John McGuinness (Carlow-Kilkenny, Fianna Fail)
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214. To ask the Minister for Health further to Parliamentary Questions Nos. 831 and 832 of 2 May 2017, the basis on which he is making the claim that unfounded false claims have been made of an association between HPV vaccination and a number of conditions experienced by a group of young persons; if he will publish research, scientific or otherwise, that he has carried out which supports this statement; if no research has been undertaken by him, if he will now do so; the supports he will put in place for over 300 persons who are suffering ill heath and whose lives are devastated; if he will meet the persons concerned; and if he will make a statement on the matter. [30725/17]

Simon Harris (Wicklow, Fine Gael)
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As I have stated in previous PQ responses, there is no scientific evidence that the HPV vaccine causes any long term illness. The safety of all medicines, including vaccines, is an important matter and there are robust regulatory and monitoring systems in place at both EU and national level to ensure that the medicines we use are safe and effective.

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.

As part of its monitoring of the safety of medicines, the HPRA operates an adverse reaction reporting system, with healthcare professionals and patients 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.

In addition, pharmaceutical companies are obliged, as a condition of the authorisation to market a medicine, to submit reports of adverse reactions received directly, to the HPRA. In accordance with its reporting obligations, the HPRA provides anonymised details of reports received to the EMA, the WHO and to the relevant pharmaceutical companies. The fact that a suspected adverse reaction has been reported does not necessarily mean that the medicine has caused the observed effect, which may have also been caused by the disease being treated, a new disease the patient developed, or by another medicine that the patient is taking. Further data are usually needed to complete the picture.

In the context of monitoring the safety of medicines, new information on a possible risk is called a signal. Signals may arise from various data sources, including spontaneous reports, clinical trials and epidemiological studies. Once a signal has been identified, investigations are undertaken to consider the likelihood that a medicine may have caused or contributed to the effect, try to identify risk factors and estimate the frequency of occurrence. Following the assessment, a decision on the most appropriate regulatory action is taken by the competent authorities. The regulatory action is communicated to healthcare professionals, patients and the general public through established channels, and timelines reflect the degree of urgency.

The majority of reports received by the HPRA have been consistent with the expected pattern of adverse effects for the vaccines, as described in the product information (Summary of Product Characteristics and Package Leaflet). Vaccination related events, occurring at the time of vaccine administration, such as syncope (faints) has been among the most commonly reported effects. Other commonly reported symptoms include gastrointestinal symptoms, malaise, headache, dizziness and injection site reactions.

There is no indication or signal of a causal link between the symptoms suffered by the young women and administration of the HPV vaccine. However, this does not mean that their symptoms do not have a physical basis and it is important that any conditions they may have are properly diagnosed and receive appropriate treatment. The families of any girls suffering symptoms following HPV vaccination are advised to seek medical advice from their family doctor in the normal manner and be referred to consultants familiar with these syndromes for appropriate diagnosis and management.

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 applies 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 individual nature of the needs of some children may require access to specialist services and the HSE are currently working to put in place a clinical care pathway appropriate to the medical needs of this group.