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

Black, Steven; Eskola, Juhani; Siegrist, Claire-Anne; Halsey, Neal; Macdonald, Noni; Law, Barbara; Miller, Elizabeth; Andrews, Nick; Stowe, Julia; Salmon, Daniel; Vannice, Kirsten; Izurieta, Hector S.; Akhtar, Aysha; Gold, Mike; Oselka, Gabriel; Zuber, Patrick; Pfeifer, Dina; Vellozzi, Claudia

doi:10.1016/S0140-6736(09)61877-8

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Title		Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines
Authors		Black, Steven Eskola, Juhani Siegrist, Claire-Anne Halsey, Neal Macdonald, Noni Law, Barbara Miller, Elizabeth Andrews, Nick Stowe, Julia Salmon, Daniel Vannice, Kirsten Izurieta, Hector S. Akhtar, Aysha Gold, Mike Oselka, Gabriel Zuber, Patrick Pfeifer, Dina Vellozzi, Claudia show all authors [1 - 18]
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		Adolescent — Adult — Child, Preschool — Female — Guillain-Barre Syndrome — Humans — Influenza A Virus, H1N1 Subtype/immunology — Influenza Vaccines/adverse effects/standards — Male — *Mass Vaccination/adverse effects — Multiple Sclerosis/etiology — Myelitis, Transverse/etiology — Neuritis/etiology — Obstetric Labor, Premature/etiology — Optic Neuritis/etiology — Pregnancy
Identifiers		DOI: 10.1016/S0140-6736(09)61877-8 PMID: 19880172
Full text		Article - Limited access to UNIGE Other version: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2861912/pdf/nihms183100.pdf
Structures		Faculté de médecine / Section de médecine clinique / Département de pédiatrie, gynécologie et obstétrique
Research group		Centre de Vaccinologie et d'Immunologie néonatale (177)
Citation (ISO format)		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