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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.
SUBMITTER: Weibel D
PROVIDER: S-EPMC6404226 | biostudies-literature | 2018 Oct
REPOSITORIES: biostudies-literature
Weibel Daniel D Sturkenboom Miriam M Black Steven S de Ridder Maria M Dodd Caitlin C Bonhoeffer Jan J Vanrolleghem Ann A van der Maas Nicoline N Lammers Gert Jan GJ Overeem Sebastiaan S Gentile Angela A Giglio Norberto N Castellano Vanesa V Kwong Jeffrey C JC Murray Brian J BJ Cauch-Dudek Karen K Juhasz Diana D Campitelli Michael M Datta Alexandre N AN Kallweit Ulf U Huang Wan-Ting WT Huang Yu-Shu YS Hsu Chung-Yao CY Chen Hsi-Chung HC Giner-Soriano Maria M Morros Rosa R Gaig Carles C Tió Ester E Perez-Vilar Silvia S Diez-Domingo Javier J Puertas Francisco Javier FJ Svenson Lawrence W LW Mahmud Salaheddin M SM Carleton Bruce B Naus Monika M Arnheim-Dahlström Lisen L Pedersen Lars L DeStefano Frank F Shimabukuro Tom T TT
Vaccine 20180816 41
<h4>Background</h4>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.<h4>Methods</h4>We used electronic health databases to conduct a dynamic retrospective cohort study to assess narcolepsy incidence rates (IR) before and ...[more]