Ischemic stroke after COVID-19 bivalent vaccine administration in patients aged 65 years and older in the United States

Abstract The Centers for Disease Control and Prevention announced in January 2023 a potential connection between administration of the Pfizer novel coronavirus disease-2019 (COVID-19) bivalent vaccine booster and ischemic stroke (IS). A retrospective cohort study was conducted to compare the hazard...

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Autori principali: Maria P. Gorenflo, Pamela B. Davis, David C. Kaelber, Rong Xu
Natura: Articolo
Lingua:English
Pubblicazione: Nature Portfolio 2023-11-01
Serie:npj Vaccines
Accesso online:https://doi.org/10.1038/s41541-023-00777-w
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author Maria P. Gorenflo
Pamela B. Davis
David C. Kaelber
Rong Xu
author_facet Maria P. Gorenflo
Pamela B. Davis
David C. Kaelber
Rong Xu
author_sort Maria P. Gorenflo
collection DOAJ
description Abstract The Centers for Disease Control and Prevention announced in January 2023 a potential connection between administration of the Pfizer novel coronavirus disease-2019 (COVID-19) bivalent vaccine booster and ischemic stroke (IS). A retrospective cohort study was conducted to compare the hazard of IS in patients aged 65 years and over administered the Pfizer bivalent booster versus those administered the Pfizer/Moderna monovalent or Moderna bivalent boosters. De-identified patient electronic health data were collected from TriNetX, a cloud-based analytics platform that includes data from over 90 million unique patients in the United States. Patients aged 65 years and over at the time of administration of a Pfizer bivalent, Moderna bivalent, or Pfizer/Moderna monovalent booster were included for analysis. Cohorts were propensity-score matched. The hazard ratios (HR) and 95% confidence intervals (CI) for IS between matched cohorts at 1–21 and 22–42 days after booster administration were calculated. There was reduced hazard of IS in the Pfizer bivalent cohort compared to the monovalent cohort at both timepoints: 1–21 days after vaccination (HR: 0.54, 95% CI: 0.47–0.62), and 22–42 days after vaccination (HR: 0.62, 95% CI: 0.54–0.72) (n = 79,036 patients per cohort). There was reduced hazard of IS in the Pfizer bivalent cohort compared to the Moderna bivalent cohort at 1–21 days after vaccination (HR: 0.75, 95% CI: 0.58–0.96) (n = 26,962 patients per cohort). This analysis provides no evidence that the Pfizer bivalent vaccine is associated with increased hazard of IS compared to the monovalent or Moderna bivalent vaccines.
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spelling doaj.art-e85e6ee1c6b64d7ca44c899a8e7eec012023-11-26T12:16:30ZengNature Portfolionpj Vaccines2059-01052023-11-01811510.1038/s41541-023-00777-wIschemic stroke after COVID-19 bivalent vaccine administration in patients aged 65 years and older in the United StatesMaria P. Gorenflo0Pamela B. Davis1David C. Kaelber2Rong Xu3Center for Artificial Intelligence in Drug Discovery, Case Western Reserve University School of MedicineCenter for Community Health Integration, Case Western Reserve University School of MedicineCenter for Clinical Informatics Research and Education, The MetroHealth System, and Department of Internal Medicine, Pediatrics, and Population and Quantitative Health Sciences, Case Western Reserve UniversityCenter for Artificial Intelligence in Drug Discovery, Case Western Reserve University School of MedicineAbstract The Centers for Disease Control and Prevention announced in January 2023 a potential connection between administration of the Pfizer novel coronavirus disease-2019 (COVID-19) bivalent vaccine booster and ischemic stroke (IS). A retrospective cohort study was conducted to compare the hazard of IS in patients aged 65 years and over administered the Pfizer bivalent booster versus those administered the Pfizer/Moderna monovalent or Moderna bivalent boosters. De-identified patient electronic health data were collected from TriNetX, a cloud-based analytics platform that includes data from over 90 million unique patients in the United States. Patients aged 65 years and over at the time of administration of a Pfizer bivalent, Moderna bivalent, or Pfizer/Moderna monovalent booster were included for analysis. Cohorts were propensity-score matched. The hazard ratios (HR) and 95% confidence intervals (CI) for IS between matched cohorts at 1–21 and 22–42 days after booster administration were calculated. There was reduced hazard of IS in the Pfizer bivalent cohort compared to the monovalent cohort at both timepoints: 1–21 days after vaccination (HR: 0.54, 95% CI: 0.47–0.62), and 22–42 days after vaccination (HR: 0.62, 95% CI: 0.54–0.72) (n = 79,036 patients per cohort). There was reduced hazard of IS in the Pfizer bivalent cohort compared to the Moderna bivalent cohort at 1–21 days after vaccination (HR: 0.75, 95% CI: 0.58–0.96) (n = 26,962 patients per cohort). This analysis provides no evidence that the Pfizer bivalent vaccine is associated with increased hazard of IS compared to the monovalent or Moderna bivalent vaccines.https://doi.org/10.1038/s41541-023-00777-w
spellingShingle Maria P. Gorenflo
Pamela B. Davis
David C. Kaelber
Rong Xu
Ischemic stroke after COVID-19 bivalent vaccine administration in patients aged 65 years and older in the United States
npj Vaccines
title Ischemic stroke after COVID-19 bivalent vaccine administration in patients aged 65 years and older in the United States
title_full Ischemic stroke after COVID-19 bivalent vaccine administration in patients aged 65 years and older in the United States
title_fullStr Ischemic stroke after COVID-19 bivalent vaccine administration in patients aged 65 years and older in the United States
title_full_unstemmed Ischemic stroke after COVID-19 bivalent vaccine administration in patients aged 65 years and older in the United States
title_short Ischemic stroke after COVID-19 bivalent vaccine administration in patients aged 65 years and older in the United States
title_sort ischemic stroke after covid 19 bivalent vaccine administration in patients aged 65 years and older in the united states
url https://doi.org/10.1038/s41541-023-00777-w
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