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 Kelman; Tehri 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

doi:10.1016/j.vaccine.2013.06.032

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 journal › Article › peer-review

89 Scopus citations

Abstract

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 language	English
Pages (from-to)	4448-4458
Number of pages	11
Journal	Vaccine
Volume	31
Issue number	40
DOIs	https://doi.org/10.1016/j.vaccine.2013.06.032
State	Published - 13 Sep 2013
Externally published	Yes

Funding

Funders	Funder number
Pfizer
GlaxoSmithKline

Keywords

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.vaccine.2013.06.032

Cite this

Dodd, C. N., Romio, S. A., Black, S., Vellozzi, C., Andrews, N., Sturkenboom, M., Zuber, P., Hua, W., Bonhoeffer, J., Buttery, J., Crawford, N., Deceuninck, G., de Vries, C., De Wals, P., Gimeno, M. V. G., Heijbel, H., Hughes, H., Hur, K., Hviid, A., ... Zhang, R. (2013). International collaboration to assess the risk of Guillain Barré Syndrome following Influenza A (H1N1) 2009 monovalent vaccines. Vaccine, 31(40), 4448-4458. https://doi.org/10.1016/j.vaccine.2013.06.032

@article{9d3114f919a9448e9a8e18a7383a56cf,

title = "International collaboration to assess the risk of Guillain Barr{\'e} Syndrome following Influenza A (H1N1) 2009 monovalent vaccines",

abstract = "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-Barr{\'e} 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.",

keywords = "Adjuvant, Adverse events following immunization (AEFI), Guillain Barr{\'e} Syndrome (GBS), International, Monovalent H1N1 Vaccine (H1N1), Self-controlled case-series method (SCCS)",

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

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. ",

year = "2013",

month = sep,

day = "13",

doi = "10.1016/j.vaccine.2013.06.032",

language = "אנגלית",

volume = "31",

pages = "4448--4458",

journal = "Vaccine",

issn = "0264-410X",

publisher = "Elsevier Ltd.",

number = "40",

}

Dodd, CN, Romio, SA, Black, S, Vellozzi, C, Andrews, N, Sturkenboom, M, Zuber, P, Hua, W, Bonhoeffer, J, Buttery, J, Crawford, N, Deceuninck, G, de Vries, C, De Wals, P, Gimeno, MVG, Heijbel, H, Hughes, H, Hur, K, Hviid, A, Kelman, J, Kilpi, T, Chuang, SK, Macartney, K, Rett, M, Lopez-Callada, VR, Salmon, D, Sanchez, FG, Sanz, N, Silverman, B, Storsaeter, J, Thirugnanam, U, van der Maas, N, Yih, K, Zhang, T, Izurieta, H, Addis, A, Akhtar, A, Cope, J, Davis, R, Gargiullo, P, Kurz, X, Law, B, Sahinovic, I, Tokars, J, Serrano, P, Cheng, A, Andrews, N, Charles, P, Clothier, H, Day, B, Day, T, Gates, P, MacDonnell, R, Roberts, L, Rodriguez-Casero, VT, Wijeratne, T, Kiers, L, Blyth, C, Booy, R, Elliott, E, Gold, M, Marshall, H, McIntyre, P, Richmond, P, Royle, J, Wood, N, Zurynski, Y, Calvo, G, Campins, M, Corominas, N, Torres, F, Valls, J, Vilella, A, Dutra, D, Eick-Cost, A, Jackson, HM, Garman, P, Hu, Z, Rigo, M, Badoo, J, Cho, D, Polakowski, LL, Sandhu, SK, Sun, G, Chan, HSS, Chan, KY, Cheung, R, Cheung, YF, Cherk, S, Chuang, SK, Fok, JWM, Fung, BH, Ko, KF, Lau, KW, Lau, KK, Li, P, Liu, HT, Liu, SH, Mok, T, So, J, Wong, W, Wu, SP, Avagyan, A, Ball, R, Burwen, D, Franks, RL, Gibbs, JM, Kliman, RE, Kropp, GF, MaCurdy, TE, Martin, DB, Sandhu, SDK, Worrall, CM, Fuentes, DEF, González, PCO, Reyna, J, Vázquez, RPV, Kulldorff, M, Lee, G, Lieu, TA, Platt, R, Serres, GD, Jabin, K, Soh, BLS, Arnheim-Dahlstrom, L, Castot, A, de Melker, H, Dieleman, J, Hallgren, J, Jacobs, B, Johansen, K, Kramarz, P, Lapeyre, M, Leino, T, Molgaard-Nielsen, D, Mosseveld, M, Olberg, HK, Sammon, CM, Saussier, C, Schuemie, M, Sommet, A, Sparen, P, Svanstrom, H, Vanrolleghem, A, Weibel, D, Domingo, JD, Esparza, JLM, Lucas, RMO, Maseres, JBM, Sánchez, JLA, Sánchez, MG, Viguer, VZ, Cunningham, F, Thakkar, B & Zhang, R 2013, 'International collaboration to assess the risk of Guillain Barré Syndrome following Influenza A (H1N1) 2009 monovalent vaccines', Vaccine, vol. 31, no. 40, pp. 4448-4458. https://doi.org/10.1016/j.vaccine.2013.06.032

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 - 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 - Andrews, Nick

AU - Charles, Pat

AU - Clothier, Hazel

AU - Day, Bruce

AU - Day, Timothy

AU - Gates, Peter

AU - MacDonnell, Richard

AU - Roberts, Les

AU - Rodriguez-Casero, Vic toria

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 - Chuang, S. K.

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

N1 - 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.

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 - ???researchoutput.researchoutputtypes.contributiontojournal.article???

C2 - 23770307

AN - SCOPUS:84882864368

SN - 0264-410X

VL - 31

SP - 4448

EP - 4458

JO - Vaccine

JF - Vaccine

IS - 40

ER -

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

Abstract

Funding

Keywords

UN SDGs

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