Les sociétés pharmaceutiques Pfizer et BioNTech ont récemment demandé une autorisation d’utilisation d’urgence, pour leur vaccin COVID-19 destiné aux enfants âgés de six mois à quatre ans.
« Pfizer Inc et BioNTech SE ont annoncé aujourd’hui, que suite à une demande de la Food and Drug Administration (FDA) des États-Unis, les sociétés ont lancé une soumission continue visant à modifier l’autorisation d’utilisation d’urgence du vaccin Pfizer-BioNTech COVID-19 pour inclure enfants de 6 mois à 4 ans, en réponse au besoin urgent de santé publique de cette population », ont déclaré Pfizer et BioNTech dans un communiqué mardi (heure locale).
Si l’autorisation est accordée, le vaccin Pfizer-BioNTech serait le premier vaccin COVID-19 disponible pour les populations pédiatriques de moins de 5 ans.
Pfizer et BioNTech ont déclaré qu’ils prévoyaient de terminer la soumission de l’autorisation dans les prochains jours.
« Alors que les hospitalisations d’enfants de moins de 5 ans en raison de la COVID-19 ont grimpé en flèche, notre objectif est de nous préparer à de futures poussées de variants et de fournir aux parents une option pour aider à protéger leurs enfants contre ce virus », a déclaré Albert Bourla, président et directeur général. Président-directeur général, Pfizer.
« En fin de compte, nous pensons que trois doses du vaccin seront nécessaires pour les enfants de 6 mois à 4 ans pour atteindre des niveaux élevés de protection contre les variants actuels et futurs. Si deux doses sont autorisées, les parents auront la possibilité de commencer un série de vaccination pour leurs enfants en attendant l’autorisation potentielle d’une troisième dose », a ajouté Bourla.
De son côté, Ugur Sahin, co-fondateur de BioNTech, a déclaré que le vaccin a déjà démontré un profil d’innocuité et d’efficacité favorables dans de multiples essais cliniques et études dans le monde réel pour tous les groupes d’âge à partir de 5 ans.
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