Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment

Daniel Weibel; Miriam Sturkenboom; Steven Black; Maria de Ridder; Caitlin Dodd; Jan Bonhoeffer; Ann Vanrolleghem; Nicoline van der Maas; Gert Jan Lammers; Sebastiaan Overeem; Angela Gentile; Norberto Giglio; Vanesa Castellano; Jeffrey C. Kwong; Brian J. Murray; Karen Cauch-Dudek; Diana Juhasz; Michael Campitelli; Alexandre N. Datta; Ulf Kallweit; Wan-Ting Huang; Yu-Shu Huang; Chung-Yao Hsu; Hsi-Chung Chen; Maria Giner-Soriano; Rosa Morros; Carles Gaig; Ester Tió; Silvia Perez-Vilar; Javier Diez-Domingo; Francisco Javier Puertas; Lawrence W. Svenson; Salaheddin M. Mahmud; Bruce Carleton; Monika Naus; Lisen Arnheim-Dahlström; Lars Pedersen; Frank DeStefano; Tom T Shimabukuro

doi:10.1016/j.vaccine.2018.08.008

Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment

Daniel Weibel, Miriam Sturkenboom, Steven Black, Maria de Ridder, Caitlin Dodd, Jan Bonhoeffer, Ann Vanrolleghem, Nicoline van der Maas, Gert Jan Lammers, Sebastiaan Overeem, Angela Gentile, Norberto Giglio, Vanesa Castellano, Jeffrey C. Kwong, Brian J. Murray, Karen Cauch-Dudek, Diana Juhasz, Michael Campitelli, Alexandre N. Datta, Ulf KallweitWan-Ting Huang, Yu-Shu Huang, Chung-Yao Hsu, Hsi-Chung Chen, Maria Giner-Soriano, Rosa Morros, Carles Gaig, Ester Tió, Silvia Perez-Vilar, Javier Diez-Domingo, Francisco Javier Puertas, Lawrence W. Svenson, Salaheddin M. Mahmud, Bruce Carleton, Monika Naus, Lisen Arnheim-Dahlström, Lars Pedersen, Frank DeStefano, Tom T Shimabukuro

Research output: Contribution to journal › Article › Academic › peer-review

37 Citations (Scopus)

130 Downloads (Pure)

Abstract

BACKGROUND: In 2010, a safety signal was detected for narcolepsy following vaccination with Pandemrix, an AS03-adjuvanted monovalent pandemic H1N1 influenza (pH1N1) vaccine. To further assess a possible association and inform policy on future use of adjuvants, we conducted a multi-country study of narcolepsy and adjuvanted pH1N1 vaccines.

METHODS: We used electronic health databases to conduct a dynamic retrospective cohort study to assess narcolepsy incidence rates (IR) before and during pH1N1 virus circulation, and after pH1N1 vaccination campaigns in Canada, Denmark, Spain, Sweden, Taiwan, the Netherlands, and the United Kingdom. Using a case-control study design, we evaluated the risk of narcolepsy following AS03- and MF59-adjuvanted pH1N1 vaccines in Argentina, Canada, Spain, Switzerland, Taiwan, and the Netherlands. In the Netherlands, we also conducted a case-coverage study in children born between 2004 and 2009.

RESULTS: No changes in narcolepsy IRs were observed in any periods in single study sites except Sweden and Taiwan; in Taiwan incidence increased after wild-type pH1N1 virus circulation and in Sweden (a previously identified signaling country), incidence increased after the start of pH1N1 vaccination. No association was observed for Arepanrix-AS03 or Focetria-MF59 adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the case-control study nor for children born between 2004 and 2009 in the Netherlands case-coverage study for Pandemrix-AS03.

CONCLUSIONS: Other than elevated narcolepsy IRs in the period after vaccination campaigns in Sweden, we did not find an association between AS03- or MF59-adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the sites studied, although power to evaluate the AS03-adjuvanted Pandemrix brand vaccine was limited in our study.

