WHO reviews GSK H1N1 flu shot after narcolepsy link

[Celebration]

http://af.reuters.com/article/worldNews/idAFTRE71033Y20110201

The World Health Organisation is reviewing the safety of GlaxoSmithKline's Pandemrix H1N1 flu vaccine after a Finnish study suggested children who got the shot were nine times more likely to suffer from narcolepsy, a rare sleeping disorder.

Narcolepsy causes a person to fall asleep suddenly and unexpectedly. Its precise cause is unknown but it is generally considered to be triggered by a combination of genetic and environmental factors.

Researchers at Finland's National Institute for Health and Welfare (NIHW) said on Tuesday their research suggested it was "most likely" the increase they found in narcolepsy was a joint effect of Pandemrix and some other factor or factors.

The research, described as preliminary, was conducted by the Finnish national narcolepsy committee and published by the NIHW. It found an increase in cases of narcolepsy among children aged four to 19 years who had the vaccine.

[pnwmom]

1. The "issue of narcolepsy had not been linked with any other H1N1 pandemic flu vaccines"

Assuming the research bears this out, I wonder what is different about Glaxo's version.

[HuckleB]

2. Here is a fair review of this issue, IMO: Follow up on Pandemrix and Narcolepsy

http://theness.com/neurologicablog/?p=2794

[HuckleB]

3. WHO Statement on narcolepsy and vaccination

http://www.who.int/vaccine_safety/topics/influenza/pandemic/h1n1_safety_assessing/narcolepsy_february2011/en/index.html

More on the WHO review:

The Flu Vaccine and Narcolepsy
http://www.sciencebasedmedicine.org/?p=10720#more-10720

[mhatrw]

4. Could unknown risk factor X possibly be genetics? Ya think? (redux)

http://voices.washingtonpost.com/checkup/2011/02/why_flu_vaccine_may_cause_narc.html

Scientists think they have found a clue to why there may be an increased risk for the sleeping disorder narcolepsy among some people who got the H1N1 flu vaccine: The cases appear to have occurred among those carrying a gene that increases the risk for the rare disorder, which causes people to suddenly fall asleep, according to the World Health Organization.

Cases of narcolepsy have been reported among children and adolescents who received the vaccine during the swine flu epidemic in 2009 in 12 countries, with Sweden and Finland reporting the most cases. A total of 60 cases were reported in Finland.

On Feb. 1, Finland's National Institute of Health and Welfare reported the results of an analysis of all new narcolepsy cases reported between 2006 and 2010 among those born after 1990. The analysis found an increased risk of narcolepsy among those ages 4 to 19 who received the Pandemerix H1N1 vaccine made by GlaxoSmithKline. The risk was about nine times higher among those who got the vaccine, corresponding to a risk of about one case out of every 12,000 people in that age group vaccinated, officials estimated. Those ages 5 to 15 appeared to have the greatest risk.

Of 22 of the cases in Finland tested so far, all were carrying a gene known to increase the risk for the condition, the WHO announced Tuesday. ...

http://www.theglobeandmail.com/life/health/andre-picard/who-looking-at-reported-link-between-h1n1-vaccine-and-narcolepsy/article1899303/

The WHO said there have been reports of post-vaccination narcolepsy in at least 12 of the 47 countries where the Pandemrix vaccine (a product of GlaxoSmithKline PLC) was used, but the problem was most acute in Nordic countries such as Finland, Sweden and Iceland. ...

The Finnish report concluded that there was a clear association between vaccination and onset of the sleep disorder, but also stressed that there seems to be a strong genetic factor at play. ... Researchers noted that all the children who developed narcolepsy carried a genetic marker for the disease. Not everyone with the human leukocyte antigen DQB1*0602 genotype develops narcolepsy, but their risk is much higher. ...

The adjuvant used in Arepanrix was called AS03. It consisted of squalene (shark liver oil), DL-alpha-tocopherol (vitamin E) and polysorbate 80 (an emulsifier also used in ice cream). The European version of the vaccine, Pandemrix, contained the same adjuvant.

http://www.businessweek.com/ap/financialnews/D9L8L9700.htm

Genetic factors may have contributed to a spike in narcolepsy cases observed among children in Finland who received the swine flu vaccine Pandemrix, the World Health Organization said Tuesday. A WHO expert panel says of 22 narcolepsy patients tested, all had a gene commonly associated with narcolepsy, a disorder that causes people to suddenly fall asleep but is rarely fatal. About 30 percent of people in Finland have that particular gene, compared with 15 percent in the rest of Europe, said Patrick Zuber, WHO's top vaccine safety official.

Last week, Finnish authorities said they had found a nine-fold increased risk of narcolepsy among 4- to 19-year-olds who were given the swine flu shots. In total, 60 children and adolescents contracted narcolepsy in Finland in 2009 and 2010. Fifty-two of them -- or almost 90 percent -- had received the Pandemrix vaccine. Lesser increases were also observed in Sweden and Iceland, WHO said.

WHO's Global Advisory Committee on Vaccine Safety said in a statement Tuesday that it agreed with Finnish authorities that there was a "strong association" between the vaccination, the genetic makeup of the patients, and the narcolepsy cases. ...

To date, at least 12 countries have informed Pandemrix's British manufacturer GlaxoSmithKline PLC of narcolepsy cases following vaccination.