Details:

Alternative Title:
Vaccine
Publisher's site:
http://dx.doi.org/10.1016/j.vaccine.2018.08.008
Personal Author:
Weibel, Daniel ; Sturkenboom, Miriam ; Black, Steven ; de Ridder, Maria ; Dodd, Caitlin ; ... More +
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. ; Less -
Description:
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.
Subject:
[+]
Adjuvants, Immunologic
Case-Control Studies
Humans
Influenza, Human
Influenza A Virus, H1N1 Subtype
Influenza Vaccines
Retrospective Studies
Vaccination

Source:
Vaccine. 36(41):6202-6211 ;
Pubmed ID:
30122647
Pubmed Central ID:
PMC6404226
Document Type:
Journal Article ;
Funding:
CC999999/Intramural CDC HHS/United States ;
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:63771f8457ce27952dc0b6c50640761afedf72ecda6d6c44adb2423c80ed9ae9
File Type:

Supporting Files

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