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. 2021 Feb 13;223(3):416-425.
doi: 10.1093/infdis/jiaa543.

Guillain-Barré Syndrome After High-Dose Influenza Vaccine Administration in the United States, 2018-2019 Season

Silvia Perez-Vilar  1 , Mao Hu  2 , Eric Weintraub  3 , Deepa Arya  1 , Bradley Lufkin  2 , Tanya Myers  3 , Emily Jane Woo  1 , An-Chi Lo  2 , Steve Chu  4 , Madeline Swarr  2 , Jiemin Liao  2 , Michael Wernecke  2 , Tom MaCurdy  2   5 , Jeffrey Kelman  4 , Steven Anderson  1 , Jonathan Duffy  3 , Richard A Forshee  1
Affiliations

Guillain-Barré Syndrome After High-Dose Influenza Vaccine Administration in the United States, 2018-2019 Season

Silvia Perez-Vilar et al. J Infect Dis. .

Abstract

Background: The Vaccine Safety Datalink (VSD) identified a statistical signal for an increased risk of Guillain-Barré 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.

Keywords: Guillain-Barré syndrome; influenza vaccines; self-controlled risk interval; sequential tests; vaccine safety.

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Figures

Figure 1.
Figure 1.
Medicare Fee-for-Service population number of overall seasonal and high-dose influenza vaccine administrations in the early-season surveillance population by vaccination week. SCRI, self-controlled risk interval.
Figure 2.
Figure 2.
Medicare Fee-for-Service population early-season self-controlled risk interval analysis, interval between influenza vaccination and Guillain-Barré syndrome diagnosis, beneficiaries ages ≥65 years, high-dose and all seasonal influenza vaccines combined; risk windows are 8–21 and 1–42 days postvaccination; control window is 43–84 days postvaccination.
Figure 3.
Figure 3.
Medicare Fee-for-Service population end-of-season self-controlled risk interval analysis, interval between influenza vaccination and Guillain-Barré syndrome diagnosis, beneficiaries ages ≥65 years, high-dose and all seasonal influenza vaccines combined; risk windows is 8–21 and 1–42 days postvaccination; control window is 43–84 days postvaccination.
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References

    1. Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ, et al. . Guillain-Barré syndrome following vaccination in the national influenza immunization program, United States, 1976–1977. Am J Epidemiol 1979; 110:105–23. - PubMed
    1. Langmuir AD. Guillain-Barré syndrome: the swine influenza virus vaccine incident in the United States of America, 1976-77: preliminary communication. J R Soc Med 1979; 72:660–9. - PMC - PubMed
    1. Langmuir AD, Bregman DJ, Kurland LT, Nathanson N, Victor M. An epidemiologic and clinical evaluation of Guillain-Barré syndrome reported in association with the administration of swine influenza vaccines. Am J Epidemiol 1984; 119:841–79. - PubMed
    1. Hurwitz ES, Schonberger LB, Nelson DB, Holman RC. Guillain-Barre syndrome and the 1978–1979 influenza vaccine. N Engl J Med 1981; 304:1557–61. - PubMed
    1. Kaplan JE, Katona P, Hurwitz ES, Schonberger LB. Guillain-Barre syndrome in the United States, 1979–1980 and 1980–1981. Lack of an association with influenza vaccination. JAMA 1982; 248:698–700. - PubMed

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