Format

Send to

Choose Destination
Vaccine. 2019 Jun 27;37(29):3856-3865. doi: 10.1016/j.vaccine.2019.05.041. Epub 2019 May 20.

Surveillance for Guillain-Barré syndrome after influenza vaccination among U.S. Medicare beneficiaries during the 2017-2018 season.

Author information

1
Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, United States. Electronic address: silvia.perezvilar@fda.hhs.gov.
2
Acumen LLC, United States. Electronic address: mwernecke@acumenllc.com.
3
Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, United States. Electronic address: deepa.arya@fda.hhs.gov.
4
Acumen LLC, United States. Electronic address: alo@sphereinstitute.com.
5
Acumen LLC, United States. Electronic address: blufkin@acumenllc.com.
6
Acumen LLC, United States. Electronic address: mhu@acumenllc.com.
7
Centers for Medicare and Medicaid Services, United States. Electronic address: steve.chu@cms.hhs.gov.
8
Stanford University, Department of Economics and Hoover Institution, United States; Acumen LLC, United States. Electronic address: tmac@acumenllc.com.
9
Centers for Medicare and Medicaid Services, United States. Electronic address: jeffrey.kelman@cms.hhs.gov.
10
Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, United States. Electronic address: richard.forshee@fda.hhs.gov.

Abstract

BACKGROUND:

The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services have been actively monitoring the risk of Guillain-Barré 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.

METHODS:

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.

RESULTS:

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).

CONCLUSIONS:

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.

KEYWORDS:

Guillain-Barré syndrome; Influenza vaccines; Near real-time surveillance; Self-controlled risk interval; Sequential tests; Vaccine safety

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center