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Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

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  • #46
    Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

    Northern Ireland: Link between narcolepsy and flu vaccine investigated

    Health officials are investigating a link between narcolepsy and the Pandemrix vaccine in two people who were treated for swine flu.

    Northern Ireland's Chief Medical Officer has confirmed to the BBC, that Northern Ireland had become the latest country to report suspected cases of the sleeping disorder.

    Dr Michael McBride said the vaccine was used during the flu pandemic of 2009.

    "Let's be clear - this is not the vaccine that we use today," he added.

    Narcolepsy is a rare and chronic sleeping condition that may also cause muscle weakness.

    Dr McBride said: "Two suspected cases have been reported to the Medicines and Healthcare Products Regulatory Agency. At this stage it is a precaution."

    No details have been given about the people involved, including if they are children.

    http://www.bbc.co.uk/news/uk-northern-ireland-15130951

    Comment


    • #47
      Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

      Finland vows care for narcolepsy kids who had swine flu shot


      HELSINKI — The Finnish government and major insurance companies announced Wednesday they will pay for lifetime medical care for children diagnosed with narcolepsy after receiving the swine flu vaccine.

      "The compensation will provide much-needed financial assistance for the families, although it cannot take away the emotional distress caused by this condition," Social Services and Health Minister Paula Risikko said in a statement.

      Finnish and international researchers recently found a conclusive link between the Pandemrix swine flu vaccine and new cases of narcolepsy, a chronic nervous system disorder which causes people to often uncontrollably fall asleep.

      The Finnish Pharmaceutical Insurance Pool (LVP), which represents insurance companies, said Wednesday it would honour all insurance claims in this category.

      LVP said it would review each claim individually to calculate the scope of the payout.

      The Finnish government meanwhile agreed to cover any medical costs exceeding the insurance claims.

      In Finland, 79 children between the ages of four and 19 developed narcolepsy after receiving the Pandemrix vaccine in 2009 and 2010.

      Of these cases, an unusually high number, 76, also suffered from bouts of cataplexy, suffering hallucinations or paralysing physical collapses, according to Finnish research.

      http://www.google.com/hostednews/afp...1191fc79dc.261

      Comment


      • #48
        Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

        http://primeiraedicao.com.br/noticia...e-tomar-vacina
        Portuguese-English translation

        Child sleeps more than 19 hours a day after taking vaccine
        13/12/2011 08:43
        Yahoo.comshare:


        Caroline Hadfield and son, Josh
        A boy of 6 years of age went to sleep over 19 hours a day after taking the vaccine Pandemrix swine flu in England. Josh Hadfield asleep every five minutes, even when he is walking, eating or doing swimming. He came to suffer sudden outbreaks of seizure while laughing, according to the Daily Mail.

        The vaccine was applied in 2009, but it causes side effects to date. "I wake it around four times a night to feed him and comfort him, because he has horrible nightmares," said the boy's mother, Caroline Hadfield, 41.

        A study conducted earlier this year linked the vaccine with cases of narcolepsy (a sleep disorder characterized by excessive sleepiness during the day) in Europe. "Nothing can convercer me that was not the vaccine that caused the problems in Josh," said Caroline.

        Josh's parents want to raise money for an awareness campaign about the vaccine. They said the government should do more tests before applying the dose.

        Comment


        • #49
          Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

          Nearly 80 getting compensation for narcolepsy from swine flu vaccination

          The payment of compensation for narcolepsy attributed to the H1N1, or swine flu vaccine during the pandemic of 2009 has started.
          In the first stages, 78 children and young people will get an advance payout of EUR 10,000 – 20,000. The sum might increase later, says Asko Nio of the Finnish Pharmaceutical Insurance Pool.
          Applications have been received on behalf of 111 children and young people. Some of the applications arrived this week, and they have not been processed yet. There are about ten uncertain cases.

          Those who were diagnosed with narcolepsy after getting the vaccination are to get a one-off payment for both temporary and permanent harm.
          For temporary damage, mainly pain and suffering, all are getting an immediate payment of EUR 8,700.

