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现实世界中与BNT162b2和AZD1222疫苗相关的不良事件:意大利一家单一疫苗中心的监测报告

Adverse Events Associated with BNT162b2 and AZD1222 Vaccines in the Real World: Surveillance Report in a Single Italian Vaccine Center.

作者信息

Costantino Maria, Sellitto Carmine, Conti Valeria, Corbi Graziamaria, Marongiu Francesco, Genovese Giovanni, Moccia Giuseppina, Capunzo Mario, Borrelli Anna, Pagliano Pasquale, Farroni Mario, Lombardi Grazia Maria, Elberti Maria Giovanna, Filippelli Amelia, De Caro Francesco

机构信息

Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, 84081 Baronissi, Italy.

Clinical Pharmacology Unit, University Hospital "San Giovanni di Dio e Ruggi d'Aragona", 84121 Salerno, Italy.

出版信息

J Clin Med. 2022 Mar 4;11(5):1408. doi: 10.3390/jcm11051408.

Abstract

AIM

Despite huge efforts in developing specific drugs, vaccination represents the only effective strategy against COVID-19. Efficacy and safety of the COVID-19 vaccines were established during clinical trials. Nonetheless, it is very important to perform continuous surveillance. This observational study aimed to report potential Adverse Events Following Immunization (AEFI) following the first dose of two different COVID-19 vaccines, BNT162b2 and AZD1222.

METHODS AND RESULTS

Subjects who underwent vaccination at the vaccine center of the University Hospital of Salerno, Italy, were interviewed using an ad hoc questionnaire. AZD-vac group ( = 175) who received AZD1222 had a higher number of AEFI than the BNT-vac group ( = 1613) who received BNT162b2 (83% vs. 42%). The most frequent AEFI associated with AZD1222 and BNT162b2 were fever and pain at the injection site, respectively. The AZD-vac group used drugs to contrast AEFI more frequently than the BNT-vac group. In the BNT-vac group, there was a higher incidence of AEFI in women than in men (26.2% vs. 15.8%, = 0.01), while no gender-related difference was observed in the AZD-vac group.

CONCLUSIONS

AZD1222 and BNT162b2 vaccines show a good safety profile. Based on our results and literature data, there are no reasons to justify the reluctance that persists towards immunization.

摘要

目的

尽管在研发特效药物方面付出了巨大努力,但接种疫苗仍是对抗新冠病毒的唯一有效策略。新冠疫苗的有效性和安全性在临床试验期间已得到确立。尽管如此,持续监测仍非常重要。这项观察性研究旨在报告接种两种不同新冠疫苗(BNT162b2和AZD1222)第一剂后的潜在免疫接种后不良事件(AEFI)。

方法与结果

在意大利萨勒诺大学医院疫苗中心接种疫苗的受试者使用专门设计的问卷进行了访谈。接种AZD1222的AZD - vac组(n = 175)的AEFI数量高于接种BNT162b2的BNT - vac组(n = 1613)(83%对42%)。与AZD1222和BNT162b2相关的最常见AEFI分别是发热和注射部位疼痛。AZD - vac组比BNT - vac组更频繁地使用药物来对抗AEFI。在BNT - vac组中,女性的AEFI发生率高于男性(26.2%对15.8%,P = 0.01),而在AZD - vac组中未观察到与性别相关的差异。

结论

AZD1222和BNT162b2疫苗显示出良好的安全性。根据我们的结果和文献数据,没有理由为持续存在的对接种疫苗的抵触情绪辩解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d399/8911524/817f9974b15d/jcm-11-01408-g001a.jpg

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