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

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

    The National Institution for Health and Welfare (THL) is to determine if vaccine for the H1N1 swine flu is behind a slight increase in the number of cases of narcolepsy. The condition causes excessive daytime sleepiness even after adequate nocturnal sleep.

    Although the THL?s Vaccine Department Director Terhi Kilpi does not fear any connection between the H1N1 jab and narcolepsy, she says doubts must be examined.

    Experts on both vaccines and the narcolepsy are meeting on Wednesday to decide what to do.

    Doubts arose when a Finnish child neurologist noticed a slightly increased level in the number of narcolepsy cases this year. Similar observations have been noticed in Sweden, reports the tabloid Iltalehti.

    Medical officials in Sweden are also examining a possible link between the Pandemrix vaccine and narcolepsy, according to the newspaper Svenska Dagbladet.

    A patient suffering from narcolepsy can suddenly fall asleep, for example, while, speaking or eating without prior warning.

    Minister of Health and Social Services Paula Risikko says it is essential to thoroughly examine suspicions that increased outbreaks of child narcolepsy might be linked to the H1N1 swine flu vaccine.

  • #2
    Re: Expert: No Probable Link Between H1N1 Vaccine and Narcolepsy

    Sweden opens inquiry into suspect flu vaccine


    STOCKHOLM ? Sweden's Medical Products Agency opened an inquiry Wednesday into vaccinations for swine flu made by British pharmaceutical company GlaxoSmithKline, suspected of provoking narcolepsy.

    "The MPA has received six reports from health care professionals regarding narcolepsy as suspected adverse drug reaction following Pandemrix flu vaccination," it said in a statement.

    "The agency will, in consultation with external experts, assess the possible relationship between the vaccination and the reported reactions."

    The reports concern children aged between 12-16 years who developed symptoms compatible with narcolepsy, a chronic sleeping disorder, that occurred one to two months after vaccination against the H1N1 pandemic.

    The Medical Products Agency said it was in contact with European Union member states for information on any similar reports in other countries.

    Finland is also looking into the possible link between narcolepsy and the swine flu vaccination, in particular Pandemrix, following an increase in the sleeping disorder among children this spring, the Finish news agency STT said.

    The preliminary results from the investigation are expected by the end of this year.

    In the European Union around 30 million people were vaccinated using Pandemrix. Sweden bought 18 million doses, which was enough to provide two injections for each person in its 9.3 million population.

    According to Finland's National Health Institute, 2.5 million Finns were vaccinated against swine flu. Some 750 showed side effects, namely fevers, headaches and coughing, and one case was linked to narcolepsy.

    Comment


    • #3
      Re: Expert: No Probable Link Between H1N1 Vaccine and Narcolepsy

      Minister Calls for Thorough Examination of Possible Link Between H1N1 and Narcolepsy




      Minister of Health and Social Services, Paula Risikko says it is essential to throughly examine suspicions that increased outbreaks of child narcolepsy might be linked to the H1N1 swine flu vaccine.

      However, the Minister said the swine flu vaccination programme would continue. In her view, Risikko thought it wise to examine any connection between narcolepsy and swine flu vaccine in other European countries.

      The National Institute for Health and Welfare (THL) is to determine if vaccine for the H1N1 swine flu could be linked to an increase in cases of narcolepsy among children.

      The condition causes excessive daytime sleepiness even after adequate nocturnal sleep.

      Although the THL?s Vaccine Department Director Terhi Kilpi does not fear any connection between the H1N1 jab and narcolepsy, she says doubts must be examined.

      Experts on both vaccines and narcolepsy met on Wednesday to discuss the issue.

      Doubts arose when a Finnish child neurologist noticed an increased level in the number of narcolepsy cases this year. Similar observations have been noticed in Sweden, reports the tabloid Iltalehti.

      Medical officials in Sweden are also examining a possible link between the Pandemrix vaccine and narcolepsy, according to the newspaper Svenska Dagbladet. The Swedish news agency TT reports six cases with a possible link to the vaccine.

      A patient suffering from narcolepsy may suddenly fall asleep, for example, while, speaking or eating without prior warning. Their muscles may also suddenly weaken, causing them to suddenly collapse. There is no known cure for the disease.

      Several Times Normal Rate of Cases

      About a dozen Finnish children fell ill with narcolepsy during or after last winter's swine flu epidemic, far more than the average rate. The THL is trying to determine whether the cases may have been related to the H1N1 vaccine or to the flu itself.

