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

Details

• Alternative Title:
  Pharmacoepidemiol Drug Saf
• Personal Author:
  Boyce, Thomas G. ; McClure, David L. ; Hanson, Kayla E. ; Daley, Matthew F. ; DeSilva, Malini B. ; Irving, Stephanie A. ; Jackson, Lisa A. ; Klein, Nicola P. ; Lewin, Bruno ; Williams, Joshua T. B. ; Duffy, Jonathan ; McNeil, Michael M. ; Weintraub, Eric S. ; Belongia, Edward A.
  More +
• Description:
  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.
• Subjects:
  • Adult
  • Aged
  • Female
  • Humans
  • Male
  • Middle Aged
  • COVID-19
  • COVID-19 Vaccines
  • Cross-Sectional Studies
  • Hospitalization
  More +
• Keywords:
  • COVID-19 vaccines
  • SARS-CoV-2
  • vaccine-associated enhanced disease
  • vaccine safety
• Source:
  Pharmacoepidemiol Drug Saf. 33(8):e5863
• Pubmed ID:
  39155049
• Pubmed Central ID:
  PMC11377022
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/ ; 200-2012-53587-0013/CC/CDC HHSUnited States/
• Volume:
  33
• Issue:
  8
• Download URL:
  https://stacks.cdc.gov/view/cdc/162372/cdc_162372_DS1.pdf
• File Type:
  [PDF - 436.34 KB]
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:ad633a0395e4856cfbb92a4a8eb278c5bdc2faf2412abadd0684e46175b03f338cb108ad67d2e1feef854004cef1b63dd5f7eef97f353792b8f471c757a924c1