SARS-CoV-2 XBB.1.5和季节性流感疫苗联合使用的安全性：来自观察性主动监测研究的数据普利亚（意大利），2023/2024赛季

IF 2.4 3区医学 Q3 VIROLOGY

Virology Pub Date : 2025-06-20 DOI:10.1016/j.virol.2025.110613

Stefanizzi Pasquale , Lorenza Moscara , Claudia Palmieri , Andrea Martinelli , Silvia Fontanelli , Cristina Bellomo , Giuseppe Spinelli , Tafuri Silvio

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引用次数: 0

摘要

意大利卫生部建议在2023/2024年流感季节联合接种流感疫苗和SARS-CoV-2疫苗。卫生保健工作者和学生被确定为疫苗接种运动的目标类别，并强调了实施药物警戒计划的重要性。我们旨在通过一项主动监测研究，研究mRNA SARS-CoV-2疫苗（XBB.1.5）、细胞基和蛋生长四价灭活流感疫苗（QIVc、QIVe）的安全性，以及共同给药对免疫后不良事件（AEFIs）的影响。在这项前瞻性观察队列研究中，纳入了在2023年10月17日至12月31日期间接受XBB.1.5、QIVc或QIVe治疗的参与者，无论是单独给药还是联合给药。收集疫苗接种后7天内发生的急性呼吸道感染事件，以调查SARS-CoV-2和流感疫苗联合或单独接种时的反应性特征[14]医护人员完成研究随访。其中34.12%的人接受了流感（QIVc或QIVe）和XBB.1.5疫苗的联合接种；63.12%的人单独接种流感疫苗（主要是QIVc），只有2.8%的人单独接种SARS-CoV-2疫苗。aefi报告率（RR）为61.3/100（622/1014）。所有组中最常见的aefi是注射部位疼痛/瘙痒和虚弱/不适。仅发生3例严重急性脑梗死（RR0.30/100）。单独使用XBB.1.5或与QIVe或QIVc联合使用XBB.1.5与AEFIs的高风险相关(or 4.82；95% ci 3.48-6.66；p & lt;0.001)。男性可降低AEFIs的发生风险(优势比0.49；95% ci 0.37-0.65；p & lt;0.001)。这项研究证实了SARS-CoV-2和流感疫苗的安全性，即使是共同接种也是如此。然而，卫生保健当局和政策制定者应调查卫生保健工作者对SARS-CoV-2疫苗接种和共同给药策略的担忧。

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Safety of SARS-CoV-2 XBB.1.5 and seasonal influenza vaccines co-administration: data from a perspective observational active surveillance study. Puglia (Italy), season 2023/2024

Italian Ministry of Health recommended co-administration of influenza and SARS-CoV-2 vaccines for the 2023/2024 influenza season. Healthcare workers and students were identified as target categories for the vaccination campaign and the importance to implement pharmacovigilance programs was highlighted. We aimed to investigate the safety profile of mRNA SARS-CoV-2 vaccine (XBB.1.5), cell-based and egg-grown quadrivalent inactivated influenza vaccines (QIVc, QIVe) and the influence of co-administration on Adverse Events Following Immunization (AEFIs) via an active surveillance study.

In this prospective observational cohort study, participants who received XBB.1.5, QIVc or QIVe, between October 17th-December 31st, 2023, either alone or in co-administration, were enrolled. AEFIs occurred in the first 7-days post-vaccination period were collected to investigate the reactogenicity profile of SARS-CoV-2 and influenza vaccines in co-administration or alone.

1014 HCWs completed the study follow-up. Of these, 34.12 % received co-administered influenza (QIVc or QIVe) and XBB.1.5 vaccine; 63.12 % either influenza vaccine alone (mostly QIVc) and only 2.8 % SARS-CoV-2 vaccine alone. The AEFIs reporting rate (RR) was 61.3/100 completed follow-ups (622/1014). The most-common AEFIs across all groups were injection site pain/itching and asthenia/malaise. Only 3 serious AEFIs occurred (RR0.30/100). Administration of XBB.1.5, either alone or co-administered with QIVe or QIVc, was associated with a higher risk of AEFIs (OR 4.82; 95 % CI 3.48–6.66; p < 0.001). Male sex was found to decrease the risk of AEFIs (OddsRatio 0.49; 95 %CI 0.37–0.65; p < 0.001).

This study confirmed the safety profile of both SARS-CoV-2 and influenza vaccines, even when co-administered. However, healthcare authorities and policymakers should investigate HCWs concerns about SARS-CoV-2 vaccination and co-administration strategies.

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来源期刊

Virology 医学-病毒学

CiteScore

6.00

自引率

0.00%

发文量

157

审稿时长

50 days

期刊介绍： Launched in 1955, Virology is a broad and inclusive journal that welcomes submissions on all aspects of virology including plant, animal, microbial and human viruses. The journal publishes basic research as well as pre-clinical and clinical studies of vaccines, anti-viral drugs and their development, anti-viral therapies, and computational studies of virus infections. Any submission that is of broad interest to the community of virologists/vaccinologists and reporting scientifically accurate and valuable research will be considered for publication, including negative findings and multidisciplinary work.Virology is open to reviews, research manuscripts, short communication, registered reports as well as follow-up manuscripts.