Sfondo:
In seguito al lancio delle iniezioni di Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 e Janssen Ad26.COV2.S per la malattia da coronavirus 2019 (COVID-19) negli Stati Uniti, milioni di individui hanno riportato eventi avversi (EA) utilizzando il sistema di segnalazione degli eventi avversi dei vaccini (VAERS). L’obiettivo di questa analisi è descrivere i dati sulla miocardite nel VAERS e nei vaccini COVID-19 come potenziali determinanti della miocardite.
Metodi:
Abbiamo utilizzato i dati VAERS per esaminare la frequenza delle segnalazioni di miocardite dall’inizio della campagna di vaccinazione di massa e li abbiamo confrontati con i valori storici dei dati VAERS e sulla somministrazione del vaccino COVID-19 dal database Our World in Data. Abbiamo esaminato le segnalazioni di miocardite nel VAERS nel contesto di sesso, età e dose. L’analisi statistica è stata effettuata utilizzando il test t di Student per determinare differenze statisticamente significative tra le età degli eventi avversi (EA) di miocardite e il test chi-quadrato per determinare le relazioni tra variabili categoriali con significatività statistica.
Risultati:
Abbiamo riscontrato che il numero di segnalazioni di miocardite nel VAERS dopo la vaccinazione COVID-19 nel 2021 era 223 volte superiore alla media di tutti i vaccini combinati negli ultimi 30 anni. Ciò ha rappresentato un aumento del 2500% nel numero assoluto di segnalazioni nel primo anno della campagna se si confrontano i valori storici prima del 2021. I dati demografici hanno rivelato che la miocardite si è verificata soprattutto nei giovani (50%) e nei maschi (69%). Un totale del 76% dei casi ha comportato cure di emergenza e ricovero ospedaliero. Sul totale delle segnalazioni di miocardite, 92 individui sono morti (3%). La miocardite era più probabile dopo la dose 2 (p < 0,00001) e gli individui di età inferiore a 30 anni avevano maggiori probabilità di contrarre la miocardite rispetto agli individui di età superiore a 30 (p < 0,00001).
Conclusione:
La vaccinazione contro il COVID-19 è fortemente associata a un grave segnale avverso alla sicurezza della miocardite, in particolare nei bambini e nei giovani adulti, con conseguente ospedalizzazione e morte. Ulteriori indagini sui meccanismi alla base della miocardite indotta dal vaccino COVID-19 sono indispensabili per creare strategie di mitigazione efficaci e garantire la sicurezza dei programmi di vaccinazione COVID-19 tra le popolazioni.
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