          ..

          http://www.hs.fi/english/article/Nea.../1135270179558

          Comment


          • #50
            Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

            H1N1 Vaccine Tied to Spike in Narcolepsy

            By Michael Smith, North American Correspondent, MedPage Today

            Published: March 28, 2012

            Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.

            Cases of childhood narcolepsy spiked in Finland in 2010, and researchers there are suggesting the adjuvanted vaccine against the H1N1 pandemic flu might have been a trigger.

            Two related studies, appearing online in PLoS ONE, found that the incidence of narcolepsy rose markedly in children and adolescents, while remaining unchanged in those 20 and older.

            Most of the cases in children occurred after vaccination with the ASO3-adjuvanted flu vaccine Pandemrix, which was the only vaccine used in Finland during the pandemic.

            The two studies, with overlapping research teams, used hospital discharge data and vaccination records to identify cases and estimate incidence.

            One study, led by Hanna Nohynek, MD, PhD, of the Finnish National Institute for Health and Welfare, focused on children and adolescents who were 4 to 19 in 2010.

            The second study, led by Markku Partinen, MD, PhD, of the Helsinki Sleep Clinic, looked at children under 17, which is the cut-off for pediatric cases in Finland.

            Narcolepsy is a chronic sleep disorder that causes excessive daytime sleepiness and cataplexy. It has a strong genetic predisposition, with specific immune system gene variations linked to onset.

            ..


            http://www.medpagetoday.com/Infectio...RItheFlu/31904

            Comment


            • #51
              Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

              Narcolepsy traced to specific vaccine batches



              Published: 1 Jun 12 07:54 CET | Double click on a word to get a translation
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              A new Swedish study shows that all Swedes who developed narcolepsy from the swine flu vaccine Pandemrix received the vaccine from 12 of the 35 batches, despite the Swedish Medical Products Agency’s (Läkemedelsverket) previous claim that no such connection exists.


              “We will have to think again,” said Maria Szirmai of the Swedish Medical Products Agency to newspaper Göteborgsposten (GP).

              Over 220 Swedes, most of them children, developed narcolepsy as a side effect from the Swine flu vaccine Pandemrix, according to the reports filed with insurance company Läkemedelsförsäkringen.

              All these had received the vaccine from some 12 of the 35 batches of vaccine delivered to Sweden.

              From 23 of the 35 shipments there is no recorded case of anyone developing the condition, according to the study, which was carried out by the Swedish Narcolepsy Association (Narkolepsiföreningen).

              The association traced the vaccine through the batch number on the side of the boxes.

              ..


              http://www.thelocal.se/41180/20120601/

              Comment


              • #52
                Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

                New ECDC technical report on “Narcolepsy in association with pandemic influenza vaccination – a multi-country European epidemiological investigation”

                ECDC technical report “Narcolepsy in association with pandemic influenza vaccination – a multi-country European epidemiological investigation” summarises results from two studies undertaken by ECDC and the Vaccine Adverse Event Surveillance and Communication (VAESCO) Consortium. It covers a study on narcolepsy background incidence rates and a case–control study to determine risk factors. Both studies concern the association between narcolepsy and specific influenza A(H1N1)pdm09 vaccines while at the same time considering other likely causes. These studies include Denmark, Finland, France, Italy, the Netherlands, Norway, Sweden and the United Kingdom.

                A summary of the report is available as a separate document.

                The case–control study confirms an association between vaccination with Pandemrix® and an increased risk of narcolepsy in children and adolescents (5 to 19 years of age) in Sweden and Finland that originally reported on this issue (signalling countries). No such association was found in adults in these two countries.

                According to the strictest primary analysis, the kind of assessment designed to avoid most biases like media and diagnostic awareness biases, no significant risk was found in children and adolescents in other countries included in the study – Denmark, Italy, France, the Netherlands, Norway and the United Kingdom (non-signalling countries).

                However, sensitivity analyses that assess the robustness of the results from the primary analysis, have highlighted the importance of several time-related factors that affect the strength of association between influenza pandemic vaccines and narcolepsy. An example of a time-related factor shown to influence results is the length of the chosen study period, that is, the inclusion of cases occurring before and after the period of media attention would give a different outcome.

