Grieshaber Vivien, Strumann Christoph, Holzwarth Sarah, Toepfner Nicole, von Meißner Wolfgang Carl Gustav, Konstantopoulos Nikos, von Poblotzki Martina, Hensel Kai O, Moor Matthias B, Chao Cho-Ming
Universität Witten/-Herdecke, Fakultät für Gesundheit, Department für Humanmedizin, Witten; Institute of Family Medicine, University Medical Center Schleswig-Holstein, Campus Luebeck, Luebeck, Germany; Department of Pediatrics, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany; Hausärzte am Spritzenhaus, Baiersbronn; Praxis die Kinderärzte, Munich; Department of Clinical Sience, Intervention and Technology (CLINTEC), Division of Renal Medicine, Karolinska Institutet, Stockholm, Schweden; Department of Laboratory Medicine (LABMED), Devision of Pathology, Karolinska Institutet, Stockholm, Sweden; Cardio-Pulmonary Institute (CPI), Universität Gießen and Marburg Lung Center (UGMLC), Mitglied des deutschen Zentrums für Lungenforschung (DZL), Justus Liebig Universität Gießen, Gießen; St. Louise Klinik für Kinder- und Jugendmedizin, Paderborn.
Dtsch Arztebl Int. 2025 May 16;122(10):257-263. doi: 10.3238/arztebl.m2025.0032.
The available safety data on the use of the messenger RNA-based COVID-19 vaccine BNT162b2 in persons under age 18 are limited to observation periods of up to six months.
In a retrospective, cross-sectional study, we evaluated self-reported vaccine tolerability (SRVT) in eleven symptom categories among persons who were under 18 years old when they received at least one dose of the BNT162b2 vaccine in Germany on or after 1 October 2021. Data were collected online from the parents or legal guardians of the vaccinated persons. Individual participation codes enabled authenticated and pseudonymous participation in the survey. In a subgroup, the SRVT of BNT162b2 was compared with that of vaccines against other illnesses than SARS-CoV-2 (e.g., influenza).
Tolerability data were obtained from 3228 persons with a median age of 5.7 years; 49.6% were male. The median period of observation was 524 days. The more commonly reported undesired effects of the vaccine, mainly in older subjects, were local reactions- pain (49.7%), redness (23%)-with less common systemic symptoms including fatigue (20.1%), fever (11.4%), general feeling of illness (8.0%), and headache (6.5%). Compared to vaccines against other illnesses, BNT162b2 was more commonly associated with local and systemic symptoms (gastrointestinal, musculo - skeletal, dermatological, neurological, psychological). 41 (1.3%) of the subjects reported that their SRVT persisted for ≥90 days after vaccination with BNT162b2: these symptoms were mainly psychological (15 subjects), neurological (9 subjects), and dermatological (8 subjects). There were 45 serious adverse events; these were associated with female sex (OR = 4.70, 95% confidence interval [2.17; 10.20]) and with long-term medication use (OR = 4.06 [1.53; 10.79]).
Vaccination with BNT162b2 was reportedly well tolerated by more than 98% of the children and adolescents who received it, although symptoms were more common than after vaccination against other illnesses than SARS-CoV-2. The participants in our study may have had a more positive attitude toward vaccination. On the other hand, a selection bias might exist for participants who experienced vaccination side effects.
关于基于信使核糖核酸的新冠疫苗BNT162b2在18岁以下人群中使用的现有安全性数据仅限于长达六个月的观察期。
在一项回顾性横断面研究中，我们评估了2021年10月1日或之后在德国接种至少一剂BNT162b2疫苗时年龄在18岁以下的人群在11种症状类别中的自我报告疫苗耐受性（SRVT）。数据通过在线方式从接种疫苗者的父母或法定监护人处收集。个人参与代码使调查能够进行身份验证和匿名参与。在一个亚组中，将BNT162b2的SRVT与针对除SARS-CoV-2以外的其他疾病的疫苗（如流感疫苗）的SRVT进行了比较。
获得了3228人的耐受性数据，中位年龄为5.7岁；49.6%为男性。中位观察期为524天。疫苗更常报告的不良影响主要出现在年龄较大的受试者中，为局部反应——疼痛（49.7%）、发红（23%）——较少见的全身症状包括疲劳（20.1%）、发热（11.4%）、全身不适感（8.0%）和头痛（6.5%）。与针对其他疾病的疫苗相比，BNT162b2更常与局部和全身症状（胃肠道、肌肉骨骼、皮肤、神经、心理）相关。41名（1.3%）受试者报告其在接种BNT162b2疫苗后SRVT持续≥90天：这些症状主要是心理方面的（15名受试者）、神经方面的（9名受试者）和皮肤方面的（8名受试者）。有45例严重不良事件；这些事件与女性（比值比=4.70，95%置信区间[2.17；10.20]）和长期用药（比值比=4.06[1.53；10.79]）有关。
据报道，超过98%接种BNT162b2疫苗的儿童和青少年对该疫苗耐受性良好，尽管症状比接种除SARS-CoV-2以外的其他疾病疫苗后更常见。我们研究中的参与者可能对疫苗接种态度更积极。另一方面，经历疫苗副作用的参与者可能存在选择偏倚。
