Clare Daly (Dublin North, United Left)
Link to this: Individually | In context | Oireachtas source

118. To ask the Minister for Health the analysis he will carry out into the fact that 220 young girls are displaying the same symptoms within a similar timeframe of receiving the human papilloma virus, HPV, vaccine and the measures he will put in place to assist these young girls; and if he will make a statement on the matter. [2379/16]

Leo Varadkar (Dublin West, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I am aware of claims of an association between HPV vaccination and a number of conditions experienced by a group of young women. I want to make it quite clear from the outset that anyone who is suffering ill health is eligible to seek medical attention, and to access appropriate health and social care services, irrespective of the cause of their symptoms. People are assessed for eligibility for Medical Cards, disability or carers allowance individually. The assessment takes into account their family income and individual needs rather than a specific diagnosis.

It appears that some girls first suffered symptoms around the same time that they received the HPV vaccine, and understandably some parents have connected the vaccine to their daughters condition. The young women and their families should seek medical advice from their family doctor in the normal manner and be guided by this advice in accessing appropriate services including specialist opinion where necessary.

In Ireland, the Health Products Regulatory Authority (HPRA) is the regulatory authority for medicines in Ireland. There are 2 licensed HPV vaccines available in Ireland (Gardasil and Cervarix). Gardasil is the vaccine used by the HSE in the School Immunisation Programme and over 100,000 girls have received this vaccine since its introduction.

No medicine, including vaccines, is entirely without risk, there is therefore on-going pharmacovigilance and monitoring of medicinal products once they are authorised for use. The safety profile of Gardasil has been continuously monitored since it was first authorised. The European Medicines Agency has recently advised healthcare professionals that available data does not warrant any change to the use of HPV vaccines as there are no new safety concerns regarding HPV vaccines. Therefore healthcare professionals should continue using the vaccines in accordance with the current product information.

As part of its monitoring of the safety of medicines, the HPRA operates an adverse reaction reporting system, where healthcare professionals and patients are encouraged to report adverse reactions they consider may be associated with their treatment, through the range of options in place for reporting. All reports received are evaluated and considered in the context of the safety profile of the product concerned, with reports followed up as necessary for further information, that may assist in the assessment of the case.

The HPV vaccine, which was introduced in 2010, protects girls from developing cervical cancer when they are adults. It is available free of charge from the HSE for all girls in the first year of secondary school. This is in accordance with the recommendation received from the National Immunisation Advisory Committee (NIAC) which indicated that the HPV vaccine should be offered on an annual basis to all girls aged 12. As you are aware the immunisation programme in Ireland is based on the advice of the NIAC. The advice, based on public health considerations and supported by the cost-effectiveness analysis, is that HPV vaccines confer maximum benefit both individually and on a population basis if administered prior to HPV exposure.

The introduction of new vaccines is based on the expert advice of the NIAC. Decisions on the supply of vaccines into the market are undertaken by specific expert agencies rather than being the responsibility of the Minister of the day.

Each year in Ireland around 300 women are diagnosed with cervical cancer. The HPV vaccine protects against two high risk types of HPV (16 & 18) that cause 73% of all cervical cancers. Vaccinated women and girls will still be at risk from other high risk types of HPV that can cause cervical cancer and will therefore need to continue to have regular cervical smear tests.