Di Lorenzo Antonio, Bianchi Francesco Paolo, Martinelli Andrea, Lattanzio Sabrina, Carbonara Antonella, Diella Giusy, Tafuri Silvio, Stefanizzi Pasquale
Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Piazza Giulio Cesare 11, 70124 Bari, Italy.
Vaccines (Basel). 2021 Nov 9;9(11):1302. doi: 10.3390/vaccines9111302.
Adolescence is a critical period for immunization, in which the adhesion rate to recommended vaccinations is often lower than desired. Since the safety of new vaccines is one of the most important factors determining vaccination hesitancy, post-marketing surveillance of adverse events following immunization (AEFIs) is recommended by the World Health Organization (WHO) to better understand the safety of these drugs. This report describes AEFIs notified in Puglia (Italy) after recommended vaccinations in adolescents aged 12 to 18 years in 2016-2020 to determine the safety profile of these products in a real-life scenario. This is a retrospective observational study. Data were gathered from the list of AEFIs notified in subjects between 12 and 18 years of age following administration of recommended vaccines in Puglia in 2016-2020. AEFIs were classified according to the WHO's decisional algorithm, and causality assessment was carried out for serious AEFIs. From 2016 to 2020, 323,627 doses of vaccine were administered to adolescents in Puglia and 50 AEFIs were reported (reporting rate: 15.4 × 100,000 doses). Of these, 17 (34.0%) were classified as serious, and causality assessment identified 13 of them (76.5%) as vaccine related. The most common symptoms were local reactions, fever and neurological symptoms. No deaths were notified. The benefits of immunization in adolescents appear to be greater than the risk of AEFIs for all studied vaccines; in fact, AEFIs occur in less than 0.1‰ of patients and are generally mild and self-limiting.
青春期是免疫接种的关键时期，在此期间，对推荐疫苗接种的依从率往往低于预期。由于新疫苗的安全性是决定疫苗犹豫的最重要因素之一，世界卫生组织（WHO）建议对免疫接种后不良事件（AEFI）进行上市后监测，以更好地了解这些药物的安全性。本报告描述了2016 - 2020年意大利普利亚地区12至18岁青少年接种推荐疫苗后报告的AEFI，以确定这些产品在实际情况下的安全性概况。这是一项回顾性观察研究。数据收集自2016 - 2020年普利亚地区12至18岁人群接种推荐疫苗后报告的AEFI清单。AEFI根据WHO的决策算法进行分类，并对严重AEFI进行因果关系评估。2016年至2020年，普利亚地区共向青少年接种了323,627剂疫苗，报告了50例AEFI（报告率：15.4/10万剂）。其中，17例（34.0%）被分类为严重AEFI，因果关系评估确定其中13例（76.5%）与疫苗有关。最常见的症状是局部反应、发热和神经症状。未报告死亡病例。对于所有研究的疫苗，青少年免疫接种的益处似乎大于AEFI的风险；事实上，AEFI在不到0.1‰的患者中发生，且通常为轻度且具有自限性。
