ÍSLAND Í FYRSTA SÆTI MEÐ DRÓMASÝKIS TILFELLI AF 7 LÖNDUM.

SAMT AFNEITA SÓTTVARNARLÆKNAR TENGINGU VIÐ H1N1 SVÍNAFLENSU BÓLUEFNIÐ

REPORTED INCIDENCE OF NARCOLEPSY IN CHIILDREN AND ADOLESCENTS AFTER PANDEMRIX®/AREPANRIX® VACCINATION

Terhi Kilpi1, Jukka Jokinen1, Hanna Nohynek1, Barbara Law2, Julie A. Laroche3, Þórólfur Guðnason4, Jann Storsaeter5, Brigitte Keller-Stanislawski6, Birgitta Grundmark7, Annika Linde8, Philip Bryan9, Richard Pebody10

https://www.thl.fi/documents/10531/104009/Narkolepsia_posteri.pdf

 

 

25.09.12 Samband drómasýki og bólusetningar gegn svínainflúensu

http://www.landlaeknir.is/um-embaettid/frettir/frett/item17978/Samband-dromasyki-og-bolusetningar-gegn-svinainfluensu

 Ísland tók ekki þátt í þessari rannsókn en eins og áður hefur komið fram þá sást ekki marktækt samband bólusetningar hér á landi við drómasýki (sjá nánar á heimasíðu embætti landlæknis). 

(Innskot Agný..Hvað er marktækt í huga yfirmanna sóttvarna er mér sko spurn! En allavega raðaði þetta sjálfvirka skráningakerfi Íslandi á toppinn af 7 löndum með drómasýkis tilfelli eftir svínaflensu bólusetningu...Eins og þið sjáið þá er Dr.Þórólfur Guðnason á listanum hér fyrir neðan og sóttvarnar embættið hér á landi..Halda þeir að hinn almenni borgari lesi ekki neitt annað en það sem þeir láta frá sér fara munnlega sem skriflega ?)

 TILKYNNT UM DRÓMASÝKIS TILFELLI HJÁ BÖRNUM OG UNGLINGUM  EFTIR PANDEMRIX®/AREPANRIX®  BÓLUSETNINGU.

REPORTED INCIDENCE OF NARCOLEPSY IN CHIILDREN AND ADOLESCENTS AFTER PANDEMRIX®/AREPANRIX® VACCINATION

VACCINATION Terhi Kilpi1, Jukka Jokinen1, Hanna Nohynek1, Barbara Law2, Julie A. Laroche3, Þórólfur Guðnason4, Jann Storsaeter5, Brigitte Keller-Stanislawski6, Birgitta Grundmark7, Annika Linde8, Philip Bryan9, Richard Pebody10 Pebody 101Department of Vaccination and Immune Protection, National Institute for Health and Welfare (THL), 2Public Health Agency of Canada 3Centre for Immunization and Respiratory Infectious Diseases (CIRID), Public Health Agency of Canada, Ottawa, ON, 4Centre for Health Security and Infectious Disease Control, Reykjavik, Iceland, 5Norwegian Institute of Public Health, Oslo, Norway, 6Paul-Ehrlich-Institut, Langen, Germany,7Pharmacovigilance unit, Medical Products Agency, Uppsala, 8Smittskyddsinstitutet, Stockholm, Sweden, 9Vigilance and Risk Management of Medicines (VRMM), Medicines and Healthcare products Regulatory Agency,10Health Protection Agency, London, UK

Bakgrunnur og markmið

Sumar og haust 2010 var skýrt frá nokkrum drómatilfellum eftir Pandemrix bólusetningu í Svíþjóð og Finnlandi, þar sem herferð gegn heimsfaraldri af A/ H1N1 flensu hafði verið í gangi frá haustinu 2009 og byrjun 2010. Börn og unglingar á aldrinu 4-19 ára voru 85% tilfellanna sem skýrt var frá. Safnað var upplýsingum frá 7 löndum sem skýrt höfðu frá dróma tilfellum hjá þeim aldurshóp sem sýndi skýrustu merkin í kjölfar bólusetningar með AS03 ónæmisglæddu heimsfaraldurs bóluefni. 

