Lombardi Niccolò, Crescioli Giada, Bettiol Alessandra, Tuccori Marco, Rossi Marco, Bonaiuti Roberto, Ravaldi Claudia, Levi Miriam, Mugelli Alessandro, Ricci Silvia, Lippi Francesca, Azzari Chiara, Bonanni Paolo, Vannacci Alfredo
Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy.
Tuscan Regional Centre of Pharmacovigilance, Florence, Italy.
Front Pharmacol. 2019 Aug 30;10:948. doi: 10.3389/fphar.2019.00948. eCollection 2019.
The concern for adverse events following immunization (AEFI) and anti-vaccination movements that lacked scientific evidence-based supports may reduce vaccine uptake in the general population. Thus, the aims of the present study were to characterize AEFI in general population (all age groups), in terms of frequency, preventability, and seriousness and to define predictors of their seriousness in children. A retrospective study was performed on suspected AEFI reports for children and adults who received any form of vaccinations, collected in Tuscany, Italy, between 1 January and 31 December 2017. Patients' characteristics, suspected vaccines, and AEFI description were collected. Causality and preventability were assessed using WHO and Schumock and Thornton algorithms, respectively. Logistic regression was used to estimate the reporting odds ratios of potential predictors of AEFI seriousness in children. A total of 223 suspected AEFI reports were collected, and the majority of them were defined as non-serious (76.7%). Reports were mostly related to one vaccine, and to a median of two to five strains/toxoids. The total number of simultaneously administered strains/toxoids and the presence of allergens did not correlate with AEFI seriousness. Considering vaccines with a high number of administered doses (≥60,000 doses), the rates estimated for serious AEFI reports were always very low, ranging between 0.01 and 0.2/1,000 doses. Twenty-four vaccines (8,993 doses) were not related to any AEFI. Results of present study showed that AEFI were very rare; the vast majority of them was non-serious and, despite the claims of anti-vaccination movements, the simultaneous administration of vaccines was safe and did not influence the risk of reporting a serious AEFI, particularly in children.
对缺乏科学证据支持的免疫接种后不良事件（AEFI）的担忧以及反疫苗运动可能会降低普通人群的疫苗接种率。因此，本研究的目的是从频率、可预防性和严重性方面描述普通人群（所有年龄组）中的AEFI，并确定儿童中AEFI严重性的预测因素。对2017年1月1日至12月31日期间在意大利托斯卡纳收集的接受任何形式疫苗接种的儿童和成人的疑似AEFI报告进行了回顾性研究。收集了患者特征、疑似疫苗和AEFI描述。分别使用世界卫生组织（WHO）以及舒莫克和桑顿算法评估因果关系和可预防性。使用逻辑回归估计儿童AEFI严重性潜在预测因素的报告比值比。共收集到223份疑似AEFI报告，其中大多数被定义为非严重（76.7%）。报告大多与一种疫苗相关，且中位数为两到五种菌株/类毒素。同时接种的菌株/类毒素总数和过敏原的存在与AEFI严重性无关。考虑到接种剂量较高（≥60,000剂）的疫苗，严重AEFI报告的估计发生率始终非常低，介于0.01至0.2/1000剂之间。24种疫苗（8993剂）与任何AEFI均无关。本研究结果表明，AEFI非常罕见；绝大多数AEFI是非严重的，并且尽管有反疫苗运动的说法，但同时接种疫苗是安全的，不会影响报告严重AEFI的风险，尤其是在儿童中。
