{"id":13881,"date":"2021-03-22T18:34:19","date_gmt":"2021-03-22T17:34:19","guid":{"rendered":"https:\/\/www.m-q.ch\/?p=13881"},"modified":"2021-03-23T11:32:28","modified_gmt":"2021-03-23T10:32:28","slug":"approvato-il-vaccino-covid-19","status":"publish","type":"post","link":"https:\/\/www.m-q.ch\/it\/approvato-il-vaccino-covid-19\/","title":{"rendered":"Covid-19: un altro vaccino approvato"},"content":{"rendered":"
\""COVID-19
\u00a9 Depositphotos, AtlasStudio<\/figcaption><\/figure>\n

Il 7 dicembre 2020, la societ\u00e0 Janssen-Cilag AG del gruppo sanitario Johnson & Johnson ha presentato a Swissmedic una domanda di autorizzazione per il suo candidato vaccino (Ad26.COV2.S). Swissmedic approva il vaccino \"COVID-19 Vaccine Janssen\" per un periodo limitato dopo un attento esame di tutti i documenti presentati. L'organo consultivo esterno di Swissmedic, l'HMEC (Human Medicines Expert Committee), ha sostenuto la decisione in una riunione straordinaria.<\/p>\n

Il vaccino viene somministrato solo una volta<\/strong><\/p>\n

Il vaccino viene somministrato una volta (dose singola) ed \u00e8 autorizzato per persone di 18 anni e pi\u00f9. Si basa su un adenovirus umano (virus del freddo umano) che contiene il blueprint delle proteine spike del coronavirus SARS-CoV-2, sulla base del quale la risposta immunitaria desiderata contro il virus viene innescata nelle cellule immunitarie umane.<\/p>\n

I dati dello studio presentato mostrano un'efficacia 14 giorni dopo la vaccinazione in tutti i gruppi di et\u00e0 studiati che vanno da 64,2 % (gruppo di et\u00e0 da 18 a 64 anni) a 82,4 % (65 anni e oltre). Corsi gravi e critici della malattia Covid-19 possono essere prevenuti con questa vaccinazione (a quasi 85 %). Inoltre, \u00e8 stato dimostrato un buon effetto con le mutazioni che dominano in Brasile e Sudafrica (varianti SARS-CoV-2). \u00a0<\/p>\n

Le reazioni avverse pi\u00f9 comuni documentate negli studi clinici sono state mal di testa, sonnolenza, dolore al sito di iniezione o nausea. La maggior parte delle reazioni al vaccino si sono verificate entro 1 o 2 giorni dopo la vaccinazione e sono state di breve durata (da 1 a 2 giorni).<\/p>\n

Il vaccino pu\u00f2 essere conservato congelato da -25 \u00b0C a -15 \u00b0C e trasportato congelato o scongelato da 2 \u00b0C a 8 \u00b0C. Dopo la rimozione dal congelatore, il vaccino non aperto pu\u00f2 essere conservato in frigorifero per un massimo di 3 mesi.<\/p>\n

Swissmedic ha anche esaminato questa domanda di autorizzazione all'immissione in commercio ad un ritmo molto accelerato in una procedura a rotazione. I risultati degli studi in corso e le risposte alle domande poste sono stati presentati dalla societ\u00e0 su base continuativa e rivisti da Swissmedic non appena disponibili.<\/p>\n

Con l'approvazione del vaccino Covid-19 di Johnson & Johnson, Swissmedic ha dato una valutazione positiva a tre delle quattro domande di vaccini Covid-19 presentate finora. I vaccini di Pfizer\/BioNTech (Comirnaty) e Moderna sono gi\u00e0 stati approvati. La domanda di AstraZeneca \u00e8 attualmente ancora in fase di revisione.<\/p>\n

Va notato che il vaccino della Johnson & Johnson non \u00e8 stato ancora ordinato dall'Ufficio federale della sanit\u00e0 pubblica. Per questo motivo, \u00e8 improbabile che venga utilizzato in Svizzera a causa dei limiti di tempo.\u00a0\u00a0<\/p>\n

Fonte: Swissmedic<\/em><\/p>\n

 <\/p>","protected":false},"excerpt":{"rendered":"

Il 7 dicembre 2020, Janssen-Cilag AG, parte del gruppo sanitario Johnson & Johnson, ha presentato a Swissmedic una domanda di autorizzazione per il suo candidato vaccino (Ad26.COV2.S). Swissmedic autorizza il vaccino \"COVID-19 Vaccine Janssen\" per un periodo limitato dopo un attento esame di tutti i documenti presentati. In una riunione straordinaria, il comitato consultivo esterno HMEC (Human Medicines Expert Committee) di Swissmedic ha approvato il [...]<\/p>","protected":false},"author":35,"featured_media":13882,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4448],"tags":[4869,4281,4867,4868],"class_list":["post-13881","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-allgemein","tag-covid-19-vaccine-janssen","tag-covid-19","tag-impfstoff","tag-johnson-johnson"],"acf":[],"yoast_head":"\nCovid-19: weiterer Impfstoff genehmigt - MQ Management und Qualit\u00e4t<\/title>\n<meta name=\"description\" content=\"Swissmedic hat den vom Pharmakonzern Johnson & Johnson entwickelten Covid-19 Impfstoff \u00abCOVID-19 Vaccine Janssen\u00bb f\u00fcr Personen ab 18 Jahren befristet zugelassen. Damit sind in der Schweiz drei Impfstoffe zur Pr\u00e4vention einer Covid-19 Erkrankung offiziell verkehrsf\u00e4hig. Der auf einem menschlichen Adenovirus basierende Vektor-Impfstoff muss nur einmal verabreicht werden. 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