The perfect vaccine

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Source: The Lancet, Volume 378, Issue 9802, Pages 1545 – 1546, 29 October 2011

Guillain-Barré syndrome and H1N1 influenza vaccine in UK childrendoi:10.1016/S0140-6736(11)61665-6Cite or Link Using DOI
In 1976, the US National Influenza Immunization Programme (against swine influenza) was discontinued because of an increased risk of Guillain-Barré syndrome within 6 weeks of vaccination.1 Guillain-Barré syndrome surveillance was therefore imperative for pandemic H1N1 (swine) influenza vaccines and was fast-tracked for UK children younger than 17 years by use of the British Paediatric Surveillance Unit (BPSU) system. Fisher’s syndrome is related to Guillain-Barré syndrome, so both disorders were included. Follow-up clinical questionnaires were sent to paediatricians who reported cases via the BPSU. Histories of H1N1 and seasonal influenza vaccination were obtained from general practitioners.
Between September, 2009, and August, 2010, 55 children developed symptoms of Guillain-Barré syndrome and two of Fisher’s syndrome. Of these, 49 had clinical or laboratory evidence (or both) of an infection in the 3 months before the neurological symptoms started—22 had respiratory infections, 13 gastroenteritis, seven H1N1 influenza (five laboratory-confirmed), two seasonal influenza (one laboratory confirmed), two Epstein-Barr virus, one chickenpox, and two had unexplained fevers. Three children with Guillain-Barré syndrome had received H1N1 or seasonal influenza vaccines. One child had two H1N1 doses of a whole-virion unadjuvanted vaccine at 5 weeks and 10 days before onset—the only case with an interval potentially indicating a causal relation with Guillain-Barré syndrome.1 Another had received one dose of H1N1 vaccine 6 months before and the third a seasonal influenza vaccine 4 months before onset.
Between October, 2009, and March 31, 2010, an estimated 855 378 children in England received H1N1 vaccine,2 most with an AS03B adjuvanted split-virion vaccine. Additional children were vaccinated elsewhere in the UK (which our study covers). A single case of Guillain-Barré syndrome with onset within 6 weeks of H1N1 vaccination is what would be expected by chance in the vaccinated cohort given the background rate of Guillain-Barré syndrome in this age group.3
Of the 57 cases of Guillain-Barré syndrome or Fisher’s syndrome, nine had influenza (six laboratory-confirmed). This finding is consistent with that of a recent study that found no association between Guillain-Barré syndrome and seasonal influenza vaccination but a 16-fold increased risk within 1 month of an influenza-like illness.4 The peak in the number of children with Guillain-Barré syndrome or Fisher’s syndrome shortly after the peak of the second wave of H1N1 infection in November, 2009, might reflect this causal association (figure). Given the proven effectiveness of pandemic influenza vaccine used in UK children,5the vaccination programme might have had an overall protective effect against Guillain-Barré syndrome.
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Children reported to our study who first developed symptoms of Guillain-Barré syndrome or Fisher’s syndrome between September, 2009, and Aug 31, 2010
This study was funded by the UK Department of Health Policy Research Programme, grant numbers 019/0047 and 039/0031. The views expressed in this letter are those of the authors and not necessarily those of the Department of Health. We declare that we have no conflicts of interest.


1 Schonberger LBBregman DJSullivan-Bolyai JZ, et alGuillain-Barré syndrome following vaccination in the National Influenza Immunization Program, United States, 1976—1977Am J Epidemiol 1979110105PubMed
2 Sethi MPebody RPandemic H1N1 (swine) influenza vaccine uptake amongst patient groups in primary care in England 2009/2010. May 16, 2011).
3 Black SEskola JSiegrist CA, et alImportance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccinesLancet 20093742115-2122Summary | Full Text | PDF(113KB) |CrossRef | PubMed
4 Stowe JAndrews NWise LMiller EInvestigation of the temporal association of Guillain-Barré syndrome with influenza vaccine and influenza-like illness using the United Kingdom General Practice Research DatabaseAm J Epidemiol 2009169382-388CrossRef | PubMed
5 Andrews NWaight PYung CFMiller EAge-specific effectiveness of an oil-in-water adjuvanted pandemic (H1N1) 2009 vaccine against confirmed infection in high risk groups in EnglandJ Infect Dis 201120332-39CrossRef | PubMed
a PIND/GBS Research Group, Box 267, Addenbrooke’s Hospital, Hills Road, Cambridge CB2 0QQ, UK
b Health Protection Agency, London, UK

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