1. Lack of Evidence for Vaccine-Associated Enhanced Disease From COVID-19 Vaccines Among Adults in the Vaccine Safety Datalink.
- Author
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Boyce TG, McClure DL, Hanson KE, Daley MF, DeSilva MB, Irving SA, Jackson LA, Klein NP, Lewin B, Williams JTB, Duffy J, McNeil MM, Weintraub ES, and Belongia EA
- Subjects
- Adult, Aged, Female, Humans, Male, Middle Aged, Cross-Sectional Studies, Intensive Care Units statistics & numerical data, United States epidemiology, Vaccination adverse effects, COVID-19 prevention & control, COVID-19 epidemiology, COVID-19 Vaccines adverse effects, COVID-19 Vaccines administration & dosage, Hospitalization statistics & numerical data, Severity of Illness Index
- 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., (© 2024 John Wiley & Sons Ltd. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.)
- Published
- 2024
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