La FDA américaine ajoute un avertissement concernant une inflammation cardiaque rare aux vaccins Pfizer et Moderna COVID.
Le régulateur américain des médicaments a ajouté vendredi un avertissement à la littérature qui accompagne les vaccins Pfizer Inc/BioNTech et Moderna COVID pour indiquer le risque rare d’inflammation cardiaque après son utilisation.
Pour chaque vaccin, les fiches d’information destinées aux prestataires de soins de santé ont été révisées pour inclure un avertissement indiquant que les rapports d’événements indésirables suggèrent des risques accrus de myocardite et de péricardite, en particulier après la deuxième dose et avec l’apparition de symptômes quelques jours après la vaccination, a déclaré la FDA. .
Au 11 juin, plus de 1 200 cas de myocardite ou de péricardite ont été signalés au système américain de notification des événements indésirables des vaccins (VAERS), sur environ 300 millions de doses de vaccin à ARNm administrées.
Les cas semblent être nettement plus élevés chez les hommes et dans la semaine suivant la deuxième dose de vaccin. Le CDC a identifié 309 hospitalisations dues à une inflammation cardiaque chez des personnes de moins de 30 ans, dont 295 ont obtenu leur congé.
Les régulateurs de la santé de plusieurs pays ont enquêté sur des cas de myocardite et de péricardite, plus fréquemment retrouvés chez les jeunes hommes, après une injection de Pfizer ou de Moderna, des vaccins basés sur la technologie de l’ARNm.
La dernière mise à jour de la FDA fait suite à un examen approfondi des informations et à la discussion du comité consultatif du CDC sur les pratiques d’immunisation réuni mercredi.
Pfizer et Moderna n’ont pas immédiatement répondu aux demandes de commentaires après les heures de bureau.
Source: reuters
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