Okada Yusuke, Sakai Ryota, Sato-Fitoussi Marie, Nodera Marika, Yoshinaga Shoichi, Shibata Akiko, Kurasawa Takahiko, Kondo Tsuneo, Amano Koichi
Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.
Front Med (Lausanne). 2021 Sep 30;8:751598. doi: 10.3389/fmed.2021.751598. eCollection 2021.
Immune thrombocytopenia is an autoimmune disease that can cause bleeding in severe cases. Although available published data do not associate the BNT162b2 vaccine (Pfizer-BioNTech) with the risk of developing thrombocytopenia, the ChAdOx1 nCov-19 vaccine has raised concerns about its potential link with thrombosis and thrombocytopenia. We would like to clarify whether the BNT162b2 vaccine administration may interfere with pre-existing conditions and whether it may cause a risk of thrombocytopenia. Herein, we report three cases of post-vaccine thrombocytopenia among patients with rheumatoid arthritis (RA); one case in which a causal relationship cannot be ruled out with the BNT162b2 vaccine was officially announced. Furthermore, we reviewed reports of adverse events and death cases with a focus on thrombocytopenia and hemorrhages, following vaccination with BNT162b2 in Japan between February 17, 2021 and July 16, 2021, as reported by the Ministry of Health, Labour, and Welfare within the general population. The three cases in this report share the common features of old age, RA, chronic renal failure or hypertension, and pre-existing mild thrombocytopenia at baseline. A total of 746 death cases were reported during this time period, with death by bleeding accounting for 8.8% of the total deaths, of which 84.8% were cranial and statistically higher in young women than among elderly women. The risk-benefit ratio of the vaccine needs to be reconsidered based on high- and low-risk population types and ethnicity. To do so, the expansion of the pharmacovigilance system for BNT162b2 vaccination is urgently required worldwide.
免疫性血小板减少症是一种自身免疫性疾病，严重时可导致出血。尽管现有已发表的数据未将BNT162b2疫苗（辉瑞-生物科技公司）与血小板减少症的发生风险相关联，但ChAdOx1 nCov-19疫苗引发了人们对其与血栓形成和血小板减少症潜在关联的担忧。我们希望阐明接种BNT162b2疫苗是否会干扰既往存在的疾病，以及是否会引发血小板减少症风险。在此，我们报告了3例类风湿关节炎（RA）患者接种疫苗后出现血小板减少症的病例；其中1例已正式公布，无法排除与BNT162b2疫苗存在因果关系。此外，我们还审查了日本厚生劳动省报告的2021年2月17日至2021年7月16日期间普通人群接种BNT162b2疫苗后，重点关注血小板减少症和出血情况的不良事件及死亡病例报告。本报告中的3例病例具有老年、RA、慢性肾功能衰竭或高血压以及基线时存在轻度血小板减少症的共同特征。在此期间共报告了746例死亡病例，出血导致的死亡占总死亡人数的8.8%，其中84.8%为颅内出血，且年轻女性的发生率在统计学上高于老年女性。需要根据高风险和低风险人群类型及种族重新考虑疫苗的风险效益比。为此，全球迫切需要扩大针对BNT-162b2疫苗接种的药物警戒系统。
