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

[tetano]

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

Suddenly tired


It was a Sunday evening in January 2010, as a Christian Schneider * collapsed and fell down the stairs. For weeks now the 17-year-old was noticeably tired and depressed. Maybe it was the weekend where they often went out with friends? But it got worse. Every day she went up to twenty times in the knee. The budding Abiturientin, who lives near Koblenz, changed: She fell asleep in school and grew. The doctors were baffled.


Early on Christin's mother harbored a suspicion: Could a vaccine that attacks have caused crash? Two months earlier, in autumn 2009, was her daughter against the epidemic of swine flu were vaccinated with Pandemrix. The vaccine was highly controversial, because it put the additive AS03, which increased its full effect. Critics such as the Flensburg SPD politician Wolfgang Wodarg described the vaccine as a reason "" risky. In Germany, the distrust of Pandemrix was so great that only eight percent of the vaccinated population left. Now, two years after the operation, experts consider it possible that the skeptics with their warning to keep at least half right.
Two weeks ago recommended the European Medicines Agency EMA, children and adolescents under 20 years only to administer the drug Pandemrix in exceptional cases. Your reminder is the conclusion of a months-long debate among virologists, epidemiologists, neurologists and sleep researchers.

..


http://www.zeit.de/2011/33/M-Narkolepsie

 

[tetano]

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

Stanford study draws connection between narcolepsy and influenza


STANFORD, Calif. ? The onset of narcolepsy appears to follow seasonal patterns of H1N1 and other upper airway infections, according to a new study of patients in China that was led by Stanford University School of Medicine narcolepsy expert Emmanuel Mignot, MD.

The findings, which will be published online Aug. 22 in Annals of Neurology, a journal of the American Neurological Association and Child Neurology Society, show that a peak in narcolepsy cases occurred five to seven months after a peak in flu/cold or H1N1 infections in the country.

"Together with recent findings, these results strongly suggest that winter airway infections such as influenza A (including H1N1), and/or Streptococcus pyogenes are triggers for narcolepsy," Mignot, a professor of psychiatry and behavioral sciences, and his colleagues wrote in the paper.

The study follows recent reports that a particular H1N1 vaccine, not one used in the United States or China, seemed to lead to narcolepsy. This new paper, however, found no correlation between vaccination and narcolepsy among the patients studied in China. "The new finding of an association with infection, and not vaccination, is important as it suggests that limiting vaccination because of a fear of narcolepsy could actually increase overall risk," the authors wrote.

Approximately 3 million people worldwide suffer from narcolepsy, a neurological disease that is characterized by daytime drowsiness, irregular sleep at night and cataplexy ? a sudden loss of muscle tone and strength. In 2009 Mignot and colleagues confirmed scientists' long-held suspicion that narcolepsy is an autoimmune disease, caused when patients' immune systems kill the neurons that produce the protein hypocretin.

Experts believe that a person has a genetic predisposition to the disease, and some environmental factor kicks his or her immune system into action leading to narcolepsy. As noted in the paper, past studies have shown that Streptococcus pyogenes infections, such as strep throat, have preceded the onset of narcolepsy in Caucasians, suggesting a role for upper airway infections in triggering the disease, Mignot said.

Last year, several European countries reported new cases of narcolepsy in children who had been vaccinated for the H1N1 strain of influenza; children who received the Pandemrix H1N1 vaccine in Finland, for example, faced a ninefold increased risk of narcolepsy. The World Health Organization led an investigation and determined that something about this particular vaccine acted in a "joint effort" with "some other, still unknown factor" to increase risk in those already genetically predisposed. (Pandemrix contains two adjuvants to invoke a stronger immune response; these additives are not included in the H1N1 vaccines used in the United States and China.)

For the new study, the researchers looked at the data of 906 patients who were diagnosed with narcolepsy in Beijing between September 1998 and February 2011, and determined the patients' month of onset of cataplexy and sleepiness. They conducted brief phone interviews with 154 patients whose narcolepsy appeared after October 2009, the date of the first H1N1 vaccination administered in China. The researchers also queried the patients about their history of seasonal flu, H1N1 vaccinations and other diseases.

Mignot's group found that the occurrence of narcolepsy onset was seasonal and significantly influenced by month. Onset was least frequent in November and most frequent in April; there was a five- to seven-month delay between the seasonal peak in flu/cold or H1N1 infections and the peak in narcolepsy onset occurrences.

The paper doesn't show cause and effect, but it does show a strong correlation between narcolepsy onset and this seasonal pattern.

The team also found a threefold increase in disease onset following the 2009-10 H1N1 winter flu pandemic compared with other years.

Only a small amount ? 5.6 percent ? of the patients interviewed recalled receiving an H1N1 vaccine. The onset, the researchers concluded, is unlikely to be explained by vaccinations. Instead, as they wrote in the paper, these winter infections appear to "initiate or reactivate an immune response that leads to hypocretin cell loss and narcolepsy in genetically susceptible individuals."

