Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, NY, United States.
School of Pharmacy, Jeonbuk National University, Jeonju, Republic of Korea.
JMIR Public Health Surveill. 2022 May 24;8(5):e35311. doi: 10.2196/35311.
COVID-19 messenger RNA (mRNA) vaccines have demonstrated efficacy and effectiveness in preventing symptomatic COVID-19, while being relatively safe in trial studies. However, vaccine breakthrough infections have been reported.
This study aims to identify risk factors associated with COVID-19 breakthrough infections among fully mRNA-vaccinated individuals.
We conducted a series of observational retrospective analyses using the electronic health records (EHRs) of the Columbia University Irving Medical Center/New York Presbyterian (CUIMC/NYP) up to September 21, 2021. New York City (NYC) adult residences with at least 1 polymerase chain reaction (PCR) record were included in this analysis. Poisson regression was performed to assess the association between the breakthrough infection rate in vaccinated individuals and multiple risk factors-including vaccine brand, demographics, and underlying conditions-while adjusting for calendar month, prior number of visits, and observational days in the EHR.
The overall estimated breakthrough infection rate was 0.16 (95% CI 0.14-0.18). Individuals who were vaccinated with Pfizer/BNT162b2 (incidence rate ratio [IRR] against Moderna/mRNA-1273=1.66, 95% CI 1.17-2.35) were male (IRR against female=1.47, 95% CI 1.11-1.94) and had compromised immune systems (IRR=1.48, 95% CI 1.09-2.00) were at the highest risk for breakthrough infections. Among all underlying conditions, those with primary immunodeficiency, a history of organ transplant, an active tumor, use of immunosuppressant medications, or Alzheimer disease were at the highest risk.
Although we found both mRNA vaccines were effective, Moderna/mRNA-1273 had a lower incidence rate of breakthrough infections. Immunocompromised and male individuals were among the highest risk groups experiencing breakthrough infections. Given the rapidly changing nature of the SARS-CoV-2 pandemic, continued monitoring and a generalizable analysis pipeline are warranted to inform quick updates on vaccine effectiveness in real time.
COVID-19 信使 RNA（mRNA）疫苗在预防有症状的 COVID-19 方面已被证明具有疗效和有效性，并且在试验研究中相对安全。然而，已报告疫苗突破性感染。
本研究旨在确定与完全接种 mRNA 疫苗的个体中 COVID-19 突破性感染相关的危险因素。
我们使用哥伦比亚大学欧文医学中心/纽约长老会医院（CUIMC/NYP）的电子健康记录（EHR）进行了一系列观察性回顾性分析，截至 2021 年 9 月 21 日。纳入本分析的是至少有 1 次聚合酶链反应（PCR）记录的纽约市（NYC）成人住所。使用泊松回归评估突破性感染率与多种危险因素（包括疫苗品牌、人口统计学和潜在疾病）之间的关联，同时调整日历月、就诊次数和 EHR 中的观察天数。
总体估计突破性感染率为 0.16（95%CI 0.14-0.18）。接种辉瑞/BNT162b2 的个体（与 Moderna/mRNA-1273 的发病率比 [IRR]为 1.66，95%CI 1.17-2.35）为男性（与女性相比 IRR 为 1.47，95%CI 1.11-1.94），免疫系统受损（IRR 为 1.48，95%CI 1.09-2.00）的个体发生突破性感染的风险最高。在所有潜在疾病中，原发性免疫缺陷、器官移植史、活动期肿瘤、使用免疫抑制药物或阿尔茨海默病的个体风险最高。
尽管我们发现两种 mRNA 疫苗都有效，但 Moderna/mRNA-1273 的突破性感染发生率较低。免疫功能低下和男性个体是发生突破性感染的最高危人群之一。鉴于 SARS-CoV-2 大流行的快速变化性质，需要持续监测和通用分析管道，以便实时快速更新疫苗有效性信息。