                One such sensitivity analysis was based on the date of onset of excessive day-time sleepiness before media attention. This identified an increased risk for narcolepsy for children and adolescents following influenza A(H1N1)pdm09 vaccination in both signalling and non-signalling countries.

                A similar sensitivity analysis also addressed date of onset of excessive daytime sleepiness and showed an association in adults in non-signalling countries before awareness increased.

                To further inform the regulatory actions and the public, the report recommends increasing the statistical power by ensuring completeness of the case–control study through an exhaustive case inclusion in all age groups in the primary study period before increased awareness.

                VAESCO is a European research network funded by ECDC and coordinated for ECDC by the Brighton Collaboration. It includes researchers from public health institutes, regulatory agencies and universities. The long term aim of the work is to create an independent infrastructure and epidemiological resource in support of vaccine safety monitoring and investigation in Europe.

                http://ecdc.europa.eu/en/press/news/...124029a&ID=731

                Comment


                • #53
                  Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

                  ECDC: Technical report In Brief: Narcolepsy in association with pandemic influenza vaccination

                  This report summarises the results from two epidemiological studies to investigate a possible association between an unexpected increase in narcolepsy cases following the use of the influenza A(H1N1)pdm09 vaccines. The studies were conducted by the Vaccine Adverse Event Surveillance and Communication (VAESCO) Consortium under the auspices of ECDC and undertaken in Denmark, Finland, France, Italy, the Netherlands, Norway, Sweden and the United Kingdom.

                  full pdf file:

                  http://ecdc.europa.eu/en/publication...ef%20final.pdf

                  Comment


                  • #54
                    Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

                    European Medicines Agency reviews hypothesis on Pandemrix and development of narcolepsy


                    The European Medicines Agency's Committee on Human Medicinal Products (CHMP) at the request of the Agency’s Executive Director Guido Rasi has reviewed preliminary research results by the Finnish National Institute of Health and Welfare (THL) investigating differences in the immunological response
                    triggered by different pandemic influenza vaccines as a potential root cause for the development of narcolepsy in persons vaccinated with Pandemrix.

                    After careful consideration, the CHMP concluded that the data presented by the Finnish researchers are preliminary and that the evidence presented so far is insufficient to allow conclusions to be drawn, and does not lead to any new concerns regarding Pandemrix or other vaccines, including other influenza
                    vaccines. On the basis of the current evidence, the role of the Pandemrix antigen and its adjuvant on the association between Pandemrix and narcolepsy remains unknown.

                    The CHMP welcomes the work of academic researchers to understand the biological mechanism for the association between Pandemrix and narcolepsy and has expressed its appreciation to the Finnish research team for making these results available for scrutiny in a timely manner. The Committee also said it would welcome the opportunity to evaluate any further analyses produced by these researchers or others as their work progresses.

                    The CHMP also expects the marketing authorisation holder for Pandemrix, GSK, to take into account the hypothesis generated by the Finnish research in their experimental research programme into the root cause for the association between Pandemrix and narcolepsy.

                    Pandemrix was authorised in the EU in September 2009 to protect against influenza (flu) caused by the A (H1N1)v 2009 virus. The vaccine was used extensively during the 2009 (H1N1) pandemic, with at least 30.8 million people vaccinated in the EU.

                    Pandemrix is currently not available in the EU.

                    Data in some EU countries have shown an increased risk of narcolepsy in children and adolescents. A similar risk has not been confirmed but cannot be ruled out in other countries. In a 2011 review the Committee therefore concluded that Pandemrix should only be used in persons under 20 years of age if the recommended annual seasonal trivalent influenza vaccine is not available and if immunisation against (H1N1)v is considered necessary.

                    http://www.ema.europa.eu/ema/index.j...01ac058004d5c1

                    Comment


                    • #55
                      Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

