08/09/2008- A PARENT group last night urged the Health Minister to reconsider her backing for a cervical cancer vaccination programme for 12-year-old girls because of their concerns about one of the licensed vaccines.
The Mother and Child Campaign called on Minister Mary Harney to change her mind on the programme because 20 girls in the U.S. who had received the vaccine Gardasil died within days.
The Irish Daily Mail has learned that a possible connection between the jabs and the young girls? deaths has been investigated but has not been substantiated.
The Mother and Child Campaign says that links between the Gardasil Human Papillomavirus (HPV) vaccine and the rare debilitating disorder Guilliun Barre Syndrome are being explored in the U.S.
There are two vaccines licensed in Ireland: Gardasil and Cervarix.
No decision has yet been taken on which will be used if the planned immunisation programme goes ahead in September next year.
The minister has given the go-ahead to the Health Service Executive to enter into a tendering process with manufacturers of the vaccines.
Mother and Child Campaign spokesman Niamh Uí Bhríain said she was ?shocked and appalled? that the minister had failed to make herself aware of the controversy surrounding Gardasil. She said: ?The minister should reconsider her approval until the outcome of all studies relating to Gardasil.?
The minister made the decision to roll-out a national vaccination programme following a study by the Health Information Quality Authority which approved it.
The report noted that U.S. and European drugs watchdogs had investigated the issue and had not found any links between Gardasil and the deaths of the young girls who had taken the vaccine.
The U.S. Food and Drug Administration (FDA) confirmed that concerns had been raised after the cases of the 20 girls who had received Gardasil and who had later died were reported to the Vaccine Adverse Event Reporting System.
But in a statement last month, it said: ?There was not a common pattern to the deaths that would suggest they were caused by the vaccine.
In cases where autopsy, death certificate and medical records were available, the cause of death was explained by factors other than the vaccine.?
The FDA found there is no evidence to link Gardasil to an increase in Guillain Barre Syndrome above that expected in the population.
The company marketing Gardasil in Europe, SanofiPasteur MSD, dismissed the claims made by the Mother and Child Campaign group yesterday and said there have been no confirmed deaths as a result of the vaccine.
A spokesman for the company said: ?Since it has been licensed in 2006, 30 million doses have been distributed worldwide. As is the case of any new vaccine there is ongoing surveillance.?
A spokesman for the Miss Harney said she approved the vaccination programme following a report from the HIQA. He said: ?The minister is aware of the issues raised.?
The HIQA report noted that a possible association between Gardasil and Guillian Barre Syndrome is being investigated in the U.S. It said no causal relationship was established between the deaths of the young women in the U.S. and Gardasil.
It added that on the basis of the evidence available the experts were satisfied that the benefits of Gardasil continued to outweigh its risks.