Is an Increased Risk of Developing Guillain-Barré Syndrome Associated with Seasonal Influenza Vaccination? A Systematic Review and Meta-Analysis.

Marek Petráš,Jana Dáňová,Alexander M Čelko,Ivana Králová Lesná

doi:10.3390/vaccines8020150

Marek Petráš, Jana Dáňová + Show 2 more

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https://doi.org/10.3390/vaccines8020150

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Journal: Vaccines	Publication Date: Mar 27, 2020
Citations: 16	License type: CC BY 4.0

Affiliation: Charles University

Abstract

While the weight of epidemiological evidence does not support a causal link with influenza vaccination evaluated over the last 30 years, Guillain–Barré syndrome (GBS) has been considered a vaccine-associated adverse event of interest since 1976. To investigate the existence of GBS risk after vaccination against seasonal influenza, a systematic review and meta-analysis have been conducted based on 22 eligible epidemiological studies from 1981 to 2019 reporting 26 effect sizes (ESs) in different influenza seasons. The primary result of our meta-analysis pointed to no risk of vaccine-associated GBS, as documented by a pooled ES of 1.15 (95% CI: 0.97–1.35). Conversely, an obvious high risk of GBS was observed in patients with previous influenza-like illness (ILI), as demonstrated by a pooled ES of 9.6 (95% CI: 4.0–23.0) resulting from a supplementary analysis. While the meta-analysis did not confirm the putative risk of vaccine-associated GBS suggested by many epidemiological studies, vaccination against seasonal influenza reduced the risk of developing ILI-associated GBS by about 88%. However, to obtain strong evidence, more epidemiological studies are warranted to establish a possible coincidence between vaccination and ILI prior to GBS onset.

Highlights

Guillain–Barré syndrome (GBS) is a rare but serious cause of acute neuromuscular paralysis, resulting in muscle weakness and a loss of reflexes in about two cases per 100,000 people per year [1,2]
A possible causal link was again documented in summary studies designed to evaluate GBS onset after immunization with a monovalent vaccine only used in the 2009–2010 season to prevent a pandemic of influenza type A subtype H1N1 [23,24,25]
We only focused on GBS occurrence after immunization against seasonal influenza carried out every year using a common inactivated trivalent vaccine, in order to exclude the effect of the extraordinary use of a monovalent pandemic influenza vaccine with or without adjuvants

Summary

Introduction

Guillain–Barré syndrome (GBS) is a rare but serious cause of acute neuromuscular paralysis, resulting in muscle weakness and a loss of reflexes in about two cases per 100,000 people per year [1,2]. The syndrome has been shown to be associated with antecedent gastrointestinal or upper respiratory tract infections, including influenza [3,4,5]. The initiative of rapid vaccination of the USA population against swine influenza in 1976 entailed an unexpected increase in GBS risk in adults, alerting researchers to a dangerous vaccine association with GBS [8,9,10]. GBS has been a potential vaccine-associated adverse event of interest, later studies looking into the association between GBS and influenza vaccination have suggested its absence [11,12,13,14,15,16,17,18,19,20,21,22]. A possible causal link was again documented in summary studies designed to evaluate GBS onset after immunization with a monovalent vaccine only used in the 2009–2010 season to prevent a pandemic of influenza type A subtype H1N1 [23,24,25]

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