Prospectele vaccinurilor au fost revizuite pentru a include un avertisment potrivit căruia reacţiile adverse sugerează riscuri crescute de miocardită şi pericardită, în special după a doua doză şi cu apariţia simptomelor în câteva zile după vaccinare, a transmis FDA.
Începând cu 11 iunie, peste 1.200 de cazuri de miocardită sau pericardită au fost înregistrate ca reacţii adverse la cele două seruri, din aproape 300 de milioane de doze de vaccin mARN administrate. Cazurile au fost întâlnite mai des în cazurile bărbaților, mai ales în săptămâna de după efectuarea celei de-a doua doză de vaccin.
Un grup de consultanţi al Centrului pentru Prevenirea şi Controlul bolilor a constatat că inflaţiile cardiace în cazul unor adolescenţi şi tineri adulţi au probabil legătură cu vaccinurile, însă beneficiile imunizării sunt mult mai mari decât riscurile, potrivit Reuters.
As part of our commitment to vigilant safety monitoring of #COVID19 vaccines, FDA updated the public on its ongoing evaluation of adverse event reports of myocarditis & pericarditis following vaccination with Moderna and Pfizer-BioNTech COVID-19 vaccines. https://t.co/xI8nzp1GEm pic.twitter.com/FlmaICfpQY
— U.S. FDA (@US_FDA) June 26, 2021
Pfizer, al cărei vaccin a fost autorizat în SUA pentru administrare de la vârsta de 12 ani, a transmis prin intermediul unui comunicat de presă că știe despre cazurile de miocardite şi pericardite apărute după vaccinarea cu vaccinul ARNm. Potrivit companiei, profilul beneficii/risc „rămâne pozitiv”.
La rândul său, Moderna a afirmat că are cunoştință despre informaţiile referitoare la cazurile de inflamaţie cardiacă şi că lucrează cu autorităţile de reglementare.
Peste 138 de milioane de americani au fost până în prezent complet vaccinaţi cu unul dintre cele două vaccinuri ARNm, potrivit datelor CDC.
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