Original language	English
Pages (from-to)	6202-6211
Number of pages	10
Journal	Vaccine
Volume	36
Issue number	41
Early online date	16 Aug 2018
DOIs	https://doi.org/10.1016/j.vaccine.2018.08.008
Publication status	Published - 1 Oct 2018

Keywords

AS03
Adjuvant
MF59
Narcolepsy
Pandemic H1N1 influenza
Influenza Vaccines/therapeutic use
Humans
Vaccination
Influenza, Human/immunology
Case-Control Studies
Narcolepsy/immunology
Influenza A Virus, H1N1 Subtype/immunology
Adjuvants, Immunologic/therapeutic use
Retrospective Studies

UN SDGs

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

Access to Document

10.1016/j.vaccine.2018.08.008

published versionFinal published version, 707 KBLicence: CC BY-NC-ND

Cite this

Weibel, D., Sturkenboom, M., Black, S., de Ridder, M., Dodd, C., Bonhoeffer, J., Vanrolleghem, A., van der Maas, N., Lammers, G. J., Overeem, S., Gentile, A., Giglio, N., Castellano, V., Kwong, J. C., Murray, B. J., Cauch-Dudek, K., Juhasz, D., Campitelli, M., Datta, A. N., ... Shimabukuro, T. T. (2018). Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment. Vaccine, 36(41), 6202-6211. https://doi.org/10.1016/j.vaccine.2018.08.008

@article{f69b5de0c4c14a3baaaba73aa75d5bc2,

title = "Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment",

abstract = "BACKGROUND: In 2010, a safety signal was detected for narcolepsy following vaccination with Pandemrix, an AS03-adjuvanted monovalent pandemic H1N1 influenza (pH1N1) vaccine. To further assess a possible association and inform policy on future use of adjuvants, we conducted a multi-country study of narcolepsy and adjuvanted pH1N1 vaccines.METHODS: We used electronic health databases to conduct a dynamic retrospective cohort study to assess narcolepsy incidence rates (IR) before and during pH1N1 virus circulation, and after pH1N1 vaccination campaigns in Canada, Denmark, Spain, Sweden, Taiwan, the Netherlands, and the United Kingdom. Using a case-control study design, we evaluated the risk of narcolepsy following AS03- and MF59-adjuvanted pH1N1 vaccines in Argentina, Canada, Spain, Switzerland, Taiwan, and the Netherlands. In the Netherlands, we also conducted a case-coverage study in children born between 2004 and 2009.RESULTS: No changes in narcolepsy IRs were observed in any periods in single study sites except Sweden and Taiwan; in Taiwan incidence increased after wild-type pH1N1 virus circulation and in Sweden (a previously identified signaling country), incidence increased after the start of pH1N1 vaccination. No association was observed for Arepanrix-AS03 or Focetria-MF59 adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the case-control study nor for children born between 2004 and 2009 in the Netherlands case-coverage study for Pandemrix-AS03.CONCLUSIONS: Other than elevated narcolepsy IRs in the period after vaccination campaigns in Sweden, we did not find an association between AS03- or MF59-adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the sites studied, although power to evaluate the AS03-adjuvanted Pandemrix brand vaccine was limited in our study.",

keywords = "AS03, Adjuvant, MF59, Narcolepsy, Pandemic H1N1 influenza, Influenza Vaccines/therapeutic use, Humans, Vaccination, Influenza, Human/immunology, Case-Control Studies, Narcolepsy/immunology, Influenza A Virus, H1N1 Subtype/immunology, Adjuvants, Immunologic/therapeutic use, Retrospective Studies",