                      Vaccine. 2012 Dec 13. pii: S0264-410X(12)01782-3. doi: 10.1016/j.vaccine.2012.12.015. [Epub ahead of print]
                      The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns.
                      Wijnans L, Lecomte C, de Vries C, Weibel D, Sammon C, Hviid A, Svanström H, Mølgaard-Nielsen D, Heijbel H, Dahlström LA, Hallgren J, Sparen P, Jennum P, Mosseveld M, Schuemie M, van der Maas N, Partinen M, Romio S, Trotta F, Santuccio C, Menna A, Plazzi G, Moghadam KK, Ferro S, Lammers GJ, Overeem S, Johansen K, Kramarz P, Bonhoeffer J, Sturkenboom MC.
                      Source

                      Erasmus University Medical Center, Rotterdam, the Netherlands; Medicines Evaluation Board, the Netherlands.
                      Abstract
                      BACKGROUND:

                      In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification.
                      METHODS:

                      We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom.
                      RESULTS:

                      Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women>men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time.
                      CONCLUSIONS:

                      The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.

                      Copyright © 2012. Published by Elsevier Ltd.

                      PMID:
                      23246544
                      [PubMed - as supplied by publisher]

                      http://www.ncbi.nlm.nih.gov/pubmed/23246544

                      Comment


                      • #56
                        Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

                        INSIGHT-Evidence grows for narcolepsy link to GSK swine flu shot

                        Tue, 22 Jan 2013 06:55 GMT

                        Source: reuters // Reuters

                        By Kate Kelland, Health and Science Correspondent

                        STOCKHOLM, Jan 22 (Reuters) - Emelie is plagued by hallucinations and nightmares. When she wakes up, she's often paralysed, unable to breathe properly or call for help. During the day she can barely stay awake, and often misses school or having fun with friends. She is only 14, but at times she has wondered if her life is worth living.

                        Emelie is one of around 800 children in Sweden and elsewhere in Europe who developed narcolepsy, an incurable sleep disorder, after being immunised with the Pandemrix H1N1 swine flu vaccine made by British drugmaker GlaxoSmithKline in 2009.

                        Finland, Norway, Ireland and France have seen spikes in narcolepsy cases, too, and people familiar with the results of a soon-to-be-published study in Britain have told Reuters it will show a similar pattern in children there.

                        Their fate, coping with an illness that all but destroys normal life, is developing into what the health official who coordinated Sweden's vaccination campaign calls a "medical tragedy" that will demand rising scientific and medical attention.

                        ..


                        http://www.trust.org/alertnet/news/i...swine-flu-shot

                        Comment


                        • #57
                          Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

                          The incidence of narcolepsy in Europe: Before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns

                          Leonoor Wijnansa, b,
                          Coralie Lecomtea,
                          Corinne de Vriesc,
                          Daniel Weibela, d, Corresponding author contact information, E-mail the corresponding author,
                          Cormac Sammonc,
                          Anders Hviide,
                          Henrik Svanströme,
                          Ditte Mølgaard-Nielsene,
                          Harald Heijbelf,
                          Lisen Arnheim Dahlströmg,
                          Jonas Hallgreng,
                          Par Spareng,
                          Poul Jennumh,
                          Mees Mossevelda,
                          Martijn Schuemiea,
                          Nicoline van der Maasi,
                          Markku Partinenj,
                          Silvana Romioa,
                          Francesco Trottak,
                          Carmela Santucciok,
                          Angelo Mennal,
                          Giuseppe Plazzim,
                          Keivan Kaveh Moghadamm,
                          Salvatore Ferron,
                          Gert Jan Lammerso,
                          Sebastiaan Overeemp,
                          Kari Johansenq,
                          Piotr Kramarzq,
                          Jan Bonhoefferd, r, E-mail the corresponding author,
                          Miriam C.J.M. Sturkenbooma

                          a Erasmus University Medical Center, Rotterdam, The Netherlands
                          b Medicines Evaluation Board, The Netherlands
                          c University of Bath, Bath, United Kingdom
                          d Brighton Collaboration Foundation, Basel, Switzerland
                          e Statens Serum Institut, Copenhagen, Denmark
                          f Swedish Institute for Infectious Disease Control, Lund, Sweden
                          g The Karolinska Institute, Stockholm, Sweden
                          h Danish Center for Sleep Medicine, Copenhagen, Denmark
                          i National Institute of Public Health, Bilthoven, The Netherlands
                          j Helsingin Uniklinikka, Helsinki, Finland
                          k Italian Medicines Agency, Rome, Italy
                          l Regional Health Authority, Tuscany, Italy
                          m Department of Neurological Sciences, University of Bologna, Bologna, Italy
                          n Regional Health Authority, Emilia Romagna, Italy
                          o Leiden University Medical Center, Leiden, The Netherlands
                          p Department of Neurology, Donders Institute for Neuroscience, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands
                          q European Centre for Disease Prevention and Control, Stockholm, Sweden
                          r University Children's Hospital, Basel, Switzerland

