Lack of Evidence for Vaccine-Associated Enhanced Disease From COVID-19 Vaccines Among Adults in the Vaccine Safety Datalink.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2024-08-01 DOI:10.1002/pds.5863

Thomas G Boyce, David L McClure, Kayla E Hanson, Matthew F Daley, Malini B DeSilva, Stephanie A Irving, Lisa A Jackson, Nicola P Klein, Bruno Lewin, Joshua T B Williams, Jonathan Duffy, Michael M McNeil, Eric S Weintraub, Edward A Belongia

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引用次数: 0

Abstract

Purpose: 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).

Methods: 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.

Results: 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.

Conclusion: Among hospitalized patients, reduced disease severity in those vaccinated against COVID-19 supports the absence of VAED.

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疫苗安全数据链接》（Vaccine Safety Datalink）中没有证据表明 COVID-19 疫苗会在成人中引发疫苗相关性疾病。

目的：疫苗相关强化疾病（VAED）是新疫苗的一个理论问题，尽管针对SARS-CoV-2的授权疫苗试验并未发现VAED的标记。本研究的目的是检测接种 2019 年冠状病毒病疫苗（COVID-19）的成年人中是否存在 VAED 信号：在这项横断面研究中，我们评估了 2021 年 3 月至 10 月期间在美国 8 个医疗保健系统中因接种 COVID-19 而住院的 400 名成人中 COVID-19 的严重程度，作为 VAED 的替代指标。主要结果是入住重症监护室（ICU）和重症（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 疫苗初级系列接种的患者与未接种者的结局风险。我们在双重稳健回归模型中加入了疫苗接种状态的反倾向权重，以估算平均治疗效果的因果关系：结果：接种疫苗与未接种疫苗的因果风险比为：入住重症监护室的风险比为 0.36（95% 置信区间 [CI]，0.15-0.94），重症风险比为 0.46（95% 置信区间 [CI]，0.25-0.76）：结论：在住院患者中，接种 COVID-19 疫苗的患者疾病严重程度较低，这证明不存在 VAED。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.