State solely responsible for vaccine, says maker

 

THE MAKERS of the swine flu vaccine associated with an increase in sleeping disorders among children in Ireland has said the State is the sole bearer of responsibility for any compensation claims.

Drug maker GSK manufactured the Pandemrix vaccine, which is associated with a thirteenfold rise in narcolepsy among children and adolescents in Ireland.

At least 24 young people who received the vaccine went on to develop narcolepsy, a life-long disorder associated with excessive sleepiness and hallucinations. Support groups say they are aware of other potential cases which have yet to be officially confirmed.

In a statement, GSK said it took the safety of individuals very seriously and was committed to the highest standards of patient safety. “We would never allow any medicine or vaccine that did not meet the stringent internal criteria as well as regulatory standards to be made available for use,” it said.

“Throughout the development of our pandemic vaccines there were no data that suggested a potential for an increased risk of narcolepsy among those vaccinated with our H1N1 pandemic vaccine, Pandemrix.”

The company said it was reviewing a report published by the Department of Health last week which found an association between the vaccine and the sleeping disorder, but believed that “further questions need to be explored before definitive conclusions on the association”.

While details of the deal between health authorities and GSK over supply of the vaccine have not been released, it is understood the State paid €5-€15 million for more than 900,000 doses.

The use of Pandemrix is no longer recommended in Ireland and GPs have been advised to return any remaining stocks. This year’s seasonal flu vaccine does not contain Pandemrix.

As part of the deal, the State signed an indemnity agreement in which it took sole responsibility for any potential compensation claims.

GSK said: “Within the unique circumstances of the pandemic, an unprecedented number of people, many of whom had underlying medical conditions, needed to be vaccinated in a very short period of time. Previous experience with large-scale immunisation programmes has shown there would be a significant volume of adverse events reported under such circumstances.”

It said some of these adverse events may be attributable to the vaccine and in many instances they would be the result of underlying medical conditions.

The company said “it was recognised that both circumstances may potentially lead to many complaints and claims for compensation, even if they were later found to be unconnected with the vaccine. It was likely that many people would assert that these events were caused by the pandemic vaccine, purely based on the temporal association.”

As a result, it said it agreed the Government would become the sole bearer of responsibility for issues arising from the vaccine.

Minister for Health James Reilly is drawing up proposals for Cabinet on compensation.

A campaign group established by families of children affected by the disorder has called on the Government to follow the Finnish government’s moves to compensate children and meet their ongoing needs.