilt hat. Diese gilt für die aktive Immunisierung bei Personen ab dem 16. Lebensjahr zum Schutz vor COVID-19, der Krankheit, die durch das SARS-CoV-2-Virus ausgelöst wird.
COMIRNATY® (bekannt als BNT162b2) erhält bedingte Marktzulassung von der Europäischen Kommission; dieser Meilenstein spiegelt die gemeinschaftlichen, globalen Bemühungen wider, einen mRNA-Impfstoff zu entwickeln.
Die Zulassung durch die EK beruht auf der positiven Beurteilung des Committee for Medicinal Products for Human Use (CHMP) der Europäischen Arzneimittel-Agentur (EMA), die heute abgegeben wurde. Die EK hat die bedingte Marktzulassung im Interesse der öffentlichen Gesundheit erteilt, um einen Beitrag zur Bekämpfung der COVID-19-Pandemie zu leisten. Die bedingte Marktzulassung ist in allen 27 EU-Mitgliedsstaaten gültig.
Impfdosen für Europa Pfizer und BioNTech sind bereit, die ersten Dosen unmittelbar an die 27 EU-Mitgliedsstaaten auszuliefern.
Pfizer und BioNTech haben zuvor eine Liefervereinbarung von 200 Millionen Impfstoffdosen an die EU-Mitgliedsstaaten mit der Europäischen Kommission bekanntgegeben; die EU hat außerdem die Option, weitere 100 Millionen Dosen im Jahr 2021 zu erwerben.
Der Impfstoff wird in der EU unter dem Namen COMIRNATY vermarktet. Der Name vereint die Wörter „COVID-19”, „mRNA”, „Community” (engl. für „Gemeinschaft”) und „Immunity” (engl. für „Immunität”). Dies soll die erste Zulassung eines messenger RNA (mRNA)-basierten Impfstoffes überhaupt hervorheben.
Zudem soll er die gemeinschaftlichen globalen Bemühungen unterstreichen, die diese Zulassung zum Wohl der gesamten Weltbevölkerung in einer beispiellosen Stringenz und Effizienz und mit der Impfstoffsicherheit als oberste Priorität während der laufenden Pandemie ermöglicht haben.
COMIRNATY ist der erste COVID-19-Impfstoff, der eine bedingte Marktzulassung in der EU erhält. Die Aufteilung von COMIRNATY in den EU-Mitgliedsstaaten wird sich anhand der in den europäischen und nationalen Verordnungen festgelegten Personengruppen orientieren.
„Die heutige bedingte Marktzulassung durch die Europäische Kommission ist eine historische Errungenschaft.
Es ist der erste Impfstoff, der in nicht einmal einem Jahr in einer groß angelegten Studie in mehr als 44.000 Probanden getestet und zugelassen wurde. Diese große Leistung basiert auf der jahrzehntelangen Arbeit vieler Wissenschaftler weltweit und ist außerdem eine Bestätigung unserer erfolgreichen Zusammenarbeit mit unserem Partner Pfizer“, sagte Ugur Sahin, M.D., CEO und Mitgründer von BioNTech.
„Als Unternehmen, das im Herzen von Europa gegründet wurde und dort seinen Hauptsitz hat, freuen wir uns besonders, in den nächsten Tagen unseren Impfstoff der europäischen Bevölkerung bereitzustellen. Wir werden in den nächsten zwei Jahren weitere Daten zu Wirksamkeit und Sicherheit in unseren Studienteilnehmern erheben und den Impfstoff gegenüber allen neu auftauchenden Mutationen untersuchen.“
„Während die Pandemie weiterhin in vielen Ländern grassiert, arbeiten wir rund um die Uhr daran, den Impfstoff so schnell wie möglich, so effizient wie möglich und so gerecht wie möglich verfügbar zu machen“, sagte Albert Bourla, Chairman und Chief Executive Officer, Pfizer.
„Ich möchte mich besonders bei unserem Partner BioNTech für die Zusammenarbeit bedanken sowie bei der Europäischen Arzneimittel-Agentur und der Europäischen Kommission für die sorgfältige und effiziente Prüfung unseres Antrags. Dies soll dabei helfen, ein Virus zu besiegen, das bisher hunderttausende Leben in Europa gekostet hat. Wir sind dankbar dafür, dass diese Zulassung Menschen in ganz Europa Hoffnung gibt. Wir hoffen, dass wir damit zu Beginn des neuen Jahres einen Wendepunkt in dieser Krise erreichen.“
Intensive Prüfung vor EU-Zulassung Die bedingte Zulassung in der EU basiert auf der Gesamtheit der wissenschaftlichen Ergebnisse, die von den beiden Unternehmen im Rahmen des rollierenden Einreichungsprozesses sowie im Antrag auf bedingte Marktzulassung am 1. Dezember 2020 bereitgestellt wurden. Dazu gehören die Ergebnisse der zulassungsrelevanten klinischen Phase-3-Studie, die im vergangenen Monat bekanntgegeben wurden und vor kurzem in der wissenschaftlichen Fachzeitschrift The New England Journal of Medicine veröffentlicht wurden.