Aðferðir

Öll drómasýkis tilfellin  í kjölfar Pandemrix/Arepanrix bólusetningarinnar hjá einstaklingum á aldrinum 4-19 ára og tilkynnt hafði verið  í gegnum sjálfvirkt skráningarkerfi  alvarlegra aukaverkana um 24 Janúar 2011.  Nefnari var fenginn í gegnum  bólusetningarskrár eða umfjallanir  úr könnunum.

 Niðurstaða

Sjálfkrafa tilkynnt drómatilfelli voru töluvert mismunandi frá einu landi til annars, en voru hæst á Íslandi og Finnlandi, fæst í Kanada (Tafla). Skráð tilfelli fóru yfir það sem gert var ráð fyrir ( Innskot Agný..Þarna segir nú bara beint að GSK hafi reiknað með dróma tilfellum tengdum svínaflensu bóluefninu! Bara ekki alveg svona mörgum! )í aldurshópnum 4-19 ára í Finnlandi(1), á Íslandi, í Svíþjóð (2) og í Þýskalandi (3), en var innan fyrirfram gefinna  marka í Noregi, Bretlandi og Kanada.

Ályktanir.

Óvæntur fjöldi drómasýki tilfellanna sem skýrt var frá  í sumum löndum eftir Pandemrix /Arepanrix bólusetningar hjá börnum og unglingum kalla á umfangsmeiri faralds rannsóknir til að sjá hvort  að aukin hætta á drómasýki tengist AS03  ( AS03 er samnefnari fyrir squelene, DL.-a-tocopherol og polysorbate 80 ) ónæmisglæddu (H1N1) bóluefni.

*5-19-year olds

**5-16 –year olds

*** 0-17-year olds

LAND-TILFELLI-BÓLUSETT 4-19 ÁRA-TILFELLI/100.000-BÓLUSETT

Iceland    3             31,958                        9,4

Finland     54           668.000                             8,1

Sweden     58        1.193.000                             4,9

Norway       8          510.000*                           1,6

Great Britain     2  295.000**                         0,7

Germany   5           928.000***                       0,5

Canada      2        1.974.865                             0,1

HEIMILDIR.

ÞÝÐANDI AGNÝ.

1.National Narcolepsy Task Force Interim Report 30 January 2011. 

http://www.zentrum-der-gesundheit.de/pdf/impfen-ia_01.pdf

2.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.

www.lakemedelsverket.se

3.Berner R et al.: Erhebungseinheit für seltene pädiatrische Erkrankungen in Deutschland (ESPED). Monatsschr Kinderheilk. 2004;152:7779.

Referenced at www.pei.de

https://www.thl.fi/en/web/thlfi-en

https://lakemedelsverket.se/english/

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The Flu Vaccine and Narcolepsy

Posted by Steven Novella on February 9, 2011 23 Comments

https://www.sciencebasedmedicine.org/the-flu-vaccine-and-narcolepsy/

Last year it was reported that there was a possible increase in narcolepsy, a sleep disorder characterized by excessive sleepiness, in children who had received the Pandemrix brand of H1N1 flu vaccine in Sweden, Finland, and Iceland.

However a review of the data did not find a convincing connection, although concluded there was insufficient data at present and recommended further surveillance. A narcolepsy task force was formed in Finland, and now we have their preliminary report.

They conclude that the evidence suggests there is a connection:

Based on the preliminary analyses, the risk of falling ill with narcolepsy among those vaccinated in the 4-19 years age group was 9-fold in comparison to those unvaccinated in the same age group.

This increase was most pronounced among those 5–15 years of age. No cases were observed among those under 4 years of age. Also, no increase in cases of narcolepsy or signs of vaccination impacting risk of falling ill with narcolepsy was observed among those above 19 years of age.

The World Health Organization (WHO)

has reviewed these results and concluded:

WHO’s Global Advisory Committee on Vaccine Safety (GACVS) reviewed this data by telephone conference on 4 February 2011. GACVS agrees that further investigation is warranted concerning narcolepsy and vaccination against influenza (H1N1) 2009 with Pandemrix and other pandemic H1N1 vaccines.

An increased risk of narcolepsy has not been observed in association with the use of any vaccines whether against influenza or other diseases in the past. Even at this stage, it does not appear that narcolepsy following vaccination against pandemic influenza is a general worldwide phenomenon and this complicates interpretation of the findings in Finland.

I agree with the WHO, who is basically saying that these results are intriguing, but are problematic and should be considered preliminary. They then follow with – more research is needed. Epidemiology is a complex endeavor, and there are lots of wrinkles to this data.

