Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023-24 season.

IF 4.1 4区医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Human Vaccines & Immunotherapeutics Pub Date : 2025-12-01 Epub Date: 2025-03-18 DOI:10.1080/21645515.2025.2475616

Marina Amaral de Avila Machado, Sophie Gallo, Alexander Goldstein, Parth Vachhani, Reddappa Maniganahally Byrareddy, Anu Kantele, Hanna Välimaa, Jörg Schelling

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Abstract

Enhanced Passive Safety Surveillance was used to detect safety signals before the peak period of immunization with quadrivalent inactivated influenza vaccines (IIV4) in Finland (standard dose [SD]) and Germany (high dose [HD]) in the 2023-24 season. The primary objective was to evaluate adverse drug reactions (ADRs) occurring ≤7 days following IIV4 vaccination. Enrolled participants were vaccinated in routine clinical care settings and encouraged to report ADRs. Exposure data and ADR reports were collected in a near real-time manner using an electronic system. Vaccinee reporting rate (RR) with 95% confidence interval (CI) was calculated as the number of vaccinees reporting ≥ 1 ADR divided by total number of vaccinees. In Finland for SD-IIV4, among 1,003 vaccinees aged ≥ 6 months, 81 reported a total of 192 suspected ADRs occurring ≤ 7 days following vaccination (vaccinee RR 8.08%; 95% CI 6.46, 9.94). In Germany for HD-IIV4, among 1,075 vaccinees aged ≥ 60 years, 15 reported 46 ADRs that occurred in ≤ 7 days of vaccination (vaccinee RR 1.40%; 95% CI 0.78, 2.29). No safety signal was detected during this surveillance. The 2023-24 season surveillance did not suggest any clinically significant changes in safety profile compared with previously reported safety data for SD-IIV4 and HD-IIV4.

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芬兰和德国在2023-24流感季节加强了标准剂量和高剂量流感疫苗的被动安全性监测。

在2023-24年流感季，芬兰（标准剂量[SD]）和德国（高剂量[HD]）的四价灭活疫苗（IIV4）免疫高峰期前，采用增强被动安全监测方法检测安全信号。主要目的是评估IIV4疫苗接种后≤7天发生的药物不良反应（adr）。入选的参与者在常规临床护理环境中接种疫苗，并鼓励他们报告不良反应。使用电子系统以近乎实时的方式收集暴露数据和不良反应报告。接种者报告率（RR）的95%置信区间（CI）计算为报告≥1个不良反应的接种者人数除以总接种者人数。在芬兰，1003名年龄≥6个月的SD-IIV4疫苗接种者中，81人报告了接种后≤7天发生的192例疑似adr(疫苗接种者RR 8.08%；95% ci 6.46, 9.94)。在德国，1075名年龄≥60岁的HD-IIV4疫苗接种者中，15人报告了46例不良反应，发生在接种后≤7天(疫苗接种者RR 1.40%；95% ci 0.78, 2.29)。在此监视期间未检测到安全信号。与之前报道的SD-IIV4和HD-IIV4的安全性数据相比，2023-24季监测未显示任何临床显著的安全性变化。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Human Vaccines & Immunotherapeutics BIOTECHNOLOGY & APPLIED MICROBIOLOGY-IMMUNOLOGY

CiteScore

7.90

自引率

8.30%

发文量

489

审稿时长

3-6 weeks

期刊介绍： (formerly Human Vaccines; issn 1554-8619) Vaccine research and development is extending its reach beyond the prevention of bacterial or viral diseases. There are experimental vaccines for immunotherapeutic purposes and for applications outside of infectious diseases, in diverse fields such as cancer, autoimmunity, allergy, Alzheimer’s and addiction. Many of these vaccines and immunotherapeutics should become available in the next two decades, with consequent benefit for human health. Continued advancement in this field will benefit from a forum that can (A) help to promote interest by keeping investigators updated, and (B) enable an exchange of ideas regarding the latest progress in the many topics pertaining to vaccines and immunotherapeutics. Human Vaccines & Immunotherapeutics provides such a forum. It is published monthly in a format that is accessible to a wide international audience in the academic, industrial and public sectors.