本文由小咖机器人翻译整理

期刊来源：Ann Intern Med

原文链接：https://doi.org/10.7326/M23-1754

摘要内容如下：

背景

在Omicron变种出现之前，通过随机试验评估了BNT162B2疫苗在儿科中的效力。在奥米克龙时期，疫苗保护在这一人群中的长期持久性仍然有限。

目的

评估BNT162B2在以前未感染的儿童和青少年中预防各种SARS-CoV-2病毒株感染和严重疾病的有效性。

设计

3个研究队列中疫苗接种报告不足的比较有效性研究：Delta阶段的青少年（12至20岁）和Omicron阶段的儿童（5至11岁）和青少年（12至20岁）。

设置

全国儿科卫生系统协作网（PEDSNET）。

参与者

在Delta阶段，77392名青少年（45007名接种疫苗）；在Omicron阶段，111539名儿童（50398名接种疫苗）和56080名青少年（21180名接种疫苗）。

干预

第一剂BNT162B2疫苗与未接种Covid-19疫苗的对比。

测量

相关结果包括记录的感染、COVID-19疾病严重程度、入住重症监护室（ICU）和心脏并发症。有效性报告为（1-相对风险）*100，混杂因素通过倾向评分分层进行平衡。

结果

在Delta期间，BNT162B2疫苗对记录在案的青少年感染的估计有效性为98.4%（95%CI，98.1%至98.7%），在接受第一剂疫苗后没有统计学意义上的显著减弱。对心脏并发症的分析表明，接种疫苗组和未接种疫苗组之间没有统计学上的显著差异。在Omicron期间，对儿童中记录的感染的有效性估计为74.3%（CI，72.2%至76.2%）。与中度或重度COVID-19（75.5%[CI，69.0%至81.0%]）和入住ICU的COVID-19（84.9%[CI，64.8%至93.5%]）相比，疗效更高。在青少年中，对记录的Omicron感染的有效性为85.5%（CI，83.8%至87.1%），对中度或重度COVID-19的有效性为84.8%（CI，77.3%至89.9%），对COVID-19入住ICU的有效性为91.5%（CI，69.5%至97.6%）。BNT162B2疫苗对Omicron变异体的效力在首次接种后4个月下降，然后稳定。分析显示，在Omicron变异期，接种组的心脏并发症风险较低。

局限性

观察性研究设计和潜在的未记录感染。

结论

这项研究表明，在Delta和Omicron期间，BNT162B2对儿童和青少年的各种COVID-19相关结果有效，并且有一些证据表明随着时间的推移，有效性逐渐减弱。

英文原文如下：

Abstracts

BACKGROUND  The efficacy of the BNT162b2 vaccine in pediatrics was assessed by randomized trials before the Omicron variant's emergence. The long-term durability of vaccine protection in this population during the Omicron period remains limited.

OBJECTIVE  To assess the effectiveness of BNT162b2 in preventing infection and severe diseases with various strains of the SARS-CoV-2 virus in previously uninfected children and adolescents.

DESIGN  Comparative effectiveness research accounting for underreported vaccination in 3 study cohorts: adolescents (12 to 20 years) during the Delta phase and children (5 to 11 years) and adolescents (12 to 20 years) during the Omicron phase.

SETTING  A national collaboration of pediatric health systems (PEDSnet).

PARTICIPANTS  77 392 adolescents (45 007 vaccinated) during the Delta phase and 111 539 children (50 398 vaccinated) and 56 080 adolescents (21 180 vaccinated) during the Omicron phase.

INTERVENTION  First dose of the BNT162b2 vaccine versus no receipt of COVID-19 vaccine.

MEASUREMENTS  Outcomes of interest include documented infection, COVID-19 illness severity, admission to an intensive care unit (ICU), and cardiac complications. The effectiveness was reported as (1-relative risk)*100, with confounders balanced via propensity score stratification.

RESULTS  During the Delta period, the estimated effectiveness of the BNT162b2 vaccine was 98.4% (95% CI, 98.1% to 98.7%) against documented infection among adolescents, with no statistically significant waning after receipt of the first dose. An analysis of cardiac complications did not suggest a statistically significant difference between vaccinated and unvaccinated groups. During the Omicron period, the effectiveness against documented infection among children was estimated to be 74.3% (CI, 72.2% to 76.2%). Higher levels of effectiveness were seen against moderate or severe COVID-19 (75.5% [CI, 69.0% to 81.0%]) and ICU admission with COVID-19 (84.9% [CI, 64.8% to 93.5%]). Among adolescents, the effectiveness against documented Omicron infection was 85.5% (CI, 83.8% to 87.1%), with 84.8% (CI, 77.3% to 89.9%) against moderate or severe COVID-19, and 91.5% (CI, 69.5% to 97.6%) against ICU admission with COVID-19. The effectiveness of the BNT162b2 vaccine against the Omicron variant declined 4 months after the first dose and then stabilized. The analysis showed a lower risk for cardiac complications in the vaccinated group during the Omicron variant period.

LIMITATION  Observational study design and potentially undocumented infection.

CONCLUSION  This study suggests that BNT162b2 was effective for various COVID-19-related outcomes in children and adolescents during the Delta and Omicron periods, and there is some evidence of waning effectiveness over time.

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