Seán Fleming (Laois, Fianna Fail)
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217. To ask the Minister for Health if he will address concerns raised in correspondence (details supplied); and if he will make a statement on the matter. [15878/17]

Simon Harris (Wicklow, Fine Gael)
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This PQ concerns correspondence from an individual representing a group opposed to immunisation against HPV. In this correspondence he expresses concern about the vaccine and it effectiveness in preventing cervical cancer. Cervical cancer is the fourth most common cancer in women worldwide. Each year in Ireland around 300 women are diagnosed with cervical cancer and 100 die from the disease. All cervical cancers are linked to high risk Human Papillomavirus (HPV) types. In 2009 the National Immunisation Advisory Committee (NIAC) recommended HPV vaccination for all 12 year old girls to reduce their risk of cervical cancer and in September 2010 the HPV vaccination programme was introduced for all girls in first year of second level schools.

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 is provided free of charge to girls in first year of second level school. Gardasil has been authorised for use across the European Union since September 2006 following a positive opinion from the Committee for Medicinal Products for Human Use at the European Medicines Agency (EMA). It is a fully tested vaccine which protects against the main cancer-causing strains of the Human Papilloma Virus (HPV 16 & 18) and will eventually save around 60 lives in Ireland every year. 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.

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. The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines that are licensed in Ireland. The HPRA and the European Medicines Agency (EMA) in Europe continually monitor adverse events to vaccination. The vast majority of reports received by the HPRA have been consistent with the expected pattern of short term adverse side effects for the vaccine, as described in the product information. The most frequently reported side effects are local redness and /or swelling at the point of injection and fever. These are usually mild and temporary reactions to any kind of vaccination. Fainting has occurred after vaccination with Gardasil, especially in adolescents.

The EMA completed a detailed scientific review in November 2015 of the evidence surrounding reports of two conditions: complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS). The Agency’s Committee for Medicinal Products for Human Use concurred that the available evidence does not support that CRPS and POTS are caused by HPV vaccines. It therefore did not recommend any changes to the terms of licensing or the product information for these medicines. On 12 January 2016 the European Commission endorsed the conclusions of the European Medicines Agency, that there is no change to the way HPV vaccines are used, or to amend the current product information. This final outcome by the Commission is now binding in all members states.

I am aware of claims of an association between HPV vaccination and a number of conditions experienced by a group of young women. An illness that occurs around the time a vaccine is given and is already known to be common in adolescence does not imply the vaccine caused the problem. 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 diverse nature of these symptoms, which can have both physical and psychological causes, are shared by many conditions which has implications for both diagnostic and treatment services. The individual nature of the needs of some children may require access to specialist services and the HSE are currently working to put in place clinical care pathways appropriate to the differing medical needs of this group. As there is no scientific evidence that the vaccine causes long term illnesses, the HPV vaccine cannot be held responsible for these illnesses.

It is important to counter misinformation in relation to the safety of vaccines, and to increase the uptake rates of all vaccines in the State’s immunisation programmes. The scientific evidence is clear and misinformation is causing real harm to those unvaccinated children and adults who develop vaccine preventable diseases, and to people who seek inappropriate treatments for real conditions that are not caused by vaccines. The benefits of HPV vaccines outweigh the known side effects. The safety of these vaccines, as with all medicines, will continue to be carefully monitored and will take into account any future new evidence of side effects that becomes available.

My Department has already sent a reply to the original query.