The Department of Health says it continually monitors the HPV cervical cancer vaccine following concerns about possible adverse reactions. Some 861 cases have now been reported to the health authorities.
Gardasil, the vaccine manufactured by Sanofi-Pasteur, is offered to girls from the age of 12 to protect them against developing certain strains of cervical cancer.
Speculation about potential adverse reaction to the vaccine has grown internationally, and this week, the European Medicines Agency launched a review of the cervical cancer vaccine’s safety, while asserting that the review should not raise questions about whether the vaccine’s benefits in preventing cervical cancer outweigh their risks.
The agency also said there should be no change to national HPV vaccination recommendations.
Fianna Fáil has called for a review of suspected cases of serious side effects from the HPV vaccine, after Senator Darragh O’Brien raised concerns about reported cases of severe side effects from the vaccine.
“I have spoken to a number of parents whose daughters became seriously ill after receiving the vaccine. These were happy, active girls who now struggle to get out of bed due to severe dizziness, seizures, lethargy, headaches and joint pain. While the parents suspect that the illness may be linked to the vaccine, they want concrete answers about any possible links,” he said.
Diane Harper, who helped develop Gardasil for Merck has said that there is no data to substantiate that the benefits outweigh the risks.
“The truth is that we know very little about the side effects of the HPV vaccine,” said Dr Harper.
However, establishing a causal link between a vaccine and its possible side-effects can be difficult, according to consultant oncologist John Crown.
“The risk may be zero. We have no evidence that there is any risk. There is no proven evidence at this stage that there is any serious side effect that is clearly caused by this vaccine,” he said.
Cervical cancer can be lethal. It kills 80 to 100 women each year in Ireland.
However, fatalities have fallen in countries where female populations are routinely screened for pre-cancerous cell changes in the cervix. As cervical cancer develops slowly, health policy that involves regular screening, and treatment where necessary, has a high success rate.
The HPV vaccine was first authorised in the EU in 2006, and was introduced to the national immunisation programme in 2010.
“While no medicine (including vaccines) are entirely without risk, the safety profile of Gardasil has been continuously monitored since it was first authorised both nationally and at EU level,” Health Minister Leo Varadkar wrote in response to a letter sent by Mr O’Brien which raised concerns about the vaccine.
Despite no proven link between the vaccine and the symptoms people are reporting, parents in Spain are suing for damages that they believe were caused by the vaccine, and a judge in France has awarded damages to a young girl, saying that her MS was partially caused by the Gardasil vaccine.
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