Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the 2022/23 influenza season.

IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-03-06 DOI:10.1080/21645515.2024.2322196
Marina Amaral de Avila Machado, Sonja Gandhi-Banga, Sophie Gallo, Tathyana Giannotti Cousseau, Reddappa Maniganahally Byrareddy, Markku Nissilä, Jörg Schelling, Celine Monfredo
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Abstract

Enhanced Passive Safety Surveillance (EPSS) was conducted for quadrivalent inactivated split-virion influenza vaccines (IIV4) in Germany (high dose [HD]) and Finland (standard dose [SD]) for the northern hemisphere (NH) 2022/23 influenza season. The primary objective was to assess adverse events following immunization (AEFI) occurring ≤7 days post-vaccination. In each country, the EPSS was conducted at the beginning of the NH influenza season. Exposure information was documented using vaccination cards (VC), and AEFI were reported via an electronic data collection system or telephone. AEFI were assessed by seriousness and age group (Finland only). The vaccinee reporting rate (RR) was calculated as the number of vaccinees reporting ≥ 1 AEFI divided by the total vaccinees. In Germany, among 1041 vaccinees, there were 31 AEFI (ten vaccinees) during follow-up, including one serious AEFI. Of 16 AEFI (six vaccinees) with reported time of onset, 15 occurred ≤7 days post-vaccination (RR 0.58%, 95% confidence interval [CI] 0.21, 1.25), which was lower than the 2021/22 season (RR 1.88%, 95% CI: 1.10, 3.00). In Finland, among 1001 vaccinees, there were 142 AEFI (51 vaccinees) during follow-up, none of which were serious. Of 133 AEFI (48 vaccinees) with time of onset reported, all occurred ≤7 days post-vaccination (RR 4.80%, 95% CI: 3.56, 6.31), which was similar to the 2021/22 season (RR 4.90%, 95% CI: 3.65, 6.43). The EPSS for HD-IIV4 and for SD-IIV4 in the 2022/23 influenza season did not suggest any clinically relevant changes in safety beyond what is known/expected for IIV4s.

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德国和芬兰在 2022/23 流感季节加强对高剂量和标准剂量四价灭活分裂病毒流感疫苗的被动安全性监测。
针对北半球(NH)2022/23流感季节,在德国(高剂量[HD])和芬兰(标准剂量[SD])对四价灭活分裂病毒流感疫苗(IIV4)进行了强化被动安全监测(EPSS)。首要目标是评估接种后7天内发生的免疫接种不良事件(AEFI)。在每个国家,EPSS都是在北半球流感季节开始时进行的。暴露信息通过疫苗接种卡(VC)记录,AEFI则通过电子数据收集系统或电话报告。AEFI 按严重程度和年龄组进行评估(仅芬兰)。接种者报告率 (RR) 的计算方法是:报告 AEFI ≥ 1 例的接种者人数除以接种者总人数。在德国的 1041 名接种者中,有 31 人(10 名接种者)在随访期间发生了 AEFI,其中包括 1 例严重 AEFI。在报告发病时间的 16 例 AEFI(6 名接种者)中,15 例发生在接种后 7 天以内(RR 0.58%,95% 置信区间 [CI] 0.21,1.25),低于 2021/22 季度(RR 1.88%,95% 置信区间:1.10,3.00)。在芬兰的 1001 名接种者中,有 142 例 AEFI(51 名接种者)在随访期间发生,其中没有一例是严重的。在报告了发病时间的 133 例 AEFI(48 例接种者)中,全部发生在接种后 7 天以内(RR 4.80%,95% CI:3.56, 6.31),与 2021/22 季度(RR 4.90%,95% CI:3.65, 6.43)相似。在2022/23流感季节,HD-IIV4和SD-IIV4的EPSS表明,除了已知/预期的IIV4之外,安全性没有任何临床相关变化。
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来源期刊
Human Vaccines & Immunotherapeutics
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.
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