DÁIL QUESTIONS addressed to the Minister for Health (Leo Varadkar) by Deputy Regina Doherty (09/06/2015)  

QUESTION NOS: 501 to 503, For WRITTEN answer on Thursday, 9th June, 2015:

* 501. To ask the Minister for Health the persons and bodies responsible financially for the medical costs for the young persons who as a result of receiving the Human Papilloma Virus vaccine had an adverse reaction; and if he will make a statement on the matter.
- Regina Doherty T.D.

* 502. To ask the Minister for Health the reason the age category of 12 to 13 years of age was chosen to administer the Human Papilloma Virus vaccine; and if he will make a statement on the matter.
- Regina Doherty T.D.

* 503. To ask the Minister for Health if the manufacturer of the Human Papilloma Virus vaccine (details supplied) is indemnified against prosecution; and if he will make a statement on the matter.
- Regina Doherty T.D.

Details Supplied: Gardasil

REPLY.
The Joint Oireachtas Committee Report on Childhood Immunisation made recommendations in relation to the development of vaccination services for children in Ireland. Since that time the majority of the recommendations made in the report have been addressed and implemented. In relation to the recommendation regarding a no fault vaccine damage compensation scheme my Department convened an expert group to examine this issue. The report from this Group is available on my Department's website (www.health.gov.ie). There are no plans to introduce a vaccine damage compensation scheme at this time. The HPV vaccine protects girls from developing cervical cancer when they are adults. It is available free of charge from the HSE for all girls in 1st year of secondary school. This is in accordance with the recommendation received from the National Immunisation Advisory Committee which indicated that the vaccine should be offered on an annual basis to all girls aged 12. 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 manufacturer of the HPV vaccine used in the immunisation programme in Ireland has not been indemnified against criminal prosecution.

QUESTION NO: 504
DÁIL QUESTION addressed to the Minister for Health (Leo Varadkar)
by Deputy Regina Doherty
for WRITTEN ANSWER on 09/06/2015
* To ask the Minister for Health since the commencement of the HPV vaccine, the number of young persons who have had a reaction to the vaccine; the type of reaction by category; the percentage of the young persons vaccinated who had a reaction; and if he will make a statement on the matter.
Regina Doherty T.D.

REPLY.
Gardasil® has been authorised for use across the European Union (EU) since 2006 and has been in widespread use in a number of member states since then. In addition to the European approval, it is currently authorised for use in 133 countries worldwide, including approvals by both the US Food and Drug Administration (FDA) and the Therapeutic Good Administration in Australia. It is estimated that over 165 million doses of Gardasil® have been distributed worldwide since it was first authorised (figures to end of May 2014). Figures on national distribution and usage are available from the HSE.
Since first authorisation the Health Products Regulatory Authority (HPRA) has continuously monitored the safety of Gardasil®. This monitoring includes review of global safety data in addition to national experience with use of the vaccine.
Up to 20 April 2015, the HPRA has received 849 reports of adverse reactions associated with Gardasil®. The vast majority of these reports relate to adolescents, with a smaller number occurring in adults >18 years of age, which is reflective of Gardasil® usage as part of the national HPV immunisation programme. No new risks have been identified in association with national use of Gardasil®. The national monitoring experience has been consistent with the expected pattern of adverse effects for the vaccine, as outlined in the product information, including injection site reactions, malaise, headache, myalgia, fatigue, gastrointestinal symptoms and skin reactions (including urticaria). Vaccination related events such as dizziness and syncope were among the most commonly reported reactions. Hypersensitivity reactions have also been reported including a small number of anaphylactic-type reactions in patients, who have recovered following intervention and treatment. It is estimated that over 590,000 doses of Gardasil® have been distributed in Ireland to date since the commencement of the HPV schools immunisation programme.. 

If your child has suffered health issues that you think may have been triggered by Gardasil, and you wish to get in contact with other parents who have had a similar experience, please contact us at: