Rudan Igor, Kerr Steven, Sullivan Christopher, Jeffrey Karen, Grange Zoe, Fenton Lynda, Kurdi Amanj, Shi Ting, Cullen Lucy, Simpson Colin R, Katikireddi Srinivasa Vittal, Ritchie Lewis D, Robertson Chris, Sheikh Aziz
Usher Institute, The University of Edinburgh, Edinburgh, UK.
Nuffield Department of Primary Care Health Sciences, Oxford University, UK.
J Glob Health. 2025 Aug 29;15:04250. doi: 10.7189/jogh.15.04250.
Few large-scale population studies have examined both safety and vaccine effectiveness (VE) specifically for 5-11-year-olds during the Omicron-dominant period in a setting with low vaccine uptake. The BNT162b2 (Pfizer-BioNTech) vaccine, administered in two doses, has shown strong efficacy against symptomatic and severe COVID-19 in clinical trials involving children and young people (CYP). Accordingly, we examined the uptake, real-world safety, VE, and waning of BNT162b2 VE against symptomatic COVID-19 among children aged 5-11 years in Scotland.
This national prospective cohort study used the Scotland-wide Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) platform. We evaluated vaccine uptake using national data from the Turas Vaccination Management Tool, up to 16 April 2024. We assessed vaccine safety through national records on hospital admissions, employing a self-controlled case series design to examine 17 predefined health outcomes. We estimated VE against symptomatic, COVID-19 infection confirmed by reverse transcription-polymerase chain reaction and caused by the Omicron variant using a test-negative design.
From 19 March 2022 to 1 January 2023, 25.3% of the 392 658 children aged 5-11 years received their first COVID-19 vaccine dose and 16.2% completed the second dose. We found no increased risk of safety related hospital admission for 17 health outcomes in the post-vaccination period. During the Omicron period, VE against symptomatic COVID-19 was 60.8% (95% confidence interval (CI) = 0.3-84.5%) at 2-26 weeks post-first dose and 41.6% (95% CI = -89.6, 82.0) at 2-26 weeks post-second dose. The protective effect against symptomatic disease was no longer detectable in the period ≥27 weeks following both the first and second doses.
The BNT162b2 vaccine demonstrated a strong safety profile in this age group. Receiving both doses was linked to a reduction in the risk of symptomatic COVID-19 during the Omicron variant period, but this protection waned over the following six months.
在疫苗接种率较低的环境中，很少有大规模的人群研究专门考察了奥密克戎主导时期5至11岁儿童的疫苗安全性和有效性（VE）。两剂接种的BNT162b2（辉瑞 - 生物科技）疫苗在涉及儿童和青少年（CYP）的临床试验中显示出对有症状和严重COVID-19的强大疗效。因此，我们考察了苏格兰5至11岁儿童中BNT162b2疫苗对有症状COVID-19的接种率、实际安全性、VE及VE的减弱情况。
这项全国性前瞻性队列研究使用了全苏格兰范围的COVID-19早期大流行评估和强化监测（EAVE II）平台。我们使用来自Turas疫苗接种管理工具的全国数据评估疫苗接种率，数据截至2024年4月16日。我们通过医院入院的全国记录评估疫苗安全性，采用自我对照病例系列设计来检查17种预先定义的健康结局。我们使用检测阴性设计估计针对由奥密克戎变体引起的、经逆转录 - 聚合酶链反应确认的有症状COVID-19感染的VE。
从2022年3月19日至2023年1月1日，392658名5至11岁儿童中，25.3%接种了第一剂COVID-19疫苗，16.2%完成了第二剂接种。我们发现在接种疫苗后的时期内，17种健康结局的安全相关住院风险没有增加。在奥密克戎时期，第一剂接种后2至26周，针对有症状COVID-19的VE为60.8%（95%置信区间（CI）=0.3 - 84.5%），第二剂接种后2至26周为41.6%（95% CI = -89.6，82.0）。在第一剂和第二剂接种后≥27周的时期内，针对有症状疾病的保护作用不再可检测到。
BNT162b2疫苗在这个年龄组中显示出强大的安全性。接种两剂与在奥密克戎变体时期有症状COVID-19风险的降低相关，但这种保护在接下来的六个月内减弱。
