WHO Confirms H1N1 Vaccine Concerns

[Windsor]

WHO confirms H1N1 vaccine concerns
2011-02-08 16:27
Share EmailPrint
Related Links

* Swine flu vaccine causes narcolepsy - study

kalahari.net

* Global Time Bomb

Surviving the H1n1 Swine Flu Pandemic and Other Global Health Threats. Was R264.95 Now R225.21

buy now

Geneva - Twelve countries have reported suspected cases of narcolepsy linked to swine flu jabs, the World Health Organisation said on Tuesday as its scientists said the findings warranted more investigation.

The WHO said in a statement that such sleep disorders, mainly in youngsters, had not been seen with vaccines in the past, and were more frequent in Sweden, Finland and Iceland than in other countries.

Its Global Advisory Committee on Vaccine Safety (GACVS) reviewed data from a Finnish study which found that children injected with the Pandemrix flu vaccine were nine times more likely to contract narcolepsy than those who were not vaccinated.

"The committee agrees that further investigation is warranted concerning narcolepsy and vaccination against influenza (H1N1) 2009 with Pandemrix and other pandemic H1N1 vaccines," the WHO said.

"An increased risk of narcolepsy has not been observed in association with the use of any vaccines whether against influenza or other diseases in the past," it added.

Extreme fatigue

The European Medicines Agency has also launched a probe into the suspected connection.

Narcolepsy is a sleep disorder which causes extreme fatigue and often results in the patient falling soundly asleep without warning, even in the middle of an activity.

"Since August 2010, following widespread use of vaccines against influenza (H1N1) 2009, cases of narcolepsy, especially in children and adolescents, have been reported from at least 12 countries," the WHO said.

A preliminary study by Finland's National Institute for Health and Welfare, THL published a week ago said the most likely explanation of the pattern found in four to 19 year olds was the "joint effect of the vaccine and some other factor(s)".

The Finnish institute stressed that more investigation was needed, but said young people had a "manifold increased risk of falling ill with narcolepsy" if they had been vaccinated with the vaccine made by GlaxoSmithKline.

Last August, THL recommended discontinuing use of that vaccine against A(H1N1) until it could study the signs of a connection.

Pandemrix vaccine was used in 47 countries worldwide during the 2009 - 2010 season, according to the WHO.

- SAPA

http://www.news24.com/SciTech/News/WHO-confirms-h1n1-vaccine-concerns-20110208

 

[Windsor]

I am glad I followed the advice of my friends not to have my family vaccinated. Here is another link confirming the story.

http://www.reuters.com/article/2011/02/01/us-flu-pandemrix-finland-idUSTRE7103SN20110201

WHO reviews GSK H1N1 flu shot after narcolepsy link

*
* Share this
* Link this
* 0diggsdigg
* Email

Related News

* UPDATE 5-U.S. rejects Orexigen diet drug over heart risks
Tue, Feb 1 2011
* REFILE-Finnish study links GSK flu shot to narcolepsy
Tue, Feb 1 2011
* UPDATE 1-EU approves Astra's nasal flu vaccine for kids
Tue, Feb 1 2011
* PRESS DIGEST - New York Times business news - Feb 1
Tue, Feb 1 2011
* UPDATE 3-Sanofi, Takeda drugs on FDA early safety probe list
Mon, Jan 31 2011

Analysis & Opinion

* US Fed cash-flow data called underused weapon in war on drugs (Complinet Special Report)
* Congress’s corruption calamities continue as the Thomas saga unravels

Related Topics

* Health »

A GlaxoSmithKline logo is seen outside one of its buildings in west London, February 6, 2008. REUTERS/Toby Melville

A GlaxoSmithKline logo is seen outside one of its buildings in west London, February 6, 2008.

Credit: Reuters/Toby Melville

By Kate Kelland and Terhi Kinnunen

LONDON/HELSINKI | Tue Feb 1, 2011 8:41am EST

LONDON/HELSINKI (Reuters) - The World Health Organization 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 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.

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

GSK said it was aware of the research but believed it was too soon to draw any conclusions. A separate investigation by European drugs regulators is already underway.

The Geneva-based WHO said in a statement that further investigation was required "concerning narcolepsy and Pandemrix vaccine" and it was working on this.

"WHO's Global Advisory Committee on Vaccine Safety (GACVS) is considering all available data relating to reports of increased rates of narcolepsy and is expected to issue a statement on its website within the coming days," it said.

Recommendations for the use of seasonal flu vaccines for 2010/2011 remain unchanged, it said, the issue of narcolepsy had not been linked with any other H1N1 pandemic flu vaccines, seasonal flu vaccines or any other adjuvanted, or boosted, vaccines used in childhood immunization programs.

GSK said it was reviewing the report and "it would be premature to draw any conclusions on a potential association between Pandemrix and narcolepsy until this European investigation has been completed."

Hanna Nohynek, the NIHW's vaccine safety officer, said the baseline risk for narcolepsy in children aged four to 19 was less than 1 per 100,000, and the study found that among those who had the Pandemrix shot the risk rose to 8.1 per 100,000.

According to GSK, more than 31 million doses of Pandemrix have been administered worldwide in 47 countries. The company said it had received reports of a total of 162 cases of narcolepsy as of January 31, 2011, with 70 percent of these cases of narcolepsy originating from Finland and Sweden.

The EMA, which regulates and reviews the safety of drugs in the European Union, said in September it was reviewing Pandemrix after reports of a link between the vaccine and narcolepsy, but there was no evidence yet to confirm a link. An EMA spokeswoman said the safety review was continuing. "For the time being ... the benefit-risk balance of Pandemrix remains positive," she said.

The Finnish report said that during 2009 and 2010, 60 children and adolescents aged four to 19 years fell ill in Finland with narcolepsy. Of those who fell ill, 52, or almost 90 percent, had received Pandemrix, it said, and the vaccine coverage in the entire age group was 70 percent.

The Finnish institute said it would seek to confirm its findings in further investigations by August 2011.

(Editing by Greg Mahlich)