Die Daten der Phase-3-Studie zeigen einen 95 %igen Impfschutz in Probanden ohne vorherige SARS-CoV-2-Infektion (erstes Hauptziel der Studie). Auch in Probanden mit oder ohne vorherige SARS-CoV-2-Infektion konnte ein Impfschutz erreicht werden (zweites Hauptziel der Studie). In beiden Fällen wurde der Impfschutz sieben Tage nach der zweiten Dosis erzielt.
Bislang konnte das Data Monitoring Committee keine schwerwiegenden Nebenwirkungen in Studienteilnehmern feststellen. Die Wirksamkeit der Impfung war über alle Alters- und Geschlechtsgruppen in der gesamten diversen Studienpopulation konsistent. Alle Probanden werden weiterhin beobachtet, um Daten zur Dauer des Impfschutzes und zur Sicherheit für zwei weitere Jahre nach der zweiten Impfung zu erfassen.
Mit der heutigen bedingten Marktzulassung werden Pfizer und BioNTech sofort die ersten Lieferungen in die EU-Mitgliedsstaaten basierend auf dem Verteilungsplan der EK und den Vertragsbedingungen veranlassen. Im November 2020 haben Pfizer und BioNTech eine Vereinbarung mit der EK über die Lieferung von 200 Millionen COVID-19 Impfstoffdosen in den Jahren 2020 und 2021 geschlossen sowie eine Option zum Erwerb von bis zu 100 Millionen zusätzlichen Dosen vereinbart, vorbehaltlich einer Absprache zwischen den Parteien.
Die Lieferungen werden sofort beginnen und schrittweise im Laufe der Jahre 2020 und 2021 erfolgen, um eine gerechte Verteilung der Impfstoffe entsprechend der Vertragsbedingungen in der EU zu gewährleisten. Die Impfstoffdosen für Europa werden in BioNTechs Produktionsstätten in Deutschland sowie in Pfizers Produktionsstätte in Puurs, Belgien hergestellt.
Pfizer und BioNTech bedanken sich für die fortlaufende Teilnahme der über 44.000 Studienteilnehmer. Die Unternehmen stehen zu ihrem Versprechen, die Sicherheit und das Wohlergehen der Probanden stets an oberste Stelle zu setzen.
Die Teilnehmer der COVID-19-Studie sind couragierte Freiwillige. Sie haben eine persönliche und wichtige Entscheidung getroffen, um zum entscheidenden Unterschied in der verheerenden Pandemie beizutragen. Pfizer und BioNTech planen, den Probanden ab 16 Jahren der Placebo-Gruppe die Möglichkeit zu geben, zu einem bestimmten Zeitpunkt der Studie auch den Impfstoff zu erhalten. Der Übergang in die Impfstoffgruppe ist freiwillig und wird in Absprache mit den jeweiligen Behörden umgesetzt.
Über die Phase-2/3-Studie Die laufende Phase-3-Studie zu BNT162b2, welcher auf der unternehmenseigenen mRNA-Technologie von BioNTech basiert, hat bis heute mehr als 44.000 Probanden rekrutiert. Die Mehrheit der Probanden hat bereits die zweite Dosis des Impfstoffs oder des Placebos erhalten. Die genaue Verteilung in den mehr als 150 Studienzentren in den Vereinigten Staaten, Deutschland, der Türkei, Südafrika, Brasilien und Argentinien kann hier eingesehen werden.
In die randomisierte, verblindete Phase-3-Studie wurden Probanden im Verhältnis 1:1 auf Placebo- oder Impfstoffarm aufgeteilt. Die Studie generierte die für die Zulassung relevanten Daten zur Sicherheit, Immunantwort und Wirksamkeit des Impfstoffs. Zu den primären Endpunkten gehören die Prävention von COVID-19 in Teilnehmern, die sich vor der Impfung noch nicht mit SARS-CoV-2 infiziert hatten, sowie die Prävention von COVID-19 unabhängig vom Infektionsstatus der Teilnehmer. Sekundäre Studienendpunkte beinhalten die Prävention schwerer COVID-19-Verläufe in diesen Gruppen. Weiterhin wird die Studie die Prävention einer Infektion mit SARS-CoV-2, dem Virus, das COVID-19 verursacht, untersuchen.
