Government 'told of swine flu drug trouble in Sweden' before roll-out started
The Government apparently proceeded with the roll-out of a €120m swine flu vaccine in 2009 despite being notified of suspected adverse reactions in Sweden.
This is according to allegations made in a landmark case to open before the High Court on October 8.
A young woman, Aoife Bennett, will seek damages from the State and drug giant GlaxoSmithKline (GSK) over contracting the debilitating sleep illness narcolepsy after receiving the swine flu vaccine Pandemrix. A further 80 cases are pending.
The vaccine was rushed into service over fears in 2009 of a swine flu pandemic.
It had not fully completed clinical trials and, to get it into service, the Government agreed to indemnify GSK.
The national immunisation programme began on November 19, 2009.
The Irish Independent has learned that, on October 28 that year, the Irish health authorities were alerted to the fact Sweden was recording a number of suspected adverse reactions to Pandemrix.
These included hospitalisations and a number of apparent allergic reactions.
On October 31, 2009, Irish Government officials went on RTÉ to insist that Pandemrix was important to combat the threat of swine flu and was perfectly safe.
However, the public was not informed the vaccine had not completed full drug trials.
Similarly, the public was not informed of the emerging evidence of suspected adverse reactions to the vaccine in Sweden.
The Government has denied liability in High Court actions over Pandemrix.
Plaintiffs are being represented by Michael Boylan and Gillian O'Connor, of Michael Boylan Litigation in Dublin.
Ms O'Connor declined to comment on the High Court action for legal reasons.
"We believe our client has a very strong case but it is troubling to note that the State defendants have spent and continue to spend millions of euro fighting this case for the last seven years - even denying that they owe the plaintiff a duty of care," she said.
An HSE spokesperson said it had only sought tender applications from pandemic vaccine manufacturers in Europe whose products were licensed by the European Medicines Agency.
The Health Product Regulatory Authority (HPRA) confirmed that: "The Swedish medicines regulatory authority, the MPA, shared... publications made available on its website regarding reports of suspected adverse reactions with Pandemrix.
"As indicated... by the MPA on October 29, 2009, the reporting pattern was noted to be consistent with the types of side effects known and expected to occur with the vaccine."
GSK said: "Due to ongoing litigation in Ireland concerning Pandemrix, we are unable to comment."
Campaign group Sound (Sufferers Of Unique Narcolepsy Disorder) was troubled by the latest revelations.
"We are shocked but not surprised," said Tom Matthews, one of Sound's founders.
"Sound has always stated that it is not anti-vaccine, and that the Pandemrix scandal was a result of the State rushing to get whatever vaccine it could and that it was acting with the best intentions.
"But we believe it is way past time for the State to finally step up on this issue and to fulfil the duty of care it is morally bound to provide to the children and young adults who have been injured by the State."