# 4832
Over the past several days European media sources have been reporting on concerns surfacing – first in Sweden, and now in Finland – over what appears to be an increase in reported cases of narcolepsy among children who received GSK’s Pandemrix vaccine.
While any connection between the vaccine and the increases in Narcolepsy remains unproven, as a precaution, Finland has suspended the use of the Pandemrix monovalent H1N1 vaccine.
It may take months, or perhaps even years, to establish a causal relationship . . . assuming, of course, that one even exists.
Finland’s National Institute for Health and Welfare has released a lengthy press release on the matter, excerpts of which you can find below.
I’ll return with a few comments.
National Institute for Health and Welfare recommends discontinuation of Pandemrix vaccinations
25 Aug 2010
The Finnish National Institute for Health and Welfare (THL) recommends that vaccination with Pandemrix vaccine is discontinued until an explanation is found for the observed rise in cases of narcolepsy among children and adolescents. THL’s recommendation is based on a proposal from the Finnish National Advisory Committee on Vaccines. The Committee convened on Tuesday 24 August 2010 to consider the matter.
The discontinuation of vaccinations is a safety measure put in place until the matter can be fully investigated. At present there is no swine flu epidemic, so there is no immediate need for swine flu vaccinations in Finland. Moreover, a large part of the Finnish population already has some protection from swine flu as a result of vaccination or from having had swine flu. The vaccine may still be used upon consideration in individual cases, for instance for people travelling to areas where an epidemic is in progress.
A number of different reasons may be behind the observed rise in the incidence of narcolepsy: A(H1N1) infection, vaccination, a compound effect of infection and vaccination, or some other factor entirely. Infections in general are known to cause narcolepsy.
So far, the THL register for adverse events following immunization (AEFI) has received reports of six cases where narcolepsy has followed vaccination. The number is consistent with the annual incidence of narcolepsy under normal circumstances. However, in addition to the above, AEFI reports have not yet been submitted for a further nine possible cases. The symptoms of all the children with narcolepsy started at the end of 2009 and beginning of 2010.
Worldwide, somewhere in the order of 90 million people have received GSK’s adjuvanted Pandemrix vaccine, including millions of children. Thus far, only Sweden and Finland have reported any concerns over narcolepsy, and those numbers are small.
Narcolepsy is probably more common than most people realize, with its prevalence estimated at being between 25 and 50 per 100,000 people.
According to the NHLBI (NIH) webpages on Narcolepsy:
Narcolepsy affects between 50,000 and 2.4 million people in the United States. Symptoms usually begin during the teen or young adult years. The disorder also can develop later in life or in children, but it's rare before age 5. Narcolepsy affects both men and women.
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It can take as long as 10 to 15 years after the first symptoms appear before narcolepsy is recognized and diagnosed. This is because narcolepsy is fairly rare. Also, many of the symptoms of narcolepsy are liked symptoms of other illnesses.
Narcolepsy, by all accounts, is under-diagnosed by the medical community. Which means that the true incidence is probably far higher than statistics might indicate.
While Health Authorities in Finland have suggested that the increase in narcolepsy could be due to the H1N1 virus itself (neurological manifestations are not uncommon following viral infections), or the vaccine, or some compound effect of infection and vaccination, another possibility needs to be considered as well.
Given the concerns over seeing a repeat of the 1976 swine flu fiasco, where a few hundred cases of GBS (Guillain Barre Syndrome) were linked to the vaccine, elaborate surveillance and reporting systems were put in place to look for any unusual spike in adverse affects.
Greater scrutiny, better reporting systems, and the public’s concern over the vaccine’s safety might well account for a greater number of diagnoses of narcolepsy in children over the past 6 months.
Essentially, the harder we look for diseases, the more we are likely to find.
Of course, it is possible the vaccine is the culprit here. Time, and further study, will tell.
In the meantime, the halting of the Pandemrix vaccine should have little impact, since the seasonal vaccine that will be offered in Finland this fall contains the H1N1 strain, along with H3N2 and Influenza B.
For Americans that might be concerned, Pandemrix is an adjuvanted vaccine, and was not offered in this country.