Die Daten der Studie, einschließlich langfristiger Sicherheitsdaten, umfassender Informationen über die Dauer des Impfschutzes, der Wirksamkeit gegen asymptomatische SARS-CoV-2-Infektionen sowie Daten zur Sicherheit und Wirksamkeit in Jugendlichen zwischen 12 und 17 Jahren werden in den kommenden Monaten ermittelt. Zusätzliche Studien, die BNT162b2 in Schwangeren, Kindern unter 12 Jahren sowie in speziellen Risikogruppen, wie beispielweise in immunsupprimierten Probanden, untersuchen, sind bereits in Planung.
Informationen zu Herstellung und Lieferung Pfizer und BioNTech arbeiten weiterhin eng mit den für die Verteilung zuständigen Regierungen und Gesundheitsbehörden weltweit zusammen. So soll gewährleistet werden, dass der Impfstoff im Falle einer Zulassung oder Genehmigung entsprechend der jeweiligen Versorgungsvereinbarungen so schnell wie möglich den Menschen zugutekommt, die ihn am dringendsten benötigen.
Die beiden Unternehmen bringen Pfizers führende Fähigkeiten in den Bereichen Produktion und Lieferung in dieses Unterfangen ein, um zügig die Herstellung zu skalieren und den Vertrieb großer Mengen eines qualitativ hochwertigen Impfstoffs zu ermöglichen. Hierzu trägt insbesondere auch BioNTechs fast zehnjährige Expertise bei der mRNA-Produktion bei. Pfizer blickt zurück auf 171 Jahre Erfahrung in der Erforschung, Entwicklung, Herstellung und Lieferung innovativer Medikamente und Impfstoffe für Menschen, die diese dringend benötigen.
Pfizer und BioNTech sind zuversichtlich, dass sie den Impfstoff an die EU-Bevölkerung ausliefern können. Mit Hilfe des Produktionsnetzwerks von Pfizer und BioNTech haben die beiden Unternehmen das Potenzial, weltweit bis zu 50 Millionen Impfstoffdosen im Jahr 2020 auszuliefern sowie bis zu 1,3 Milliarden Dosen bis Ende des Jahres 2021 herzustellen (abhängig von den Produktionskapazitäten und der Zulassung oder Genehmigung durch die entsprechenden Zulassungsbehörden).
Mittels der beiden existierenden mRNA-Produktionsstätten in Deutschland ist BioNTech in der Lage, den Pfizer-BioNTech COVID-19-Impfstoff für den kommerziellen Gebrauch herzustellen. Die Produktionsstätten von BioNTech kamen bereits bei der Herstellung des Impfstoffkandidaten für die klinischen Studien zum Einsatz.
Des Weiteren wird BioNTech seine Produktionskapazitäten im Jahr 2021 erhöhen, sobald die dritte deutsche Produktionsstätte in Marburg in Betrieb genommen wird und so weitere Kapazitäten für die globale Versorgung geschaffen werden. Außerdem wird Pfizers Produktionsstätte in Puurs, Belgien zur Versorgung in Europa beitragen. Diese ist eine der größten Produktionsstätten zur Herstellung steriler, injizierbarer Medikamente und wird primär für die Versorgung Europas und lediglich in Ausnahmefällen als Zusatz zu der Stätte in Kalamazoo, Michigan, für den US-Markt dienen.
Pfizer verfügt über umfangreiche Erfahrungen und Fachkenntnisse im Bereich des Kühlkettenversands sowie über eine etablierte Infrastruktur zur weltweiten Lieferung des Impfstoffs. Des Weiteren besitzt Pfizer Vertriebszentren, in denen Impfstoffdosen bis zu ihrem Verfallsdatum gelagert werden können.
Die Lieferung basiert auf einem flexiblen just-in-time-System, mit dem die gefrorenen Impfstoffdosen bei Bedarf zügig zu dem jeweiligen Impfzentrum transportiert werden können, wodurch dort eine mögliche längere Lagerung minimiert werden kann. Es wird davon ausgegangen, dass eine Impfung in Pandemiezeiten rasch erfolgen wird.
Daher nehmen die Unternehmen nicht an, dass ein Impfstoff länger als 30 Tage gelagert werden muss. Die Unternehmen haben für den Impfstoff spezielle temperaturstabile Versandeinheiten entwickelt, die die empfohlenen Liefer-Temperaturbedingungen von -90°C bis -60°C mit Trockeneis aufrechterhalten können, um eine hohe Produktqualität zu gewährleisten.
