by Ian Sample

science correspondent
28 March 2012

from Guardian Website

British health officials are investigating whether a steep rise in narcolepsy

in other countries is linked to a specific flu vaccination

Photograph: Alamy
 

British health officials are investigating cases of narcolepsy in children amid concerns that pandemic flu vaccinations lie behind a rise in the sleep disorder seen in other countries.

The Health Protection Agency is gathering vaccination histories and medical data on children aged four to 18 who have been assessed for narcolepsy at sleep centers in England in the past few years.

The investigation centers on the GlaxoSmithKline (GSK) vaccine Pandemrix, which was given extensively in 2009/10 during the H1N1 "swine flu" pandemic that spread around the world.

The vaccine was used very little in 2010/11 and was unavailable during the 2011/12 influenza season. Pandemrix is only used to combat pandemics and differs from the more familiar seasonal flu vaccine.

The HPA said:

"There is no evidence of any association between seasonal influenza vaccines and narcolepsy."

Clinical details including dates of first symptoms and diagnoses are being obtained from clinics and GP records checked for dates of any pandemic vaccination given to the children.

The information will help the HPA identify how many children and teenagers with narcolepsy received the pandemic vaccine and spot any clustering of the disorder shortly after vaccination. The findings from the HPA study are due to be published later this year, the agency said.

The latest evidence for a link between Pandemrix and narcolepsy appears in two studies from Finland published in the journal Plos One.

The authors of the papers, Markku Partinen of the Helsinki Sleep Clinic and Hanna Nohynek of the National Institute for Health and Welfare in Finland, found narcolepsy in children under 17 averaged from 0.31 cases per 100,000 between 2002 and 2009, but rose 17-fold to 5.3 cases per 100,000 in 2010, when Pandemrix was used.

Further work revealed that in children born between January 1991 and December 2005 narcolepsy rates for those who had Pandemrix jabs were nine per 100,000, compared with 0.7 per 100,000 for unvaccinated children - almost 13 times lower.

"We can't exclude the possibility that there are simultaneous environmental factors at work here, but we can say Pandemrix was one of the factors involved," Partinen said.

He added that the overall risk from Pandemrix was low, with less than one in 10,000 people vaccinated developing narcolepsy.

Professor David Salisbury, director of immunization at the Department of Health, said the government was aware of the Finnish data and that further UK research was underway into the risk associated with Pandemrix.

"This follows a European-wide review last year, which reached the conclusion that Pandemrix may only be used in people under 20 if the annual seasonal vaccine is not available and there is a particular need to immunize against H1N1," he said.

GSK said:

"GSK fully maintains its responsibility and commitment to the highest standards of patient safety.

"It remains the case that a causal link with Pandemrix cannot be confirmed and that other unknown factors may have contributed.

"These questions need to be further clarified before definitive conclusions on an association of Pandemrix and narcolepsy can be drawn.

"GSK will continue to work closely with the European Medicines Agency and other national regulatory organizations in the best interest of patients."

Could Swine Flu Vaccine Cause Narcolepsy?

Scientists Probe Link Between Drug and Increase in Cases
by Daily Mail Reporter
28 March 2012

from DailyMail Website

Swine flu vaccine may have been responsible for a sudden increase in cases of narcolepsy among schoolchildren in Finland, a study has found.

The sleep disorder is characterized by periods of extreme drowsiness, sudden naps, and paralysis attacks. Scientists spotted a sudden increase in narcolepsy rates among Finnish children early in 2010.

Side effect: Scientists in Finland believe a sudden rise

in narcolepsy rates among children may be due to the swine flu vaccine
 

Research showed it was associated with the Pandemrix vaccine, given to children to protect them against H1N1 swine flu.

One study found that the incidence rate of narcolepsy among children and teenagers under the age of 17 shot up 17-fold after the vaccinations. In contrast, the incidence rate for adults over 20 was unchanged.

The study compared narcolepsy rates between 2002 and 2009, and 2010.

During the first period, the rate for children was 0.31 per 100,000 individuals. After swine flu vaccination, it rose to 5.3 per 100,000.

A further study involving the same researchers, led by Dr Markku Partinen from the Helsinki Sleep Clinic, collected narcolepsy and vaccination data for children born between January 1991 and December 2005.

It found that narcolepsy incidence for vaccinated individuals was 13 times higher than for those who were unvaccinated.

Research:

The study found that narcolepsy incidence for individuals

vaccinated with Pandemrix was 13 times higher

than for those who were unvaccinated
 

Both studies appear in the online journal Public Library of Science ONE.

The researchers concluded:

'We consider it likely that Pandemrix vaccination contributed, perhaps together with other environmental factors, to this increase in genetically susceptible children.'

The scientists suspect the vaccine may have contributed to an auto-immune effect linked to narcolepsy.









 

Swine Flu Vaccine 'Linked to' Sleeping Disorder
by Rebecca Smith

Medical Editor
29 March 2012

from Telegraph Website
 

The pandemic swine flu vaccine has been linked to narcolepsy

after a study found children who had been vaccinated

with 13 times more likely to suffer from the condition.
Photo: Lewis Whyld/PA
 

A study in Finland has found that children vaccinated against the H1N1 swine flu virus with Pandemrix were more likely to develop the sleep disorder narcolepsy.

The condition causes excessive daytime sleepiness and sufferers can fall asleep suddenly and unintentionally.

The researchers found that between 2002 and 2009, before the swine flu pandemic struck, the rate of narcolepsy in children under the age of 17 was 0.31 per 100,000.

In 2010 this was about 17 times higher at 5.3 per 100,000 while the narcolepsy rate remained the same in adults.

Markku Partinen of the Helsinki Sleep Clinic and Hanna Nohynek of the National Institute for Health and Welfare in Finland, also collected vaccination and childhood narcolepsy data for children born between January 1991 and December 2005.

They found that in those who were vaccinated the rate of narcolepsy was nine per 100,000 compared to 0.7 per 100,000 unvaccinated children, or 13 times lower.

The findings were published in the journal Public Library of Sciences One.

Pandemrix was the main vaccine used in Britain against the swine flu epidemic in which six million people were vaccinated.

It was formulated specifically for the swine flu pandemic virus and is no longer in use.

The World Health Organization has conducted an investigation after the link was first suggested in Finland and Sweden two years ago and found no other countries experienced a increase in narcolepsy rates during or after the pandemic.

A spokesman for the UK regulator, the Medicines and Healthcare products Regulatory Agency, said:

"The MHRA is aware of the study from Finland concerning Pandemrix vaccine and narcolepsy.

 

"The data from Finland, as well as from Sweden, were considered as part of an in-depth European safety review of Pandemrix in 2011.

"The outcome of this review was that Pandemrix may only be used in persons aged under 20 years if the annual seasonal vaccine was not available and if there was a particular need to immunize against H1N1. No restrictions on use in adults were imposed, and the EU review acknowledged the important role that Pandemrix played in reducing the consequences of H1N1 in Europe during the pandemic.

"Further work is ongoing to establish if a similar risk is evident in other countries where the vaccine was used. This includes a UK study led by the Health Protection Agency. The MHRA will review any new data as it becomes available."

Professor Sir David Salisbury, director of immunization at the Department of Health, said:

“The Department of Health is aware of the Finnish data, and keeps all new evidence under review.

"Through the MHRA and HPA, further UK research is going on into the risks associated with Pandemrix.

"This follows a European-wide review last year, which reached the conclusion that Pandemrix may only be used in people under 20 if the annual seasonal vaccine is not available and there is a particular need to immunize against H1N1.”