BNT162b2和科兴新冠疫苗对儿童及青少年新冠相关严重后果的有效性：一项巴西全国队列研究。

Effectiveness of BNT162b2 and CoronaVac against COVID-19-related severe outcomes among children and adolescents: A Brazilian nationwide cohort study.

作者信息

de Lima Eliandra da Silveira, Antunes Marcos Otávio Brum, de Souza Jesuely Spieckert, Jones Marcus H, Stein Renato T, Pinto Leonardo A, Friedrich Frederico, Scotta Marcelo Comerlato

机构信息

School of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil..

School of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.; Hospital Moinhos de Vento, Ramiro Barcelos st. 910, Porto Alegre, Rio Grande do Sul, Brazil.

出版信息

Vaccine. 2025 Jan 12;44:126550. doi: 10.1016/j.vaccine.2024.126550. Epub 2024 Nov 26.

DOI:10.1016/j.vaccine.2024.126550

PMID:39603074

Abstract

INTRODUCTION

Nationwide databases from large countries may provide real-world evidence about COVID-19 vaccine effectiveness (VE). This study sought to assess the VE of BNT162b2 and CoronaVac against COVID-19-related severe outcomes in school-aged children and adolescents during the Omicron wave of the COVID-19 pandemic in Brazil.

METHODS

A nationwide population-based cohort study compared the incidence risk ratios (IRRs) of hospitalization due to COVID-19-associated severe acute respiratory syndrome (SARS), need for invasive ventilatory support, and death among school-aged children (age 5 to 11 years) and adolescents (age 12 to 17 years), stratified by vaccination status (none, one, or two doses), in 2022. The period included epidemiological weeks (EW) 10 to 34 for school-aged children and EW 1 to EW 22 for adolescents. Data from all individuals hospitalized due to laboratory-confirmed COVID-19-related SARS were extracted from OpenDATASUS, where individual data including clinical outcomes and vaccination status are available. Vaccine coverage was estimated using data from the Brazilian Ministry of Health "Vacinômetro COVID-19" dashboard.

RESULTS

An eligible population of 19,219,424 school-aged children and 22,580,918 adolescents was assessed. For school-aged children, the VE against hospitalization for SARS, invasive ventilatory support, and death after one and two doses was 61 % and 58 %, 62 % and 74 %, and 81 % and 88 %, respectively (all p < 0.01). Among adolescents, the VE against the same outcomes after one and two doses was 55 % and 72 %, 60 % and 78 %, and 83 % and 80 %, respectively (all p < 0.05). CoronaVac was noninferior to BNT162b2 considering all outcomes among fully vaccinated school-aged children, a group that could have received either of the two vaccines.

CONCLUSIONS

COVID-19 vaccines are effective against severe outcomes in school-aged children and adolescents and are protective against mortality even after a single dose. CoronaVac was not inferior to BNT162b2 in school-aged children.

摘要

引言

来自大国的全国性数据库可能提供有关新冠病毒疫苗有效性（VE）的真实世界证据。本研究旨在评估在巴西新冠疫情的奥密克戎毒株流行期间，BNT162b2和科兴新冠疫苗对学龄儿童和青少年中与新冠病毒相关的严重后果的疫苗有效性。

方法

一项基于全国人群的队列研究比较了2022年学龄儿童（5至11岁）和青少年（12至17岁）中因新冠病毒相关严重急性呼吸综合征（SARS）住院、需要有创通气支持以及死亡的发病风险比（IRR），按疫苗接种状态（未接种、接种一剂或两剂）分层。该时间段包括学龄儿童的第10至34个流行病学周（EW）和青少年的第1至22个EW。从OpenDATASUS中提取所有因实验室确诊的与新冠病毒相关的SARS住院的个体数据，其中可获得包括临床结局和疫苗接种状态的个体数据。使用巴西卫生部“新冠疫苗接种计量表”仪表盘的数据估算疫苗接种覆盖率。

结果

评估了19,219,424名学龄儿童和22,580,918名青少年的合格人群。对于学龄儿童，接种一剂和两剂疫苗后预防SARS住院、有创通气支持和死亡的疫苗有效性分别为61%和58%、62%和74%、81%和88%（所有p<0.01）。在青少年中，接种一剂和两剂疫苗后预防相同结局的疫苗有效性分别为55%和72%、60%和78%、83%和80%（所有p<0.05）。考虑到完全接种疫苗的学龄儿童（这组儿童可能接种了两种疫苗中的任何一种）的所有结局，科兴新冠疫苗不劣于BNT162b2。