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

被引：198

作者：

Black, Steven ^{[1
,2
]}

Eskola, Juhani ^{[3
]}

Siegrist, Claire-Anne ^{[4
]}

Halsey, Neal ^{[5
]}

MacDonald, Noni ^{[6
]}

Law, Barbara ^{[7
]}

Miller, Elizabeth ^{[8
]}

Andrews, Nick ^{[8
]}

Stowe, Julia ^{[8
]}

Salmon, Daniel ^{[9
]}

Vannice, Kirsten ^{[9
]}

Izurieta, Hector S. ^{[10
]}

Akhtar, Aysha ^{[10
]}

Gold, Mike ^{[11
]}

Oselka, Gabriel ^{[12
]}

Zuber, Patrick ^{[13
]}

Pfeifer, Dina ^{[13
]}

Vellozzi, Claudia ^{[14
]}

机构：

[1] Cincinnati Childrens Hosp, Ctr Global Hlth, Cincinnati, OH 45229 USA

[2] Cincinnati Childrens Hosp, Div Infect Dis, Cincinnati, OH 45229 USA

[3] Natl Inst Hlth & Welf, Helsinki, Finland

[4] Univ Geneva, Ctr Vaccinol & Neonatal Immunol, Dept Pediat, Geneva, Switzerland

[5] Johns Hopkins Bloomberg Sch Publ Hlth, Dept Int Hlth, Inst Vaccine Safety, Baltimore, MD USA

[6] Dalhousie Univ, Dept Pediat, Div Infect Dis, Halifax, NS, Canada

[7] Publ Hlth Agcy Canada, Vaccine Safety Sect, Ctr Immunizat & Resp Infect Dis, Ottawa, ON, Canada

[8] Hlth Protect Agcy, Ctr Infect, London, England

[9] Dept Hlth & Human Serv, Natl Vaccine Program Off, Washington, DC USA

[10] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA

[11] Univ Adelaide, Discipline Paediat, Sch Paediat & Reprod Hlth, Adelaide, SA 5005, Australia

[12] Univ Sao Paulo, Dept Pediat, Fac Med, Sao Paulo, Brazil

[13] WHO, Qual Safety & Stand Team, CH-1211 Geneva, Switzerland

[14] Ctr Dis Control & Prevent, Immunizat Safety Off, Atlanta, GA USA

来源：

LANCET | 2009年 / 374卷 / 9707期

关键词：

GUILLAIN-BARRE-SYNDROME; MULTIPLE-SCLEROSIS; OPTIC NEURITIS; SUDDEN-DEATH; RISK; POPULATION; EPIDEMIOLOGY; ANAPHYLAXIS; PREVALENCE; STATES;

D O I：

10.1016/S0140-6736(09)61877-8

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：2115 / 2122

页数：8

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