Swine flu storyMikko 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– 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

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

The threat in summer 2009

• mortality 0,6% of those infected

• Infects 5-15% of poulationhttp://fi.wikipedia.org/wiki/Vuoden_2009_sikainfluenssapandemia

• I.e. ca. 500.000 with swine flu (according to10%) and 3.000 deaths

ca. 100 nm

Global situation 2009

WHO pandemic-alert:

4 - 27.4.2009

5 - 29.5.2009

6 - 11.6.2009

(6 is the highest alert level)

4 5 6

2009

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Narcolepsy (ICD-10 G47.4)

• Wikipedia:– a chronic sleep 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”

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

www.thl.fi > sikainfluenssahttp://www.thl.fi/thl-client/pdfs/f890b9f3-9922-4efe-889b-157fe2e03aa4

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.

THLdosentti Terhi Kilven THL:n Rokotusten ja immuunisuojan

osastolta, lääketieteen tohtori Hanna Nohynekin THL:n

Rokotusohjelmayksiköstäfilosofian tohtori Jukka Jokisen THL:n Rokotetutkimusyksiköstä, tutkimusprofessori Ilkka Julkusen THL:n Virusinfektioyksiköstä tutkimusprofessori Outi Vaaralan THL:n Immuunivasteyksiköstä.

A committee was set on 13.10.2010to study the possible connection betweenPandemrix vaccine and narcolepsy

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

Narcolepsy in other countries

Iceland: icreased narcolepsy incidence also among non-vaccinated

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)

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

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

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

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 pharmacies2. Pregnant women3. 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 months5. Healthy children and young people of age 3-24 years, and

those currently in military service6. Risk groups of age 65 years and older7. Others

Vaccinations

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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)

Vaccine efficacy?

• Did the vaccination campaign subdue the epidemic or was it already subsiding by itself?

• Herd immunity?

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