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Ischemic Stroke After Bivalent COVID-19 Vaccination: Self-Controlled Case Series Study.
Stanley Xu1, Lina S Sy1, Vennis Hong1
1Department of Research & Evaluation, Southern California Permanente Medical Group, Pasadena, CA, United States.
Bivalent COVID-19 vaccination did not increase ischemic stroke risk overall. A potential increased risk was observed within 42 days for younger individuals receiving both Pfizer-BioNTech and flu vaccines, warranting further study.
Area of Science:
- Epidemiology
- Vaccinology
- Neurology
Background:
- The association between bivalent COVID-19 vaccines and ischemic stroke risk is not fully understood.
- Existing studies have yielded uncertain conclusions regarding this potential link.
Purpose of the Study:
- To assess the risk of ischemic stroke following bivalent COVID-19 vaccination during the 2022-2023 season.
- Evaluate potential associations in specific subgroups and with coadministered vaccines.
Main Methods:
- A self-controlled case series study design was employed.
- Utilized electronic health records for ischemic stroke identification (ICD-10 codes).
- Analyzed risk intervals of 1-21 and 1-42 days post-vaccination using conditional Poisson regression.
Main Results:
- No increased ischemic stroke risk was found within 21 days for either vaccine.
- An elevated risk was noted within 42 days for individuals under 65 receiving Pfizer-BioNTech and influenza vaccines concurrently.
- Subgroup analyses revealed potential elevated risks in specific populations, though often not statistically significant after chart review.
Conclusions:
- The study found no statistically significant increase in ischemic stroke risk associated with bivalent COVID-19 vaccination overall.
- Further investigation is needed for specific subgroups, particularly younger individuals receiving concurrent influenza vaccination and those with prior SARS-CoV-2 infection.
- Highlights the importance of ongoing vaccine safety surveillance, including for monovalent vaccines in the subsequent season.
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