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

Vaccine

Volumn 36, Issue 41, 2018, Pages 6202-6211

  Weibel, Daniel ^a   Sturkenboom, Miriam ^b   Black, Steven ^c   de Ridder, Maria ^a   Dodd, Caitlin ^a   Bonhoeffer, Jan ^d,e   Vanrolleghem, Ann ^a   van der Maas, Nicoline ^f   Lammers, Gert Jan ^g,h   Overeem, Sebastiaan ⁱ   Gentile, Angela ^j   Giglio, Norberto ^j   Castellano, Vanesa ^j   Kwong, Jeffrey C ^k   Murray, Brian J ^l   Cauch Dudek, Karen ^k   Juhasz, Diana ^k   Campitelli, Michael ^k   Datta, Alexandre N ^m   Kallweit, Ulf ^n,o   Huang, Wan Ting ^p   Huang, Yu Shu ^q   Hsu, Chung Yao ^r   Chen, Hsi Chung ^s   Giner Soriano, Maria ^t   Morros, Rosa ^t   Gaig, Carles ^u   Tió, Ester ^v   Perez Vilar, Silvia ^a,w   Diez Domingo, Javier ^w   Puertas, Francisco Javier ^x   Svenson, Lawrence W ^y   Mahmud, Salaheddin M ^z   Carleton, Bruce ^aa   Naus, Monika ^aa   Arnheim Dahlström, Lisen ^ab   Pedersen, Lars ^ac   DeStefano, Frank ^ad   Shimabukuro, Tom T ^ad   more..

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

^c CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^d UNIVERSITY CHILDREN S HOSPITAL   (Switzerland)

^e Brighton Collaboration Foundation   (Switzerland)

^f NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^g LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^h STICHTING EPILEPSIE INSTELLINGEN NEDERLAND SEIN   (Netherlands)

ⁱ EPILEPSY CENTER KEMPENHAEGHE   (Netherlands)

^j HOSPITAL DE NIÑOS RICARDO GUTIÉRREZ   (Argentina)

^k INSTITUTE FOR CLINICAL EVALUATIVE SCIENCES   (Canada)

^l SUNNYBROOK RESEARCH INSTITUTE   (Canada)

^m UNIVERSITY HOSPITAL BASEL   (Switzerland)

ⁿ UNIVERSITY OF BERN   (Switzerland)

^o UNIVERSITY OF WITTEN HERDECKE   (Germany)

^p CENTER FOR DISEASE CONTROL   (Taiwan)

^q CHANG GUNG MEMORIAL HOSPITAL   (Taiwan)

^r KAOHSIUNG MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^s NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^t Research Institute University Primary Care IDIAP Jordi Gol   (Spain)

^u HOSPITAL CLÍNIC   (Spain)

^v Althaia   (Spain)

^w Fundacion para el Fomento de la Investigacion Sanitaria y Biomedica de la Comunitat Valenciana   (Spain)

^x HOSPITAL CLÍNICO UNIVERSITARIO   (Spain)

^y UNIVERSITY OF ALBERTA   (Canada)

^z UNIVERSITY OF MANITOBA   (Canada)

^aa UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^ab KAROLINSKA INSTITUTE   (Sweden)

^ac AARHUS UNIVERSITY   (Denmark)

^ad CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

more..

Author keywords

Adjuvant; AS03; MF59; Narcolepsy; Pandemic H1N1 influenza

Indexed keywords

AS03; IMMUNOSTIMULATING AGENT; INFLUENZA VACCINE; MIFAMURTIDE; UNCLASSIFIED DRUG; IMMUNOLOGICAL ADJUVANT;

ADJUVANT THERAPY; ADOLESCENT; ADULT; ARTICLE; CASE CONTROL STUDY; CHILD; COHORT ANALYSIS; CONTROLLED STUDY; DISEASE ASSOCIATION; DRUG DOSAGE FORM COMPARISON; DRUG SAFETY; HUMAN; INCIDENCE; INCIDENT REPORT; INFLUENZA A; INFLUENZA A VIRUS (H1N1); MAJOR CLINICAL STUDY; MIDDLE AGED; NARCOLEPSY; PANDEMIC INFLUENZA; PRESCHOOL CHILD; PRIORITY JOURNAL; RETROSPECTIVE STUDY; RISK ASSESSMENT; SWEDEN; TAIWAN; VACCINATION; VACCINATION COVERAGE; IMMUNOLOGY; INFLUENZA; PATHOGENICITY;

