Ciccimarra Francesco, Luxi Nicoletta, Bellitto Chiara, L'Abbate Luca, Raethke Monika, van Hunsel Florence, Lieber Thomas, Mulder Erik, Riefolo Fabio, Dureau-Pournin Caroline, Farcas Andreea, Batel Marques Francisco, Morton Kathryn, Roy Debabrata, Sonderlichová Simona, Thurin Nicolas H, Villalobos Felipe, Sturkenboom Miriam C, Trifirò Gianluca
Department of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy.
Department of Medicine, University of Verona, 37134 Verona, Italy.
Vaccines (Basel). 2024 Feb 26;12(3):241. doi: 10.3390/vaccines12030241.
In all pivotal trials of COVID-19 vaccines, the history of previous SARS-CoV-2 infection was mentioned as one of the main exclusion criteria. In the absence of clinical trials, observational studies are the primary source for evidence generation. This study aims to describe the patient-reported adverse drug reactions (ADRs) following the first COVID-19 vaccination cycle, as well as the administration of booster doses of different vaccine brands, in people with prior SARS-CoV-2 infection, as compared to prior infection-free matched cohorts of vaccinees. A web-based prospective study was conducted collecting vaccinee-reported outcomes through electronic questionnaires from eleven European countries in the period February 2021-February 2023. A baseline questionnaire and up to six follow-up questionnaires collected data on the vaccinee's characteristics, as well as solicited and unsolicited adverse reactions. Overall, 3886 and 902 vaccinees with prior SARS-CoV-2 infection and having received the first dose or a booster dose, respectively, were included in the analysis. After the first dose or booster dose, vaccinees with prior SARS-CoV-2 infection reported at least one ADR at a higher frequency than those matched without prior infection (3470 [89.6%] vs. 2916 [75.3%], and 614 [68.2%] vs. 546 [60.6%], respectively). On the contrary side, after the second dose, vaccinees with a history of SARS-CoV-2 infection reported at least one ADR at a lower frequency, compared to matched controls (1443 [85.0%] vs. 1543 [90.9%]). The median time to onset and the median time to recovery were similar across all doses and cohorts. The frequency of adverse reactions was higher in individuals with prior SARS-CoV-2 infection who received Vaxzevria as the first dose and Spikevax as the second and booster doses. The frequency of serious ADRs was low for all doses and cohorts. Data from this large-scale prospective study of COVID-19 vaccinees could be used to inform people as to the likelihood of adverse effects based on their history of SARS-CoV-2 infection, age, sex, and the type of vaccine administered. In line with pivotal trials, the safety profile of COVID-19 vaccines was also confirmed in people with prior SARS-CoV-2 infection.
在所有新冠病毒疫苗的关键试验中，既往感染过严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的病史被列为主要排除标准之一。在缺乏临床试验的情况下，观察性研究是产生证据的主要来源。本研究旨在描述既往感染过SARS-CoV-2的人群在首个新冠病毒疫苗接种周期后以及接种不同品牌加强针后的患者报告的药物不良反应（ADR），并与未感染过的匹配疫苗接种队列进行比较。2021年2月至2023年2月期间，在11个欧洲国家开展了一项基于网络的前瞻性研究，通过电子问卷收集疫苗接种者报告的结果。一份基线问卷和多达六份随访问卷收集了疫苗接种者的特征数据以及主动和被动报告的不良反应。总体而言，分析纳入了3886名既往感染过SARS-CoV-2且接种了第一剂疫苗的疫苗接种者以及902名接种了加强针的疫苗接种者。在接种第一剂或加强针后，既往感染过SARS-CoV-2的疫苗接种者报告至少一种ADR的频率高于未感染过的匹配者（分别为3470例[89.6%]对2916例[75.3%]，以及614例[68.2%]对546例[60.6%]）。相反，在接种第二剂后，有SARS-CoV-2感染史的疫苗接种者报告至少一种ADR的频率低于匹配的对照组（1443例[85.0%]对1543例[90.9%]）。所有剂量和队列的不良反应发作中位时间和恢复中位时间相似。接受阿斯利康新冠疫苗（Vaxzevria）作为第一剂、辉瑞-BioNTech新冠疫苗（Spikevax）作为第二剂和加强针的既往感染过SARS-CoV-2的个体不良反应频率更高。所有剂量和队列的严重ADR频率都很低。这项针对新冠病毒疫苗接种者的大规模前瞻性研究的数据可用于告知人们基于其SARS-CoV-2感染史、年龄、性别和接种疫苗类型出现不良反应的可能性。与关键试验一致，既往感染过SARS-CoV-2的人群中新冠病毒疫苗的安全性也得到了证实。
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