Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India.
Expert Opin Drug Saf. 2024 Jul;23(7):855-867. doi: 10.1080/14740338.2024.2359616. Epub 2024 May 30.
Vaccine-associated paralytic poliomyelitis (VAPP) is a rare adverse event of oral poliovirus vaccines (OPV), particularly affecting immunodeficient individuals.
This study aimed to (1) Assess the association between OPV and VAPP using Vaccine Adverse Event Reporting System (VAERS) database (2) Outline patient characteristics and risk factors associated with the occurrence of VAPP in OPV recipients through a systematic review of case reports and case series. A disproportionality analysis was conducted using the data from VAERS, encompassing adverse events reported from 1990 till February 2023. Additionally, we conducted a systematic review of case reports and case series using PubMed, Scopus, and Embase databases.
The VAERS data revealed 130 VAPP reports among 1,739,903 OPV linked adverse events, with year 2010 reporting the strongest association. The systematic review of 37 studies highlighted VAPP occurrence within 2 months to 4 years post-vaccination, typically with acute flaccid paralysis. Immunodeficiency and perianal abscess emerged as major risk factors. Out of the 37 included studies, 27 showed consistent causal association of VAPP with OPV using WHO-AEFI causality assessment tool.
The study emphasized the seriousness of VAPP and highlights its association with OPV, identifying immunodeficiency as a prominent contributor to VAPP manifestation.
疫苗相关麻痹性脊髓灰质炎(VAPP)是口服脊髓灰质炎疫苗(OPV)的罕见不良反应,尤其影响免疫功能低下者。
本研究旨在:(1)利用疫苗不良事件报告系统(VAERS)数据库评估 OPV 与 VAPP 的相关性;(2)通过对病例报告和病例系列的系统回顾,总结 OPV 接种者发生 VAPP 的患者特征和相关风险因素。利用 VAERS 数据(涵盖 1990 年至 2023 年 2 月报告的不良事件)进行比例失调分析。此外,我们还利用 PubMed、Scopus 和 Embase 数据库进行了病例报告和病例系列的系统回顾。
VAERS 数据显示,在 1739903 例与 OPV 相关的不良事件中,有 130 例报告为 VAPP,其中 2010 年的关联性最强。对 37 项研究的系统回顾显示,VAPP 发生在接种疫苗后 2 个月至 4 年内,通常表现为急性弛缓性麻痹。免疫功能低下和肛周脓肿是主要的风险因素。在纳入的 37 项研究中,有 27 项研究使用世卫组织 AEFI 因果关系评估工具显示 VAPP 与 OPV 之间存在一致的因果关系。
本研究强调了 VAPP 的严重性及其与 OPV 的关联,并指出免疫功能低下是 VAPP 发生的主要原因。