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 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

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

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 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

^*Corresponding author for this work

Immunisation Hepatitis and Blood Safety

Research output: Contribution to journal › Article › peer-review

217 Citations (Scopus)

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 language	English
Pages (from-to)	2115-2122
Number of pages	8
Journal	The Lancet
Volume	374
Issue number	9707
DOIs	https://doi.org/10.1016/S0140-6736(09)61877-8
Publication status	Published - 2009

Bibliographical note

Funding Information:
SB serves on a data monitoring safety board for pneumococcal conjugate vaccine for GSK and has received honoraria for participation in scientific advisory boards for Novartis. NH has grants from the Centers for Disease Control and Prevention (CDC) to study adverse events after vaccination. He also serves on data safety review committees for clinical trials sponsored by CDC, Merck, and Novartis. C-AS has received honoraria for participation in scientific advisory boards and research grants from GSK, Wyeth, and Sanofi Pasteur. All other authors declare that they have no conflicts of interest.

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Black, S., Eskola, J., Siegrist, C. A., Halsey, N., MacDonald, N., Law, B., Miller, E., Andrews, N., Stowe, J., Salmon, D., Vannice, K., Izurieta, H. S., 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, 374(9707), 2115-2122. https://doi.org/10.1016/S0140-6736(09)61877-8

@article{dbb78a8272c94b6894298cd64ea370a7,

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

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-Barr{\'e} 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-Barr{\'e} 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.",

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

note = "Funding Information: SB serves on a data monitoring safety board for pneumococcal conjugate vaccine for GSK and has received honoraria for participation in scientific advisory boards for Novartis. NH has grants from the Centers for Disease Control and Prevention (CDC) to study adverse events after vaccination. He also serves on data safety review committees for clinical trials sponsored by CDC, Merck, and Novartis. C-AS has received honoraria for participation in scientific advisory boards and research grants from GSK, Wyeth, and Sanofi Pasteur. All other authors declare that they have no conflicts of interest. ",

year = "2009",

doi = "10.1016/S0140-6736(09)61877-8",

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Black, S, Eskola, J, Siegrist, CA, Halsey, N, 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

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T1 - Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines

AU - Black, Steven

AU - Eskola, Juhani

AU - Siegrist, Claire Anne

AU - Halsey, Neal

AU - MacDonald, Noni

AU - Law, Barbara

AU - Miller, Elizabeth

AU - Andrews, Nick

AU - Stowe, Julia

AU - Salmon, Daniel

AU - Vannice, Kirsten

AU - Izurieta, Hector S.

AU - Akhtar, Aysha

AU - Gold, Mike

AU - Oselka, Gabriel

AU - Zuber, Patrick

AU - Pfeifer, Dina

AU - Vellozzi, Claudia

N1 - Funding Information: SB serves on a data monitoring safety board for pneumococcal conjugate vaccine for GSK and has received honoraria for participation in scientific advisory boards for Novartis. NH has grants from the Centers for Disease Control and Prevention (CDC) to study adverse events after vaccination. He also serves on data safety review committees for clinical trials sponsored by CDC, Merck, and Novartis. C-AS has received honoraria for participation in scientific advisory boards and research grants from GSK, Wyeth, and Sanofi Pasteur. All other authors declare that they have no conflicts of interest.

PY - 2009

Y1 - 2009

N2 - 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.

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DO - 10.1016/S0140-6736(09)61877-8

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SN - 0140-6736

VL - 374

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JO - The Lancet

JF - The Lancet

IS - 9707

ER -

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

Abstract

Bibliographical note

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