Back to Search
Start Over
Stroke Risk After COVID-19 Bivalent Vaccination Among US Older Adults.
- Source :
-
JAMA [JAMA] 2024 Mar 19; Vol. 331 (11), pp. 938-950. - Publication Year :
- 2024
-
Abstract
- Importance: In January 2023, the US Centers for Disease Control and Prevention and the US Food and Drug Administration noted a safety concern for ischemic stroke among adults aged 65 years or older who received the Pfizer-BioNTech BNT162b2; WT/OMI BA.4/BA.5 COVID-19 bivalent vaccine.<br />Objective: To evaluate stroke risk after administration of (1) either brand of the COVID-19 bivalent vaccine, (2) either brand of the COVID-19 bivalent plus a high-dose or adjuvanted influenza vaccine on the same day (concomitant administration), and (3) a high-dose or adjuvanted influenza vaccine.<br />Design, Setting, and Participants: Self-controlled case series including 11 001 Medicare beneficiaries aged 65 years or older who experienced stroke after receiving either brand of the COVID-19 bivalent vaccine (among 5 397 278 vaccinated individuals). The study period was August 31, 2022, through February 4, 2023.<br />Exposures: Receipt of (1) either brand of the COVID-19 bivalent vaccine (primary) or (2) a high-dose or adjuvanted influenza vaccine (secondary).<br />Main Outcomes and Measures: Stroke risk (nonhemorrhagic stroke, transient ischemic attack, combined outcome of nonhemorrhagic stroke or transient ischemic attack, or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day risk window after vaccination vs the 43- to 90-day control window.<br />Results: There were 5 397 278 Medicare beneficiaries who received either brand of the COVID-19 bivalent vaccine (median age, 74 years [IQR, 70-80 years]; 56% were women). Among the 11 001 beneficiaries who experienced stroke after receiving either brand of the COVID-19 bivalent vaccine, there were no statistically significant associations between either brand of the COVID-19 bivalent vaccine and the outcomes of 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 window vs the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12). Among the 4596 beneficiaries who experienced stroke after concomitant administration of either brand of the COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine, there was a statistically significant association between vaccination and nonhemorrhagic stroke during the 22- to 42-day risk window for the Pfizer-BioNTech BNT162b2; WT/OMI BA.4/BA.5 COVID-19 bivalent vaccine (IRR, 1.20 [95% CI, 1.01-1.42]; risk difference/100 000 doses, 3.13 [95% CI, 0.05-6.22]) and a statistically significant association between vaccination and transient ischemic attack during the 1- to 21-day risk window for the Moderna mRNA-1273.222 COVID-19 bivalent vaccine (IRR, 1.35 [95% CI, 1.06-1.74]; risk difference/100 000 doses, 3.33 [95% CI, 0.46-6.20]). Among the 21 345 beneficiaries who experienced stroke after administration of a high-dose or adjuvanted influenza vaccine, there was a statistically significant association between vaccination and nonhemorrhagic stroke during the 22- to 42-day risk window (IRR, 1.09 [95% CI, 1.02-1.17]; risk difference/100 000 doses, 1.65 [95% CI, 0.43-2.87]).<br />Conclusions and Relevance: Among Medicare beneficiaries aged 65 years or older who experienced stroke after receiving either brand of the COVID-19 bivalent vaccine, there was no evidence of a significantly elevated risk for stroke during the days immediately after vaccination.
- Subjects :
- Aged
Female
Humans
Male
2019-nCoV Vaccine mRNA-1273 adverse effects
2019-nCoV Vaccine mRNA-1273 therapeutic use
Adjuvants, Immunologic adverse effects
Adjuvants, Immunologic therapeutic use
BNT162 Vaccine adverse effects
BNT162 Vaccine therapeutic use
COVID-19 Vaccines adverse effects
COVID-19 Vaccines therapeutic use
Hemorrhagic Stroke chemically induced
Hemorrhagic Stroke epidemiology
Hemorrhagic Stroke etiology
Medicare
United States epidemiology
Vaccination adverse effects
Vaccination methods
Vaccines, Combined adverse effects
Vaccines, Combined therapeutic use
Centers for Disease Control and Prevention, U.S. statistics & numerical data
United States Food and Drug Administration statistics & numerical data
Aged, 80 and over
COVID-19 prevention & control
Influenza Vaccines adverse effects
Influenza Vaccines therapeutic use
Ischemic Attack, Transient chemically induced
Ischemic Attack, Transient epidemiology
Ischemic Attack, Transient etiology
Stroke epidemiology
Stroke etiology
Stroke prevention & control
Ischemic Stroke chemically induced
Ischemic Stroke epidemiology
Ischemic Stroke etiology
Influenza, Human prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 1538-3598
- Volume :
- 331
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- JAMA
- Publication Type :
- Academic Journal
- Accession number :
- 38502075
- Full Text :
- https://doi.org/10.1001/jama.2024.1059