[Posted: Tue 31/08/2010 by Niall Hunter, Editor – www.irishhealth.com]
The European Medicines Agency has launched a review of the swine flu vaccine Pandemrix, following reports of a link with the vaccine and the sleep disorder narcolepsy.
The review is to be carried out by the agency at the request of the European Commission following a limited number of cases of narcolepsy following Pandemrix vaccination, reported mainly in Finland and Sweden.
Narcolepsy is a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly. It is believed to be triggered by a combination of genetic and environmental factors.
The Agency stressed that it is at present not known if the vaccine caused the disorder.
Pandemrix has been used for vaccination against H1N1 influenza in at least 30.8 million Europeans and was the most commonnly-used H1N1 vaccine in Ireland. Swine flu killed 24 Irish people in the recent outbreak.
Narcolepsy is a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly. Its precise cause is unknown, but it is generally considered to be triggered by a combination of genetic and environmental factors, including infections.
The Agency says it will look carefully at all of the available data to determine whether there is evidence for a causal association between the swine flu vaccine and narcolepsy.
As part of its evaluation the agency will also consider the “background” rate for narcolepsy; that is, the number of cases that would normally be expected to be diagnosed.
The Agency says it will be working with experts from across the EU to assess this possible safety concern and any impact on the benefit risk balance of Pandemrix. It says it will will consider at its September 2010 meeting the need for any provisional measures pending completion of the evaluation.
Meanwhile, Fine Gael Deputy for Cork South Central Deirdre Clune has called on Health Minister Mary Harney to address those who are worried following media reports of risks associated with the new cervical cancer vaccination.
“Minister Harney needs to reassure parents of the benefits of the HSE HPV cervical cancer vaccine and to outline the research she carried out resulting in her decision to implement the programme. I am concerned about the negative commentary surrounding the HPV vaccination programme”, Deputy Clune said.
This vaccine is to be provided to 12-year-old girls across the country next month.
“The HSE is hoping for an 80% take-up of this vaccine. In an era of multimedia outlets there is a lot of information available, some reliable, some not. Parents of 12- year-old girls need support and reassurance before they agree to have their daughters vaccinated,” Deputy Clune said.