Le laboratoire Pfizer a annoncé dans un communiqué publié lundi 20 septembre, que son vaccin à ARN messager contre le Covid-19 était sûr et efficace chez les enfants de 5 à 11 ans.
Le groupe américain et son partenaire allemand BioNTech s’apprêtent à déposer, d’ici à la fin du mois, une demande d’autorisation provisoire auprès de la Food and Drug Administration (FDA), pour pouvoir vacciner les adultes et les adolescents.
Le géant pharmaceutique a toutefois fourni un certain nombre de précisions a indiqué l’AFP. En effet, les enfants ont reçu deux injections de 10 microgrammes de principe actif, à trois semaines d’intervalle, soit trois fois moins que celle injectée aux adultes et aux adolescents.
Des études préalables avaient montré que la dose entière pouvait provoquer des effets indésirables plus sérieux chez les enfants. Selon le communiqué, les 2 268 volontaires de 5 à 11 ans ont présenté des réactions comparables à celles de leurs aînés avec la formule complète.
Le laboratoire a précisé que les enfants testés ont présenté une réponse immunitaire robuste. Une façon de conclure à l’efficacité du vaccin. Le laboratoire n’a en effet pas comparé, comme préalablement lors de la phase 3 des essais cliniques, le nombre de personnes malades dans deux échantillons de volontaires, l’un vacciné, l’autre non vacciné.
Au lieu de cela, le laboratoire a comparé le titre moyen d’anticorps neutralisant chez les jeunes volontaires, un mois après l’administration de la seconde dose, à celui d’un groupe témoin de quelque 1 100 adolescents de 16 à 25 ans ayant reçu une pleine dose.
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