The Irish Medicines Board has played down claims for Pandemrix narcolepsy connection, despite a report showing 779 adverse reactions to the H1N1 swine flu vaccine between January 2010 and December 2011.
In a statement responding to the report, the Irish Medicines Board (IMB) said that the high number of reported adverse reactions – which included thirty confirmed cases of young people with the sleeping disorder narcolepsy – was due to “both the extent of usage and repeated requests and reminders by the IMB and Health Service Executive for reporting of experience with their use”.
Many of the recorded adverse reactions were relatively mild and included health issues such as gastrointestinal problems and flu-like symptoms; however the report comes at an important time for those making claims for Pandemrix narcolepsy connection following the news that the Finnish government has started making compensation payments to those who developed narcolepsy due to the vaccine in Finland.
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. As narcolepsy is a life-long condition, and can be passed down to later generations, Finnish Permanent Secretary at the Minister of Social Affairs and Health – Kari Välimäki – has acknowledged that the fund is unlikely to sufficient to cover the claims for Pandemrix narcolepsy, and that the State may have to substantially increase the amount available to cover claims of medical negligence.
The connection between Pandemrix and the subsequent development of narcolepsy in young people was supported by research from Finland’s Institute for Health and Welfare. It was discovered that children administered with Pandemrix were nine times more likely to develop narcolepsy than those who did not have the H1N1 swine flu vaccine.
Their findings were confirmed in Sweden where, in March 2011, the Swedish Medical Products Agency compiled a report which revealed a four-fold increase in cases of narcolepsy among children under the age of nineteen who had received the Pandenrix swine flu vaccine as opposed to those who had not.
The European Medicines Agency´s own study in July 2011 showed a six to thirteen-fold “increased risk of narcolepsy in children and adolescents” vaccinated with Pandemrix compared with unvaccinated children.
Despite the alarming reports coming out of the rest of Europe, in September 2011 Health Minister, Dr James Reilly defended the actions of his predecessor Mary Harney who encouraged people to be vaccinated with the Pandemrix H1N1 swine flu vaccine when Ireland faced the risk of an epidemic. Dr Reilly told the Dáil that “no link has been established yet between the swine flu vaccine and narcolepsy, but the Government will endeavour to ensure all families [of children diagnosed with narcolepsy] get the medical and social supports they need”.
The IMB added that despite adverse reactions to the Pandemrix swine flu vaccine heading the list of the drugs to which people had suffered side effects, the presence of a medicine on an overall list of adverse reactions could not be taken as an indicator of relative safety or risk.
The use of Pandemrix is no longer recommended in Ireland and GPs have been advised to return any remaining stocks.