The increased risk of narcolepsy was only seen within a certain age range. In Iceland (but not Sweden or Finland) the increase in narcolepsy was also seen in those who were not vaccinated.

And further, other countries (47 in total) that also used the Pandemrix vaccine have seen no increase in narcolepsy, including Norway, the UK, Germany, and Canada.

Overall we have a very inconsistent pattern. The vaccine does not appear to be a consistent or unique risk factor for narcolepsy in these populations.

The task force concludes from this that there must be another factor or factors that is combining with the vaccine to increase the risk. This is logically possible, but until this factor X is identified it remains speculation.

Narcolepsy is a neurological disorder characterized by excessive daytime sleepiness (narcoleptics sleep all night and all day), cataplexy (a tendency to lose muscle tone and collapse in response to stress), hypnagogia (hallucinations associated with a fusion of the dream state and the waking state, so-called waking dreams), and sleep paralysis (being paralyzed upon awaking from sleep).

There is a strong genetic predisposition for narcolepsy.

In fact it is only seen with a certain genetic type known as the (HLA) DQB1*0602 genotype.

All of the individuals who developed narcolepsy following the Pandemrix vaccine have the narcolepsy HLA type.

Therefore there is the possibility that the vaccine only increases risk within this genetic populations, perhaps combined with other gene variants. Perhaps something else is also triggering the increase in Iceland, but not Finland and Sweden, to explain the rise in narcolepsy there in the unvaccinated.

Another possibility is that there is one or more confounding factors leading to the increase in narcolepsy, and the vaccines are a correlating but not causative factor.

Such is the nature of epidemiology, or observational studies. Variables are not controlled for and confounding factors are always a possibility. That does not mean that observational data is not useful or cannot be definitive – but it requires careful, thoughtful, and thorough collection and analysis of data from multiple different angles.

The data we have so far from Finland is very preliminary, and generates more questions than answers. There is certainly sufficient cause for caution and further analysis. But at this point I would not be surprised by any particular outcome, since the data can be interpreted in many ways.

Conclusion

While there is an intriguing correlation between the Pandemrix vaccine and narcolepsy, this correlation is inconsistent – it is isolated to a few countries and to one age group and there is a rise in narcolepsy in Iceland not correlated to the vaccine.

Further the cases identified so far are restricted to those with a known genetic predisposition to narcolepsy. This could mean that this population is susceptible to some factor in the vaccine, but it could also mean that they are susceptible to some other trigger, or perhaps were destined to get narcolepsy and the apparent increase in entirely an artifact of observation and reporting.

I agree with the WHO that this data should be considered preliminary – which means it is worthy of further monitoring and research, but we are not able to make any firm conclusions at this time.  I would not be surprised if it turns out to be a real effect of the Pandemrix vaccine.

Vaccines are not without risk, although over the decades the risks have proven to be very small and vastly outweighed by the benefits. Obviously it would be hugely useful to identify which ingredient was the culprit and exactly how it triggered narcolepsy in this population. But I would also not be surprised if this turns out to be entirely a red herring. Such is the nature of observational data.

Athugasemdir

[Agný, 14.2.2013 kl. 21:01]

http://www.tga.gov.au/pdf/auspar/auspar-pandemic.pdf 

D-Pan-H1N1-007 (Day 0 to Day 6 solicited adverse events following 1 dose of 3.75 μg HA+ AS03 vaccine versus 1 dose of 15 μg HA unadjuvanted H1N1 vaccine) - Adverse Events with a causal relationship

H1N1+ AS03 = H1N1 containing antigen-sparing dose of HA+AS03 adjuvant
H1N1 = H1N1 containing HA antigen without adjuvant

Það er sko þokkalegur munur á aukaverkunum á þessum tveim hópum!

Þar sem er með bæði squlane og polysorbate er með það mikið af aukaverkunum og það margir fá þær að ég held að se nú bara skárra að taka sénsinn á því að fá flensu....Svo er bara að muna að vera í bælinu þegar maður er veikur..fá nægan vökva ...maður fer að borða þegar líkaminn er búinn að klára að vinna á veirunni.. Það eru varnarviðbrögð að hafa ekki matarlyst á meðan að ónæmiskerfið er í 100 % vinnu...Hann ræður ekki við meira á meðan.......