Glaxosmithkline tells court there is no link between swine flu vaccine and narcolepsy
Pharmaceutical company Glaxosmithkline, which supplied the Pandemrix vaccine during the threatened swine flu pandemic, has told the High Court no causal link has been established between the vaccine and the sleep disorder narcolepsy.
GLacosmithkiline (GSK) was making a submission in the case of 26-year-old Aoife Bennett who is suing claiming she developed narcolepsy after she got the swine flu Pandemrix vaccination.
Counsel Douglas Clarke SC said GSK wanted to sympathise with Ms Bennett and the company’s defence of the case should not be seen as a criticism of her.
Each of the allegations against GSK, which include that the vaccine product was allegedly defective, he said were extremely grave and “misplaced.”
He said the Pandemrix vaccine was designed and manufactured in emergency circumstances in response to a swine flu pandemic declared by the World Health Organisation.
GSK, Counsel said, had meticulously adhered to the requirements of good clinical practices and regulations.
It was the fifth day of Ms Bennett’s action which is a test case for as many as 100 other cases relating to the swine flu vaccine,. The court has to decide on liability.
Aoife Bennett was only 16 years old when she got the vaccine as part of a mass vaccination programme as the country braced itself for a threatened human swine flu pandemic 10 years ago.
Ms Bennett, Lakelands, Naas, Co Kildare, a third-level student has sued the Minister for Health, the HSE, the vaccine producer Glaxosmithkline Biologicals S.A. and the Health Products Regulatory Authority.
HSE brochures on the vaccine, it is claimed, had the effect of allegedly misleading those who read them as to the safety of the Pandemrix vaccine and the alleged risk associated with its use.
It is claimed the brochures contained advice which was not consistent with the the actual facts. One brochure, it is alleged, was written in a manner that most reading it would believe that everybody except those with a confirmed lab test for swine flu needed to get the vaccine and that it was safe to use Pandemrix.
It is further claimed the Health Minister and HSE ought to have known those who read the brochures were likely to come to an alleged erroneous conclusion as to the safety of the Pandemrix vaccine and whether it had been adequately tested at all on children and adolescents prior to its release to the public.
Glaxosmithkline, it is claimed, demanded an indemnity from liability from the State before it would agree to supply the vaccine.
Parents, if they had known all this, would likely have not consented to the administration of Pandemrix to their children, it is claimed.
The Health Products Regulation Authority, it is alleged, was well aware there was an alternative vaccine which had more clinical data available in relation to its safety and efficacy.
All the defendants deny the claims and deny liability.
The case before Mr Justice Michael McGrath continues.
