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

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

Research output: Contribution to journalArticle

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-Barré 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-Barré 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.

Original languageEnglish (US)
Pages (from-to)2115-2122
Number of pages8
JournalThe Lancet
Volume374
Issue number9707
DOIs
StatePublished - 2009

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Mass Vaccination
Influenza Vaccines
Pandemics
Vaccination
Vaccines
Safety
Spontaneous Abortion
Human Influenza
Optic Neuritis
Immunization Programs
Geography
Sudden Death
Pregnant Women
Health
Population

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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 A; 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.

In: The Lancet, Vol. 374, No. 9707, 2009, p. 2115-2122.

Research output: Contribution to journalArticle

Black, S, Eskola, J, Siegrist, CA, Halsey, NA, MacDonald, N, Law, B, Miller, E, Andrews, N, Stowe, J, Salmon, D, Vannice, K, Izurieta, HS, Akhtar, A, Gold, M, Oselka, G, Zuber, P, Pfeifer, D & Vellozzi, C 2009, 'Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines', The Lancet, vol. 374, no. 9707, pp. 2115-2122. https://doi.org/10.1016/S0140-6736(09)61877-8
Black, Steven ; Eskola, Juhani ; Siegrist, Claire Anne ; Halsey, Neal A ; 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. / 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, No. 9707. pp. 2115-2122.
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