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WHO: Statement On Pandemrix Vaccine & Narcolepsy

 

 

 

# 5276

 

 

Another major entity has weighed in on today’s report (see Finland: Statement On Pandemrix And Narcolepsy Link) from the Finnish National Institute for Health and Welfare report on what they are calling a `probable link’ between GSK’s Pandemrix vaccination, and an increase in narcolepsy in children and adolescents 4-19 years of age.

 

The World Health Organization agrees that further investigation is warranted, and expects a statement to be forthcoming over the next few days from WHO's Global Advisory Committee on Vaccine Safety (GACVS).

 

In the meantime, they are not recommending any changes on the use of seasonal 2010/2011 influenza vaccines in children and adolescents.

 

One should  note that – despite many of the imprecise headlines on today’s newswires claiming that the `Swine Flu Vaccine’ has been linked to narcolepsy -that this report only suggested a link with one  vaccine (Pandemrix) from one manufacturer (GSK), and only found elevated rates in 2 or 3 countries.

 

And no one has suggested any relationship to this year’s seasonal flu shot.

 

A couple of small, but important clarifications.

Here then is the WHO statement.

 

Pandemrix® vaccine and increased risk of narcolepsy

01-02-2011

The National Institute of Health and Welfare of Finland today issued a statement indicating an increased risk of narcolepsy (a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly) observed among children and adolescents vaccinated with Pandemrix®, an adjuvanted pandemic H1N1 vaccine manufactured by GlaxoSmithKline.

The National Institute (on the advice of the Finnish National Narcolepsy Task Force) concludes that the risk of falling ill with narcolepsy among those vaccinated in the 4-19 year age group is 9 times greater than those unvaccinated in the same age group. The National Institute considers it probable that the Pandemrix® vaccine was a contributing factor to this observed increase, but states that further investigation is required of other significant co-factors associated with the increased risk of narcolepsy. The final report from the Finnish National Narcolepsy Task Force is expected to be issued by 31 August 2011.

 

Pandemrix® vaccine has been used in 38 countries worldwide during the 2009/2010 season. An increase in cases of narcolepsy has been observed only in Finland, Sweden and Iceland.

 

The issue of an increased rate of narcolepsy has not been raised in association with the use of other influenza A(H1N1) pandemic vaccines, seasonal influenza vaccines or any other adjuvanted vaccines used in childhood immunization programmes.

 

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 web site within the coming days.

 

WHO agrees that further investigation is required concerning narcolepsy and Pandemrix® vaccine. In collaboration with a number of European Union Member States, the European Centre for Disease Prevention and Control (ECDC) is currently conducting a joint epidemiological study of narcolepsy and pandemic vaccines.

 

Recommendations for the use of seasonal 2010/2011 influenza vaccines in children and adolescents remain unchanged.

 

WHO's attention was first drawn to reports of narcolepsy following vaccination with Pandemrix® in Finland and Sweden in August 2010  and committed, through GACVS, to monitor the situation as new data became available.

 

Updates will be provided as further information becomes available and is assessed.

Related Post:

Pandemrix
Vaccine
Narcolepsy

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