                          http://dx.doi.org/10.1016/j.vaccine.2012.12.015

                          Background

                          In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification.
                          Methods

                          We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000–2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom.
                          Results

                          Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90–0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women > men) and around 60 years of age. In the age group 5–19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1–3.1) in Denmark, 6.4 (95% CI: 4.2–9.7) in Finland and 7.5 (95% CI: 5.2–10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time.
                          Conclusions

                          The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.
                          Highlights

                          ► We identified 2608 narcolepsy cases in 6 EU countries between 2000 and 2010. ► After pandemic vaccination, incidence rates increased in Finland, Sweden and Denmark. ► In Denmark, the increase did not follow high pandemic vaccination coverage. ► In Italy, the Netherlands and the United Kingdom no increased rates were seen.

                          http://www.sciencedirect.com/science...64410X12017823

                          Comment


                          • #58
                            Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

                            UK study strengthens link between GSK flu shot and narcolepsy

                            (Reuters) - Children in Britain who were vaccinated with a GlaxoSmithKline shot against H1N1 swine flu had a significantly increased risk of developing the rare sleep disorder narcolepsy, according to results of a scientific study.

                            The findings, which have not yet been published in full, are the first firm evidence in Britain that the flu vaccine, called Pandemrix, is linked to narcolepsy cases in children.

                            Research in Finland, Sweden and Ireland has already found clear associations and Reuters reported last week that similar links were expected to be found in Britain.

                            Pandemrix was given to 30 million people - including around six million in Britain - during the 2009-2010 flu pandemic.
                            The abstract shows that the research team, led by Liz Miller, a consultant epidemiologist at the UK Health Protection Agency (HPA), found an almost 10-fold increased risk in cases of the sleep disorder in children seen in sleep centers who had been immunized with Pandemrix.

                            ...

                            The full HPA study with peer review is due to be published in the British Medical Journal in the coming months.

                            http://www.reuters.com/article/2013/...90U0JW20130131

                            Comment


                            • #59
                              Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

                              Insight: GSK vaccine ingredient scrutinized for narcolepsy clues

                              LONDON (Reuters) - Mounting evidence of a link between GlaxoSmithKline's Pandemrix flu shot and a spike in narcolepsy cases among children in Europe is putting one of the vaccine's key ingredients, AS03, under intense scrutiny.

                              The ingredient is one of a class of pharmaceuticals known as adjuvants, or boosters, designed to turbo charge the potency of a vaccine and the body's immune response to it.

                              AS03 was widely used in Europe during the 2009-2010 H1N1 flu pandemic and is also contained in a GSK adjuvanted flu vaccine which in November last year became the first of its kind to be recommended for approval by the normally adjuvant-wary United States Food and Drug Administration (FDA).

                              There's little doubt AS03 does its job well.

                              ..


                              KEY INGREDIENTS

                              Independent groups of researchers around the world working hard to do that are homing in on AS03 and its super immune response boosting capability.

                              The adjuvant is not a single ingredient, but a combination of three - squalene, an oil derived from shark livers, a form of vitamin E called DL-alpha-tocopherol, and an emulsifier, or mixing agent, called polysorbate 80.

                              Both the squalene and the vitamin E are there to boost the response of the immune system to the H1N1 antigen - the molecule the immune system needs to learn to recognize in order to protect against infection in future.

                              At Stanford University in the United States, professor of psychiatry and narcolepsy expert Emmanuel Mignot believes the mistake may have been in putting the H1N1 virus, which itself produces a strong immune response and is used in the vaccine, together with such a potent booster combination.

