swine flu story
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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
Narcolepsy incidence in Finland
0
20
40
60
80
100
120
2006 2007 2008 2009 2010
Vuosi
Nar
kole
psi
atap
auks
ia S
uo
mes
sa
Age-stratified narcolepsy incidence in Finland
0
5
10
15
20
25
30
35
0-4 5-9 10-14
15-19
20-24
25-29
30-34
35-39
40-44
45-49
50-54
55-59
60-64
65-69
70-74
75-79
80-
2006
2007
2008
2009
2010
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
0
50 000
100 000
150 000
200 000
250 000
300 000
350 000
400 000
450 000
0-4 5-9 10-14
15-19
20-24
25-29
30-34
35-39
40-44
45-49
50-54
55-59
60-64
65-69
70-74
75-79
80-
Ikäryhmä
Väe
stö
mää
rä i
käry
hm
ittä
in
Rokottamatta
Rokotetut
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