Department of Pediatric Infectious Diseases, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wrocław, Poland.
Department of Pediatric Infectious Diseases, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wrocław, Poland; Department of Histology and Embryology, Department of Human Morphology and Embryology, Wroclaw Medical University, Ludwika Pasteura 1, 50-367 Wrocław, Poland.
Vaccine. 2023 Mar 24;41(13):2289-2299. doi: 10.1016/j.vaccine.2023.02.072. Epub 2023 Mar 2.
To assess the safety of Pfizer-BioNTech COVID-19 mRNA BNT162b2 vaccine (Comirnaty®) among patients with the anamnesis of paediatric inflammatory syndrome temporally associated with COVID-19 (PIMS-TS), we conducted a prospective cohort study of 21 patients with history of PIMS (PIMS group, median age 7.4 years, 71% male) and 71 healthy controls without such an anamnesis (CONTROL group, median age 9.0 years, 39% male) aged 5-18 years. Among them, 85 patients (all PIMS patients and 64 CONTROL patients) completed the two dose schedule of vaccination administered 21 days apart and 7 children in the CONTROL group received a single, age appropriate dose of a COVID-19 mRNA BNT162b2 vaccine during the study period. The frequency and character of reported adverse events (AEs) after each dose and results of flow cytometry (FC) 3 weeks after a second dose were compared between those groups. COVID-19 mRNA BNT162b2 vaccine safety profile was very good and comparable in both groups. No severe AEs were observed. 30% of all patients reported some general AE after any vaccine dose and 46% - some local AE. Frequency of reported AEs did not differ between groups except for local hardening at injection site, more common in PIMS group (20% vs 4% after any vaccine dose, p = 0,02). All AEs were benign, general AEs lasted up to 5 days and localised - up to 6 days after a vaccine dose. COVID-19 mRNA BNT162b2 vaccine did not induce any PIMS-like symptoms in any patient. We did not observe any significant T cells or B cells subset abnormalities in the PIMS group compared to the CONTROL group three weeks after a second dose except for terminally differentiated effector memory T cells that were higher in PIMS group (p < 0.0041). To sum up COVID-19 mRNA BNT162b2 vaccine in children with PIMS-TS was safe. Further studies are required to support our findings.
为评估辉瑞-生物科技 COVID-19 mRNA BNT162b2 疫苗（Comirnaty®）在与 COVID-19 相关儿科炎症综合征病史（PIMS-TS）患者中的安全性，我们对 21 名有 PIMS 病史的患者（PIMS 组，中位年龄 7.4 岁，71%为男性）和 71 名无此类病史的健康对照者（对照组，中位年龄 9.0 岁，39%为男性）进行了前瞻性队列研究，年龄为 5-18 岁。其中，85 名患者（所有 PIMS 患者和 64 名对照患者）完成了 21 天间隔的两剂接种计划，对照组的 7 名儿童在研究期间接受了一剂适合年龄的 COVID-19 mRNA BNT162b2 疫苗。比较了两组之间每次接种后报告的不良事件（AE）的频率和特征以及第二次接种后 3 周时的流式细胞术（FC）结果。辉瑞-生物科技 COVID-19 mRNA BNT162b2 疫苗的安全性良好，且两组之间相当。未观察到严重不良事件。所有患者中有 30%在任何一剂疫苗后报告有一些一般不良事件，46%有一些局部不良事件。报告的不良事件频率除了注射部位局部硬结更常见于 PIMS 组（任何一剂疫苗后分别为 20%和 4%，p=0.02）外，两组之间没有差异。所有不良事件均为良性，一般不良事件持续时间不超过接种后 5 天，局部不良事件持续时间不超过接种后 6 天。辉瑞-生物科技 COVID-19 mRNA BNT162b2 疫苗未在任何患者中引起任何类似 PIMS 的症状。与对照组相比，在第二次接种后 3 周时，PIMS 组中除了终末分化效应记忆 T 细胞更高外（p<0.0041），我们没有观察到任何显著的 T 细胞或 B 细胞亚群异常。综上所述，辉瑞-生物科技 COVID-19 mRNA BNT162b2 疫苗在 PIMS-TS 患儿中是安全的。需要进一步的研究来支持我们的发现。
