Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

196. To ask the Minister for Health further to Parliamentary Question No. 1060 of 2 May 2017, if he will clarify a matter (details supplied). [22243/17]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

As I stated in my previous response, there is no scientific evidence that the HPV vaccine causes any long-term illness. The safety of all medicines, including vaccines, is not a trivial 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 should seek medical advice from their family doctor in the normal manner and be referred to consultants familiar with these syndromes for diagnosis and management.

More than 80 million girls and women worldwide have now received these vaccines, and in some European countries they have been given to 90% of the age group recommended for vaccination. Use of these vaccines is expected to prevent many cases of cervical cancer (cancer of the neck of the womb, which is responsible for over 20,000 deaths in Europe each year) and various other cancers and conditions caused by HPV.

Unfortunately, the false claims have led to a significant drop in uptake rates of the HPV vaccine from 87% in 2014/15 to 72% in 2015/16. This means that a large cohort of girls is now at risk of developing cervical cancer later in their lives.