Lee Kyung Jae, Choi So Yoon, Lee Yoo Min, Kim Han Wool
Department of Pediatrics, Hallym University Sacred Heart Hospital, Anyang 14068, Korea.
Department of Pediatrics, College of Medicine, Hallym University, Chuncheon 24252, Korea.
Vaccines (Basel). 2022 Aug 6;10(8):1265. doi: 10.3390/vaccines10081265.
The vaccination of immunocompromised children against coronavirus disease 2019 is an important public health issue. We evaluated the serological response, safety, and efficacy of the BNT162b2 vaccine in children with and without inflammatory bowel disease (IBD). A prospective, multicenter, case-control study was conducted in a pediatric population, including patients with IBD, aged 12-18 years. Clinical characteristics, safety profile, and serum samples for surrogate virus-neutralizing antibody testing pre- and post-BNT162b2 vaccination were assessed. The breakthrough infection rate during the Omicron outbreak was calculated to evaluate efficacy. Fifteen controls and twenty-three patients with IBD were enrolled. After two vaccine doses, the median level of percentage inhibition was highly increased, without significant differences between the groups (control 96.9 and IBD 96.3). However, it was significantly reduced in IBD patients receiving combination therapy (anti-tumor necrosis factor-α + immunomodulators) relative to those in other therapies and controls. Serious adverse events were not observed. The breakthrough infection rate was 42.1%, without statistical differences between the groups. Immunization with BNT162b2 in patients with IBD was comparable with that in healthy adolescents in terms of immunogenicity and safety. Nevertheless, the efficacy of BNT162b2 in preventing infection caused by the Omicron variant in the pediatric population was insufficient.
对免疫功能低下的儿童接种2019冠状病毒病疫苗是一个重要的公共卫生问题。我们评估了BNT162b2疫苗在患有和未患有炎症性肠病（IBD）的儿童中的血清学反应、安全性和有效性。在包括12至18岁IBD患者在内的儿科人群中进行了一项前瞻性、多中心、病例对照研究。评估了BNT162b2疫苗接种前后的临床特征、安全性概况以及用于替代病毒中和抗体检测的血清样本。计算了奥密克戎毒株暴发期间的突破性感染率以评估有效性。纳入了15名对照和23名IBD患者。两剂疫苗接种后，抑制百分比的中位数大幅提高，两组之间无显著差异（对照组为96.9，IBD组为96.3）。然而，相对于接受其他疗法的患者和对照组，接受联合治疗（抗肿瘤坏死因子-α+免疫调节剂）的IBD患者的该指标显著降低。未观察到严重不良事件。突破性感染率为42.1%，两组之间无统计学差异。就免疫原性和安全性而言，IBD患者接种BNT162b2疫苗与健康青少年相当。尽管如此，BNT162b2在预防儿科人群中奥密克戎变异株引起的感染方面的有效性不足。
