Longitudinal safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine in children aged 4–11 years with juvenile-onset autoimmune inflammatory rheumatic diseases: A prospective multicenter study

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2024-10-17 DOI:10.1016/j.vaccine.2024.126426

Tali Eviatar , Amit Ziv , Amir Oved , Adi Miller-Barmak , Adi Pappo , Ruth Livny , Gil Amarilyo , Yonatan Butbul Aviel , Rinat Naor , Sara Pel , Victoria Furer , Ori Elkayam , Yosef Uziel , Merav Heshin-Bekenstein

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Abstract

This prospective, longitudinal, multicenter study assessed the safety and efficacy of the Pfizer-BioNTech BNT162b2 mRNA COVID-19 vaccine among children 4–11 years-old with autoimmune inflammatory rheumatologic disease (AIIRD), compared to healthy controls. The study was conducted from 11/2021–12/2022 at 4 tertiary pediatric rheumatology units in Israel. Participants received at least 2 vaccine doses. Safety analysis included adverse events and disease activity measures. Efficacy was assessed by COVID-19 infection rates. Immunogenicity was evaluated in a subset of participants using anti- receptor binding domain antibody titers. Thirty-one children with AIIRD and 45 immunocompetent controls with similar baseline characteristics were included. Safety profile was favorable, with mild or no adverse events reported. The adverse event rates were similar in the AIIRD and control groups after the first (27 (60 %) vs. 14 (45.2 %), p = 0.2977) and the second vaccine doses (22 (49.0 %) vs. 18 (58.1 %), p = 0.5799), respectively. AIIRD activity remained stable and low after vaccination. Breakthrough COVID-19 infection rates were similar between groups, with 15 (48.4 %) in the AIIRD vs. 25 (55.6 %) in the control group (p = 0.7029). All reported COVID-19 infections in the AIIRD group and 18 (72 %) in the control group were symptomatic (p = 0.033), although symptoms were generally mild, with no severe disease. The safety of the BNT162b2 COVID-19 vaccine was excellent in children ages 4–11 years with AIIRD and healthy controls. Efficacy between groups was similar.

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BNT162b2 mRNA COVID-19 疫苗对 4-11 岁幼年自身免疫性炎症性风湿病患儿的纵向安全性和有效性：一项前瞻性多中心研究

这项前瞻性纵向多中心研究评估了辉瑞生物技术公司生产的 BNT162b2 mRNA COVID-19 疫苗在 4-11 岁自身免疫性炎症性风湿病 (AIIRD) 儿童中与健康对照组相比的安全性和有效性。该研究于 2021 年 11 月至 2022 年 12 月在以色列的 4 家三级儿科风湿病单位进行。参与者至少接种了两剂疫苗。安全性分析包括不良事件和疾病活动指标。疗效通过 COVID-19 感染率进行评估。使用抗受体结合域抗体滴度对部分参与者的免疫原性进行评估。31名AIIRD患儿和45名免疫功能正常的对照组患儿的基线特征相似。安全性状况良好，不良反应轻微或无。接种第一剂（27（60%）对 14（45.2%），p = 0.2977）和第二剂（22（49.0%）对 18（58.1%），p = 0.5799）后，AIIRD 组和对照组的不良反应发生率相似。接种疫苗后，AIIRD活性保持稳定且较低。各组的 COVID-19 突破性感染率相似，AIIRD 组为 15 例（48.4%），对照组为 25 例（55.6%）（p = 0.7029）。AIIRD 组和对照组分别有 18 例（72%）报告的 COVID-19 感染均有症状（p = 0.033），但症状一般较轻，没有严重疾病。BNT162b2 COVID-19疫苗在4-11岁的AIIRD儿童和健康对照组中安全性极佳。各组之间的疗效相似。

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

期刊介绍： Vaccine is unique in publishing the highest quality science across all disciplines relevant to the field of vaccinology - all original article submissions across basic and clinical research, vaccine manufacturing, history, public policy, behavioral science and ethics, social sciences, safety, and many other related areas are welcomed. The submission categories as given in the Guide for Authors indicate where we receive the most papers. Papers outside these major areas are also welcome and authors are encouraged to contact us with specific questions.