基于人群的 SARS-CoV-2 疫苗有效性的阴性对照病例对照分析：加拿大安大略省的孕妇。

A Population-Based Test-Negative Matched Case-Control Analysis of SARS-CoV-2 Vaccine Effectiveness Among Pregnant People in Ontario, Canada.

机构信息

Department of Obstetrics and Gynaecology, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; Department of Obstetrics and Gynecology, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.

Institute for Clinical Evaluative Sciences, Toronto, ON, Canada; Department of Surgery, University of Toronto, Toronto, ON, Canada; Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada; Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada; School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.

出版信息

J Obstet Gynaecol Can. 2024 Feb;46(2):102239. doi: 10.1016/j.jogc.2023.102239. Epub 2023 Oct 14.

DOI:10.1016/j.jogc.2023.102239

PMID:37839731

Abstract

OBJECTIVE

Pregnancy is a risk factor for severe SARS-CoV-2 infection, which can result in adverse pregnancy outcomes, thus making understanding vaccine effectiveness (VE) in this population important. This study aimed to assess the VE of mRNA COVID-19 vaccines against symptomatic SARS-CoV-2 infection and COVID-19-related hospitalization in pregnant people.

METHODS

Population-based matched test-negative case-control study of pregnant people aged 18-49 years, of 12 or more weeks gestation in Ontario, Canada, symptomatic with possible SARS-CoV-2 infection, and having at least 1 positive (n = 1842) or negative (n = 8524) real-time polymerase chain reaction (RT-PCR) SARS-CoV-2 test between December 14, 2020, and December 31, 2021. The exposure was receipt of ≥1 dose of mRNA COVID-19 vaccine versus no vaccination. Exposure was further stratified by number and recency of doses. The primary outcome was a positive SARS-CoV-2 RT-PCR test. As a secondary outcome, VE for COVID-19-related hospitalization was assessed.

RESULTS

In the primary outcome analysis, there were 1821 positive cases, matched to 1821 negative controls. The mean (SD) maternal age was 31 (5) years. When compared to those unvaccinated, receipt of ≥1 dose was associated with an estimated VE of 39% (95% CI 29%-48%) for symptomatic infection, and 85% (95% CI 72%-92%) for COVID-19 hospitalization. VE estimates demonstrated waning with increased time since last vaccination.

CONCLUSIONS

mRNA COVID-19 vaccines provide protection against symptomatic COVID-19 illness and are highly effective at preventing severe illness in pregnant people. The observed effect of vaccine waning highlights the importance of booster doses to provide optimal protection for pregnant people.

摘要

目的

妊娠是严重 SARS-CoV-2 感染的危险因素，可能导致不良妊娠结局，因此了解该人群中疫苗有效性（VE）非常重要。本研究旨在评估 mRNA COVID-19 疫苗对孕妇中出现症状的 SARS-CoV-2 感染和与 COVID-19 相关住院的有效性。

方法

在加拿大安大略省，对 18-49 岁、妊娠 12 周或以上、有症状疑似 SARS-CoV-2 感染且至少有 1 次（n=1842）或阴性（n=8524）实时聚合酶链反应（RT-PCR）SARS-CoV-2 检测的孕妇进行基于人群的匹配病例对照研究。暴露为接种≥1 剂 mRNA COVID-19 疫苗与未接种疫苗。进一步按接种次数和最近一次接种时间进行分层。主要结局是 SARS-CoV-2 RT-PCR 检测阳性。次要结局是评估与 COVID-19 相关住院的 VE。

结果

在主要结局分析中，有 1821 例阳性病例，匹配 1821 例阴性对照。母亲平均（SD）年龄为 31（5）岁。与未接种疫苗者相比，接种≥1 剂疫苗与出现症状感染的估计 VE 为 39%（95%CI 29%-48%），与 COVID-19 住院的 VE 为 85%（95%CI 72%-92%）。随着最近一次接种时间的延长，VE 估计值呈下降趋势。