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Swine flu story

Swine flu story. Mikko Pohjola, THL. Contents. Introductory overview Step by step walk-through Swine flu (AH1N1 influenza) Beginning of the pandemic Preparedness in Finland Vaccination campaign Public doubts THL-GSK connections? Exaggerated risk? Vaccine efficacy? Counter-campaigning

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Swine flu story

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  1. Swine flu story Mikko Pohjola, THL

  2. Contents • Introductory overview • Step by step walk-through • Swine flu (AH1N1 influenza) • Beginning of the pandemic • Preparedness in Finland • Vaccination campaign • Public doubts • THL-GSK connections? Exaggerated risk? Vaccine efficacy? Counter-campaigning • Narcolepsy cases • Public discussions vs. experts • Halting of vaccination campaign • Pandemrix vs. narcolepsy elsewhere? • THL narcolepsy study • Publication of results and apologies • Public rage • Sacking of the guilty? Vaccine testing? Actions of S&H Ministry, THL, doctors?, Spoiled vaccine batche(es)? • EMA statement on connections between Pandemrix and narcolepsy • Re-occurence of swine flu and new vaccinations • Further vaccine/narcolepsy studies in Finland and elsewhere

  3. Introductory overview • Swine flu vaccinations and narcolepsy in Finland • Effects and side-effects? • Vaccination campaign vs. threat? • Big thanks to Otto Hänninen, THL • Many slides translated from his recent presentation on the topic in Finnish

  4. The threat in summer 2009 ca. 100 nm • mortality 0,6% of those infected • Infects 5-15% of poulation http://fi.wikipedia.org/wiki/Vuoden_2009_sikainfluenssapandemia • I.e. ca. 500.000 with swine flu (according to10%) and 3.000 deaths

  5. 2009 4 5 6 Global situation 2009 WHO pandemic-alert: 4 - 27.4.2009 5 - 29.5.2009 6 - 11.6.2009 (6 is the highest alert level)

  6. Narcolepsy incidence in Finland

  7. Age-stratified narcolepsy incidence in Finland

  8. Narcolepsy (ICD-10 G47.4) • Wikipedia: • a chronicsleep disorder, or dyssomnia, characterized by excessive daytime sleepiness (EDS) in which a person experiences extreme fatigue and possibly falls asleep at inappropriate times, such as while at work or at school. • Another problem that some narcoleptics experience is cataplexy, a sudden muscular weakness brought on by strong emotions (though many people experience cataplexy without having an emotional trigger). • ”numbness attack”

  9. Narcolepsy • International background incidence in whole population 0.05% (1/2000), in Finland 0,026% (1/4000) • Normally ca. 60 incidences/year in Finland • Genetic factors important, but no deterministic inheritability • Some possible triggers: infections (streptococcus, virus), allergic reactions, autoimmune diseases, brain damage, hypothyreosis, psychological traumas

  10. A committee was set on 13.10.2010 to study the possible connection between Pandemrix vaccine and narcolepsy • Asiantuntijat, Suomen unitutkimusseura ja Suomen Lastenneurologiyhdistys suosittelijoina: • LT Päivi Olsén, Oulun yliopistollisen sairaalan lastenneurologian yksiköstä, • dosentti Christer Hublin, Työterveyslaitoksen Aivot ja työ tutkimuskeskuksesta, • dosentti Sari-Leena Himanen, Päijät-Hämeen sairaanhoitopiirin Kliinisen neurofysiologian yksiköstä, • dosentti Turkka Kirjavainen Helsingin yliopistollisen keskussairaalan Naisten- ja lastentautien tulosyksiköstä, • dosentti Markku Partinen Helsingin uniklinikalta ja • lääketieteen tohtori Outi Saarenpää-Heikkilä Tampereen yliopistollisen sairaalan lastenneurologian yksiköstä. • Sosiaali- ja terveysministeriön edustajana ryhmässä toimi lääkintöneuvos Merja Saarinen 31.12.2010 asti. • THL • dosentti Terhi Kilven THL:n Rokotusten ja immuunisuojan osastolta, • lääketieteen tohtori Hanna Nohynekin THL:n Rokotusohjelmayksiköstä • filosofian tohtori Jukka Jokisen THL:n Rokotetutkimusyksiköstä, • tutkimusprofessori Ilkka Julkusen THL:n Virusinfektioyksiköstä • tutkimusprofessori Outi Vaaralan THL:n Immuunivasteyksiköstä. www.thl.fi > sikainfluenssa http://www.thl.fi/thl-client/pdfs/f890b9f3-9922-4efe-889b-157fe2e03aa4

