Written answers

Wednesday, 3 February 2016

Department of Health

Vaccination Programme

Photo of John BrowneJohn Browne (Wexford, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

68. To ask the Minister for Health to establish an independent investigation into the adverse affects of the Gardasil vaccination; and if he will make a statement on the matter. [4555/16]

Photo of John BrowneJohn Browne (Wexford, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

69. To ask the Minister for Health to put financial and educational supports in place to assist persons affected by the adverse affects of the Gardasil vaccination; and if he will make a statement on the matter. [4556/16]

Photo of Leo VaradkarLeo Varadkar (Minister, Department of Transport, Tourism and Sport; Dublin West, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 68 and 69 together.

The HPV vaccine, Gardasil 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.

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.

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.

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.

I am aware of claims of an association between HPV vaccination and a number of conditions experienced by a group of young women. It appears that some girls first suffered symptoms around the time they received the HPV vaccine, and understandably some parents have connected the vaccine to their daughter’s condition.

I want to make it quite clear 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. The individual nature of the needs of some children may require access to specialist services.

In November 2015 the European Medicines Agency completed a detailed scientific review of the HPV vaccine. The review, in which the HPRA participated, found no evidence of a causal link between the vaccine and the two conditions examined.

On 12 January 2016 the European Commission endorsed the conclusion of the European Medicines Agency stating that there is no need to change the way HPV vaccines are used or to amend the product information. This final outcome by the Commission is now binding in all member states.

Comments

No comments

Log in or join to post a public comment.