tetano
Editor, Senior Moderator
J Infect Dis
. 2020 Nov 2;jiaa543.
doi: 10.1093/infdis/jiaa543. Online ahead of print.
Guillain-Barr? Syndrome After High-Dose Influenza Vaccine Administration in the United States, 2018-2019 Season
Silvia Perez-Vilar[SUP] 1 [/SUP], Mao Hu[SUP] 2 [/SUP], Eric Weintraub[SUP] 3 [/SUP], Deepa Arya[SUP] 1 [/SUP], Bradley Lufkin[SUP] 2 [/SUP], Tanya Myers[SUP] 3 [/SUP], Emily Jane Woo[SUP] 1 [/SUP], An-Chi Lo[SUP] 2 [/SUP], Steve Chu[SUP] 4 [/SUP], Madeline Swarr[SUP] 2 [/SUP], Jiemin Liao[SUP] 2 [/SUP], Michael Wernecke[SUP] 2 [/SUP], Tom MaCurdy[SUP] 2 5 [/SUP], Jeffrey Kelman[SUP] 4 [/SUP], Steven Anderson[SUP] 1 [/SUP], Jonathan Duffy[SUP] 3 [/SUP], Richard A Forshee[SUP] 1 [/SUP]
Affiliations
Abstract
Background: The Vaccine Safety Datalink (VSD) identified a statistical signal for an increased risk of Guillain-Barr? 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-Barr? syndrome; influenza vaccines; self-controlled risk interval; sequential tests; vaccine safety.
. 2020 Nov 2;jiaa543.
doi: 10.1093/infdis/jiaa543. Online ahead of print.
Guillain-Barr? Syndrome After High-Dose Influenza Vaccine Administration in the United States, 2018-2019 Season
Silvia Perez-Vilar[SUP] 1 [/SUP], Mao Hu[SUP] 2 [/SUP], Eric Weintraub[SUP] 3 [/SUP], Deepa Arya[SUP] 1 [/SUP], Bradley Lufkin[SUP] 2 [/SUP], Tanya Myers[SUP] 3 [/SUP], Emily Jane Woo[SUP] 1 [/SUP], An-Chi Lo[SUP] 2 [/SUP], Steve Chu[SUP] 4 [/SUP], Madeline Swarr[SUP] 2 [/SUP], Jiemin Liao[SUP] 2 [/SUP], Michael Wernecke[SUP] 2 [/SUP], Tom MaCurdy[SUP] 2 5 [/SUP], Jeffrey Kelman[SUP] 4 [/SUP], Steven Anderson[SUP] 1 [/SUP], Jonathan Duffy[SUP] 3 [/SUP], Richard A Forshee[SUP] 1 [/SUP]
Affiliations
- PMID: 33137184
- DOI: 10.1093/infdis/jiaa543
Abstract
Background: The Vaccine Safety Datalink (VSD) identified a statistical signal for an increased risk of Guillain-Barr? 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-Barr? syndrome; influenza vaccines; self-controlled risk interval; sequential tests; vaccine safety.