Friday, March 28, 2014

5 years after H1N1 Swine Flu was discovered, what do we know about Pandemrix and Narcolepsy?

1.  How widely was Pandemrix vaccine used?

Virtually all the narcolepsy data comes from Europe, where the GlaxoSmithKline Pandemrix swine flu vaccine was given to about 31 million Europeans and was used in 47 countries.  It was used in Canada (12 million doses) and a number of developing countries, but little is known about increased cases of narcolepsy outside Europe.  Increased narcolepsy cases have been confirmed post-vaccination in (at least) Finland, Sweden, England, Ireland, France, and Norway. 

2.  Did the US use Pandemrix?

No. The US purchased novel adjuvants as it prepared to deal with the swine flu epidemic, including Pandemrix's ASO3, but then chose not use Pandemrix, instead using other brands of H1N1 vaccines (without novel adjuvants) for swine flu.  This was almost certainly in response to extensive public discourse on the subject. I wrote a number of pieces on the potential risks of novel adjuvants in 2009-10, including those herehere, here and here.

3.  How many people developed narcolepsy as a result of Pandemrix?

800 European children are reported to have developed this condition after Pandemrix vaccine in about 6 European countries.  The number in other countries and excess cases in adults are not known.

Several studies, but not all, found maximum rates of narcolepsy (attributable risk from the vaccine) of 6/100,000 in vaccinated children aged about 4-19.  According to Ireland's Health Protection Surveillance Center, the increased rate of developing narcolepsy after receiving a Pandemrix inoculation, compared to the unvaccinated baseline rate, ranged from 4-5 fold in Sweden and France, up to 16 fold in the UK.  The increase was 13 fold in Finland and Ireland, and 15 fold in Norway.

In addition to kids being more susceptible to narcolepsy following Pandemrix, there were also relatively more children than adults vaccinated.  In Ireland, 42% of all children were vaccinated, but only 14% of adults over 20. Therefore almost exactly the same number of Irish children as adults received the vaccine, even though 3/4 of Ireland's people are adults.  In other European countries as well, higher percentages of children were vaccinated than adults.

Although the greatest risk for narcolepsy occurred in children aged 4-19, there is also a mildly increased risk of narcolepsy in vaccinated adults (2-3 times the baseline rate) and younger children.

4. Who is responsible to pay damages for narcolepsy?

Because all countries that purchased or were given the vaccine were required to give a liability waiver to GlaxoSmithKline (GSK) (and to the other manufacturers of different brands of swine flu vaccines), GSK is not responsible to compensate families for illnesses related to the vaccine.

Instead, the taxpayers of each country are responsible for paying families for serious illnesses caused by the vaccine, because this was the agreement made by their governments.  Each country is evaluating and compensating affected families its own way. In countries where no studies were done to look at whether Pandemrix caused narcolepsy, there may be no method for affected individuals to receive compensation.

There is a financial conflict of interest when a government that is responsible for damages is the same government that determines whether Pandemrix caused narcolepsy cases.

5.  What was WHO's role regarding liability?

It was the World Health Organization (WHO) that facilitated this vaccine "tort reform," transferring the liability for vaccine injuries from manufacturers to taxpayers, as noted in this 2012 WHO report:
     "To facilitate the acceptance of vaccines by the large number of recipient countries involved, WHO developed a Letter of Agreement that was signed by each recipient-country government as a condition of receiving vaccines. This Letter of Agreement acknowledged and incorporated clauses from the donation agreement outlined above. All agreements with countries therefore included the same required terms, including those relating to limitations of liability, that were included in the agreements between WHO and donors.
     Because the initial urgency of the pandemic response required an unprecedented number of doses of a new vaccine to be deployed globally in a period of only a few months, vaccine manufacturers required that all customers (primarily developed-country governments) indemnify them (or otherwise discharge them from liability) for any adverse events arising from the use of the pandemic H1N1 vaccine, except to the extent that such adverse events were caused by a failure to comply with cGMP or to meet agreed specifications..."
WHO in 2012 also downplayed the significance of Pandemrix to narcolepsy, despite a report by Canada's Globe and Mail in 2011 that WHO acknowledged increased narcolepsy cases in 12 of 47 countries that used Pandemrix:
Although the preliminary information was not conclusive, subsequent data indicated an increased incidence of narcolepsy in children between the ages of 4 and 19 years who had been immunized against pandemic H1N1 influenza. These increased incidences were observed only in Finland, Iceland and Sweden (where higher rates of narcolepsy normally occur)...  
6.  How did Pandemrix cause narcolepsy?

There is some evidence that a portion of the hemagglutinin of the 2009 swine flu virus (and vaccine) resembles hypocretin (which is the hormone produced in the hypothalamus that induces wakefulness, and is in short supply or absent in narcolepsy patients), and therefore may stimulate an immune response via "molecular mimicry" against cells producing hypocretin.  But against this hypothesis is the fact that getting the swine flu illness did not increase cases of narcolepsy (here and here); only the vaccine did that. So the answer is we don't know yet.

7.  Did Pandemrix cause other medical problems?

Were other neurological conditions caused by Pandemrix?  This question should have been asked by many international enhanced surveillance projects put in place in 2009.  It has been answered for Sweden as "no"--only narcolepsy cases increased.  There may be slightly increased risks for other conditions, such as paresthesias and inflammatory bowel disease.  I await more studies on this subject.

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