Mignot said the work is exciting because it provides insight on how the disease is triggered. "We're much closer to understanding what's happening in the autoimmune destruction of hypocretin cells," he explained.

From a public-health standpoint, Mignot said the work suggests that getting vaccinated and avoiding influenza may provide a protective benefit to patients. He said, "It's very possible that being vaccinated with a mild vaccine, one without the adjuvants in question, blocks you from getting a big infection that could increase your risk of narcolepsy."

As for the differences between the findings of the study and what has been observed in Europe, Mignot said it's possible that the strong immune response prompted by the Pandemrix vaccine increases the risk of narcolepsy. He emphasized, however, that more study is needed and that people shouldn't avoid getting vaccinated.

"Even with Pandemrix, it's still a very small risk ? and there's a bigger risk from dying of an infection if you don't get vaccinated," he said.

http://www.eurekalert.org/pub_releases/2011-08/sumc-ssd081811.php

 

[tetano]

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

for the original article see:

http://www.flutrackers.com/forum/showthread.php?p=419088&posted=1#post419088

 

[tetano]

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

Association between Pandemrix and narcolepsy confirmed among Finnish children and adolescents

An association between Pandemrix and narcolepsy among children and adolescents in Finland is confirmed

In its final report, the National Narcolepsy Task Force confirms the tentative conclusion published in its Interim Report last January that the Pandemrix vaccine used in the winter of 2009–2010 contributed to the increased incidence of narcolepsy observed among 4–19-year-olds in Finland. According to the report, the increased risk associated with vaccination amounted to six cases of narcolepsy per 100 000 persons vaccinated in the 4–19 age group during the eight months following vaccination. This was 12.7 times the risk of a person in the same age group who had not been vaccinated. No increased incidence of narcolepsy was observed among children under the age of four or among adults over the age of 19.

In all the cases examined, narcolepsy associated with Pandemrix vaccination has been identified in persons who carry a genetic risk factor for narcolepsy. Because of this very strong association with the genetic risk factor which regulates immune responses, narcolepsy is considered an immune-mediated disease.

In approximately one quarter of those who developed narcolepsy following Pandemrix vaccination, the THL Immunology laboratory found antibodies binding to the AS03 adjuvant component of the vaccine. Adjuvants containing squalene have not previously been reported to induce the production of antibodies. The significance of this preliminary observation will be the subject of further research.

Tests on viral antibodies indicated that less than 10 per cent of the children and adolescents who developed narcolepsy had been infected with swine flu. Swine flu infection thus does not appear to play a significant role or be in joint effect with the Pandemrix vaccine in the onset of narcolepsy.
Only Finland and Sweden have confirmed increased incidence of narcolepsy

In addition to Finland, Sweden is so far the only other country which by using epidemiological research has confirmed an increase in narcolepsy cases associated with pandemic vaccination. In Sweden, too, the increased risk of narcolepsy has been observed specifically in children and adolescents. The added risk associated with vaccination was about three cases of narcolepsy in every 100 000 persons vaccinated. Norway and France also report more than the number of expected cases of narcolepsy among children and adolescents who received the Pandemrix vaccine. However, in the absence of data on people who were not vaccinated, a reliable assessment on the possible link with the vaccine cannot be made in these countries. Several studies on the association between pandemic vaccine and narcolepsy are underway in countries where considerable numbers of Pandemrix or Arepanrix, a pandemic vaccine with a similar composition, were used.

By 25 August 2011, the National Vaccine Adverse Event Register maintained by THL had received notifications of 98 cases of narcolepsy subsequent to vaccination with Pandemrix; 79 of the subjects were between 4–19 years old at the time of vaccination. Narcolepsy was associated with cataplexy in 78 of the cases. Most of the persons affected developed symptoms within a couple of months after receiving the vaccination.
Information provided by the Task Force also important for the European Medicines Agency evaluation

The evidence produced by the Task Force concerning the association between narcolepsy and Pandemrix vaccination observed in Finland played a crucial role in the European Medicines Agency’s assessment of the observation, which led to a recommendation for limiting the use of Pandemrix vaccine. The European Medicines Agency considered the epidemiological studies carried out in Finland and Sweden to be well planned, and considered that the results indicated an association between Pandemrix vaccine and the cases of narcolepsy affecting children and young people in those countries. The European Medicines Agency recommends that the use of Pandemrix among those below 20 years of age should be limited to situations where seasonal influenza vaccine is not available and if the person requires protection from the swine flu virus because of being at risk of developing a severe form of the disease or its complications.
Pandemrix vaccine reduced the number of deaths from swine flu and the need for intensive care

The Pandemrix vaccine was used in the winter of 2009–2010 to prevent the swine flu epidemic. About half of the Finnish population chose to be vaccinated. In autumn 2009 at the peak of the epidemic, the daily number of people (mainly under the age of 65) in hospital care was 400, with more than 50 patients in intensive care. There were 44 deaths from swine flu confirmed by laboratory tests. A significant number of severe cases were prevented during the 2009–2010 season, even if vaccines were given at about the same time as the epidemic reached Finland. Vaccinations of the groups most at risk from swine flu were completed by the local authorities before the first wave of the epidemic struck.

