Vaccines Safety in Children and in General Population: A Pharmacovigilance Study on Adverse Events Following Anti-Infective Vaccination in Italy
Vaccines Safety in Children and in General Population: A Pharmacovigilance Study on Adverse Events Following Anti-Infective Vaccination in Italy
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DOI：
10.3389/fphar.2019.00948
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发表时间：
2019-08-30
影响因子：
5.6
通讯作者：
Vannacci, Alfredo
中科院分区：
文献类型：
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作者：
Lombardi, Niccolo;Crescioli, Giada;Vannacci, Alfredo
背景：对免疫不良事件的关注（AEFI）和缺乏科学证据支持的反疫苗运动可能会减少普通人群的疫苗接种率。因此，本研究的目的是在一般人群（所有年龄组）中，从频率、可预防性和严重性方面描述急性脑损伤的特征，并确定其在儿童中的严重性的预测因素。方法：对2017年1月1日至12月31日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报告进行回顾性研究。收集患者特征、疑似疫苗和AEFI描述。因果关系和可预防性分别使用WHO和Schumock和Thornton算法进行评估。采用Logistic回归估计儿童急性脑损伤严重程度潜在预测因素的报告优势比。结果：共收集疑似AEFI报告223份，其中以非严重报告占76.7%。报告大多与一种疫苗有关，中位数为两至五种毒株/类毒素。同时给药的毒株/类毒素总数和过敏原的存在与AEFI的严重程度无关。考虑到接种剂量大的疫苗（>= 60000剂），严重急性呼吸道感染报告的估计发生率总是很低，在0.01至0.2/ 1000剂之间。24种疫苗（8,993剂）与任何AEFI无关。结论：本研究结果显示急性脑损伤非常罕见；其中绝大多数不严重，尽管有反疫苗运动的说法，但同时接种疫苗是安全的，不会影响报告发生严重急性脑损伤的风险，特别是在儿童中。
Background: 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.Methods: 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.Results: 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.Conclusion: 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.