Hodel Katharine Valéria Saraiva, Fiuza Bianca Sampaio Dotto, Conceição Rodrigo Souza, Aleluia Augusto Cezar Magalhães, Pitanga Thassila Nogueira, Fonseca Larissa Moraes Dos Santos, Valente Camila Oliveira, Minafra-Rezende Cintia Silva, Machado Bruna Aparecida Souza
SENAI Institute of Innovation (ISI) in Health Advanced Systems (CIMATEC ISI SAS), SENAI CIMATEC University Center, Salvador 41650-010, Bahia State, Brazil.
Department of Medicine, College of Pharmacy, Federal University of Bahia, Salvador 40170-115, Bahia State, Brazil.
Pharmaceuticals (Basel). 2024 Jun 19;17(6):807. doi: 10.3390/ph17060807.
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.
药物警戒通过持续监测疫苗安全性在保障公众健康方面发挥核心作用,在疫苗犹豫的氛围中至关重要,因为公众信任至关重要。用于收集免疫后不良事件(AEFI)信息的药物警戒策略包括预注册数据、媒体报道、临床试验和社会报告。在临床试验期间早期发现AEFI对于进行全面的安全性分析以及在疫苗部署后预防严重反应至关重要。本综述强调了社会报告的重要性,包括社区成员、医护人员和制药公司的贡献。快速响应(QR)码等技术进步可以促进AEFI的及时报告。虽然疫苗显然是安全的,但不良事件的可能性使得上市后持续监测成为必要。然而,报告不足仍然是一个挑战,这凸显了公众参与药物警戒的关键作用。这篇叙述性综述全面审视并综合了病毒疫苗药物警戒的关键方面,并特别考虑了特定人群。我们探讨了适用的立法、与主要疫苗相关的AEFI范围,以及该领域药物警戒所面临的独特挑战和观点。