tetano
Editor, Senior Moderator
Vaccine. 2019 May 20. pii: S0264-410X(19)30665-6. doi: 10.1016/j.vaccine.2019.05.041. [Epub ahead of print]
[h=1]Surveillance for Guillain-Barr? syndrome after influenza vaccination among U.S. Medicare beneficiaries during the 2017-2018 season.[/h] Perez-Vilar S[SUP]1[/SUP], Wernecke M[SUP]2[/SUP], Arya D[SUP]3[/SUP], Lo AC[SUP]4[/SUP], Lufkin B[SUP]5[/SUP], Hu M[SUP]6[/SUP], Chu S[SUP]7[/SUP], MaCurdy TE[SUP]8[/SUP], Kelman J[SUP]9[/SUP], Forshee RA[SUP]10[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services have been actively monitoring the risk of Guillain-Barr? syndrome (GBS) following influenza vaccination among Fee-for-Service (FFS) Medicare beneficiaries every season since 2008. We present our evaluation of the GBS risk following influenza vaccinations during the 2017-2018 season.
[h=4]METHODS:[/h] We implemented a multilayered approach to active safety surveillance that included near real-time surveillance early in the season, comparing GBS rates post-vaccination during the 2017-2018 season with rates from five prior seasons using the Updating Sequential Probability Ratio Test (USPRT), and end-of-season self-controlled risk interval (SCRI) analyses.
[h=4]RESULTS:[/h] We identified approximately 16 million influenza vaccinations. The near real-time surveillance did not signal for a potential 2.5-fold increased GBS risk either in days 8-21 or 1-42 post-influenza vaccination. In the SCRI analyses, we did not detect statistically significant increased GBS risks among influenza-vaccinated Medicare beneficiaries ≥65 years for either the 8-21 or 1-42-day risk windows for all seasonal vaccines combined, high-dose vaccine, or standard-dose vaccines; we did detect an increased GBS risk in days 8-21 post-vaccination for individuals vaccinated with the adjuvanted vaccine (OR: 3.75; 95% CI: 1.01, 13.96), although this finding was not statistically significant after multiplicity adjustment (p = 0.146).
[h=4]CONCLUSIONS:[/h] Our multilayered surveillance approach-which allows for early detection of elevated GBS risk and provides reliable end-of-season SCRI estimates of effect size-did not identify an increased GBS risk following 2017-2018 influenza vaccinations. The slightly increased GBS risk with the adjuvanted vaccine, which was not statistically significant following multiplicity adjustment, is consistent with the package inserts of all U.S.-licensed influenza vaccines, which warn of a potential low increased GBS risk. The benefits of influenza vaccines in preventing morbidity and mortality heavily outweigh this potential risk.
Copyright ? 2019. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Guillain-Barr? syndrome; Influenza vaccines; Near real-time surveillance; Self-controlled risk interval; Sequential tests; Vaccine safety
PMID: 31122853 DOI: 10.1016/j.vaccine.2019.05.041
[h=1]Surveillance for Guillain-Barr? syndrome after influenza vaccination among U.S. Medicare beneficiaries during the 2017-2018 season.[/h] Perez-Vilar S[SUP]1[/SUP], Wernecke M[SUP]2[/SUP], Arya D[SUP]3[/SUP], Lo AC[SUP]4[/SUP], Lufkin B[SUP]5[/SUP], Hu M[SUP]6[/SUP], Chu S[SUP]7[/SUP], MaCurdy TE[SUP]8[/SUP], Kelman J[SUP]9[/SUP], Forshee RA[SUP]10[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services have been actively monitoring the risk of Guillain-Barr? syndrome (GBS) following influenza vaccination among Fee-for-Service (FFS) Medicare beneficiaries every season since 2008. We present our evaluation of the GBS risk following influenza vaccinations during the 2017-2018 season.
[h=4]METHODS:[/h] We implemented a multilayered approach to active safety surveillance that included near real-time surveillance early in the season, comparing GBS rates post-vaccination during the 2017-2018 season with rates from five prior seasons using the Updating Sequential Probability Ratio Test (USPRT), and end-of-season self-controlled risk interval (SCRI) analyses.
[h=4]RESULTS:[/h] We identified approximately 16 million influenza vaccinations. The near real-time surveillance did not signal for a potential 2.5-fold increased GBS risk either in days 8-21 or 1-42 post-influenza vaccination. In the SCRI analyses, we did not detect statistically significant increased GBS risks among influenza-vaccinated Medicare beneficiaries ≥65 years for either the 8-21 or 1-42-day risk windows for all seasonal vaccines combined, high-dose vaccine, or standard-dose vaccines; we did detect an increased GBS risk in days 8-21 post-vaccination for individuals vaccinated with the adjuvanted vaccine (OR: 3.75; 95% CI: 1.01, 13.96), although this finding was not statistically significant after multiplicity adjustment (p = 0.146).
[h=4]CONCLUSIONS:[/h] Our multilayered surveillance approach-which allows for early detection of elevated GBS risk and provides reliable end-of-season SCRI estimates of effect size-did not identify an increased GBS risk following 2017-2018 influenza vaccinations. The slightly increased GBS risk with the adjuvanted vaccine, which was not statistically significant following multiplicity adjustment, is consistent with the package inserts of all U.S.-licensed influenza vaccines, which warn of a potential low increased GBS risk. The benefits of influenza vaccines in preventing morbidity and mortality heavily outweigh this potential risk.
Copyright ? 2019. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Guillain-Barr? syndrome; Influenza vaccines; Near real-time surveillance; Self-controlled risk interval; Sequential tests; Vaccine safety
PMID: 31122853 DOI: 10.1016/j.vaccine.2019.05.041