                              "It's clear that H1N1 is a key ingredient. But it's also clear that if you didn't have the adjuvant you also didn't have this dramatically increased risk (of developing narcolepsy)," said Mignot, who is being funded by GSK to conduct further research into the links.

                              "So my opinion is that it was a combination of both in Pandemrix that made it very nasty for narcolepsy."

                              ..

                              Because both narcolepsy and vaccines are linked to the function of the immune system, the biological plausibility of a link between the disorder and a vaccine with such an effective adjuvant has a sound scientific basis, says Outi Vaarala of the Immune Response Unit at Finland's National Institute for Health and Welfare, who has been studying links between narcolepsy and Pandemrix since cases appeared there in 2010.

                              Narcolepsy is also strongly linked to a variant in a gene called HLA, which controls the function of a subtype of white blood cells. White blood cells are key to the immune system and experts say this link underpins the theory that narcolepsy is most likely an autoimmune disease.

                              Around 25 percent of people in northern and central Europe are thought to have the HLA genetic vulnerability to narcolepsy, with a lower percentage in southern European countries.

                              Vaarala is investigating the details of the vaccine's ingredients and, like others, thinks the answer may lie in the way certain children's immune systems responded to the antigen and then had that response supercharged by AS03.

                              Vaarala's studies also raise questions over whether GSK's own investigations, which are centered on use of Arepanrix in Canada, may turn out to be a something of a red herring.

                              There is no evidence so far of increases in narcolepsy cases in children in Canada. While this could reflect variables like differences in the genetic makeup of those vaccinated, or the timing of when they got their shots during the pandemic, some believe the answer may lie tiny differences between the Arepanrix and Pandemrix vaccines.

                              Ingredients lists for Pandemrix and Arepanrix show the two vaccines have the same antigen and the same adjuvant, but GSK's Begg says the two products have some "minor formulation differences" because they were manufactured at different sites.

                              ...


                              http://news.yahoo.com/insight-gsk-va...093926909.html

                              Comment


                              • #60
                                Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection + other countries investigate

                                Risk of narcolepsy in children and young people receiving AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine: retrospective analysis

                                BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f794 (Published 26 February 2013)
                                Cite this as: BMJ 2013;346:f794

                                Abstract
                                Objective To evaluate the risk of narcolepsy in children and adolescents in England targeted for vaccination with ASO3 adjuvanted pandemic A/H1N1 2009 vaccine (Pandemrix) from October 2009.

                                Design Retrospective analysis. Clinical information and results of sleep tests were extracted from hospital notes between August 2011 and February 2012 and reviewed by an expert panel to confirm the diagnosis. Vaccination and clinical histories were obtained from general practitioners.

                                Setting Sleep centres and paediatric neurology centres in England.

                                Participants Children and young people aged 4-18 with onset of narcolepsy from January 2008.

                                Main outcome measures The odds of vaccination in those with narcolepsy compared with the age matched English population after adjustment for clinical conditions that were indications for vaccination. The incidence of narcolepsy within six months of vaccination compared with the incidence outside this period measured with the self controlled cases series method.

                                Results Case notes for 245 children and young people were reviewed; 75 had narcolepsy (56 with cataplexy) and onset after 1 January 2008. Eleven had been vaccinated before onset; seven within six months. In those with a diagnosis by July 2011 the odds ratio was 14.4 (95% confidence interval 4.3 to 48.5) for vaccination at any time before onset and 16.2 (3.1 to 84.5) for vaccination within six months before onset. The relative incidence from the self controlled cases series analysis in those with a diagnosis by July 2011 with onset from October 2008 to December 2010 was 9.9 (2.1 to 47.9). The attributable risk was estimated as between 1 in 57 500 and 1 in 52 000 doses.

                                Conclusion: The increased risk of narcolepsy after vaccination with ASO3 adjuvanted pandemic A/H1N1 2009 vaccine indicates a causal association, consistent with findings from Finland. Because of variable delay in diagnosis, however, the risk might be overestimated by more rapid referral of vaccinated children.

                                http://www.bmj.com/content/346/bmj.f794

                                Comment

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