L’Agence Européenne des Médicaments (AEM) a annoncé, jeudi 25 novembre, être favorable à une autorisation du vaccin de BioNTech-Pfizer contre la Covid-19 pour les enfants de 5 à 11 ans.
L’AEM recommande donc d’étendre l’autorisation européenne actuelle pour le Pfizer, qui l’empêchait d’être administré aux moins de 12ans.
Le comité a examiné les données issues d’une étude menée chez près de 2000 enfants de cette tranche d’âge, dont un groupe a été vacciné avec le sérum Comirnaty (BioNTech-Pfizer), tandis que l’autre recevait un placebo.
Selon l’AEM, l’étude a démontré une efficacité de 90,7% pour éviter les cas de Covid-19 symptomatiques, mais le taux d’efficacité réel pourrait être «entre 67,7% et 98,3%».
En ce qui concerne les effets secondaires du vaccin, il n’y a pas eu de différence flagrante observée par rapport aux plus âgés, précise l’AEM.
L’autorisation, en tant que telle, reste entre les mains de la Commission Européenne, qui se base sur les recommandations de l’Agence Européenne des Médicaments.
À rappeler que, hors du continent européen, le vaccin Pfizer a déjà été approuvé pour les enfants de 5 à 11 ans dans des pays comme: Les Etats-Unis, le Canada et l’Israël.
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