Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment
Weibel, Daniel; Sturkenboom, Miriam; Black, Steven; de Ridder, Maria; Dodd, Caitlin; Bonhoeffer, Jan; Vanrolleghem, Ann; van der Maas, Nicoline; Lammers, Gert Jan; Overeem, Sebastiaan; Gentile, Angela; Giglio, Norberto; Castellano, Vanesa; Kwong, Jeffrey C.; Murray, Brian J.; Cauch-Dudek, Karen; Juhasz, Diana; Campitelli, Michael; Datta, Alexandre N.; Kallweit, Ulf; Huang, Wan Ting; Huang, Yu Shu; Hsu, Chung Yao; Chen, Hsi Chung; Giner-Soriano, Maria; Morros, Rosa; Gaig, Carles; Tió, Ester; Perez-Vilar, Silvia; Diez-Domingo, Javier; Puertas, Francisco Javier; Svenson, Lawrence W.; Mahmud, Salaheddin M.; Carleton, Bruce; Naus, Monika; Arnheim-Dahlström, Lisen; Pedersen, Lars; DeStefano, Frank; Shimabukuro, Tom T.
(2018) Vaccine, volume 36, issue 41, pp. 6202 - 6211
(Article)
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
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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.
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Keywords: Adjuvant, AS03, MF59, Narcolepsy, Pandemic H1N1 influenza, Molecular Medicine, General Immunology and Microbiology, General Veterinary, Public Health, Environmental and Occupational Health, Infectious Diseases
ISSN: 0264-410X
Publisher: Elsevier BV
Note: Funding Information: We acknowledge funding from the U.S. Centers for Disease Control and Prevention (CDC), Atlanta, USA, under CDC contract number 200-2012-53425_addendum 0001. Publisher Copyright: © 2018 The Authors
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