In 2010, doctors in Scandinavia began reporting a sudden increase in the normally rare condition of narcolepsy. By October, Finnish and Swedish authorities issued the first warnings that it might be linked to the Pandemrix vaccine manufactured by GlaxoSmithKline. A 2013 study in the British Medical Journal found that for every 55,000 children who were given the injection, one has developed narcolepsy. A French study published in Brain, (Aug. 2013) reported – “H1N1 vaccination was strongly associated with an increased risk of narcolepsy-cataplexy in both children and adults in France.” And a Norwegian study, published in Sleep Medicine (Sept. 2013) reported: “The data collected during 3 years following vaccination showed a significantly increased risk for narcolepsy with cataplexy the first year after Pandemrix vaccination.”
Finland, Norway Ireland, France, Sweden and the U.K. all saw spikes in narcolepsy and found a high number of cases in children following immunization with the Pandemrix vaccine. Pandemrix (produced in Germany) was used in more than 47 countries starting October 2009.
Neither GlaxoSmithKline nor the UK’s Department of Health has admitted that the vaccine can cause narcolepsy. In 2013 a spokesman for the UK’s Vaccine Damage Compensation Scheme, said on the BBC that, “there is currently insufficient medical evidence to show that the swine flu vaccine causes narcolepsy.”
Under a Freedom of Information request about the cost of the UK’s H1N1 vaccination program, the total cost of the vaccination program was around $108 million.
GlaxoSmithKline received an indemnity from the UK government which gave GSK legal indemnity against having to pay compensation. As of June 2015, only one family has received compensation, from those who applied to the Government’s Vaccine Damage Payment (VDP).
In Sweden, as of 2013, 192 patients have received compensation. A fund of 30 million Euros has been set aside in Finland to pay for medical care, medication and travel costs for treatment, along with other expenses incurred as a result of narcolepsy caused by the Pandemrix vaccinations. The Irish Medicines Board has played down claims for a Pandemrix narcolepsy connection, despite a report showing 779 adverse reactions to the swine flu vaccine between January 2010 and December 2011. In 2014 a dozen law suits were initiated against the Irish State, the health minister and GlaxoSmithKline by individuals who developed narcolepsy. The use of Pandemrix is no longer recommended in Ireland.
US CDC statement on Pandemrix: “An increased risk of narcolepsy was found following vaccination with Pandemrix, a monovalent 2009 H1N1 influenza vaccine that was used in several European countries during the H1N1 influenza pandemic. Narcolepsy is a chronic neurological disorder caused by the brain’s inability to regulate sleep-wake cycles normally.
“Pandemrix is manufactured by GlaxoSmithKline in Europe and was specifically produced for pandemic 2009 H1N1 influenza. It was not used before 2009, and has not been used since the influenza pandemic season (2009-2010). It contains an oil-in-water emulsion adjuvant called ASO3. Adjuvants are substances added to a vaccine to increase the body’s immune response to that vaccine.”
Basically an adjuvant is a booster, designed to turbo charge the potency of a vaccine and the body’s immune response to it. AS03 is the trade name for a squalene-based immunologic adjuvant used in various vaccine products by GlaxoSmithKline.
ASO3 contains squalene, an oil found naturally in the body but also derived from shark livers, DL- alpha- tocopherol (a type of vitamin E), and a mixing agent called polysorbate 80. AS03 was widely used in Europe during the 2009-2010 H1N1 flu pandemic. (The FDA found squalene in the anthrax vaccine. It has been alleged that thousands of military personnel are suffering from very serious side effects caused by squalene in some anthrax vaccines)
Some experts believe the turbo-charged immune response AS03 generates, or the ingredients that drive it, may be the answer to why almost 800 cases of the incurable sleeping disorder narcolepsy have been linked to Pandemrix’s use in Europe during the 2009/2010 H1N1 pandemic.
“The adjuvant in the Pandemrix vaccine is very potent and we think it may have played a role,” said Markku Partinen, a neurologist at the Helsinki Sleep Clinic in Finland, in a Reuters story. He reports there are no longer scientific grounds for doubting the association between elevated risk for narcolepsy and the Pandemrix vaccine. (Partinen’s initial findings were rejected by the New England Journal of Medicine, which declined to publish his study. The Lancet also refused to publish it. It was only finally published in March 2012, in the open-access journal of the Public Library of Science, PLoS One – after other scientists had replicated his findings.)
Partinen and other researchers think it may be because the adjuvant’s strength boosted not just a good immune response but possibly an adverse one too.
Narcolepsy’s most common symptoms are bouts of daytime sleepiness, but in its severe forms it also brings nightmares, hallucinations, sleep paralysis and cataplexies – when strong emotions trigger a sudden loss of muscle strength.
“There is absolutely no doubt that people vaccinated with our vaccine were shown in published studies to be more likely to develop narcolepsy than people who were not,” said Norman Begg, chief medical officer at GSK’s vaccines division. “As a statistical association that’s clear. It’s a very different thing, though, to say that then means A causes B.”
In 2012, an FDA advisory committee endorsed the safety and immunogenicity of an GSK adjuvant-containing H5N1 influenza vaccine proposed for inclusion in the US pandemic emergency stockpile, signaling it could become the first adjuvanted flu vaccine to win approval in the United States. In 2013, the FDA approved GlaxoSmithKline’s Q-Pan vaccine that contains the adjuvant AS03, the first influenza A (H5N1) monovalent “bird flu” vaccine. It is included in the U.S. vaccine stockpile.
In Canada around 2 million doses of a GSK vaccine called Arepanrix (very similar to Pandemrix and containing the same AS03 adjuvant) were used to immunize children during the H1N1 pandemic. A study was published in Eurosurveillance, Volume 19, Issue 36, 11 September 2014 – “Did narcolepsy occur following administration of AS03-adjuvanted A(H1N1) pandemic vaccine in Ontario, Canada?” The report concluded: “No reports of narcolepsy were identified.”
Stanford University’s Dr. Emmanuel Mignot (who is being funded by GSK) has been collecting blood samples from children who developed narcolepsy during the swine flu outbreak from around the world. He’s found that in some countries, like China, there was a swell in new pediatric cases of narcolepsy that followed h1N1 and seemed to be associated with the flu infection itself, not with flu vaccinations. Few children in China were vaccinated against the pandemic strain of H1N1.
A study, published this month in the journal Science Translational Medicine, suggests that in rare cases, Pandemrix led to patients producing antibodies that attacked and destroyed a critical hub of brain cells that help regulate tiredness. After having the vaccine, the patients affected would have lost most of a group of 70,000 neurons that are responsible for producing the “wakefulness” hormone, hypocretin. As a result, they developed narcolepsy.