Tony McLoughlin (Sligo-Leitrim, Fine Gael)
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238. To ask the Minister for Health his views on the 2008 FDA closing statement on Gardasil that reports that 73.3% of the healthy girls who participated in the clinical trials developed new medical conditions; if his attention has been drawn to the fact, whether he is aware that the vaccine was taken off the recommended vaccine schedule in Japan due to its adverse effects; and if he will make a statement on the matter. [31360/16]

Simon Harris (Wicklow, Fine Gael)
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The immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). NIAC is a committee of the Royal College of Physicians of Ireland comprising of experts in a number of specialties including infectious diseases, paediatrics and public health. The committee's recommendations are informed by public health advice and international best practice.

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. NIAC recommended that the human papillomavirus (HPV) vaccine be given to all girls aged 12-13 in 2009 and in September 2010 the HPV vaccination programme was introduced for all girls in first year of second level schools.

By January 2016, over 200 million doses of Gardasil had been distributed worldwide. In Ireland over 580,000 doses of Gardasil have been administered and over 220,000 girls have been fully vaccinated against HPV since it was introduced in 2010.

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. In Ireland, the Health Products Regulatory Authority (HPRA) is the statutory regulatory authority for medicines in Ireland. While no medicine (including vaccines) is entirely without risk, the safety profile of Gardasil has been continuously monitored since it was first authorised both nationally and at EU level.

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. It is important to reassure people 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. The HSE are currently working to put in place a clinical care pathway appropriate to the medical needs of this group.

In November 2015, the European Medicines Agency completed a detailed scientific review of the HPV vaccine. The review, which the HPRA participated in, specifically focused on rare reports of two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome associated with heart rate increase. The outcome of the review which was carried out by the EMA Pharmacovigilance and Risk Assessment Committee (PRAC) found no evidence of a causal link between the vaccine and the two conditions examined. The European Medicines Agency has advised health care 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. Healthcare professionals should therefore continue using the vaccines in accordance with the current product information.

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.

The Deputy refers to vaccination policy in Japan. While it would be inappropriate for me to comment on the vaccination policy of another country I note that the controversy over HPV vaccination in Japan has led to much confusion among health care professionals and parents. HPV vaccination was approved in Japan in 2009. Free vaccination began in December 2010 for Japanese girls aged 12–16 years, and since April 2013 the vaccine has been included in the national immunisation programme. However, in June 2013 the Japanese Ministry of Health, Labour, and Welfare suspended pro-active recommendations for the HPV vaccine after unconfirmed reports of adverse events following vaccination appeared in the media. In January 2014 the Vaccine Adverse Reactions Review Committee in Japan investigating these adverse events concluded that there was no evidence to suggest a causal association between the HPV vaccine and the reported adverse events after vaccination. Consequently Japan's regulatory authority has not removed this vaccine. It is still categorised as a publicly subsidised routine vaccination and is available to those who request it.

I encourage the parents of all eligible girls to ensure that their daughters receive this important cancer preventing vaccine.