Abstract
We aimed to analyze the incidence of Guillain-Barré syndrome (GBS) and its association with influenza vaccination (IV) in the elderly population. This study included 2470 patients hospitalized with GBS (G61.0) between 2014 and 2016 based on the Korean National Health Insurance Service (NHIS) claims data. We reviewed every medical claim in the 42 days preceding GBS diagnosis looking for precedent causes of GBS. To assess the relationship between IV and the development of GBS, data from the NHIS and the National Vaccination Registry were combined and analyzed. Using a self-controlled case series (SCCS) approach, we calculated the incidence rate ratio by setting the risk period as 42 days following vaccination. The annual background incidence of GBS was estimated at 4.15 per 100,000 persons. More than half of the patients with newly developed GBS had a previous infection or surgery. The incidence of GBS within 42 days of IV was estimated at 0.32 per 100,000 vaccinated persons. SCCS analysis showed that the risk of GBS was not significantly higher. While GBS can potentially develop from various infections, no association was found between GBS and IV. These results will contribute to developing an evidence-based vaccine policy that includes a clear causality assessment of adverse events.
Highlights
Influenza is a common infectious disease considered to be socially and economically burdensome, especially because of its frequent complications [1,2]
In Korea, influenza vaccination has been included in the National Immunization Program (NIP) since 1997 [6], and its coverage among the elderly population reached levels above 85% in 2018, which is the highest coverage rate in the world [7]
To estimate the incidence rate of Guillain-Barré syndrome (GBS) among vaccinated individuals and to assess the association between influenza vaccination and GBS, we used two national datasets: the vaccination registry established by the Korea Centers for Diseases Control and Prevention (KCDC) [24] and the National Health Insurance Service (NHIS)
Summary
Influenza is a common infectious disease considered to be socially and economically burdensome, especially because of its frequent complications [1,2]. In Korea, influenza vaccination has been included in the National Immunization Program (NIP) since 1997 [6], and its coverage among the elderly population reached levels above 85% in 2018, which is the highest coverage rate in the world [7]. Demographic and health care utilization characteristics of the incident GBS patients were examined, including gender, age, type of national health security program, month of hospital admission, specialty department in which they were treated when hospitalized, type of healthcare institution utilized, and registration in the rare-disease registry. We analyzed the frequency distribution of precedent infections, surgeries, or influenza vaccination, observed within 42 days of the date of admission with new-onset GBS. More than half of the elderly patients with new-onset GBS were aged 65–74 years (59.1%) and no seasonality was observed in the development of GBS (Table 2).
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