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Assessment of potential adverse events following the 2022-2023 seasonal influenza vaccines among U.S. adults aged 65 years and older.
- Source :
-
Vaccine [Vaccine] 2024 May 31; Vol. 42 (15), pp. 3486-3492. Date of Electronic Publication: 2024 May 03. - Publication Year :
- 2024
-
Abstract
- Background: While safety of influenza vaccines is well-established, some studies have suggested potential associations between influenza vaccines and certain adverse events (AEs). This study examined the safety of the 2022-2023 influenza vaccines among U.S. adults ≥ 65 years.<br />Methods: A self-controlled case series compared incidence rates of anaphylaxis, encephalitis/encephalomyelitis, Guillain-Barré Syndrome (GBS), and transverse myelitis following 2022-2023 seasonal influenza vaccinations (i.e., any, high-dose or adjuvanted) in risk and control intervals among Medicare beneficiaries ≥ 65 years. We used conditional Poisson regression to estimate incidence rate ratios (IRRs) and 95 % confidence intervals (CIs) adjusted for event-dependent observation time and seasonality. Analyses also accounted for uncertainty from outcome misclassification where feasible. For AEs with any statistically significant associations, we stratified results by concomitant vaccination status.<br />Results: Among 12.7 million vaccine recipients, we observed 76 anaphylaxis, 276 encephalitis/encephalomyelitis, 134 GBS and 75 transverse myelitis cases. Only rates of anaphylaxis were elevated in risk compared to control intervals. With all adjustments, an elevated, but non-statistically significant, anaphylaxis rate was observed following any (IRR: 2.40, 95% CI: 0.96-6.03), high-dose (IRR: 2.31, 95% CI: 0.67-7.91), and adjuvanted (IRR: 3.28, 95% CI: 0.71-15.08) influenza vaccination; anaphylaxis IRRs were 2.54 (95% CI: 0.49-13.05) and 1.64 (95% CI: 0.38-7.05) for persons with and without concomitant vaccination, respectively.<br />Conclusions: Rates of encephalitis/encephalomyelitis, GBS, or transverse myelitis were not elevated following 2022-2023 seasonal influenza vaccinations among U.S. adults ≥ 65 years. There was an increased rate of anaphylaxis following influenza vaccination that may have been influenced by concomitant vaccination.<br />Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.<br /> (Copyright © 2024. Published by Elsevier Ltd.)
- Subjects :
- Aged
Aged, 80 and over
Female
Humans
Male
Anaphylaxis epidemiology
Drug-Related Side Effects and Adverse Reactions epidemiology
Guillain-Barre Syndrome epidemiology
Guillain-Barre Syndrome etiology
Guillain-Barre Syndrome chemically induced
Incidence
Medicare statistics & numerical data
Myelitis, Transverse epidemiology
Myelitis, Transverse etiology
Seasons
United States epidemiology
Influenza Vaccines adverse effects
Influenza Vaccines administration & dosage
Influenza, Human prevention & control
Influenza, Human epidemiology
Vaccination adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1873-2518
- Volume :
- 42
- Issue :
- 15
- Database :
- MEDLINE
- Journal :
- Vaccine
- Publication Type :
- Academic Journal
- Accession number :
- 38704258
- Full Text :
- https://doi.org/10.1016/j.vaccine.2024.04.051