      The cases were diagnosed during the spring and early summer. Dr Markku Partinen, a docent in neurology at the University of Helsinki and former president of the World Association of Sleep Medicine, notes that the cases appear to have a chronological link to the H1N1 epidemic.

      Doctors began to wonder when an unusually large number of cases of narcolepsy began to appear last spring.

      ?When it became clear that the symptoms began to appear in December, January and February, we began to consider a link to the swine flu epidemic,? says Partinen.

      So far about 12-14 cases have been detected, all with symptoms that began between December and February, says Partinen. The patients are aged 5 to 15.

      On average about three cases of the illness are diagnosed in Finland annually.


      Minister of Health and Social Services Paula Risikko says it is essential to thoroughly examine suspicions that increased outbreaks of child narcolepsy might be linked to the H1N1 swine flu vaccine.

      Comment


      • #4
        Re: Suspected link Between H1N1 Vaccine and Narcolepsy

        Vaccine Expert: Doctors Withheld Narcolepsy Symptoms

        Kari Lankinen, head physician of the Finnish Medicines Agency says that doctors have failed to report suspicions of side effects of the H1N1 swine flu vaccine. Lankinen is also a member of a national group of vaccine experts.

        In an interview with the Savo local service of YLE, Lankinen said that doctors seem to have deliberately refrained from informing authorities about their suspicions of side effects of the swine flu vaccine Pandemrix, even though there were several cases of suspected side effects.

        Lankinen suspects that the reason for the silence was the doctors? concern about their own professional goals ? such as getting their articles published in international medical journals. The doctors who made the observations in recent months now work with the National Institute for Health and Welfare (THL).

        Deliberate Deception Denied

        Paediatrician Turkka Kirjavainen of the Children?s Hospital of the Helsinki and Uusimaa Health Care District (HUS), who also works with THL, admits that the first symptoms of narcolepsy among children were investigated at the beginning of the year, but insists that there were no suspicions of any connections between the narcolepsy and the H1N1 vaccine. He sharply denies any deliberate deception.

        Doctors are not legally required to report suspected side-effects of vaccines. Nine suspected cases of narcolepsy have been reported by HUS so far.

        Kari Lankinen, head physician of the Finnish Medicines Agency says that doctors have failed to report suspicions of side effects of the H1N1 swine flu vaccine. Lankinen is also a member of a national group of vaccine experts.

        Comment


        • #5
          Re: Suspected link Between H1N1 Vaccine and Narcolepsy

          Turku, Pori, and Rauma Examine Future of Swine Flu Vacinations

          Several local authorities have stopped vaccinating children and young people for the H1N1 or Swine flu virus, after suspicions were raised that the vaccines might be linked with a surge in narcolepsy among children and young people.

          The city of Turku is not offering the vaccines actively, but the shots are available for those who ask for it. Pori and Rauma have also suspended vaccinating children.

          The municipalities are waiting for further instructions from the National Institute for Health and Welfare on the matter.

          Several local authorities have stopped vaccinating children and young people for the H1N1 or Swine flu virus, after suspicions were raised that the vaccines might be linked with a surge in narcolepsy among children and young people.

          Comment


          • #6
            Re: Suspected link Between H1N1 Vaccine and Narcolepsy

            Authorities used by the expert, the swine flu vaccination is stopped until the vaccine, the potential link narcolepsy has been resolved.
            - My opinion is that when there is a clear temporal link, the vaccine should not be used until we have a more detailed study, "says associate professor of neurology, unitutkija Markku Partinen sleep clinic in Helsinki.
            MTV's Morning in Finland were interviewed Partinen participate in an expert group meeting tomorrow, where the authorities decide on the possible suspension of the vaccination campaign.
            Narkolepsiatapausta is known about twenty, of which 14 have varying levels of certainty and some doubts. Partinen the vaccine has been a factor in the disease apparently the last launch.
            - Other factors have been in the background. Yet it is not known how many people have fallen ill swine flu or seasonal influenza, "he says.
            In his view, be investigated narkolepsiatapauksissa it comes to children and young people who are not so good immune protection than adults. All the symptoms have started last December and February during the period. According Partinen ill also connects to the same tissue type, which is less than one fifth part of the children.
            Partinen according to the child's activities should start paying attention, if this is beginning to sleep habits unlike more naps.

            Suomen suosituimmat viihdeohjelmat ja kuumimmat puheenaiheet. Parasta aikaa MTV Katsomossa!

