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Vaccine
Article in Press, Uncorrected Proof - Note to users
doi:10.1016/j.vaccine.2011.08.069 | How to Cite or Link Using DOI
Guillain?Barr? syndrome and H1N1 (2009) pandemic influenza vaccination using an AS03 adjuvanted vaccine in the United Kingdom: Self-controlled case seriesstar, open
Nick Andrewsa, Corresponding Author Contact Information, E-mail The Corresponding Author, Julia Stoweb, Rustam Al-Shahi Salmanc and Elizabeth Millerb
a Statistics Modelling and Economics Department, Health Protection Services, Health Protection Agency, Colindale, London NW9 5EQ, United Kingdom
b Immunisation, Hepatitis and Blood Safety Department, Health Protection Services, Health Protection Agency, Colindale, London NW9 5EQ, United Kingdom
c Division of Clinical Neurosciences, University of Edinburgh, Western General Hospital, Edinburgh EH4 2XU, United Kingdom
Received 5 July 2011;
revised 2 August 2011;
accepted 15 August 2011.
Available online 27 August 2011.
Abstract
In 1976 a swine influenza vaccine was associated with an increased risk of Guillain?Barr? syndrome (GBS). Although subsequent studies did not find an increased risk of GBS following seasonal influenza vaccine, there was concern that the monovalent H1N1 vaccines developed against the swine influenza pandemic of 2009 might increase the risk of GBS. In the UK a split-virion AS03 oil-in-water adjuvanted vaccine (Pandemrix?) was predominantly used. To determine whether the risk of GBS increased after Pandemrix administration, we sought GBS cases during the period of vaccine use from neurologists and a patient support group, and following the vaccination period from hospital episode statistics (HES) in England. We obtained cases? vaccination histories and illness onset dates from general practitioners. We determined the relative incidence of GBS in the 6 weeks after vaccination using the self-controlled case series method on the cases identified in HES. We included 327 GBS cases, of whom 37 received pandemic vaccine in the study period, nine of whom developed GBS within 6 weeks of vaccination (relative incidence 1.05 [95% confidence interval (CI) 0.37 to 2.24]). We found no evidence of an increased risk of GBS in the 6 weeks following pandemic influenza vaccination.
Highlights
► In 2009/10 an adjuvanted H1N1 pandemic vaccine was used in the United Kingdom. ► We sought to estimate the risk of Guillain?Barr? syndrome following vaccination. ► A passive neurologist reporting system gave a low return rate. ► Hospital admission data could be used along with vaccination history from GPs. ► No increased risk was found in the 6 week post vaccination period.
Keywords: Guillain?Barr? syndrome; Pandemic influenza vaccine; Self controlled case series; Vaccine safety; Influenza like illness
Abbreviations: GBS, Guillain?Barr? syndrome; ILI, influenza like illness; HES, hospital episode statistics; RI, relative incidence; BNSU, British Neurological Surveillance Unit; HPA, Health Protection Agency; ICD, international classification of diseases
http://www.sciencedirect.com/science/article/pii/S0264410X11013284
Article in Press, Uncorrected Proof - Note to users
doi:10.1016/j.vaccine.2011.08.069 | How to Cite or Link Using DOI
Guillain?Barr? syndrome and H1N1 (2009) pandemic influenza vaccination using an AS03 adjuvanted vaccine in the United Kingdom: Self-controlled case seriesstar, open
Nick Andrewsa, Corresponding Author Contact Information, E-mail The Corresponding Author, Julia Stoweb, Rustam Al-Shahi Salmanc and Elizabeth Millerb
a Statistics Modelling and Economics Department, Health Protection Services, Health Protection Agency, Colindale, London NW9 5EQ, United Kingdom
b Immunisation, Hepatitis and Blood Safety Department, Health Protection Services, Health Protection Agency, Colindale, London NW9 5EQ, United Kingdom
c Division of Clinical Neurosciences, University of Edinburgh, Western General Hospital, Edinburgh EH4 2XU, United Kingdom
Received 5 July 2011;
revised 2 August 2011;
accepted 15 August 2011.
Available online 27 August 2011.
Abstract
In 1976 a swine influenza vaccine was associated with an increased risk of Guillain?Barr? syndrome (GBS). Although subsequent studies did not find an increased risk of GBS following seasonal influenza vaccine, there was concern that the monovalent H1N1 vaccines developed against the swine influenza pandemic of 2009 might increase the risk of GBS. In the UK a split-virion AS03 oil-in-water adjuvanted vaccine (Pandemrix?) was predominantly used. To determine whether the risk of GBS increased after Pandemrix administration, we sought GBS cases during the period of vaccine use from neurologists and a patient support group, and following the vaccination period from hospital episode statistics (HES) in England. We obtained cases? vaccination histories and illness onset dates from general practitioners. We determined the relative incidence of GBS in the 6 weeks after vaccination using the self-controlled case series method on the cases identified in HES. We included 327 GBS cases, of whom 37 received pandemic vaccine in the study period, nine of whom developed GBS within 6 weeks of vaccination (relative incidence 1.05 [95% confidence interval (CI) 0.37 to 2.24]). We found no evidence of an increased risk of GBS in the 6 weeks following pandemic influenza vaccination.
Highlights
► In 2009/10 an adjuvanted H1N1 pandemic vaccine was used in the United Kingdom. ► We sought to estimate the risk of Guillain?Barr? syndrome following vaccination. ► A passive neurologist reporting system gave a low return rate. ► Hospital admission data could be used along with vaccination history from GPs. ► No increased risk was found in the 6 week post vaccination period.
Keywords: Guillain?Barr? syndrome; Pandemic influenza vaccine; Self controlled case series; Vaccine safety; Influenza like illness
Abbreviations: GBS, Guillain?Barr? syndrome; ILI, influenza like illness; HES, hospital episode statistics; RI, relative incidence; BNSU, British Neurological Surveillance Unit; HPA, Health Protection Agency; ICD, international classification of diseases
http://www.sciencedirect.com/science/article/pii/S0264410X11013284