Center for Clinical Epidemiology and Population Health, Marshfield Clinic Research Institute, Marshfield, Wisconsin, USA.
Institute for Health Research, Kaiser Permanente Colorado, Aurora, Colorado, USA.
Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5863. doi: 10.1002/pds.5863.
Vaccine-associated enhanced disease (VAED) is a theoretical concern with new vaccines, although trials of authorized vaccines against SARS-CoV-2 have not identified markers for VAED. The purpose of this study was to detect any signals for VAED among adults vaccinated against coronavirus disease 2019 (COVID-19).
In this cross-sectional study, we assessed COVID-19 severity as a proxy for VAED among 400 adults hospitalized for COVID-19 from March through October 2021 at eight US healthcare systems. Primary outcomes were admission to an intensive care unit (ICU) and severe illness (score ≥6 on the World Health Organization [WHO] Clinical Progression Scale). We compared the risk of outcomes among those who had completed a COVID-19 vaccine primary series versus those who were unvaccinated. We incorporated inverse propensity weights for vaccination status in a doubly robust regression model to estimate the causal average treatment effect.
The causal risk ratio in vaccinated versus unvaccinated was 0.36 (95% confidence interval [CI], 0.15-0.94) for ICU admission and 0.46 (95% CI, 0.25-0.76) for severe illness.
Among hospitalized patients, reduced disease severity in those vaccinated against COVID-19 supports the absence of VAED.
疫苗相关增强疾病（VAED）是新疫苗的一个理论关注点，尽管针对 SARS-CoV-2 的授权疫苗试验尚未确定 VAED 的标志物。本研究旨在检测接种针对 2019 年冠状病毒病（COVID-19）疫苗的成年人中是否存在 VAED 的任何信号。
在这项横断面研究中，我们评估了 COVID-19 的严重程度，将其作为 VAED 的替代指标，纳入了 2021 年 3 月至 10 月期间在八个美国医疗保健系统中因 COVID-19 住院的 400 名成年人。主要结局是入住重症监护病房（ICU）和重症疾病（世界卫生组织[WHO]临床进展量表评分≥6）。我们比较了完成 COVID-19 疫苗初级系列接种者和未接种者的结局风险。我们将疫苗接种状态的逆概率权重纳入双重稳健回归模型，以估计因果平均治疗效果。
接种疫苗与未接种疫苗者的 ICU 入住风险比为 0.36（95%置信区间[CI]，0.15-0.94），重症疾病的风险比为 0.46（95% CI，0.25-0.76）。
在住院患者中，COVID-19 疫苗接种者的疾病严重程度降低支持不存在 VAED。