            Comment


            • #7
              Re: Suspected link Between H1N1 Vaccine and Narcolepsy

              An expert at the Institute for Health and Welfare decides today whether vaccination against swine flu can continue or not.

              The group has been sorted out if there is a connection between Pandemrix vaccine and the increased number of cases of sleeping sickness narcolepsy in children.

              The investigations can take years, Professor Heikki Peltola of Helsinki and Uusimaa Hospital District says that it can be for years to investigate such a link. He does not address the issue of vaccination should be continued.

              - Surprising facts have been thrown up and now the most important thing now is to not jump to conclusions, "said Peltola, who is consultant in infectious diseases at HNS. The question being investigated and it requires both time and money, "he says.

              He refers to a case ten years ago in England where you suspect that a vaccine against measles, mumps and rubella were linked to autism. The relationship was examined in several years.

              Suspicions were raised last week during the past week, health authorities in Finland and Sweden highlighted the suspicions that svininfluenssavaccinet Pandemrix manufactured by Glaxo Smith Kline may have caused insomningssjukan narcolepsy in children. In Finland it has been found at least fourteen years of narcolepsy cases. Normally there are about three cases per year.

              Since last autumn, nearly 2.5 million Finns and Swedes around six million vaccinated against swine flu. In Denmark the figure is 435 000, said one of Glaxo SmithKline.

              In debating the authorities in Finland as to whether vaccination should continue. Institute for Health and Welfare has asked doctors to report suspicions, and gathers information from other countries.

              Heikki Peltola do not think that the relationship exists only locally. If it still can be a declaration that the tissue type in the Nordic countries is different than it is in England, for example, "he says.

              Inflated the threat of pandemic Peltola believes that the threat of swine flu last year was blown up in Finland and other countries and even within the World Health Organization. He is reluctant to see that it is now black paint vaccine in general.

              Petteri Knudsen, Medical Director at Glaxo Smith Kline says that the company has delivered 150 million doses of vaccine globally. He says that some 90 million individuals have been vaccinated with the company's preparations but to a temporal correlation between the swine flu vaccine and narcolepsy cases have been reported only in Finland and Sweden.

              Comment


              • #8
                Re: Suspected link Between H1N1 Vaccine and Narcolepsy

                THL Recommends Suspension of H1N1 Vaccinations



                Finland's National Institute for Health and Welfare (THL) has recommended that vaccination against the H1N1 swine flu virus with the Pandemrix vaccine be suspended. The vaccine is not to be used until it is determined if it is linked to an increase in the number of cases of narcolepsy in the country.

                THL says that the recommendation is a precautionary measure. At the moment there is no swine flu epidemic in the country that would require urgent vaccination against the virus.

                According to the National Institute for Health and Welfare, the increase in the number of cases of narcolepsy may have been caused by the flu virus, by the vaccine, by the interaction of an infection with the vaccine, or some other factor. It is known that infections can cause narcolepsy.

                THL has been notified of 15 cases of narcolepsy, six of which are more clearly associated with the vaccination than are the remainder. Preliminary research into the connection between the vaccine and the cases is expected to take several months.

                Worldwide, at least 90 million people have received the Pandemrix vaccine.

                Finland's National Institute for Health and Welfare (THL) has recommended that vaccination against the H1N1 swine flu virus with the Pandemrix vaccine be suspended. The vaccine is not to be used until it is determined if it is linked to an increase in the number of cases of narcolepsy in the country.

                Comment


                • #9
                  Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection

                  HELSINKI ? Finland's National Institute for Health and Wefare recommended Tuesday halting the use of the Pandemrix swine flu vaccine until a probe into a possible link to narcolepsy among children is concluded.

                  "At the moment we are not having a (swine flu) epidemic, so there is no immediate need for vaccination," the agency said in a statement.

                  "Besides, major parts of the population are protected against the swine flu virus either through vaccination or or after having swine flu," it added.

                  The National Institute for Health and Wefare (THL) has received six reports of children known to have received the vaccine who have developed the chronic sleep disorder since the beginning of the year, it said, stressing however that "this is in line with the normal annual rate of narcolepsy cases."

                  In addition, the agency said it was probing whether nine other cases of narcolepsy that had emerged since the beginning of 2010 could be linked to Pandemrix, which is produced by British pharmaceutical company GlaxoSmithKline.

                  Last week, neighbouring Sweden's Medical Products Agency also opened an inquiry into the Pandemrix vaccine in response to reports of young people having developed symptoms consistent with narcolepsy after getting their shot.

