Pfizer et BioNTech viennent d’annoncer les résultats finaux concernant l’efficacité de leur vaccin contre le coronavirus. Ils espèrent produire des millions de doses d’ici la fin de l’année. 

Pfizer et BioNtech ont partagé les résultats finaux de leur vaccin contre le coronavirus, BNT162b2, dans un communiqué de presse paru aujourd’hui, le 18 novembre 2020. Les résultats partagés la semaine dernière n’étaient qu’intermédiaires. La précédente efficacité de 90 % annoncée par la firme pharmaceutique américaine et son collaborateur allemand avait été mesurée sur 94 patients atteints de la Covid-19. Il restait encore à analyser les résultats de 76 participants. C’est désormais chose faite ! Sur les 170 patients testés au total (162 dans le groupe placebo et 8 dans le groupe vaccin), le vaccin BNT162b2 est efficace à 95 % pour prévenir la Covid-19 quand on considère toutes les tranches d’âges, les genres et les origines ethniques. Lorsque l’on s’intéresse uniquement aux personnes âgées de plus de 65 ans, les plus fragiles face à la Covid-19, il démontre une efficacité de 94 %.

Plusieurs personnes ont souffert de forme grave de la Covid-19, mais seulement une d’entre elles était incluse dans le groupe vaccin (les neuf autres étaient dans le groupe placebo), il est donc impossible de conclure sur l’efficacité du vaccin sur les formes aiguës de la maladie. Ces résultats finaux feront l’objet d’une publication scientifique détaillée. Dans tous les cas, Pfizer et BioNtech espèrent que cette efficacité revue à la hausse jouera en leur faveur pour obtenir la fameuse autorisation d’utilisation d’urgence (emergency use authorization) délivrée par la Food and Drug Agency. Le géant américain espère distribuer les premières doses vaccinales avant la fin de l’année 2020.

Pour en savoir plus

« Aujourd’hui est un grand jour pour la science et l’humanité », c’est par ces mots du P.-D.G. de Pfizer que commence le communiqué de presse publié ce 9 novembre 2020. Ce dernier annonce les premiers résultats de la phase 3 des études cliniques de son vaccin contre le coronavirus, élaboré avec la compagnie allemande BioNTech.

Selon la société pharmaceutique, BNT162b2 a démontré une efficacité supérieure à 90 % pour prévenir la Covid-19, sept jours après une seconde injection. Le communiqué de presse, qui n’est pas accompagné d’une publication scientifique des résultats, indique que la protection est atteinte 28 jours après la première immunisation et nécessite un seul rappel.

« Cette première analyse intermédiaire de la phase 3 de notre étude fournit une évidence, le vaccin peut effectivement prévenir la Covid-19. C’est une victoire pour l’innovation, la science et un effort collaboratif mondial », a déclaré le directeur de BioNTech.

Le vaccin a été testé sur plus de 40.000 personnes, de toutes les ethnies et avec un historique médical parfois lourd, et aucune toxicité grave n’a été observée pour le moment. Les études cliniques ne sont pas pour autant terminées. Les prochains tests auront pour objectif de déterminer si ce vaccin peut protéger contre la Covid-19 s’il est injecté après l’infection et s’il peut prévenir les formes les plus graves de cette maladie, qui a fait plus de 40.000 morts en France depuis son apparition.

Voir aussiCovid-19 : « le virus est avec nous pour toujours », prévient l’OMS

Les données encore en attente devront permettre au vaccin BNT162b2 d’être approuvé par la FDA (Food and Drug Administration) comme médicament d’urgence (Emergency Use Authorization) d’ici la troisième semaine de novembre. Selon ses estimations, Pfizer devrait produire 50 millions de doses vaccinales d’ici la fin 2020 et plus d’1,3 milliard courant 2021.

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