Northern Ireland sleep disorder victims sue over claims vaccine was cause
At least three people in Northern Ireland who developed an incurable sleep disorder after receiving a flu vaccine are suing a pharmaceutical giant and the British government.
The UK-wide class action suit is also being taken against a number of companies involved in the production of Pandemrix - including British manufacturer GlaxoSmithKline (GSK) - which remains at the centre of a global narcolepsy controversy.
Almost 350,000 doses of the swine flu vaccine, which included Pandemrix, were issued to protect certain "high risk groups" in NI as part of a mass immunisation campaign in 2009/10.
Six-month-old children and pregnant women were among the recipients, which also included 33,000 healthcare workers and medical students.
At least 119 people in the UK - including dozens of NHS staff - claim they were affected by the vaccine which can trick the human immune system into mistaking the neuropeptide Orexin - a vital regulator of sleep - for the H1N1 virus.
But health officials in England and Northern Ireland deny any link to the vaccine and insist that narcolepsy can occur spontaneously.
The Department of Health in England is involved in the legal action because the UK Government indemnified the company behind Pandemrix in order to expedite production amid fears of a swine flu pandemic. A test case is currently before the High Court in the Republic of Ireland, where dozens of cases have also been reported.
Full clinical trials had not been completed before six million doses were administered in the UK and 30 million across Europe.
The disorder causes sufferers to collapse into a deep sleep without warning, often in the middle of daily tasks such as eating and bathing.
Although there was no known link between Pandemrix and narcolepsy in 2009, campaigners say evidence was beginning to emerge in countries across Europe and as far away as China.
However, the UK Government reissued the vaccine in the 2011 as a seasonal flu jab.
A global spike in narcolepsy prompted the Medicines and Healthcare products Regulatory Agency (MHRA) to conduct a thorough review before EU regulators restricted the licensed use of Pandemrix.
It is no longer licensed at all.
In 2011, Northern Ireland's chief medical officer Dr Michael McBride said it was typical that new instances of narcolepsy would be reported, but he played down any link to the vaccine.
"The fact that symptoms occur after a vaccination is given does not mean that they have been caused by the vaccine itself, as underlying illnesses and other conditions may be responsible," he said.
The Department of Health in England and NI continue to assert that view and said narcolepsy can occur "naturally" and "spontaneously".
A spokesperson for the Department of Health and Social Care in London also said the decision to vaccinate was based on guidance from the Joint Committee on Vaccination and Immunisation and the European Medicines Agency.
They added that it would be "inappropriate" to comment further due to "ongoing personal injury claims".
A spokesperson for the Department of Health in Stormont said it is only aware of two individuals being affected.
It is feared that others have yet to display the symptoms of narcolepsy - in some cases it manifests itself many years later, such as during puberty.
A GSK spokesperson was unable to comment due to ongoing litigation.