TY - JOUR
T1 - International collaboration to assess the risk of Guillain Barré Syndrome following Influenza A (H1N1) 2009 monovalent vaccines
AU - Dodd, Caitlin N.
AU - Romio, Silvana A.
AU - Black, Steven
AU - Vellozzi, Claudia
AU - Andrews, Nick
AU - Sturkenboom, Miriam
AU - Zuber, Patrick
AU - Hua, Wei
AU - Bonhoeffer, Jan
AU - Buttery, Jim
AU - Crawford, Nigel
AU - Deceuninck, Genevieve
AU - de Vries, Corinne
AU - De Wals, Philippe
AU - Gimeno, M. Victoria Gutierrez
AU - Heijbel, Harald
AU - Hughes, Hayley
AU - Hur, Kwan
AU - Hviid, Anders
AU - Kelman, Jeffrey
AU - Kilpi, Tehri
AU - Chuang, S. K.
AU - Macartney, Kristine
AU - Rett, Melisa
AU - Lopez-Callada, Vesta Richardson
AU - Salmon, Daniel
AU - Sanchez, Francisco Gimenez
AU - Sanz, Nuria
AU - Silverman, Barbara
AU - Storsaeter, Jann
AU - Thirugnanam, Umapathi
AU - van der Maas, Nicoline
AU - Yih, Katherine
AU - Zhang, Tao
AU - Izurieta, Hector
AU - Global H1N1 GBS Consortium
AU - Addis, Antonio
AU - Akhtar, Aysha
AU - Cope, Judith
AU - Davis, Robert
AU - Gargiullo, Paul
AU - Kurz, Xavier
AU - Law, Barbara
AU - Sahinovic, Isabelle
AU - Tokars, Jerry
AU - Serrano, Pedro
AU - Cheng, Allen
AU - Charles, Pat
AU - Clothier, Hazel
AU - Day, Bruce
AU - Day, Timothy
AU - Gates, Peter
AU - MacDonnell, Richard
AU - Roberts, Les
AU - Rodriguez-Casero, Victoria
AU - Wijeratne, Tissa
AU - Kiers, Lynette
AU - Blyth, Christopher
AU - Booy, Robert
AU - Elliott, Elizabeth
AU - Gold, Michael
AU - Marshall, Helen
AU - McIntyre, Peter
AU - Richmond, Peter
AU - Royle, Jenny
AU - Wood, Nicholas
AU - Zurynski, Yvonne
AU - Calvo, Gonzalo
AU - Campins, Magda
AU - Corominas, Nuria
AU - Torres, Ferran
AU - Valls, Josep
AU - Vilella, Anna
AU - Dutra, Donald
AU - Eick-Cost, Angelia
AU - Jackson, Henry M.
AU - Garman, Patrick
AU - Hu, Zheng
AU - Rigo, Marianne
AU - Badoo, Judith
AU - Cho, David
AU - Polakowski, Laura L.
AU - Sandhu, Sukhminder K.
AU - Sun, Guoying
AU - Chan, Hoi Shan Sophelia
AU - Chan, Kwok-yin
AU - Cheung, Raymond
AU - Cheung, Yuk-fai
AU - Cherk, Sharon
AU - Fok, Joshua Wai Ming
AU - Fung, Bun-hey
AU - Ko, Kwai-fu
AU - Lau, Ka Wing
AU - Lau, Kwok-kwong
AU - Li, Patrick
AU - Liu, Hui-tung
AU - Liu, Shao-haei
AU - Mok, Tina
AU - So, Joanna
AU - Wong, Winnie
AU - Wu, Shun-ping
AU - Avagyan, Armen
AU - Ball, Robert
AU - Burwen, Dale
AU - Franks, Riley L.
AU - Gibbs, Jonathan M.
AU - Kliman, Rebecca E.
AU - Kropp, Garner F.
AU - MaCurdy, Thomas E.
AU - Martin, David B.
AU - Sandhu, Sukhmin Der K.
AU - Worrall, Christopher M.
AU - Fuentes, Dra Elvira Fuentes
AU - González, Paola Carolina Ojeda
AU - Reyna, Jesus
AU - Vázquez, Rosa Patricia Vidal
AU - Kulldorff, Martin
AU - Lee, Grace
AU - Lieu, Tracy A.
