Cases of acquired hemophilia A following COVID-19 vaccines: Cogent safety signal or possible reporting/detection bias? Preliminary evidence from Tuscany, Italy

被引：2

作者：

Roberto, Giuseppe ^{[1
]}

Paoletti, Olga ^{[1
]}

Ferraro, Sara ^{[2
]}

Hyeraci, Giulia ^{[1
]}

Franchini, Massimo ^{[3
]}

Gini, Rosa ^{[1
]}

Focosi, Daniele ^{[4
]}

Tuccori, Marco ^{[2
]}

机构：

[1] Agenzia Regionale Sanita Toscana, Epidemiol unit, Florence, Italy

[2] Univ Pisa, Dept Clin & Expt Med, Pharmacovigilance Unit, Pisa, Italy

[3] Carlo Poma Hosp, Div Hematol & Transfus Med, Mantua, Italy

[4] Univ Hosp Pisa, North West Local Hlth Unit, Blood Bank Tuscany, Pisa, Italy

来源：

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY | 2023年 / 32卷 / 06期

关键词：

acquired hemophilia A; coagulopathy; COVID-19; vaccines; pharmacovigilance; vaccine safety;

D O I：

10.1002/pds.5615

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

PurposeSeveral case reports of acquired hemophilia A (AHA) following COVID-19 vaccines were recently published. A possible increased incidence of AHA during the COVID-19 vaccination campaign was also suggested. We aimed at generating evidence for the preliminary assessment of the association between AHA and COVID-19 vaccination through an ecological study in one Italian region, Tuscany. MethodsAn ecological study was performed using the population-based administrative data source of Tuscany. Per each year between 2017 and 2021, we included patients aged 5+ and active into the database as of January 1. Temporal patterns of annual incidence of possible AHA cases and AHA-tested patients were respectively observed. The rates of possible AHA cases per AHA-tested patients were calculated in 2021 and 2017-2019, respectively (calendar year 2020 was excluded because non-representative of the pre-pandemic era). Age-sex standardization was applied. Poisson's 95% confidence intervals (95% CI) were estimated. Statically significant differences were defined as absence of 95% CI overlap. ResultsIn 2021, standardized incidence of both possible AHA cases (5.6/million subjects/year; 95% CI = 3.4-8.7) and AHA-tested patients (60.7/1000 subjects/year; 95% CI = 60.4-60.9) showed the lowest point estimates, though only the latter was statistically different compared to previous calendar years. The standardized rate of possible AHA cases per AHA-tested patients was 9.2/100000 (95% CI = 5.6-14.3) in 2021 and 12.5/100000 (95% CI = 8.2-18.1) during 2017-2019. ConclusionsThese preliminary findings do not support the hypothesis of an increased incidence of AHA cases during the COVID-19 vaccination campaign. However, in 2021, the still ongoing healthcare access restrictions might have contributed to the low incidence of AHA and laboratory tests observed. Therefore, large-scale multi-database studies are warranted.

引用

页码：694 / 699

页数：6