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. 2024 Dec 2;42(26):126440.
doi: 10.1016/j.vaccine.2024.126440. Epub 2024 Oct 22.

Incidence of ischemic stroke after COVID-19 bivalent booster vaccination in an integrated health system

Katie A Sharff  1 , Thomas K Tandy  2 , Paul F Lewis  3 , Eric S Johnson  2
Affiliations

Incidence of ischemic stroke after COVID-19 bivalent booster vaccination in an integrated health system

Katie A Sharff et al. Vaccine. .

Abstract

We conducted a retrospective cohort study of Kaiser Permanente Northwest patients 18 years and older who were vaccinated with the COVID-19 bivalent vaccine between September 1, 2022 and March 1, 2023. We replicated the Vaccine Safety Datalink (VSD) rapid cycle analysis protocol to identify cases of ischemic stroke or transient ischemic attack (TIA) in the 21 days following vaccination using ICD-10-CM diagnosis codes in the primary position. The incidence of ischemic stroke or TIA was 34.3 per 100,000 (95 % CI, 17.7-59.9) in patients 65 years or older who received the bivalent Pfizer vaccine. Although a safety signal was detected in this study, further investigation is warranted to validate an association between COVID-19 vaccination and risk of ischemic stroke. Replication of the VSD case definition confirmed the exceptionally high positive predictive value in identifying ischemic stroke or TIA within 21 days of Pfizer bivalent vaccination in individuals 65 years and older. Two physician adjudication with chart review and confirmation of ischemic stroke cases allowed accurate absolute incidence estimates of stroke per 100,000 vaccine recipients and is helpful in calculation of net benefit for policy recommendations and shared decision-making.

Keywords: Bivalent booster COVID-19 vaccine; COVID-19; Ischemic stroke; Transient ischemic attack; Vaccine safety.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Katie Sharff reports a relationship with Sanofi that includes: employment. Katie Sharff, first author, became an employee of Sanofi on 4/1/2024. The original brief report was submitted in February 2024 while she was still a full-time employee at Kaiser Permanente. The data collection and analysis were completed while Katie Sharff was an employee at Kaiser Permanente. No additional data was collected to address the reviewer comments. Katie Sharff is now employed at Sanofi as a medical director for vaccines which could be interpreted as a conflict of interest. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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