author = "Daniel Weibel and Miriam Sturkenboom and Steven Black and {de Ridder}, Maria and Caitlin Dodd and Jan Bonhoeffer and Ann Vanrolleghem and {van der Maas}, Nicoline and Lammers, {Gert Jan} and Sebastiaan Overeem and Angela Gentile and Norberto Giglio and Vanesa Castellano and Kwong, {Jeffrey C.} and Murray, {Brian J.} and Karen Cauch-Dudek and Diana Juhasz and Michael Campitelli and Datta, {Alexandre N.} and Ulf Kallweit and Wan-Ting Huang and Yu-Shu Huang and Chung-Yao Hsu and Hsi-Chung Chen and Maria Giner-Soriano and Rosa Morros and Carles Gaig and Ester Ti{\'o} and Silvia Perez-Vilar and Javier Diez-Domingo and Puertas, {Francisco Javier} and Svenson, {Lawrence W.} and Mahmud, {Salaheddin M.} and Bruce Carleton and Monika Naus and Lisen Arnheim-Dahlstr{\"o}m and Lars Pedersen and Frank DeStefano and Shimabukuro, {Tom T}",

year = "2018",

month = oct,

day = "1",

doi = "10.1016/j.vaccine.2018.08.008",

language = "English",

volume = "36",

pages = "6202--6211",

journal = "Vaccine",

issn = "0264-410X",

publisher = "Elsevier",

number = "41",

}

Weibel, D, Sturkenboom, M, Black, S, de Ridder, M, Dodd, C, Bonhoeffer, J, Vanrolleghem, A, van der Maas, N, Lammers, GJ, Overeem, S, Gentile, A, Giglio, N, Castellano, V, Kwong, JC, Murray, BJ, Cauch-Dudek, K, Juhasz, D, Campitelli, M, Datta, AN, Kallweit, U, Huang, W-T, Huang, Y-S, Hsu, C-Y, Chen, H-C, Giner-Soriano, M, Morros, R, Gaig, C, Tió, E, Perez-Vilar, S, Diez-Domingo, J, Puertas, FJ, Svenson, LW, Mahmud, SM, Carleton, B, Naus, M, Arnheim-Dahlström, L, Pedersen, L, DeStefano, F & Shimabukuro, TT 2018, 'Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment', Vaccine, vol. 36, no. 41, pp. 6202-6211. https://doi.org/10.1016/j.vaccine.2018.08.008

TY - JOUR

T1 - Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment

AU - Weibel, Daniel

AU - Sturkenboom, Miriam

AU - Black, Steven

AU - de Ridder, Maria

AU - Dodd, Caitlin

AU - Bonhoeffer, Jan

AU - Vanrolleghem, Ann

AU - van der Maas, Nicoline

AU - Lammers, Gert Jan

AU - Overeem, Sebastiaan

AU - Gentile, Angela

AU - Giglio, Norberto

AU - Castellano, Vanesa

AU - Kwong, Jeffrey C.

AU - Murray, Brian J.

AU - Cauch-Dudek, Karen

AU - Juhasz, Diana

AU - Campitelli, Michael

AU - Datta, Alexandre N.

AU - Kallweit, Ulf

AU - Huang, Wan-Ting

AU - Huang, Yu-Shu

AU - Hsu, Chung-Yao

AU - Chen, Hsi-Chung

AU - Giner-Soriano, Maria

AU - Morros, Rosa

AU - Gaig, Carles

AU - Tió, Ester

AU - Perez-Vilar, Silvia

AU - Diez-Domingo, Javier

AU - Puertas, Francisco Javier

AU - Svenson, Lawrence W.

AU - Mahmud, Salaheddin M.

