Netherlands - Two toddlers with narcolepsy - Possibly related to Pandemrix vaccin

[Gert van der Hoek]

Fri February 4, 2011

Sleeping sickness affects two toddlers

by Arianne Mantel

Amsterdam - Two children aged four years in our country were hit by the sleeping sickness narcolepsy after vaccination with the flu vaccine .

These two boys participated in the national influenza vaccination campaign one and a half year ago; they were vaccinated with the drug Pandemrix.

This was confirmed by the Medicines Evaluation Board (MEB) following the
coverage in this paper that from Finnish research shows that there is an association between the vaccine with Pandemrix and sleeping sickness.

Telegraaf

This is not about the ordinary flu vaccine.

The vaccine Pandemrix has been used in the Netherlands late 2009 and early 2010 during the mass
vaccination campaign against swine flu. In addition, the vaccine by Novartis
(Brand name: Focetria) was used.

Experts suspect that the Pandemrix vaccine somehow triggers a certain genetic predisposition
for "sleeping sickness" . One of the boys did not have "narcolepsy` , but a related disease:
"cataplexy".

If you do a search on the website of the EMEA - the European medicines agency
- you can find a report that points to possible neurological symptoms after inoculation with
Pandemrix. Abnormalities were seen in newborn mice after vaccination of
mother mouse.

Novartis vaccine was recommended for pregnant women .

 

[Gert van der Hoek]

Re: Netherlands - Two toddlers with narcolepsy - Possibly related to Pandemrix vaccin

18/02/2011

European Medicines Agency reviews further data on narcolepsy and possible association with Pandemrix

Causal relationship not established; further study results awaited

The European Medicines Agency?s Committee for Medicinal Products for Human Use (CHMP) has reviewed further data from Finland on the suspected link between narcolepsy in children and adolescents and Pandemrix. The Committee concluded that the new evidence added to the concern arising from case reports in Finland and Sweden, but that the data were still insufficient to establish a causal relationship between Pandemrix and narcolepsy. Further analyses and study results are awaited to clarify the observations in Finland.

In addition to the data from Finland, research is ongoing in Sweden where there has also been an unexpected number of narcolepsy reports following vaccination with Pandemrix. However, other non-Nordic countries have not seen similar increased rates of reporting of narcolepsy. Additionally in Canada, where there has been substantial use of this type of vaccine, there has been no evidence of an increase in reports of narcolepsy. Therefore, at present definitive conclusions cannot be drawn and no changes to the recommendations for use of Pandemrix are proposed.

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