期刊
JOURNAL OF INFECTIOUS DISEASES
卷 223, 期 3, 页码 416-425出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/infdis/jiaa543
关键词
Guillain-Barre syndrome; influenza vaccines; self-controlled risk interval; sequential tests; vaccine safety
资金
- US Food and Drug Administration
- Centers for Medicare & Medicaid Services
- US Centers for Disease Control and Prevention Vaccine Safety Datalink IDIQ
The study did not find a statistically significant association between high-dose influenza vaccine and GBS risk in Medicare beneficiaries, and the VSD's chart-confirmed analysis also did not confirm an increased risk of GBS. The findings suggest that if there is a risk, it is similar in magnitude to previous seasons.
Background. The Vaccine Safety Datalink (VSD) identified a statistical signal for an increased risk of Guillain-Barre syndrome (GBS) in days 1-42 after 2018-2019 high-dose influenza vaccine (IIV3-HD) administration. We evaluated the signal using Medicare. Methods. We conducted early- and end-of-season claims-based self-controlled risk interval analyses among Medicare beneficiaries ages >= 65 years, using days 8-21 and 1-42 postvaccination as risk windows and days 43-84 as control window. The VSD conducted chart-confirmed analyses. Results. Among 7 453 690 IIV3-HD vaccinations, we did not detect a statistically significant increased GBS risk for either the 8- to 21-day (odds ratio [OR], 1.85; 95% confidence interval [CI], 0.99-3.44) or 1- to 42-day (OR, 1.31; 95% CI, 0.78-2.18) risk windows. The findings from the end-of-season analyses were fully consistent with the early-season analyses for both the 8- to 21-day (OR, 1.64; 95% CI, 0.92-2.91) and 1- to 42-day (OR, 1.12; 95% CI, 0.70-1.79) risk windows. The VSD's chart-confirmed analysis, involving 646 996 IIV3-HD vaccinations, with 1 case each in the risk and control windows, yielded a relative risk of 1.00 (95% CI, 0.06-15.99). Conclusions. The Medicare analyses did not exclude an association between IIV3-HD and GBS, but it determined that, if such a risk existed, it was similar in magnitude to prior seasons. Chart-confirmed VSD results did not confirm an increased risk of GBS.
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