Risk of confirmed Guillain-Barre syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety Datalink Project, 2009-2010.
Open accessAbstract
An increased risk of Guillain-Barré syndrome (GBS) following administration of the 1976 swine influenza vaccine led to a heightened focus on GBS when monovalent vaccines against a novel influenza A (H1N1) virus of swine origin were introduced in 2009. GBS cases following receipt of monovalent inactivated (MIV) and seasonal trivalent inactivated (TIV) influenza vaccines in the Vaccine Safety Datalink Project in 2009-2010 were identified in electronic data and confirmed by medical record review. Within 1-42 days following vaccination, 9 cases were confirmed in MIV recipients (1.48 million doses), and 8 cases were confirmed in TIV-only recipients who did not also receive MIV during 2009-2010 (1.72 million doses). Five cases following MIV and 1 case following TIV-only had an antecedent respiratory infection, a known GBS risk factor; furthermore, unlike TIV, MIV administration was concurrent with heightened influenza activity. In a self-controlled risk interval analysis comparing GBS onset within 1-42 days following MIV with GBS onset 43-127 days following MIV, the risk difference was 5.0 cases per million doses (95% confidence interval: 0.5, 9.5). No statistically significant increased GBS risk was found within 1-42 days following TIV-only vaccination versus 43-84 days following vaccination (risk difference = 1.1 cases per million doses, 95% confidence interval: -3.1, 5.4). Further evaluation to assess GBS risk following both vaccination and respiratory infection is warranted.
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The Vaccine Safety Datalink team found an association between risk of Guillain-Barré syndrome and the monovalent inactivated vaccine against H1N1 but not the trivalent inactivated vaccine.
“The Vaccine Safety Datalink team, in a self-controlled risk interval analysis of data from the 2009–2010 influenza season found an association between risk of GBS and the monovalent inactivated vaccine (MIV) against H1N1 but not in association with the trivalent inactivated vaccine (TIV) (Greene et al., 2012).”
From Vaccine Safety: Myths and Misinformation (2020) · cites this paper as Greene et al., 2012
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Vaccine Safety: Myths and Misinformation
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“However, in a later analysis that included the 2010– 2011 season and adjusted for antecedent respiratory infection there was no increased risk following 1.27 million 2009- 10 MIV or 2.8 million 2010-11 TIV doses (Greene et al., 2013).”
BackgroundInfluentialGuillain-Barre syndrome and influenza vaccines: a meta-analysis.
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- Authors
- Greene, S. K., Rett, M., Weintraub, E. S., Li, L., Yin, R., Amato, A. A., Ho, D. T., Sheikh, S. I., Fireman, B. H., Daley, M. F., Belongia, E. A., Jacobsen, S. J., Baxter, R., Lieu, T. A., Kulldorff, M., Vellozzi, C., & Lee, G. M.
- Affiliations
- Harvard University (US)
- Corresponding author
- Greene, S. K.
- ORCID
- Venue
- American Journal of Epidemiology
- Publisher
- Oxford University Press (OUP)
- Published
- 2012-05-11
- Volume
- 175
- Issue
- 11
- Pages
- 1100-1109
- ISSN
- 0002-9262 (ISSN-L)
- 1476-6256
- PMC
- PMC6272801
- OpenAlex
- W2166891339
- Cited by
- 91
- References
- 38
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 2 · 2023: 1 · 2022: 5 · 2021: 5 · 2020: 6 · 2019: 8 · 2018: 5 · 2017: 6 · 2016: 3 · 2015: 8 · 2014: 12 · 2013: 16 · 2012: 8
- FWCI
- 9.09
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- American Journal of Epidemiology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Public Health Service (200-2002-00732)
- Sanofi Pasteur
- Topics
- Health Sciences › Medicine › Neurology › Peripheral Neuropathies and Disorders
- Health Sciences › Medicine › Epidemiology › Influenza Virus Research Studies
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- Guillain-Barré syndrome, influenza vaccine safety, vaccine adverse events, 2009 H1N1 pandemic, swine influenza, respiratory infections
- MeSH terms
- Adolescent, Adult, Aged, Child, Child, Preschool, Female, Humans, Infant, Influenza Vaccines, Male, Middle Aged, Product Surveillance, Postmarketing, Seasons, Time Factors, United States, Vaccines, Inactivated, Logistic Models, Odds Ratio, Risk Assessment, Guillain-Barre Syndrome, Influenza A Virus, H1N1 Subtype, Young Adult
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