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

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

Author Black, Steven Google Scholar
Eskola, Juhani Google Scholar
Siegrist, Claire-Anne Google Scholar
Halsey, Neal Google Scholar
MacDonald, Noni Google Scholar
Law, Barbara Google Scholar
Miller, Elizabeth Google Scholar
Andrews, Nick Google Scholar
Stowe, Julia Google Scholar
Salmon, Daniel Google Scholar
Vannice, Kirsten Google Scholar
Izurieta, Hector S. Google Scholar
Akhtar, Aysha Google Scholar
Gold, Mike Google Scholar
Oselka, Gabriel Google Scholar
Zuber, Patrick Google Scholar
Pfeifer, Dina Google Scholar
Vellozzi, Claudia Google Scholar
Institution Cincinnati Childrens Hosp
Natl Inst Hlth & Welf
Univ Geneva
Johns Hopkins Bloomberg Sch Publ Hlth
Dalhousie Univ
Publ Hlth Agcy Canada
Hlth Protect Agcy
Dept Hlth & Human Serv
Univ Adelaide
Universidade Federal de São Paulo (UNIFESP)
Ctr Dis Control & Prevent
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.
Language English
Sponsor Centers for Disease Control and Prevention
Department of Health and Human Services
US Food and Drug Administration
UK Health Protection Agency
Date 2009-12-01
Published in Lancet. New York: Elsevier B.V., v. 374, n. 9707, p. 2115-2122, 2009.
ISSN 0140-6736 (Sherpa/Romeo, impact factor)
Publisher Elsevier B.V.
Extent 2115-2122
Access rights Closed access
Type Article
Web of Science ID WOS:000273122900035

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