International collaboration to assess the risk of Guillain Barré Syndrome following Influenza A (H1N1) 2009 monovalent vaccines

Caitlin N. Dodd*, Silvana A. Romio, Steven Black, Claudia Vellozzi, Nick Andrews, Miriam Sturkenboom, Patrick Zuber, Wei Hua, Jan Bonhoeffer, Jim Buttery, Nigel Crawford, Genevieve Deceuninck, Corinne de Vries, Philippe De Wals, M. Victoria Gutierrez Gimeno, Harald Heijbel, Hayley Hughes, Kwan Hur, Anders Hviid, Jeffrey KelmanTehri Kilpi, S. K. Chuang, Kristine Macartney, Melisa Rett, Vesta Richardson Lopez-Callada, Daniel Salmon, Francisco Gimenez Sanchez, Nuria Sanz, Barbara Silverman, Jann Storsaeter, Umapathi Thirugnanam, Nicoline van der Maas, Katherine Yih, Tao Zhang, Hector Izurieta, Antonio Addis, Aysha Akhtar, Judith Cope, Robert Davis, Paul Gargiullo, Xavier Kurz, Barbara Law, Isabelle Sahinovic, Jerry Tokars, Pedro Serrano, Allen Cheng, Nick Andrews, Pat Charles, Hazel Clothier, Bruce Day, Timothy Day, Peter Gates, Richard MacDonnell, Les Roberts, Vic toria Rodriguez-Casero, Tissa Wijeratne, Lynette Kiers, Christopher Blyth, Robert Booy, Elizabeth Elliott, Michael Gold, Helen Marshall, Peter McIntyre, Peter Richmond, Jenny Royle, Nicholas Wood, Yvonne Zurynski, Gonzalo Calvo, Magda Campins, Nuria Corominas, Ferran Torres, Josep Valls, Anna Vilella, Donald Dutra, Angelia Eick-Cost, Henry M. Jackson, Patrick Garman, Zheng Hu, Marianne Rigo, Judith Badoo, David Cho, Laura L. Polakowski, Sukhminder K. Sandhu, Guoying Sun, Hoi Shan Sophelia Chan, Kwok Yin Chan, Raymond Cheung, Yuk Fai Cheung, Sharon Cherk, S. K. Chuang, Joshua Wai Ming Fok, Bun Hey Fung, Kwai Fu Ko, Ka Wing Lau, Kwok Kwong Lau, Patrick Li, Hui Tung Liu, Shao Haei Liu, Tina Mok, Joanna So, Winnie Wong, Shun Ping Wu, Armen Avagyan, Robert Ball, Dale Burwen, Riley L. Franks, Jonathan M. Gibbs, Rebecca E. Kliman, Garner F. Kropp, Thomas E. MaCurdy, David B. Martin, Sukhmin Der K. Sandhu, Christopher M. Worrall, Dra Elvira Fuentes Fuentes, Paola Carolina Ojeda González, Jesus Reyna, Rosa Patricia Vidal Vázquez, Martin Kulldorff, Grace Lee, Tracy A. Lieu, Richard Platt, Gaston De Serres, Kamilah Jabin, Bee Leng Sally Soh, Lisen Arnheim-Dahlstrom, Anne Castot, Hester de Melker, Jeanne Dieleman, Jonal Hallgren, Bart Jacobs, Kari Johansen, Piotr Kramarz, Maryse Lapeyre, Tuija Leino, Ditte Molgaard-Nielsen, Mees Mosseveld, Henning K. Olberg, Cor Mac Sammon, Christel Saussier, Martijn Schuemie, Agnes Sommet, Par Sparen, Henrik Svanstrom, Ann Vanrolleghem, Daniel Weibel, Javier Diez Domingo, José Luís Micó Esparza, Rafael M.Ortí Lucas, Juan B.Mollar Maseres, José Luís Alfonso Sánchez, Mercedes Garcés Sánchez, Vicente Zanón Viguer, Francesca Cunningham, Bharat Thakkar, Rongping Zhang

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

81 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)4448-4458
Number of pages11
Issue number40
Publication statusPublished - 13 Sep 2013

Bibliographical note

Funding Information:
Tao Zhang has received research grant support for other work from Pfizer.

Funding Information:
Philippe De Wals has received research grant support for other work from GlaxoSmithKline.


  • Adjuvant
  • Adverse events following immunization (AEFI)
  • Guillain Barré Syndrome (GBS)
  • International
  • Monovalent H1N1 Vaccine (H1N1)
  • Self-controlled case-series method (SCCS)


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