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Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines

Black, Steven
Eskola, Juhani
Halsey, Neal
Macdonald, Noni
Law, Barbara
Miller, Elizabeth
Andrews, Nick
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Published in The Lancet. 2009, vol. 374, no. 9707, p. 2115-2122
Abstract Because of the advent of a new influenza A H1N1 strain, many countries have begun mass immunisation programmes. Awareness of the background rates of possible adverse events will be a crucial part of assessment of possible vaccine safety concerns and will help to separate legitimate safety concerns from events that are temporally associated with but not caused by vaccination. We identified background rates of selected medical events for several countries. Rates of disease events varied by age, sex, method of ascertainment, and geography. Highly visible health conditions, such as Guillain-Barre syndrome, spontaneous abortion, or even death, will occur in coincident temporal association with novel influenza vaccination. On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21.5 cases of Guillain-Barre syndrome and 5.75 cases of sudden death would be expected to occur within 6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86.3 cases of optic neuritis per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant women would be predicted to have a spontaneous abortion within 1 day of vaccination.
Keywords AdolescentAdultChild, PreschoolFemaleGuillain-Barre SyndromeHumansInfluenza A Virus, H1N1 Subtype/*immunologyInfluenza Vaccines/adverse effects/*standardsMale*Mass Vaccination/adverse effectsMultiple Sclerosis/etiologyMyelitis, Transverse/etiologyNeuritis/etiologyObstetric Labor, Premature/etiologyOptic Neuritis/etiologyPregnancy
PMID: 19880172
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Research group Centre de Vaccinologie et d'Immunologie néonatale (177)
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BLACK, Steven et al. Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines. In: The Lancet, 2009, vol. 374, n° 9707, p. 2115-2122. doi: 10.1016/S0140-6736(09)61877-8 https://archive-ouverte.unige.ch/unige:19683

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Deposited on : 2012-04-23

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