AU - Platt, Richard
AU - Serres, Gaston De
AU - Jabin, Kamilah
AU - Soh, Bee Leng Sally
AU - Arnheim-Dahlstrom, Lisen
AU - Castot, Anne
AU - de Melker, Hester
AU - Dieleman, Jeanne
AU - Hallgren, Jonal
AU - Jacobs, Bart
AU - Johansen, Kari
AU - Kramarz, Piotr
AU - Lapeyre, Maryse
AU - Leino, Tuija
AU - Molgaard-Nielsen, Ditte
AU - Mosseveld, Mees
AU - Olberg, Henning K.
AU - Sammon, Cor Mac
AU - Saussier, Christel
AU - Schuemie, Martijn
AU - Sommet, Agnes
AU - Sparen, Par
AU - Svanstrom, Henrik
AU - Vanrolleghem, Ann
AU - Weibel, Daniel
AU - Domingo, Javier Diez
AU - Esparza, José Luís Micó
AU - Lucas, Rafael M.Ortí
AU - Maseres, Juan B.Mollar
AU - Sánchez, José Luís Alfonso
AU - Sánchez, Mercedes Garcés
AU - Viguer, Vicente Zanón
AU - Cunningham, Francesca
AU - Thakkar, Bharat
AU - Zhang, Rongping
PY - 2013/9/13
Y1 - 2013/9/13
N2 - Background: The global spread of the 2009 novel pandemic influenza A (H1N1) virus led to the accelerated production and distribution of monovalent 2009 Influenza A (H1N1) vaccines (pH1N1). This pandemic provided the opportunity to evaluate the risk of Guillain-Barré syndrome (GBS), which has been an influenza vaccine safety concern since the swine flu pandemic of 1976, using a common protocol among high and middle-income countries. The primary objective of this project was to demonstrate the feasibility and utility of global collaboration in the assessment of vaccine safety, including countries both with and without an established infrastructure for vaccine active safety surveillance. A second objective, included a priori, was to assess the risk of GBS following pH1N1 vaccination. Methods: The primary analysis used the self-controlled case series (SCCS) design to estimate the relative incidence (RI) of GBS in the 42 days following vaccination with pH1N1 vaccine in a pooled analysis across databases and in analysis using a meta-analytic approach. Results: We found a relative incidence of GBS of 2.42 (95% CI 1.58-3.72) in the 42 days following exposure to pH1N1 vaccine in analysis of pooled data and 2.09 (95% CI 1.28-3.42) using the meta-analytic approach. Conclusions: This study demonstrates that international collaboration to evaluate serious outcomes using a common protocol is feasible. The significance and consistency of our findings support a conclusion of an association between 2009 H1N1 vaccination and GBS. Given the rarity of the event the relative incidence found does not provide evidence in contradiction to international recommendations for the continued use of influenza vaccines.
AB - Background: The global spread of the 2009 novel pandemic influenza A (H1N1) virus led to the accelerated production and distribution of monovalent 2009 Influenza A (H1N1) vaccines (pH1N1). This pandemic provided the opportunity to evaluate the risk of Guillain-Barré syndrome (GBS), which has been an influenza vaccine safety concern since the swine flu pandemic of 1976, using a common protocol among high and middle-income countries. The primary objective of this project was to demonstrate the feasibility and utility of global collaboration in the assessment of vaccine safety, including countries both with and without an established infrastructure for vaccine active safety surveillance. A second objective, included a priori, was to assess the risk of GBS following pH1N1 vaccination. Methods: The primary analysis used the self-controlled case series (SCCS) design to estimate the relative incidence (RI) of GBS in the 42 days following vaccination with pH1N1 vaccine in a pooled analysis across databases and in analysis using a meta-analytic approach. Results: We found a relative incidence of GBS of 2.42 (95% CI 1.58-3.72) in the 42 days following exposure to pH1N1 vaccine in analysis of pooled data and 2.09 (95% CI 1.28-3.42) using the meta-analytic approach. Conclusions: This study demonstrates that international collaboration to evaluate serious outcomes using a common protocol is feasible. The significance and consistency of our findings support a conclusion of an association between 2009 H1N1 vaccination and GBS. Given the rarity of the event the relative incidence found does not provide evidence in contradiction to international recommendations for the continued use of influenza vaccines.
KW - Adjuvant
KW - Adverse events following immunization (AEFI)
KW - Guillain Barré Syndrome (GBS)
KW - International
KW - Monovalent H1N1 Vaccine (H1N1)
KW - Self-controlled case-series method (SCCS)
UR - http://www.scopus.com/inward/record.url?scp=84882864368&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2013.06.032
DO - 10.1016/j.vaccine.2013.06.032
M3 - Article
VL - 31
SP - 4448
EP - 4458
JO - Vaccine
JF - Vaccine
SN - 0264-410X
IS - 40
ER -