Did pandemic influenza or vaccination against H1N1 increase the risk of CFS/ME? Per Magnus

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1 Did pandemic influenza or vaccination against H1N1 increase the risk of CFS/ME? Per Magnus

2 Outline Occurrence in Norway Meningococcal vaccine in and ME Influenza pandemic in 2009 and ME 2

3 What is ME/CFS? Different sets of international criteria Myalgic encephalomyelitis: International Consensus Criteria Carruthers BM, et al. J Intern Med 2011 FUKUDA Criteria Fukuda K, et al Chronic Fatigue Syndrome a clinically empirical approach to its definition and study: Ann Intern Med 1994 CANADA Criteria Carruthers et al 2003 J Chronic Fatigue Syndr 3

4 Occurrence in Norway 4

5 Occurrence The Norwegian Patient Register (NPR) Study population - complete Norwegian population (Norwegian population registry) The population was followed from CFS/ME - ICD 10 code G933 5

6 Results : patients (75.4% women) aged five years or older (in 2008) were registered with CFS/ME. incidence rate 25.8 ( ) per person years incidence rate ratio of 3.2 ( ) for women compared to men. 6

registered with CFS/ME. incidence rate 25.8 (25.2-26.

7 Incidence of CFS/ME by sex and age 7

8 Number of yearly cases of CFS/ME by sex and five-year age groups estimated by Poisson regression analyses. 8

9 Incidence per County Finnmark Nordland Buskerud Aust-Agder Troms Rogaland Sogn og Fjo Vestfold Østfold Oslo Vest-Agder Hedmark Akershus Oppland Telemark Møre og Romsdal Hordaland Nord-Trøndelag Sør-Trøndelag 0 0,05 0,1 0,15 0,2 0,25 0,3 9

Hedmark Akershus Oppland Telemark Møre og Romsdal Hordaland

10 per 1, per 1, per 1, per 1,000 10

11 Meningococcal B vaccine Epidemic of MenB in Norway in the 1970s and 1980s New vaccine developed by the Norwegian Institute of Public Health Randomised, kontrolled prevention trial in Is CFS/ME a side effect of vaccination?

Institute of Public Health Randomised, kontrolled

12 Hypothesis Null hypotesis: There is no association between vaccination with MenB and the occurrence of CFS/ME later. Alternative hypothesis: The MenB vaccine is positively associated to CFS/ME. We then expect to find more vaccinated subjects among the cases in a case-control study

Alternative hypothesis: The MenB vaccine is positively associated to

13 Samples Cases: 237 patients with CFS/ME from Ullevål and Haukeland hospitals, born Controls: 889 subjects taken randomly from the central population registry, born

14 Method Send a questionnaire to cases and controls Obtain informed consent for linkage to the MenVaks registry Ask about earlier infections Ask about other background factors Link personal identification numbers to the vaccination registry Examine whether the proportion of vaccinated subjects is equal for cases and controls

background factors Link personal identification numbers to the vaccination

15 Main result Cases n % Controls n % OR (95 % CI)* Vaccinated 93 46, ,2 1,06 ( ) Not vaccinated , ,8 1.0 Total *adjusted for sex, year of birth and parental educational level

16 Interpretation At the population level there is no association between the MenB-vaccine and CFS/ME There is certain statistical imprecision and a possibility for selection bias The result does not exclude the possibility that there may be some single cases of CFS/ME that may be due to the vaccine.

possibility for selection bias The result does not exclude the possibility

17 Publication Magnus P, Brubakk O, Nyland H, Wold BH, Gjessing HK, Brandt I, Eidem T, Nøkleby H, Stene-Larsen G. Vaccination as teenagers against meningococcal disease and the risk of the chronic fatigue syndrome. Vaccine 2009;27:23-7.

Vaccination as teenagers against meningococcal disease and

18 The Influenza Pandemic in 2009 and CFS/ME RegFlu - Registry based influenza-studies at NIPH A research project where National registries are used to study health outcomes after pandemic influenza, vaccinations and use of antivirals. 18

project where National registries are used to study health

19 19

20 Registry data in CFS/ME -study Meldesystemet for smittsomme sykdommer (MSIS) Positive H1N1 tester Dato for symptomdebut Norsk Pasientregister (NPR) Diagnoser m/dato DSF - Folkeregisteret Studiepopulasjon Vaksinasjonsregisteret (SYSVAK) Vaksinasjonsstatus Dato for vaksinasjon HELFO-data fra helserefusjoner (KUHR ) Fastlege/legevakt Influensa 20

Folkeregisteret Studiepopulasjon Vaksinasjonsregisteret (SYSVAK) Vaksinasjonsstatus

21 Conclusions CFS/ME has two distinct age peaks in Norway with the highest rates in the age groups and years. CFS/ME is more common in women The risk of CFS/ME was increased after pandemic influenza The risk of CFS/ME was not increased after vaccination 21

22 Research team Sara Ghaderi Inger Johanne Bakken Nina Gunnes Kari Tveito Lill Trogstad Siri Håberg Per Magnus Camilla Stoltenberg Mady Hornig Ian Lipkin 22

Bustadkreditt Sogn og Fjordane AS cover pool data

Bustadkreditt Sogn og Fjordane AS cover pool data Report date: 31.12.2013 Report currency: NOK 1. General cover pool information 1.1 Key characteristics Total cover pool, nominal balance 9.266.583.283