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Study Finds No Elevated Stroke Risk Days After COVID-19 Vaccination
COVID-19 vaccination does not appear to be associated with an increased risk of stroke in US older adults in the early days following administration, according to a study published in JAMA.
“In this self-controlled case series among Medicare beneficiaries aged 65 years or older, the primary analysis showed no evidence of a significantly elevated stroke risk during the days immediately after administration of either brand of the COVID-19 bivalent vaccine,” wrote first author Yun Lu, PhD, of the Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, and study coauthors.
Nearly 5.4 million Medicare beneficiaries received COVID-19 bivalent vaccination over the roughly 5-month study period. Among them, 11,001 experienced stroke after receiving COVID-19 vaccination, researchers reported.
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Compared with the 43- to 90-day window after vaccination, which served as the control, neither brand of the COVID-19 bivalent vaccine show any significant association with nonhemorrhagic stroke, transient ischemic attack, nonhemorrhagic stroke or transient ischemic attack, or hemorrhagic stroke during the 1- to 21-day or 22- to 42-day risk windows, according to the study.
Secondary analyses in the study looked at stroke risk after COVID-19 vaccination plus a high-dose or adjuvanted influenza vaccine on the same day, as well as stroke risk after high-dose or adjuvanted influenza vaccine alone.
Researchers identified two significant associations among 4596 beneficiaries who experienced stroke after receiving COVID-19 and influenza vaccinations on the same day. Specifically, vaccination was associated with nonhemorrhagic stroke during the 22- to 42-day window after vaccination for the Pfizer-BioNTech BNT162b2; WT/OMI BA.4/BA.5 COVID-19 bivalent vaccine. For the Moderna mRNA-1273.222 COVID-19 bivalent vaccine, vaccination was linked with transient ischemic attack during the 1- to 21-day window.
Meanwhile, among 21,345 beneficiaries who experienced stroke after receiving influenza vaccine alone, vaccination was significantly associated with nonhemorrhagic stroke during the 22- to 42-day window after vaccination, researchers reported.
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