Finland: Task Force Report On Pandemrix-Narcolepsy Link

 

 

 

# 5803

 

 

Just over a year ago reports began to come out of Finland suggesting a link between an increase in the rate of narcolepsy among adolescents and GSK’s adjuvanted Pandemrix vaccine.

 

For early coverage of this story, you may wish to revisit Finland Suspends Use of Pandemrix Vaccine and EMA To Review Pandemrix Vaccine, both of which I wrote in August of 2010.

 

Despite some conflicting and incomplete data the European Medicines Agency issued a statement last July recommending:

 

In persons under 20 years of age Pandemrix to be used only in the absence of seasonal trivalent influenza vaccines, following link to very rare cases of narcolepsy in young people.

 

 

Note: The use of GSK’s 2009 monovalent Pandemrix vaccine has been largely supplanted by the introduction of last year’s trivalent vaccine, so the impact of this ruling should be minimal.

 

Stockpiles were released last winter in the UK during their surge in flu cases (see UK: To Release Pandemrix Vaccine Stockpile). 

 

The EMA maintained, however, that despite these concerns over the Pandemrix vaccine, the overall benefit-risk remains positive.

 

Since then, we’ve seen a study that linked an increase in narcolepsy to the flu virus itself (see Stanford Study Finds Influenza – Narcolepsy Connection) -  further confusing matters.

 

 

Today, Finland’s National Institute For Health and Welfare Narcolepsy Task Force has released a report where they find an association between the Pandemrix vaccine and increased rates of narcolepsy in children between the ages of 4 and 19.

 

 

Association between Pandemrix and narcolepsy confirmed among Finnish children and adolescents

1 Sep 2011

An association between Pandemrix and narcolepsy among children and adolescents in Finland is confirmed

 

In its final report, the National Narcolepsy Task Force confirms the tentative conclusion published in its Interim Report last January that the Pandemrix vaccine used in the winter of 2009–2010 contributed to the increased incidence of narcolepsy observed among 4–19-year-olds in Finland. According to the report, the increased risk associated with vaccination amounted to six cases of narcolepsy per 100 000 persons vaccinated in the 4–19 age group during the eight months following vaccination. This was 12.7 times the risk of a person in the same age group who had not been vaccinated. No increased incidence of narcolepsy was observed among children under the age of four or among adults over the age of 19.

 

In all the cases examined, narcolepsy associated with Pandemrix vaccination has been identified in persons who carry a genetic risk factor for narcolepsy. Because of this very strong association with the genetic risk factor which regulates immune responses, narcolepsy is considered an immune-mediated disease.

 

In approximately one quarter of those who developed narcolepsy following Pandemrix vaccination, the THL Immunology laboratory found antibodies binding to the AS03 adjuvant component of the vaccine. Adjuvants containing squalene have not previously been reported to induce the production of antibodies. The significance of this preliminary observation will be the subject of further research.

(Continue . . . )

 

 

While more research is needed to nail down exactly what happened, and why, a few key points to ponder.

 

• Of the 3 dozen countries that used the Pandemrix vaccine in 2009-2010, only Finland and Sweden have documented an increase in Narcolepsy that they can link to the Pandemrix vaccine.
• At least a dozen countries reported increased rates of narcolepsy during that time period, including some countries where the vaccine was not used.
• In all the cases the task force examined, narcolepsy associated with Pandemrix vaccination was identified in persons who carry a genetic risk factor for narcolepsy
• Regarding the use of the vaccine, despite the the `unforeseen and deeply regrettable cases of narcolepsy’, Finland’s Narcolepsy taskforce found that its use probably saved lives and that `overall benefit-risk balance remains positive.’
• While unsure of its significance, researchers found antibodies binding to the AS03 adjuvant component of the vaccine in roughly 25% of the cases examined.
• And finally, adjuvanted flu vaccines like Pandemrix were not used in the United States. 

 

Despite rare adverse side effects such as narcolepsy, flu vaccines have an excellent safety profile, and remain our best weapon against a virus that kills tens of thousands every year.

 

Taking any medicine – including a flu vaccine – entails a small degree of risk.  But those risks pale when compared to the risks from catching the flu.

 

And with the potential for seeing an increase in antiviral resistant flu viruses that might limit your treatment options in the future (see Australia Reports Cluster Of Antiviral Resistant H1N1), doing what you can now to protect yourself against infection this winter makes a lot of sense.

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Finland To Release Interim Pandemrix – Narcolepsy Study On Feb 1st.

 

 

RECENT UPDATES TO THIS STORY:

National Institute for Health and Welfare Statement – Feb 1st

WHO Statement

GSK Statement

 

 

# 5270

 

An update to a story that first emerged last August (see Finland Suspends Use of Pandemrix Vaccine),we learn today that Finland will soon release an interim report on the potential link between the Pandemrix vaccine and an unusual spike in narcolepsy which was reported in Finland, Iceland, and Sweden.

 

While we don’t have the results at hand, we do have a report from YLE.fi where the head of Finland's National Public Health Institute has conceded that administering the shot to children may possibly have been a mistake.

 

Exactly why these countries should experience a rise in narcolepsy, while other countries using the same vaccine have not reported similar problems, is unknown. 

 

Since I’ve not seen this Interim report, there is little I can say about today’s report. You can read it at the link below.

 

Health Official: Swine Flu Vaccinations for Children Possibly a Mistake

published today 04:40 PM, updated today 04:45 PM

 

While stating that further research is warranted (and will take months), earlier reports from regulatory agencies in Europe stated that no link has been found between the Pandemrix vaccine and recent reports of narcolepsy.

 

On September 9th, I ran a story called Sweden: No Link Between Pandemrix And Narcolepsy, which linked to a CIDRAP report on the findings of Sweden’s Medical Products Agency’s investigation into the matter.

 

And two weeks later, the European Medicines Agency (EMA) said its Committee for Medicinal Products for Human Use had reviewed all available data and found insufficient evidence to confirm a causal link between cases of narcolepsy and the vaccine.

 

We’ll simply have to wait to see if this interim report has credible evidence to the contrary.

 

The CDC published a statement on these concerns last September, part of which states:

 

Pandemrix is not licensed for use in the United States. No adjuvanted influenza vaccines are licensed in the United States. The European Medicines Agency has launched a review of Pandemrix to investigate whether there is a link between cases of narcolepsy and vaccination with Pandemrix. This vaccine has been used in at least 30.8 million Europeans.

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Finland Suspends Use of Pandemrix Vaccine

 

 

 

# 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.

 

(Continue . . . )

 

 

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.

<snip>

 

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.

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