{"id":7507,"date":"2023-01-30T13:32:09","date_gmt":"2023-01-30T10:32:09","guid":{"rendered":"https:\/\/urbancare.clinic\/fda-revokes-emergency-use-authorization-of-covid-drug-ineffective-against-new-variants\/"},"modified":"2023-01-30T13:32:09","modified_gmt":"2023-01-30T10:32:09","slug":"die-fda-widerruft-die-notfallzulassung-eines-gegen-neue-varianten-unwirksamen-covid-medikaments","status":"publish","type":"post","link":"https:\/\/urbancare.clinic\/de\/die-fda-widerruft-die-notfallzulassung-eines-gegen-neue-varianten-unwirksamen-covid-medikaments\/","title":{"rendered":"Die FDA widerruft die Notfallzulassung eines gegen neue Varianten unwirksamen Covid-Medikaments"},"content":{"rendered":"<div><img decoding=\"async\" src=\"https:\/\/urbancare.clinic\/wp-content\/uploads\/2023\/01\/fda-revokes-emergency-use-authorization-of-covid-drug-ineffective-against-new-variants.jpg\" class=\"ff-og-image-inserted\" style=\"display:none\"><\/div>\n<p>Die US-amerikanische Lebensmittel- und Arzneimittelbeh\u00f6rde (FDA) gab am Donnerstag bekannt, dass sie die Notfallzulassung f\u00fcr ein Covid-19-Medikament zur\u00fcckzieht, da es gegen in der Bev\u00f6lkerung zirkulierende neue Varianten wahrscheinlich nicht wirksam sein wird.<\/p>\n<p>Bei dem Medikament handelt es sich um Evusheld, hergestellt vom britisch-schwedischen Pharma- und Biotechnologieunternehmen AstraZeneca. Es wurde erstmals im Dezember 2021 als Pr\u00e4expositionsprophylaxe gegen SARS-COV-2 f\u00fcr immungeschw\u00e4chte Personen zugelassen, da bei ihnen die Wahrscheinlichkeit geringer ist, dass sie durch die Impfung Antik\u00f6rper produzieren <a href=\"https:\/\/abcnews.go.com\/Health\/fda-withdraws-authorization-covid-drug-effective-new-variants\/story?id=96715718\" rel=\"nofollow noopener\" target=\"_blank\">Abc Nachrichten<\/a>.<\/p>\n<p>Es ist eine Art von <a href=\"https:\/\/www.medicaldaily.com\/how-does-covid-19-prevention-drug-evusheld-work-and-who-should-receive-it-465508\">Behandlung mit monoklonalen Antik\u00f6rpern<\/a>, das Antik\u00f6rper enth\u00e4lt, die in einem Labor hergestellt werden und denen nachahmen, die der K\u00f6rper auf nat\u00fcrliche Weise erzeugt, wenn er auf das Virus trifft. Es handelt sich um eine Kombination aus zwei Antik\u00f6rpern, Tixagevimab und Cilgavimab, die an das Spike-Protein des Virus binden, das COVID-19 verursacht, und verhindern, dass es in Zellen eindringt und diese infiziert.<\/p>\n<p>Laut FDA neutralisiert Evusheld mehrere Omicron-Subvarianten nicht, darunter BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, XBB und XBB.1.5 in einem <a href=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-announces-evusheld-not-currently-authorized-emergency-use-us\" rel=\"nofollow noopener\" target=\"_blank\">Pressemitteilung<\/a>.<\/p>\n<div id=\"dfp-ad-oop2\" class=\"dfp-tag-wrapper\"> <\/div>\n<p>Es wird angenommen, dass diese Subvarianten die Ursache f\u00fcr 90%-F\u00e4lle in den USA sind, so die&nbsp; <a href=\"https:\/\/covid.cdc.gov\/covid-data-tracker\/#variant-proportions\" rel=\"nofollow noopener\" target=\"_blank\"> Zentren f\u00fcr Krankheitskontrolle und Pr\u00e4vention<\/a>.<\/p>\n<p>\u201eDas bedeutet, dass Evusheld voraussichtlich keinen Schutz vor der Entwicklung von COVID-19 bietet, wenn es diesen Varianten ausgesetzt ist\u201c, sagte die FDA in der Pressemitteilung.