                  But a cause-and-effect relationship between Pandemrix and narcolepsy is far from proven, with Finland's THL pointing out that the swine flu virus H1N1 itself could possibly cause the disease.

                  "Child neurologists and THL will continue to study the connection (with Pandemrix), but this will take several months," the agency said.

                  In the European Union alone, around 30 million people were vaccinated using Pandemrix.

                  Sweden bought 18 million doses, which was enough to provide two injections for each of its 9.3 million inhabitants.

                  According to Finland's National Health Institute, 2.5 million Finns were vaccinated against swine flu. Some 750 showed side effects, namely fevers, headaches and coughing, and one case was linked to narcolepsy.

                  Comment


                  • #10
                    Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection

                    THL Continues to Recommend Season Flu Shots




                    The Director of the National Institute for Health and Welfare (THL), Pekka Puska, says the vaccine providing protection against the seasonal flu should be taken as usual. On Tuesday, the THL temporarily suspended use of the Pandemrix swine flu vaccine due to a possible link between the vaccine and cases of narcolepsy.

                    ?We are not sure what type of virus will cause next winter?s seasonal flu," says Puska. "It?s likely that the swine flu will also circulate globally. Therefore, it is important that people belonging to flu risk groups get the seasonal flu vaccine in the future as well.?

                    Puska recommends that people belonging to risk groups take the seasonal flu vaccine even if they have already had the Pandemrix swine flu vaccine.

                    He adds that suspending the swine flu vaccine is just a precautionary measure in order to preserve the nation?s confidence in disease-preventing measures.

                    No changes have been made in recommendations for the seasonal flu vaccine. This year?s seasonal flu vaccine also offers protection against the swine flu virus.


                    The Director of the National Institute for Health and Welfare (THL), Pekka Puska, says the vaccine providing protection against the seasonal flu should be taken as usual. On Tuesday, the THL temporarily suspended use of the Pandemrix swine flu vaccine due to a possible link between the vaccine and cases of narcolepsy.

                    Comment


                    • #11
                      Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection

                      Neurologist Markku Partinen of Helsinki sleep clinic told YLE that the researchers failed to disclose their suspicions because they would be published in an international scientific journal. - When it comes to scientific journals, it is very important not to talk about results in advance, otherwise it published the not, "he says. The authorities learned of the allegations until the end of June. Then it was the writing of the article on the home straight. Neurologists justify its decision that it is more effective to influence by the scientific community than by authorities. Partinen believe that the links to narkolepsin had tossed to and fro between the authorities in case results are not published in a scientific tidskrift.Omsorgsminister Paula Risikko now requesting an investigation into the doctors neglected their duty to report any adverse reactions to the vaccine to the authorities.

                      En sajt om samtiden för dig som vill uppleva, delta och påverka – på svenska.

                      Comment


                      • #12
                        Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection

                        Basic Services Minister Paula Risikko is starting an examination of whether some doctors were negligent in their duty to report possible side effects from swine flu vaccine given to patients.

                        Risikko has called Director General Pekka Puska of the National Institute for Health and Welfare (THL) and the Chief of Staff of the Ministry of Social Affairs and Health, Kari V?lim?ki to a meeting on Thursday morning to discuss the issue.

                        Earlier this week, the THL recommended that vaccination against the H1N1 swine flu virus with the Pandemrix vaccine be suspended. The vaccine is not to be used until it is determined if it is linked to an increase in the number of cases of narcolepsy in the country.

                        The Basic Services Minister told YLE on Wednesday evening that she wants a thorough investigation of how doctors have handled the reporting of any possible side effects from the vaccine.

                        "In light of the information that I now have, I want to know if there has been negligence in fulfilling reporting requirements," said Risikko.

                        Health and Social Services Minister Paula Risikko is starting an examination of whether some doctors were negligent in their duty to report possible side effects from swine flu vaccine given to patients.

                        Comment


                        • #13
                          Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection

                          The suspicion that was raised recently that a surge in cases of narcolepsy among children and young people may be linked with the vaccine that was administered last winter against the H1N1, or swine flu virus, has caused many to ask who was behind the decision to acquire the vaccine.
                          The decision was made by Kari V?lim?ki, chief of staff at the Ministry of Social Affairs and Health.

                          This took place already in May last year, when V?lim?ki signed a document for the National Emergency Supply Agency. He did this after hearing the views of both Finnish and foreign experts, after which deliveries of more than five million doses of swine flu vaccine began.
                          The vaccine was ordered from GlaxoSmithKline (GSK), which was the easiest available source at a time when the epidemic was rapidly approaching Finland, and there was a need to start the vaccines as soon as possible.
                          V?lim?ki feels that the decision was the right one. He says that it made it possible to start vaccinating people in risk groups at an early stage, when the first wave of the disease was approaching.

