{"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":"covid-19-vaccin-supplementaire-approuve","status":"publish","type":"post","link":"https:\/\/www.m-q.ch\/fr\/covid-19-vaccin-supplementaire-approuve\/","title":{"rendered":"Covid-19 : un nouveau vaccin approuv\u00e9"},"content":{"rendered":"
\""Vaccin
\u00a9 Depositphotos, AtlasStudio<\/figcaption><\/figure>\n

Le 7 d\u00e9cembre 2020, la soci\u00e9t\u00e9 Janssen-Cilag AG du groupe de sant\u00e9 Johnson & Johnson a d\u00e9pos\u00e9 aupr\u00e8s de Swissmedic une demande d'autorisation pour son candidat vaccin (Ad26.COV2.S). Swissmedic approuve le vaccin \"COVID-19 Vaccine Janssen\" pour une p\u00e9riode limit\u00e9e apr\u00e8s un examen minutieux de tous les documents soumis. L'organe consultatif externe de Swissmedic, le HMEC (Human Medicines Expert Committee), a soutenu la d\u00e9cision lors d'une r\u00e9union extraordinaire.<\/p>\n

Le vaccin est administr\u00e9 une seule fois<\/strong><\/p>\n

Le vaccin est administr\u00e9 une fois (dose unique) et est autoris\u00e9 pour les personnes \u00e2g\u00e9es de 18 ans et plus. Il est bas\u00e9 sur un ad\u00e9novirus humain (virus du rhume humain) qui contient le plan des prot\u00e9ines de pointe du coronavirus SRAS-CoV-2, sur la base duquel la r\u00e9ponse immunitaire souhait\u00e9e contre le virus est d\u00e9clench\u00e9e dans les cellules immunitaires humaines.<\/p>\n

Les donn\u00e9es de l'\u00e9tude soumise montrent une efficacit\u00e9 14 jours apr\u00e8s la vaccination dans tous les groupes d'\u00e2ge \u00e9tudi\u00e9s, allant de 64,2 % (groupe d'\u00e2ge 18 \u00e0 64 ans) \u00e0 82,4 % (65 ans et plus). Les \u00e9volutions graves et critiques de la maladie de Covid-19 peuvent \u00eatre pr\u00e9venues par cette vaccination (\u00e0 pr\u00e8s de 85 %). En outre, un bon effet a \u00e9t\u00e9 d\u00e9montr\u00e9 avec les mutations qui dominent au Br\u00e9sil et en Afrique du Sud (variantes du SRAS-CoV-2). \u00a0<\/p>\n

Les effets ind\u00e9sirables les plus fr\u00e9quemment document\u00e9s lors des essais cliniques \u00e9taient les maux de t\u00eate, la somnolence, la douleur au point d'injection ou les naus\u00e9es. La plupart des r\u00e9actions au vaccin sont survenues dans les 1 \u00e0 2 jours suivant la vaccination et ont \u00e9t\u00e9 de courte dur\u00e9e (1 \u00e0 2 jours).<\/p>\n

Le vaccin peut \u00eatre conserv\u00e9 congel\u00e9 entre -25 \u00b0C et -15 \u00b0C et transport\u00e9 congel\u00e9 ou d\u00e9congel\u00e9 entre 2 \u00b0C et 8 \u00b0C. Apr\u00e8s avoir \u00e9t\u00e9 retir\u00e9 du cong\u00e9lateur, le vaccin non ouvert peut \u00eatre conserv\u00e9 au r\u00e9frig\u00e9rateur pendant 3 mois au maximum.<\/p>\n

Swissmedic a \u00e9galement examin\u00e9 cette demande d'autorisation de mise sur le march\u00e9 \u00e0 un rythme tr\u00e8s acc\u00e9l\u00e9r\u00e9 dans le cadre d'une proc\u00e9dure de roulement. Les r\u00e9sultats des \u00e9tudes en cours et les r\u00e9ponses aux questions pos\u00e9es ont \u00e9t\u00e9 soumis par l'entreprise de fa\u00e7on continue et examin\u00e9s par Swissmedic d\u00e8s qu'ils \u00e9taient disponibles.<\/p>\n

Avec l'approbation du vaccin Covid-19 de Johnson & Johnson, Swissmedic a donn\u00e9 une \u00e9valuation positive \u00e0 trois des quatre demandes de vaccins Covid-19 soumises \u00e0 ce jour. Les vaccins de Pfizer\/BioNTech (Comirnaty) et Moderna ont d\u00e9j\u00e0 \u00e9t\u00e9 approuv\u00e9s. La demande d'AstraZeneca est actuellement en cours d'examen.<\/p>\n

Il est \u00e0 noter que le vaccin de Johnson & Johnson n'a pas encore \u00e9t\u00e9 command\u00e9 par l'Office f\u00e9d\u00e9ral de la sant\u00e9 publique. Pour cette raison, il est peu probable qu'il soit utilis\u00e9 en Suisse, faute de temps.\u00a0\u00a0<\/p>\n

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

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

Le 7 d\u00e9cembre 2020, la soci\u00e9t\u00e9 Janssen-Cilag AG du groupe de sant\u00e9 Johnson & Johnson a d\u00e9pos\u00e9 aupr\u00e8s de Swissmedic une demande d'autorisation de mise sur le march\u00e9 pour son vaccin candidat (Ad26.COV2.S). Swissmedic autorise le vaccin \"COVID-19 Vaccine Janssen\" pour une dur\u00e9e limit\u00e9e apr\u00e8s un examen minutieux de tous les documents soumis. Le comit\u00e9 consultatif externe d'experts de Swissmedic HMEC (Human Medicines Expert Committee) a approuv\u00e9 lors d'une r\u00e9union extraordinaire [...].<\/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. 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