tetano
Editor, Senior Moderator
Pharmacoepidemiol Drug Saf
. 2024 Aug;33(8):e5863.
doi: 10.1002/pds.5863. Lack of Evidence for Vaccine-Associated Enhanced Disease From COVID-19 Vaccines Among Adults in the Vaccine Safety Datalink
Thomas G Boyce[SUP] 1 [/SUP], David L McClure[SUP] 1 [/SUP], Kayla E Hanson[SUP] 1 [/SUP], Matthew F Daley[SUP] 2 [/SUP], Malini B DeSilva[SUP] 3 [/SUP], Stephanie A Irving[SUP] 4 [/SUP], Lisa A Jackson[SUP] 5 [/SUP], Nicola P Klein[SUP] 6 [/SUP], Bruno Lewin[SUP] 7 [/SUP], Joshua T B Williams[SUP] 8 [/SUP], Jonathan Duffy[SUP] 9 [/SUP], Michael M McNeil[SUP] 9 [/SUP], Eric S Weintraub[SUP] 9 [/SUP], Edward A Belongia[SUP] 1 [/SUP]
Affiliations
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.
Keywords: COVID‐19 vaccines; SARS‐CoV‐2; vaccine safety; vaccine‐associated enhanced disease.
. 2024 Aug;33(8):e5863.
doi: 10.1002/pds.5863. Lack of Evidence for Vaccine-Associated Enhanced Disease From COVID-19 Vaccines Among Adults in the Vaccine Safety Datalink
Thomas G Boyce[SUP] 1 [/SUP], David L McClure[SUP] 1 [/SUP], Kayla E Hanson[SUP] 1 [/SUP], Matthew F Daley[SUP] 2 [/SUP], Malini B DeSilva[SUP] 3 [/SUP], Stephanie A Irving[SUP] 4 [/SUP], Lisa A Jackson[SUP] 5 [/SUP], Nicola P Klein[SUP] 6 [/SUP], Bruno Lewin[SUP] 7 [/SUP], Joshua T B Williams[SUP] 8 [/SUP], Jonathan Duffy[SUP] 9 [/SUP], Michael M McNeil[SUP] 9 [/SUP], Eric S Weintraub[SUP] 9 [/SUP], Edward A Belongia[SUP] 1 [/SUP]
Affiliations
- PMID: 39155049
- DOI: 10.1002/pds.5863
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.
Keywords: COVID‐19 vaccines; SARS‐CoV‐2; vaccine safety; vaccine‐associated enhanced disease.