                          The choice of the GSK vaccine was dictated by statements and expertise from the National Institute for Health and Welfare (THL).
                          There have later been claims that THL would have had a conflict of interest, as it had received financing worth EUR 6 million from GSK for its pneumococcus research. Two complaints were filed on the matter to the Chancellor of Justice in late 2009. Both complaints were made by private individuals.

                          The World Health Organisation (WHO) examined the matter and found no evidence that the research funding from the pharmaceutical company would have influenced the choice of vaccines.
                          Chancellor of Justice Jaakko Jonkka says that his office is still handling the matter. Reports have been received from THL and the Ministry of Social Affairs and Health. ?On the basis of the reports that have been received, there are no concrete indications of the claimed bribery?, Jonkka says.
                          He also notes that the complaints, which came last year, did not have anything to do with the recent cases of narcolepsy.

                          On Tuesday, THL recommended that the use of the GSK Pandemrix swine flu vaccine be suspended until all of the possible connections between the vaccine and narcolepsy are cleared up.
                          The investigation is to be conducted by THL, and V?lim?ki insists that its objectivity is reliable in this case as well.
                          If it comes out that the vaccine has led to narcolepsy, the instructions for its use will be re-examined. ?However, there is no doubt that in a similar situation, the same decisions would have been made?, V?lim?ki says.

                          Comment


                          • #14
                            Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection

                            France: cases of narcolepsie noticed at vaccinated persons

                            Six cases of narcolepsie cataplexie, a neurological disease, were signalled at Frenchman's vaccinated against influenza A (H1N1) since last August 23rd, according to figures announced by the French Agency of health security of the products of health (Afssaps) on Thursday, August 26th. If Afssaps points out that a ' link between vaccination against influenza A and happening of narcolepsie was not established at this stadium ', these new data make the object of a valuation however nowadays by the European Agency of medicament (EMA) .L' Rank Swedish of the medical products opens an inquiry, on August 18th of this year, on possible undesirable effects caused by Pandemrix, one of the vaccines used against influenza A (H1N1). This decision follows the delivery of reports by professionals of health on symptoms compatible with the narcolepsie signalled on teenagers from 12 to 16 years old, one-two months afterwards their vaccination counters influenza A. Further to this announcement, six cases of narcolepsie were noticed in Finland, four new cases in Sweden and six cases in France, other used vaccine of which one happened after the administration of Panenza, counters influenza A (H1N1).

                            The narcolepsie is a neurological disease being translated by a daytime drowsiness and a muscular weakness.
                            More than 30 million patients accepted vaccine Pandemrix in the European Union. In France, vaccine developed by the laboratory GlaxoSmithKline was profitable to more than 4 million persons, according to the French Agency of health security of the products of health.

                            Six cas de narcolepsie cataplexie, une affection neurologique, ont été signalés chez des Français vaccinés contre la grippe A (H1N1) depuis le 23 août dernier, selon des chiffres communiqués par l'Agence française de...

                            Comment


                            • #15
                              Re: Finland - National Health Dept. Suspends A/H1N1 Vaccine Due to Possible Narcolepsy Connection

                              ? Six persons (three adults and three children) who were vaccinated against influenza IN / H1N1 developed a sleeping sickness called narcolepsie / cataplexie since August 23rd ?, has just announced the Agency of health security of the products of health. Health authorities suspect a link with vaccine, even if, officially, proof is not brought.
                              France is not the only one to have doubts about this treatment. On August 18th of this year, the Sweden informed the European Agency of the medicament of the happening of six cases of narcolepsie-cataplexie at children from 12 to 16 years old, one-two months after their vaccination by vaccine Pandemrix (laboratory GSK). Other cases were signalled in Finland. In France, one of the cases happened after the injection of vaccine Panenza (laboratory Sanofi-Pasteur). In all, 22 cases were signalled in Europe.

                              The narcolepsie with cataplexie is a rare illness characterized by an extreme drowsiness in the daytime, linked to losses of muscular energy triggered off by a strong emotion. These data of pharmaco-alertness (which take a census of side effects produced after vaccination) are the object of a valuation at European level. More than 30 million persons were vaccinated in Europe against influenza HAS / H1N1, among whom 5 millions in France.

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