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Association between Guillain-Barré syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis.
Lancet. 2013 Apr 27; 381(9876):1461-8.Lct

Abstract

BACKGROUND

The influenza A (H1N1) 2009 monovalent vaccination programme was the largest mass vaccination initiative in recent US history. Commensurate with the size and scope of the vaccination programme, a project to monitor vaccine adverse events was undertaken, the most comprehensive safety surveillance agenda in the USA to date. The adverse event monitoring project identified an increased risk of Guillain-Barré syndrome after vaccination; however, some individual variability in results was noted. Guillain-Barré syndrome is a rare but serious health disorder in which a person's own immune system damages their nerve cells, causing muscle weakness, sometimes paralysis, and infrequently death. We did a meta-analysis of data from the adverse event monitoring project to ascertain whether influenza A (H1N1) 2009 monovalent inactivated vaccines used in the USA increased the risk of Guillain-Barré syndrome.

METHODS

Data were obtained from six adverse event monitoring systems. About 23 million vaccinated people were included in the analysis. The primary analysis entailed calculation of incidence rate ratios and attributable risks of excess cases of Guillain-Barré syndrome per million vaccinations. We used a self-controlled risk-interval design.

FINDINGS

Influenza A (H1N1) 2009 monovalent inactivated vaccines were associated with a small increased risk of Guillain-Barré syndrome (incidence rate ratio 2·35, 95% CI 1·42-4·01, p=0·0003). This finding translated to about 1·6 excess cases of Guillain-Barré syndrome per million people vaccinated.

INTERPRETATION

The modest risk of Guillain-Barré syndrome attributed to vaccination is consistent with previous estimates of the disorder after seasonal influenza vaccination. A risk of this small magnitude would be difficult to capture during routine seasonal influenza vaccine programmes, which have extensive, but comparatively less, safety monitoring. In view of the morbidity and mortality caused by 2009 H1N1 influenza and the effectiveness of the vaccine, clinicians, policy makers, and those eligible for vaccination should be assured that the benefits of inactivated pandemic vaccines greatly outweigh the risks.

FUNDING

US Federal Government.

Authors+Show Affiliations

National Vaccine Program Office, Office of the Assistant Secretary for Health, Department of Health and Human Services, Washington, DC, USA. dsalmon@jhsph.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, U.S. Gov't, Non-P.H.S.
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

23498095

Citation

Salmon, Daniel A., et al. "Association Between Guillain-Barré Syndrome and Influenza a (H1N1) 2009 Monovalent Inactivated Vaccines in the USA: a Meta-analysis." Lancet (London, England), vol. 381, no. 9876, 2013, pp. 1461-8.
Salmon DA, Proschan M, Forshee R, et al. Association between Guillain-Barré syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis. Lancet. 2013;381(9876):1461-8.
Salmon, D. A., Proschan, M., Forshee, R., Gargiullo, P., Bleser, W., Burwen, D. R., Cunningham, F., Garman, P., Greene, S. K., Lee, G. M., Vellozzi, C., Yih, W. K., Gellin, B., & Lurie, N. (2013). Association between Guillain-Barré syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis. Lancet (London, England), 381(9876), 1461-8. https://doi.org/10.1016/S0140-6736(12)62189-8
Salmon DA, et al. Association Between Guillain-Barré Syndrome and Influenza a (H1N1) 2009 Monovalent Inactivated Vaccines in the USA: a Meta-analysis. Lancet. 2013 Apr 27;381(9876):1461-8. PubMed PMID: 23498095.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Association between Guillain-Barré syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis. AU - Salmon,Daniel A, AU - Proschan,Michael, AU - Forshee,Richard, AU - Gargiullo,Paul, AU - Bleser,William, AU - Burwen,Dale R, AU - Cunningham,Francesca, AU - Garman,Patrick, AU - Greene,Sharon K, AU - Lee,Grace M, AU - Vellozzi,Claudia, AU - Yih,W Katherine, AU - Gellin,Bruce, AU - Lurie,Nicole, AU - ,, Y1 - 2013/03/13/ PY - 2013/3/19/entrez PY - 2013/3/19/pubmed PY - 2013/5/11/medline SP - 1461 EP - 8 JF - Lancet (London, England) JO - Lancet VL - 381 IS - 9876 N2 - BACKGROUND: The influenza A (H1N1) 2009 monovalent vaccination programme was the largest mass vaccination initiative in recent US history. Commensurate with the size and scope of the vaccination programme, a project to monitor vaccine adverse events was undertaken, the most comprehensive safety surveillance agenda in the USA to date. The adverse event monitoring project identified an increased risk of Guillain-Barré syndrome after vaccination; however, some individual variability in results was noted. Guillain-Barré syndrome is a rare but serious health disorder in which a person's own immune system damages their nerve cells, causing muscle weakness, sometimes paralysis, and infrequently death. We did a meta-analysis of data from the adverse event monitoring project to ascertain whether influenza A (H1N1) 2009 monovalent inactivated vaccines used in the USA increased the risk of Guillain-Barré syndrome. METHODS: Data were obtained from six adverse event monitoring systems. About 23 million vaccinated people were included in the analysis. The primary analysis entailed calculation of incidence rate ratios and attributable risks of excess cases of Guillain-Barré syndrome per million vaccinations. We used a self-controlled risk-interval design. FINDINGS: Influenza A (H1N1) 2009 monovalent inactivated vaccines were associated with a small increased risk of Guillain-Barré syndrome (incidence rate ratio 2·35, 95% CI 1·42-4·01, p=0·0003). This finding translated to about 1·6 excess cases of Guillain-Barré syndrome per million people vaccinated. INTERPRETATION: The modest risk of Guillain-Barré syndrome attributed to vaccination is consistent with previous estimates of the disorder after seasonal influenza vaccination. A risk of this small magnitude would be difficult to capture during routine seasonal influenza vaccine programmes, which have extensive, but comparatively less, safety monitoring. In view of the morbidity and mortality caused by 2009 H1N1 influenza and the effectiveness of the vaccine, clinicians, policy makers, and those eligible for vaccination should be assured that the benefits of inactivated pandemic vaccines greatly outweigh the risks. FUNDING: US Federal Government. SN - 1474-547X UR - https://www.unboundmedicine.com/medline/citation/23498095/Association_between_Guillain_Barré_syndrome_and_influenza_A__H1N1__2009_monovalent_inactivated_vaccines_in_the_USA:_a_meta_analysis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(12)62189-8 DB - PRIME DP - Unbound Medicine ER -