tetano
Editor, Senior Moderator
BMJ 2011; 343:d3908 doi: 10.1136/bmj.d3908 (Published 12 July 2011)
Cite this as: BMJ 2011; 343:d3908
Research
Guillain-Barr? syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccine: multinational case-control study in Europe
Free via Creative Commons: OPEN ACCESS
Jeanne Dieleman, senior pharmacoepidemiologist1,
Silvana Romio, senior medical statistician1,
Kari Johansen, senior infectious diseases scientist2,
Daniel Weibel, senior epidemiologist3,
Jan Bonhoeffer, consultant in infectious diseases and vaccines3,
Miriam Sturkenboom, professor of pharmacoepidemiology and medical informatics1
and the VAESCO-GBS Case-Control Study Group
+ Author Affiliations
1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands
2European Centre for Disease Prevention and Control, ECDC, Stockholm, Sweden
3Brighton Collaboration, Basel, Switzerland
Correspondence to: M Sturkenboom m.sturkenboom@erasmusmc.nl
Accepted 9 May 2011
Abstract
Objective To assess the association between pandemic influenza A (H1N1) 2009 vaccine and Guillain-Barr? syndrome.
Design Case-control study.
Setting Five European countries.
Participants 104 patients with Guillain-Barr? syndrome and its variant Miller-Fisher syndrome matched to one or more controls. Case status was classified according to the Brighton Collaboration definition. Controls were matched to cases on age, sex, index date, and country.
Main outcome measures Relative risk estimate for Guillain-Barr? syndrome after pandemic influenza vaccine.
Results Case recruitment and vaccine coverage varied considerably between countries; the most common vaccines used were adjuvanted (Pandemrix and Focetria). The unadjusted pooled risk estimate for all countries was 2.8 (95% confidence interval 1.3 to 6.0). After adjustment for influenza-like illness/upper respiratory tract infection and seasonal influenza vaccination, receipt of pandemic influenza vaccine was not associated with an increased risk of Guillain-Barr? syndrome (adjusted odds ratio 1.0, 0.3 to 2.7). The 95% confidence interval shows that the absolute effect of vaccination could range from one avoided case of Guillain-Barr? syndrome up to three excess cases within six weeks after vaccination in one million people.
Conclusions The risk of occurrence of Guillain-Barr? syndrome is not increased after pandemic influenza vaccine, although the upper limit does not exclude a potential increase in risk up to 2.7-fold or three excess cases per one million vaccinated people. When assessing the association between pandemic influenza vaccines and Guillain-Barr? syndrome it is important to account for the effects of influenza-like illness/upper respiratory tract infection, seasonal influenza vaccination, and calendar time.
http://www.bmj.com/content/343/bmj.d3908.abstract
Cite this as: BMJ 2011; 343:d3908
Research
Guillain-Barr? syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccine: multinational case-control study in Europe
Free via Creative Commons: OPEN ACCESS
Jeanne Dieleman, senior pharmacoepidemiologist1,
Silvana Romio, senior medical statistician1,
Kari Johansen, senior infectious diseases scientist2,
Daniel Weibel, senior epidemiologist3,
Jan Bonhoeffer, consultant in infectious diseases and vaccines3,
Miriam Sturkenboom, professor of pharmacoepidemiology and medical informatics1
and the VAESCO-GBS Case-Control Study Group
+ Author Affiliations
1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands
2European Centre for Disease Prevention and Control, ECDC, Stockholm, Sweden
3Brighton Collaboration, Basel, Switzerland
Correspondence to: M Sturkenboom m.sturkenboom@erasmusmc.nl
Accepted 9 May 2011
Abstract
Objective To assess the association between pandemic influenza A (H1N1) 2009 vaccine and Guillain-Barr? syndrome.
Design Case-control study.
Setting Five European countries.
Participants 104 patients with Guillain-Barr? syndrome and its variant Miller-Fisher syndrome matched to one or more controls. Case status was classified according to the Brighton Collaboration definition. Controls were matched to cases on age, sex, index date, and country.
Main outcome measures Relative risk estimate for Guillain-Barr? syndrome after pandemic influenza vaccine.
Results Case recruitment and vaccine coverage varied considerably between countries; the most common vaccines used were adjuvanted (Pandemrix and Focetria). The unadjusted pooled risk estimate for all countries was 2.8 (95% confidence interval 1.3 to 6.0). After adjustment for influenza-like illness/upper respiratory tract infection and seasonal influenza vaccination, receipt of pandemic influenza vaccine was not associated with an increased risk of Guillain-Barr? syndrome (adjusted odds ratio 1.0, 0.3 to 2.7). The 95% confidence interval shows that the absolute effect of vaccination could range from one avoided case of Guillain-Barr? syndrome up to three excess cases within six weeks after vaccination in one million people.
Conclusions The risk of occurrence of Guillain-Barr? syndrome is not increased after pandemic influenza vaccine, although the upper limit does not exclude a potential increase in risk up to 2.7-fold or three excess cases per one million vaccinated people. When assessing the association between pandemic influenza vaccines and Guillain-Barr? syndrome it is important to account for the effects of influenza-like illness/upper respiratory tract infection, seasonal influenza vaccination, and calendar time.
http://www.bmj.com/content/343/bmj.d3908.abstract