Die Behälter können ungeöffnet die empfohlene Temperatur für 10 Tage aufrechterhalten, was einen weltweiten Transport ermöglicht. Einmal geöffnet können die Impfzentren den Impfstoff entweder in Gefriereinheiten unter den empfohlenen Bedingungen (-70°C ±10°C) für bis zu 6 Monate lagern oder die Spezialversandeinheiten als Zwischenlager verwenden. Darin können die benötigten Temperaturbedingungen für bis zu 30 Tage aufrechterhalten werden, indem der Behälter gemäß der Gebrauchsanweisung alle 5 Tage mit Eis befüllt wird.
Jede Versandeinheit beinhaltet einen GPS-fähigen Temperatursensor, um den Standort und die Temperatur einer jeden Impfstofflieferung auf ihrer vorher festgelegten Route rund um die Uhr zu überwachen. Aufgetaut kann der Impfstoff bis zu 5 Tage im Kühlschrank gelagert werden (2 – 8°C).
Sonderregelung in Österreich In Österreich gibt es eine Sonderregelung: Die in Belgien produzierten Impfdosen werden in Österreich nicht zentral zwischengelagert, sondern nach ihrer Ankunft direkt zu mehreren Standorten im ganzen Land gebracht (vollsortierter Großhandel).
Seit Beginn des Entwicklungsprojektes Anfang dieses Jahres haben Pfizer und BioNTech den potenziellen Impfstoff erfolgreich an über 150 Studienzentren und mehr als 44.000 Probanden in den Vereinigten Staaten sowie in Europa, Lateinamerika und Südafrika geliefert.
Die Unternehmen gehen davon aus, den Impfstoff im Falle einer Zulassung oder Genehmigung mit Hilfe ihrer gemeinsamen Expertise weltweit ausliefern zu können. BioNTech wird der Zulassungsinhaber in den Vereinigten Staaten, dem Vereinigten Königreich, Kanada und in der EU sowie, falls genehmigt, in anderen Ländern sein. Pfizer wird die weltweiten Vermarktungs- und Vertriebsrechte mit Ausnahme von China, Deutschland und der Türkei besitzen.
Der Pfizer-BioNTech-COVID-19-Impfstoff ist nicht von der U.S.-amerikanischen Food and Drug Administration (FDA) zugelassen oder lizenziert, wurde jedoch von der FDA im Rahmen einer Notfallzulassung (Emergency Use Authorization, EUA) zur Vorbeugung der Coronavirus-Krankheit 2019 (COVID-19) für die Verwendung bei Personen ab 16 Jahren zugelassen.
Ein durch die Notfallzulassung genehmigtes Produkt ist nur für den Zeitraum des bestehenden Notfalls gemäß der Erklärung für Notfallzulassungen von Arzneimitteln unter Sektion 564 (b)(1) des FD&C Act zugelassen,es sei denn, die Genehmigung wird früher zurückgenommen oder beendet. Das Emergency Use Authorization (EUA) Fact Sheet für Impfstoffanbieter und die EUA Full Prescribing Information sind unter folgendem Link verfügbar: www.cvdvaccine.com.
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Quelle:
– Presseaussendung von Pfizer.com – Pressekontakt Pfizer Österreich: Sabine Sommer +43 664 536 83 82 – sabine.sommer@pfizer.com
Offenlegungshinweis von Pfizer
Die in dieser Mitteilung enthaltenen Informationen gelten für den Zeitpunkt zum 21. Dezember 2020. Pfizer übernimmt keine Verpflichtung, die in dieser Mitteilung enthaltenen zukunftsgerichteten Aussagen aufgrund neuer Informationen oder zukünftiger Ereignisse oder Entwicklungen zu aktualisieren.
Diese Pressemitteilung enthält bestimmte in die Zukunft gerichtete Aussagen bezüglich Pfizers Bemühungen, die COVID-19-Pandemie zu bekämpfen, eine Zusammenarbeit zwischen BioNTech und Pfizer zur Entwicklung eines potenziellen Impfstoffs gegen COVID-19, dem BNT162-mRNA-Impfstoffprogramm und dem modRNA-Kandidaten BNT162b2 (einschließlich qualitativer Bewertung verfügbarer Daten, möglicher Vorteile und Erwartungen zu klinischen Studien, dem laufenden Antrag auf bedingte Marktzulassung (CMA) in der EU, anderer regulatorischer Einreichungen, der angesetzten Zeit für Einreichungen für Zulassungen, regulatorischer Zulassungen oder Genehmigungen sowie der Produktion, der Verteilung und der Lieferung), welche erhebliche Risiken und Ungewissheiten beinhalten, die dazu führen können, dass die tatsächlichen Ergebnisse wesentlich von den in solchen Aussagen zum Ausdruck gebrachten oder implizierten Ergebnissen abweichen.
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