During the influenza season 2010–2011, 52 persons were treated in intensive care, and 13 succumbed. Most of these were unvaccinated. Combining the data on morbidity and mortality with data on vaccinations in the 2009–2010 pandemic season indicate that a swine flu vaccination taken in the pandemic season had provided 75–88 per cent protection against the swine flu virus in winter 2010–2011. Based on these vaccine effectiveness figures, it has been estimated that during the first wave in 2009-2010, the swine flu vaccine prevented approximately 40 000 cases of swine flu, and during the second wave in 2010-2011, another 40 000 cases of swine flu.

The Task Force concurs with the European Medicines Agency’s estimate that, despite the unforeseen and deeply regrettable cases of narcolepsy, the overall benefit-risk balance remains positive.

Further research is needed to fully understand the association between narcolepsy and Pandemrix, in order to avoid similar adverse events in future. Different research teams in Finland and other countries continue with research on the immunogenetics, pathogenesis, and the development of the clinical course of narcolepsy.

In 2010, a sudden increase was observed in Finland in the incidence of narcolepsy among children and adolescents who had received pandemic vaccine. In September 2010, the Director General of THL appointed a National Narcolepsy Task Force to investigate the potential association between the pandemic vaccination and narcolepsy. At the same time, THL initiated immunogenetic and virological studies in order to gain a deeper understanding of the observation. In its Interim Report, published on 31 January 2011, the Task Force concluded that the risk of narcolepsy among those vaccinated with Pandemrix in the age group 4–19 years was several times that of unvaccinated children in the same age group.

http://www.thl.fi/en_US/web/en/pressrelease?id=26352

 

[tetano]

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

Western Sweden worse hit by narcolepsy: study

The risk of developing the sleeping disorder narcolepsy after receiving the swine flu vaccine Pandemrix is 20 times as high for kids living in counties Halland and V?stra G?taland, in western Sweden, according to a ongoing study.



?We still don't know what the reasons behind this are, but there could be several explanations, ? said neurologist Tove Hallb??k, one of the scientists behind the study, to local paper G?reborgsposten (GP).

For the whole of Sweden, children who were inoculated with the swine flu vaccine Pandemrix are seven times as likely to develop narcolepsy than those who didn't get the shot.

One theory into why western Sweden seems to be hit worse is that there simply are more cases discovered in the region than other places in Sweden.

Scientists are hopeful that the gathered research on the cases in the area will help come up with an explanation.

?It is a terrible disease and many of the children are feeling very bad,? Hallb??k told GP.

Many of those that have contracted the disease have had to wait a long while to receive a diagnosis as doctors still know relatively little about the condition.

So far 100 children have reported adverse effects of the drug to claim recompense from the pharmaceutical insurance (L?kemedelsf?rs?kringen), which has announced a ceiling of 150 million kronor ($22.6 million) for payouts.

How much each individual sufferer will receive is so far not settled.

?We have sought legal representation to support our cause in this process and to help us understand the legal battles that might follow,? said Tomas Norbert, chairman of the Swedish Narcolepsy association, to GP.

http://www.thelocal.se/36174/20110916/

 

[tetano]

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

 

[tetano]

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/af...ocId=CNG.4b56b632b2812693ed69ed1191fc79dc.261

 

[Tonka]

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

http://primeiraedicao.com.br/notici...is-de-19-horas-por-dia-depois-de-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.

 

[tetano]

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/Ne...epsy+from+swine+flu+vaccination/1135270179558

 

[tetano]

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/InfectiousDisease/URItheFlu/31904

 

[tetano]

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 (L?kemedelsverket) previous claim that no such connection exists.


?We will have to think again,? said Maria Szirmai of the Swedish Medical Products Agency to newspaper G?teborgsposten (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 L?kemedelsf?rs?kringen.

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 (Narkolepsif?reningen).

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

..


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

 

[tetano]

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...t=32e43ee8-e230-4424-a783-85742124029a&ID=731

 

[tetano]

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/publications/Publications/Vaesco in brief final.pdf

 

[tetano]

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....news_detail_001636.jsp&mid=WC0b01ac058004d5c1

 

[tetano]

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, Svanstr?m H, M?lgaard-Nielsen D, Heijbel H, Dahlstr?m 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

 

[tetano]

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/insight-evidence-grows-for-narcolepsy-link-to-gsk-swine-flu-shot

 

[tetano]

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 Svanstr?me,
Ditte M?lgaard-Nielsene,
Harald Heijbelf,
Lisen Arnheim Dahlstr?mg,
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

 

[tetano]

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/2013/01/31/us-flu-gsk-narcolepsy-britain-idUSBRE90U0JW20130131

 

[tetano]

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-vaccine-ingredient-scrutinized-narcolepsy-clues-093926909.html

 

[tetano]

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