ADJUVANTS, IMMUNOLOGIC; CASE-CONTROL STUDIES; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; NARCOLEPSY; RETROSPECTIVE STUDIES; VACCINATION;

EID: 85051544059     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2018.08.008     Document Type: Article

References (36)

1. Medical Products Agency. A registry based comparative cohort study in four Swedish counties of the risk for narcolepsy after vaccination with Pandemrix – a first and preliminary report, by the Medical Products Agency; 2011. https://lakemedelsverket.se/upload/nyheter/2011/PandemrixRegReport110328.pdf.
2. Partinen, M., Saarenpaa-Heikkila, O., Ilveskoski, I., et al. Increased incidence and clinical picture of childhood narcolepsy following the 2009 H1N1 pandemic vaccination campaign in Finland. PLoS ONE, 7, 2012, e33723.
3. European Medicines Agency. Pandemrix: EPAR - Product Information; 2016. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500038121&mid=WC0b01ac058009a3dc.
4. Bardage, C., Persson, I., Ortqvist, A., Bergman, U., Ludvigsson, J.F., Granath, F., Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden. BMJ, 343, 2011, d5956.
5. Nohynek, H., Jokinen, J., Partinen, M., et al. AS03 adjuvanted AH1N1 vaccine associated with an abrupt increase in the incidence of childhood narcolepsy in Finland. PLoS ONE, 7, 2012, e33536.
6. Gadroen, K., Straus, S.M., Pacurariu, A., Weibel, D., Kurz, X., Sturkenboom, M.C., Patterns of spontaneous reports on narcolepsy following administration of pandemic influenza vaccine; a case series of individual case safety reports in Eudravigilance. Vaccine, 2016.
7. Kornum, B.R., Faraco, J., Mignot, E., Narcolepsy with hypocretin/orexin deficiency, infections and autoimmunity of the brain. Curr Opin Neurobiol 21 (2011), 897–903.
8. Nishino, S., Ripley, B., Overeem, S., Lammers, G.J., Mignot, E., Hypocretin (orexin) deficiency in human narcolepsy. Lancet 355 (2000), 39–40.
9. Scammell, T.E., Narcolepsy. N Engl J Med 373 (2015), 2654–2662.
10. Overeem, S., Black, J.L. 3rd, Lammers, G.J., Narcolepsy: immunological aspects. Sleep Med Rev 12 (2008), 95–107.
11. Luca, G., Haba-Rubio, J., Dauvilliers, Y., et al. Clinical, polysomnographic and genome-wide association analyses of narcolepsy with cataplexy: a European Narcolepsy Network study. J Sleep Res 22 (2013), 482–495.
12. Dauvilliers, Y., Arnulf, I., Lecendreux, M., et al. Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France. Brain: J Neurol 136 (2013), 2486–2496.
13. Heier, M.S., Gautvik, K.M., Wannag, E., et al. Incidence of narcolepsy in Norwegian children and adolescents after vaccination against H1N1 influenza A. Sleep Med 14 (2013), 867–871.
14. Miller, E., Andrews, N., Stellitano, L., et al. Risk of narcolepsy in children and young people receiving AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine: retrospective analysis. BMJ, 346, 2013, f794.
15. O'Flanagan, D., Barret, A.S., Foley, M., et al. Investigation of an association between onset of narcolepsy and vaccination with pandemic influenza vaccine, Ireland April 2009-December 2010. Euro Surveill: Bulletin Europeen sur les maladies transmissibles = Eur Commun Dis Bull 19 (2014), 15–25.
16. Persson, I., Granath, F., Askling, J., Ludvigsson, J.F., Olsson, T., Feltelius, N., Risks of neurological and immune-related diseases, including narcolepsy, after vaccination with Pandemrix: a population- and registry-based cohort study with over 2 years of follow-up. J Intern Med 275 (2014), 172–190.
17. Szakacs, A., Darin, N., Hallbook, T., Increased childhood incidence of narcolepsy in western Sweden after H1N1 influenza vaccination. Neurology 80 (2013), 1315–1321.
