La Haute Autorit\u00e9 de sant\u00e9 (HAS) int\u00e8gre le vaccin \u00e0 ARNm COMIRNATY 10 \u00b5g (Pfizer) dans la strat\u00e9gie vaccinale contre la COVID-19 pour les enfants \u00e2g\u00e9s de 6 mois \u00e0 4 ans r\u00e9volus \u00e0 risque de forme grave ou vivant au contact de personnes immunod\u00e9prim\u00e9es. Ce vaccin remplace la formulation p\u00e9diatrique COMIRNATY 3 \u00b5g, dont la commercialisation est arr\u00eat\u00e9e pour les prochaines campagnes vaccinales. La recommandation s\u2019adresse aux d\u00e9cideurs publics et vise \u00e0 d\u00e9terminer si les donn\u00e9es disponibles justifient l\u2019actualisation du sch\u00e9ma posologique dans la strat\u00e9gie vaccinale fran\u00e7aise pour cette classe d\u2019\u00e2ge.<\/p>\n
Pour \u00e9tablir son avis, la HAS a pris en compte la strat\u00e9gie vaccinale actuellement en vigueur pour les nourrissons et jeunes enfants, le calendrier vaccinal actualis\u00e9, ainsi que les caract\u00e9ristiques du vaccin COMIRNATY 10 \u00b5g. Elle s\u2019appuie sur l\u2019avis favorable du Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) et sur la d\u00e9cision de la Commission europ\u00e9enne concernant l\u2019autorisation de mise sur le march\u00e9 et l\u2019arr\u00eat de la formulation 3 \u00b5g. Les r\u00e9sultats de l\u2019\u00e9tude C4591048 montrent que COMIRNATY 10 \u00b5g induit une r\u00e9ponse immunitaire \u00e9lev\u00e9e chez les enfants de 6 mois \u00e0 moins de 5 ans, avec un profil de tol\u00e9rance jug\u00e9 globalement satisfaisant dans les \u00e9tudes disponibles. La HAS a \u00e9galement consid\u00e9r\u00e9 les donn\u00e9es de pharmacovigilance transmises par l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM).<\/p>\n
La HAS souligne toutefois l\u2019existence de donn\u00e9es manquantes, notamment en mati\u00e8re d\u2019efficacit\u00e9 clinique, de co-administration avec d\u2019autres vaccins, ainsi que d\u2019immunog\u00e9nicit\u00e9 et de tol\u00e9rance \u00e0 long terme. Elle mentionne \u00e9galement avoir examin\u00e9 les recommandations internationales relatives \u00e0 la vaccination contre la COVID-19 chez les enfants. Dans ce contexte, la HAS estime que COMIRNATY 10 \u00b5g peut \u00eatre utilis\u00e9, dans le cadre de son autorisation de mise sur le march\u00e9, pour les enfants cibl\u00e9s, afin d\u2019assurer la continuit\u00e9 de l\u2019offre vaccinale. Elle pr\u00e9cise qu\u2019une seule dose est recommand\u00e9e pour les enfants ayant un ant\u00e9c\u00e9dent document\u00e9 d\u2019infection par le SARS-CoV-2. La HAS indique enfin que cet avis est susceptible d\u2019\u00eatre actualis\u00e9 en fonction de l\u2019\u00e9volution des connaissances scientifiques.\u00a0(contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u200bLire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":" La Haute Autorit\u00e9 de sant\u00e9 (HAS) int\u00e8gre le vaccin \u00e0 ARNm COMIRNATY 10 \u00b5g (Pfizer) dans la strat\u00e9gie vaccinale contre la COVID-19 pour les enfants \u00e2g\u00e9s de 6 mois \u00e0 […]<\/p>\n","protected":false},"author":1,"featured_media":4149,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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