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隐匿性疫苗相关不良事件:亟需新的疫苗安全监测范式以提高公众对疫苗的信任度。

Cryptic vaccine-associated adverse events: The critical need for a new vaccine safety surveillance paradigm to improve public trust in vaccines.

作者信息

Poland Gregory A, Black Steven

机构信息

Mayo Vaccine Research Group, General Internal Medicine, Mayo Clinic, Rochester, MN, United States.

Global Vaccine Data Network, Auckland, New Zealand.

出版信息

Vaccine. 2024 Mar 19;42(8):1860-1862. doi: 10.1016/j.vaccine.2024.01.058. Epub 2024 Jan 30.

DOI:10.1016/j.vaccine.2024.01.058
PMID:38296703
Abstract

Vaccination is one of the most important public health tools in the prevention of infectious diseases, and in preserving life and health. While vaccines are generally safe and usually produce only transient side effects, other types of vaccine-associated adverse events do occur. Some of these reactions are immediate and easily observable or measurable, such as swelling at the injection site or a transient fever. Others however are not immediately obvious, or are even clinically "silent" or cryptic, making them challenging to identify and link directly to a vaccine. It is critical to be vigilant about rare, silent, or subtle reactions. Public health agencies and healthcare providers can play a much more favorable and vital role in establishing vaccine trust by enlarging the current vaccine safety paradigm, and in publishing and communicating, in full, these risks and benefits transparently to the public. While there are challenges in collecting and studying cryptic adverse events characterized by subjective symptoms without biomarkers, rigorous pharmacovigilance, continued research, and high-quality study designs can assist in better understanding and addressing these concerns - and in building public trust about vaccines and vaccine safety surveillance completeness.

摘要

疫苗接种是预防传染病、保护生命和健康的最重要的公共卫生工具之一。虽然疫苗总体上是安全的,通常只会产生短暂的副作用,但其他类型的疫苗相关不良事件确实会发生。其中一些反应是即时的,很容易观察到或测量到,比如注射部位肿胀或短暂发热。然而,其他一些反应并非立即显现,甚至在临床上是“无声的”或隐匿的,这使得它们难以识别并直接与疫苗联系起来。对罕见、无声或细微的反应保持警惕至关重要。公共卫生机构和医疗服务提供者可以通过扩大当前的疫苗安全范式,并向公众全面、透明地公布这些风险和益处,在建立疫苗信任方面发挥更有利且至关重要的作用。虽然在收集和研究以无生物标志物的主观症状为特征的隐匿不良事件方面存在挑战,但严格的药物警戒、持续的研究和高质量的研究设计有助于更好地理解和解决这些问题,并建立公众对疫苗和疫苗安全监测完整性的信任。

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