18. Oberle, D., Pavel, J., Mayer, G., Geisler, P., Keller-Stanislawski, B., German Narcolepsy Study G. Retrospective multicenter matched case-control study on the risk factors for narcolepsy with special focus on vaccinations (including pandemic influenza vaccination) and infections in Germany. Sleep Med 34 (2017), 71–83.
19. Verstraeten, T., Cohet, C., Dos Santos, G., et al. Pandemrix and narcolepsy: a critical appraisal of the observational studies. Hum Vaccin Immunother, 2015, 1–7.
20. Sturkenboom, M.C., The narcolepsy-pandemic influenza story: can the truth ever be unraveled?. Vaccine 33:Suppl 2 (2015), B6–B13.
21. Sarkanen, T.O., Alakuijala, A.P.E., Dauvilliers, Y.A., Partinen, M.M., Incidence of narcolepsy after H1N1 influenza and vaccinations: systematic review and meta-analysis. Sleep Med Rev 38 (2018), 177–186.
22. Choe, Y.J., Bae, G.R., Lee, D.H., No association between influenza A(H1N1)pdm09 vaccination and narcolepsy in South Korea: an ecological study. Vaccine 30 (2012), 7439–7442.
23. Montplaisir, J., Petit, D., Quinn, M.J., et al. Risk of narcolepsy associated with inactivated adjuvanted (AS03) A/H1N1 (2009) pandemic influenza vaccine in Quebec. PLoS ONE, 9, 2014, e108489.
24. Trifiro, G., Coloma, P.M., Rijnbeek, P.R., et al. Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how?. J Intern Med 275 (2014), 551–561.
25. Poli, F., Overeem, S., Lammers, G.J., et al. Narcolepsy as an adverse event following immunization: case definition and guidelines for data collection, analysis and presentation. Vaccine 31 (2013), 994–1007.
26. Wijnans, L., Lecomte, C., de Vries, C., et al. The incidence of narcolepsy in Europe: before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns. Vaccine 31 (2013), 1246–1254.
27. Stowe, J., Andrews, N., Kosky, C., et al. Risk of narcolepsy after AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine in adults: a case-coverage study in England. Sleep 39 (2016), 1051–1057.
28. Association WM. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects; 2013. http://www.wma.net/en/30publications/10policies/b3/index.html.pdf?print-media-type&footer-right=[page]/[toPage].
29. Dodd, C.N., de Ridder, M., Huang, W., et al. Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: methods for rapid assessment of potential safety issues on a population level in the SOMNIA study. PLoS One, 2018 [in press].
30. Even-Or, O., Samira, S., Ellis, R., Kedar, E., Barenholz, Y., Adjuvanted influenza vaccines. Expert Rev Vaccines 12 (2013), 1095–1108.
31. Han, F., Lin, L., Warby, S.C., et al. Narcolepsy onset is seasonal and increased following the 2009 H1N1 pandemic in China. Ann Neurol 70 (2011), 410–417.
32. Gilmour, H., Hofmann, N., H1N1 vaccination. Health Rep 21 (2010), 63–69.
33. Ahmed, S.S., Schur, P.H., MacDonald, N.E., Steinman, L., Narcolepsy, 2009 A(H1N1) pandemic influenza, and pandemic influenza vaccinations: what is known and unknown about the neurological disorder, the role for autoimmunity, and vaccine adjuvants. J Autoimmun 50 (2014), 1–11.
34. Wijnans, L., Dodd, C., de Ridder, M., et al. Pandemic influenza vaccine & narcolepsy: simulations on the potential impact of bias. Expert Rev Vaccines 15 (2016), 573–584.
35. ECDC. European Centre for Disease Prevention and Control. Narcolepsy in association with pandemic influenza vaccination (a multi-country European epidemiological investigation). Stockholm: ECDC; 2012. http://ecdc.europa.eu/en/publications/Publications/Vaesco%20report%20FINAL%20with%20cover.pdf.
36. Kallweit, U., Mathis, J., Jenni, O.G., et al. Post-H1N1 Flu Vaccination Narcolepsy in Switzerland: A Retrospective Survey in the 30 Sleep-Certified Swiss Centers. Eur Neurol 75 (2016), 105–108.