PDF(Pubmed)
Abstract：
Pharmacovigilance plays a central role in safeguarding public health by continuously monitoring the safety of vaccines, being critical in a climate of vaccine hesitancy, where public trust is paramount. Pharmacovigilance strategies employed to gather information on adverse events following immunization (AEFIs) include pre-registration data, media reports, clinical trials, and societal reporting. Early detection of AEFIs during clinical trials is crucial for thorough safety analysis and preventing serious reactions once vaccines are deployed. This review highlights the importance of societal reporting, encompassing contributions from community members, healthcare workers, and pharmaceutical companies. Technological advancements such as quick response (QR) codes can facilitate prompt AEFI reporting. While vaccines are demonstrably safe, the possibility of adverse events necessitates continuous post-marketing surveillance. However, underreporting remains a challenge, underscoring the critical role of public engagement in pharmacovigilance. This narrative review comprehensively examines and synthesizes key aspects of virus vaccine pharmacovigilance, with special considerations for specific population groups. We explore applicable legislation, the spectrum of AEFIs associated with major vaccines, and the unique challenges and perspectives surrounding pharmacovigilance in this domain.
摘要：
药物警戒通过持续监测疫苗的安全性，在保障公众健康方面发挥着核心作用。在疫苗犹豫的环境中至关重要，公众信任是最重要的。用于收集免疫后不良事件信息的药物警戒策略（AEFI）包括预注册数据，媒体报道,临床试验,和社会报道。在临床试验期间早期发现AEFI对于彻底的安全性分析和一旦部署疫苗预防严重反应至关重要。这篇综述强调了社会报道的重要性，包括社区成员的贡献，医护人员,和制药公司。诸如快速响应(QR)码之类的技术进步可以促进及时的AEFI报告。虽然疫苗是安全的，不良事件的可能性需要持续的上市后监测.然而,漏报仍然是一个挑战，强调公众参与药物警戒的关键作用。这篇叙述性综述全面审查和综合了病毒疫苗药物警戒的关键方面，对特定人群有特殊考虑。我们探索适用的立法，与主要疫苗相关的AEFI谱，以及围绕这一领域药物警戒的独特挑战和观点。