AU - Carleton, Bruce

AU - Naus, Monika

AU - Arnheim-Dahlström, Lisen

AU - Pedersen, Lars

AU - DeStefano, Frank

AU - Shimabukuro, Tom T

PY - 2018/10/1

Y1 - 2018/10/1

N2 - BACKGROUND: In 2010, a safety signal was detected for narcolepsy following vaccination with Pandemrix, an AS03-adjuvanted monovalent pandemic H1N1 influenza (pH1N1) vaccine. To further assess a possible association and inform policy on future use of adjuvants, we conducted a multi-country study of narcolepsy and adjuvanted pH1N1 vaccines.METHODS: We used electronic health databases to conduct a dynamic retrospective cohort study to assess narcolepsy incidence rates (IR) before and during pH1N1 virus circulation, and after pH1N1 vaccination campaigns in Canada, Denmark, Spain, Sweden, Taiwan, the Netherlands, and the United Kingdom. Using a case-control study design, we evaluated the risk of narcolepsy following AS03- and MF59-adjuvanted pH1N1 vaccines in Argentina, Canada, Spain, Switzerland, Taiwan, and the Netherlands. In the Netherlands, we also conducted a case-coverage study in children born between 2004 and 2009.RESULTS: No changes in narcolepsy IRs were observed in any periods in single study sites except Sweden and Taiwan; in Taiwan incidence increased after wild-type pH1N1 virus circulation and in Sweden (a previously identified signaling country), incidence increased after the start of pH1N1 vaccination. No association was observed for Arepanrix-AS03 or Focetria-MF59 adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the case-control study nor for children born between 2004 and 2009 in the Netherlands case-coverage study for Pandemrix-AS03.CONCLUSIONS: Other than elevated narcolepsy IRs in the period after vaccination campaigns in Sweden, we did not find an association between AS03- or MF59-adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the sites studied, although power to evaluate the AS03-adjuvanted Pandemrix brand vaccine was limited in our study.

AB - BACKGROUND: In 2010, a safety signal was detected for narcolepsy following vaccination with Pandemrix, an AS03-adjuvanted monovalent pandemic H1N1 influenza (pH1N1) vaccine. To further assess a possible association and inform policy on future use of adjuvants, we conducted a multi-country study of narcolepsy and adjuvanted pH1N1 vaccines.METHODS: We used electronic health databases to conduct a dynamic retrospective cohort study to assess narcolepsy incidence rates (IR) before and during pH1N1 virus circulation, and after pH1N1 vaccination campaigns in Canada, Denmark, Spain, Sweden, Taiwan, the Netherlands, and the United Kingdom. Using a case-control study design, we evaluated the risk of narcolepsy following AS03- and MF59-adjuvanted pH1N1 vaccines in Argentina, Canada, Spain, Switzerland, Taiwan, and the Netherlands. In the Netherlands, we also conducted a case-coverage study in children born between 2004 and 2009.RESULTS: No changes in narcolepsy IRs were observed in any periods in single study sites except Sweden and Taiwan; in Taiwan incidence increased after wild-type pH1N1 virus circulation and in Sweden (a previously identified signaling country), incidence increased after the start of pH1N1 vaccination. No association was observed for Arepanrix-AS03 or Focetria-MF59 adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the case-control study nor for children born between 2004 and 2009 in the Netherlands case-coverage study for Pandemrix-AS03.CONCLUSIONS: Other than elevated narcolepsy IRs in the period after vaccination campaigns in Sweden, we did not find an association between AS03- or MF59-adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the sites studied, although power to evaluate the AS03-adjuvanted Pandemrix brand vaccine was limited in our study.

KW - AS03

KW - Adjuvant

KW - MF59

KW - Narcolepsy

KW - Pandemic H1N1 influenza

KW - Influenza Vaccines/therapeutic use

KW - Humans

KW - Vaccination

KW - Influenza, Human/immunology

KW - Case-Control Studies

KW - Narcolepsy/immunology

KW - Influenza A Virus, H1N1 Subtype/immunology

KW - Adjuvants, Immunologic/therapeutic use

KW - Retrospective Studies

UR - http://www.scopus.com/inward/record.url?scp=85051544059&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2018.08.008

DO - 10.1016/j.vaccine.2018.08.008

M3 - Article

C2 - 30122647

SN - 0264-410X

VL - 36

SP - 6202

EP - 6211

JO - Vaccine

JF - Vaccine

IS - 41

ER -

Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment

Abstract

Keywords

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this