  11. Narcolepsy cases 2010 • 33 females, 24 males, in total 57 patients • Average age 12 years, median 11 years, range 4-37 years • 3 cases above 19 years of age • Symptoms appeared on average 52 days (0 days -8 months) after swine flu vaccination

  12. Narcolepsy in other countries Iceland: icreased narcolepsy incidence also among non-vaccinated

  13. Epidemiology • Retrospective cohort study • Follow-up (mainly) 1.1.2009-16.8.2010 • (publicity and potential diagnose sensitivity) • Incidences in age group 4-19 years / follow-up time • 9.2 fold risk (95% CI 4.5 - 21.4)

  14. Swine flu vaccines • Three vaccine groups • Split virus containing vaccines (80M vaccinated, 29M of them children) • Whole virus containing vaccines • Adjuvant containing vaccines • Pandemrix: Nordic countries, Great Britain, Ireland, Germany, France, the Netherlands, and Spain • Focetria: mainly in Italy, the Netherlands, and Greece • GlaxoSmithKline’s Arepanrix (used in Canada) has exactly same composition as Pandemrix

  15. Pandemrix side-effects (NIPH, Norway) • Normal side-effects in 1 out of 10 of those vaccinated (10%) • · Headache • · Tiredness • · Pain, redness, swelling, or hardness around the injection area • · Fever • · Pain in muscles or joints. • Other common side-effects in 1-10 out of every 100 vaccinated (1-10%) • · Heat, itching, or bruises around the injection area • · Increased sweating, shaking, flu-like symptoms • · Swollen lymph-nodes in the neck, armpit, or groin • Less common side-effects in 1-10 of every 1,000 vaccinated (>1‰) • · Tingling or numbness in the hands or feet • · Drowsiness • · Dizziness • · Diarrhoea, vomiting, stomach pains, or nausea • · Itching or a rash • · Feeling generally unwell • · Sleeplessness

  16. Vaccine batches • 28 production batches to Finland, in total 5.286.000 dosages • Vaccines from nine different batches used for those who came down with narcolepsy within the age range 5-19 years • Over 500.000 5-19 year olds vaccinated with vaccines from these batches • Some vaccines to both Finland and Sweden from same batches; distribution of narcolepsy cases does not indicate batch specificity

  17. Vaccination campaign in Finland • Aim: prevention of deaths and severe swine flu cases • Vaccination order: 1. Infection patients, personnel treating infection patients and service personnel in pharmacies 2. Pregnant women 3. Risk groups (6 months – 64 years of age) (sydänsairaus tai keuhkosairaus, aineenvaihduntasairaus, krooninen maksan tai munuaisten vajaatoiminta, vastustuskykyä heikentävä tauti tai hoito, krooninen neurologinen sairaus tai hermolihastauti); 4. Healthy children of age 6-35 months 5. Healthy children and young people of age 3-24 years, and those currently in military service 6. Risk groups of age 65 years and older 7. Others

  18. Vaccinations

  19. Swine flu cases in Finland 2009-2010 • In total 7669 pandemic influenza A(H1N1) 2009 –virus induced infections confirmed between 10.5.2009−8.3.2010. • 44 deaths • median 56 years (1-88 years) • 4 children • 26 men • 40 with a primary disease • 3 vaccinated (1 child)

  20. Vaccine efficacy? • Did the vaccination campaign subdue the epidemic or was it already subsiding by itself? • Herd immunity?

  21. Side effects of vaccination campaigns • Polio vaccination campaign in 1985 (94% of whole population of Finland) • 9 children diagnozed with Guillain-Barré syndrome • paralysis of the lower body Kinnunen et al., 1998

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