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Focus 29 - Mars 2022

Le développement des vaccins anti-Covid-19 est-il allé trop vite ?

F292Le 28 février dernier se tenait la Journée internationale des maladies rares. Alors que 6 à 8% de la population belge serait atteinte d’une maladie rare, on estime que 94% de ces maladies rares n’ont pas de traitement. Pour la petite proportion de maladies rares pour lesquelles un traitement est disponible, le processus allant de la découverte d’une molécule à sa commercialisation prend en moyenne 10 ans. Devant de tels longs délais, le développement des vaccins contre la Covid-19 en une petite dizaine de mois est une prouesse, et pousse à s’interroger sur les raisons de cette rapidité sans précédent.

La recherche médicale, pour un traitement, se décompose typiquement en trois grandes étapes : la «recherche pré-clinique» en laboratoire, la «recherche clinique» où le traitement est expérimenté sur des êtres humains et l’autorisation et mise sur le marché du traitement.

Dans le cas de vaccins, la recherche peut avoir trois objectifs : (1) une amélioration de vaccins existants – meilleure efficacité, moins d’effets secondaires, conditions de conservation ou d’administration plus simples, etc.; (2) une actualisation des vaccins existants – comme c’est le cas des vaccins contre la grippe, qui sont différents chaque année en fonction des souches en circulation; (3) le développement d’un nouveau vaccin.

La recherche médicale est un processus long, coûteux et incertain. La durée des différentes étapes dépend de nombreux facteurs, dont les principaux sont la difficulté de la question de recherche, les connaissances déjà acquises et également les aspects administratifs, logistiques, et financiers.

La recherche dans le contexte des vaccins anti-Covid a suivi globalement la même démarche que les autres vaccins. Elle s’est cependant distinguée par le fait qu’il a été possible de gagner du temps à plusieurs niveaux dans ce processus. Tout d’abord, le vaccin anti-Covid a bénéficié de recherches qui étaient déjà dynamiques et avancées sur les vaccins à ARN messager et à vecteur adénovirus notamment pour d’autres virus tels que Ebola ou Zika. Ensuite, le recrutement de personnes pour les essais cliniques a pu se faire en quelques semaines puisqu’il s’agissait de recruter des personnes saines et qu’un suivi de quelques mois à un an était suffisant pour établir le rapport risque-bénéfice du vaccin. Enfin, l’urgence mondiale de la situation a poussé les instances réglementaires à réduire au maximum les délais induits par les procédures administratives et logistiques.

De plus, une autre particularité du développement du vaccin anti-Covid a eu trait aux aspects financiers. Des scientifiques dans les domaines publics et privés ont collaboré et leur recherche s’est appuyée sur un investissement financier important des phases de recherche et de développement par les contributeurs habituels mais aussi des contributeurs privés et philanthropiques. De plus, l’achat en avance de doses de vaccins par plusieurs Etats a permis de partager le risque financier dans le processus de financement du vaccin.

De cette situation sans précédent, nous tirons plusieurs enseignements.

Premièrement, cette prouesse montre que la recherche médicale pourrait être menée plus rapidement. La question du financement semble clef dans ce contexte, mais d’autres aspects comme encourager plus de collaborations entre les différents acteurs privés et/ou publics et dégager un nouveau modèle de recherche pourraient permettre de raccourcir la recherche pré-clinique et clinique. Néanmoins, le temps de développement de traitements concernant des pathologies avec un mécanisme d’action complexe et encore peu connues, nécessitant un recrutement de patients plus complexes, et un suivi à long terme comme c’est souvent le cas d’une maladie rare, aura moins de chances de pouvoir être raccourci.

En second lieu, on se doit de constater que la rapidité du développement de vaccins anti-Covid-19 a accru la méfiance ou peur de la population vis-à-vis de la vaccination. La crise sanitaire a donc révélé qu’une plus grande «culture médicale» pourrait être nécessaire au sein de la population afin d’amenuiser les possibles incompréhensions, mauvaises interprétations et finalement, frustrations que cela a engendré.

Enfin, il est à craindre que cette prouesse médicale a été obtenue au prix d’une priorisation des ressources, tant humaines que logistiques et financières au profit de projets de vaccins anti-Covid-19. Ainsi, le recrutement et la participation des patients dans des essais cliniques autres que ceux dédiés à la Covid-19 durant ces deux dernières années ont vraisemblablement été ralentis voire arrêtés. Les conséquences négatives sur les autres patients que les patients Covid-19 sont difficilement quantifiables mais certainement non négligeables.

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