<\/p>\n<p>\u201eDie heutige Ma\u00dfnahme zur Einschr\u00e4nkung der Verwendung von Evusheld verhindert, dass Patienten m\u00f6glichen Nebenwirkungen von Evusheld wie allergischen Reaktionen ausgesetzt werden, die m\u00f6glicherweise schwerwiegend sein k\u00f6nnen, und das zu einem Zeitpunkt, an dem weniger als 10% der in den USA zirkulierenden Varianten, die Infektionen verursachen, f\u00fcr das Produkt anf\u00e4llig sind. \u201c, hei\u00dft es in der Pressemitteilung weiter.<\/p>\n<p>Die FDA hatte dieses Thema bereits zuvor angesprochen. Am 6. Januar erkl\u00e4rte die FDA, sie sei skeptisch, dass Evusehld die XBB.1.5-Subvariante \u201eaufgrund ihrer \u00c4hnlichkeit mit Varianten, die nicht von Evusheld neutralisiert werden\u201c neutralisieren k\u00f6nne, \u201eaufgrund ihrer \u00c4hnlichkeit mit Varianten, die nicht von Evusheld neutralisiert werden\u201c, berichtete die Verkaufsstelle.<\/p>\n<p>Unterdessen sagte AstraZeneca in einem <a href=\"https:\/\/www.astrazeneca-us.com\/content\/az-us\/media\/press-releases\/2023\/update-on-us-food-and-drug-administration-emergency-use-authorization-of-evusheld.html\" rel=\"nofollow noopener\" target=\"_blank\">Stellungnahme<\/a> dass es weiterhin mit den Entscheidungen der FDA kooperieren wird.<\/p>\n<p>\u201eAstraZeneca wird weiterhin mit der FDA und anderen Gesundheitsbeh\u00f6rden zusammenarbeiten, um relevante Daten zu Evusheld- und SARS-CoV-2-Varianten zu sammeln, zu bewerten und weiterzugeben\u201c, hei\u00dft es in der Erkl\u00e4rung. \u201eEvusheld bleibt derzeit in anderen L\u00e4ndern zugelassen, in denen es zur Pr\u00e4expositionsprophylaxe und -behandlung von COVID-19 zugelassen ist, darunter in der EU und Japan.\u201c<\/p>\n<p>Obwohl die FDA den Notfallzulassungsstatus des Medikaments widerrufen hat, riet sie den Anbietern des Arzneimittels, ihre Produkte noch nicht zu verwerfen.<\/p>\n<p>\u201eDie US-Regierung empfiehlt, dass Einrichtungen und Anbieter mit Evusheld alle Produkte behalten, f\u00fcr den Fall, dass SARS-CoV-2-Varianten, die durch Evusheld neutralisiert werden, in Zukunft in den USA h\u00e4ufiger auftreten\u201c, sagte die FDA in ihrer Pressemitteilung.<\/p>\n<p><a href=\"https:\/\/www.medicaldaily.com\/fda-revokes-emergency-use-authorization-covid-drug-ineffective-against-new-467903?utm_source=Public&#038;utm_medium=Feed&#038;utm_campaign=Distribution\">Medizinische t\u00e4gliche Quelle<\/a><\/p>\n<p>","protected":false},"excerpt":{"rendered":"<p>Evusheld neutralisiert mehrere Omicron-Subvarianten nicht, darunter BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, XBB und XBB.1.5, teilte die FDA mit eine Pressemitteilung.<\/p>","protected":false},"author":2,"featured_media":7508,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"Default","format":"standard","meta":{"fifu_image_url":"https:\/\/urbancare.clinic\/wp-content\/uploads\/2023\/01\/fda-revokes-emergency-use-authorization-of-covid-drug-ineffective-against-new-variants.jpg","fifu_image_alt":"","footnotes":""},"categories":[27],"tags":[],"class_list":["post-7507","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Revokes Emergency Use Authorization Of Covid Drug Ineffective Against New Variants - Urban Care Clinic<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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