Michael Healy-Rae
Question:118. Deputy Michael Healy-Rae asked the Minister for Health if matters (details supplied) regarding the HPV vaccine will be addressed; and if he will make a statement on the matter. [52526/18]
View answerThursday, 13 December 2018
Questions (118, 119, 120, 121, 122)
Michael Healy-Rae
Question:119. Deputy Michael Healy-Rae asked the Minister for Health if matters (details supplied) regarding the HPV vaccine will be addressed; and if he will make a statement on the matter. [52529/18]
View answerMichael Healy-Rae
Question:120. Deputy Michael Healy-Rae asked the Minister for Health if matters (details supplied) regarding the HPV vaccine will be addressed; and if he will make a statement on the matter. [52530/18]
View answerMichael Healy-Rae
Question:121. Deputy Michael Healy-Rae asked the Minister for Health if matters (details supplied) regarding the HPV vaccine will be addressed; and if he will make a statement on the matter. [52531/18]
View answerMichael Healy-Rae
Question:122. Deputy Michael Healy-Rae asked the Minister for Health if matters (details supplied) regarding the HPV vaccine will be addressed; and if he will make a statement on the matter. [52532/18]
View answerWritten answers
I propose to take Questions Nos. 118 to 122, inclusive, together.
The Health Service Executive is committed to providing accurate information for parents about diseases, the vaccines to prevent them and potential side effects to allow them to choose whether or not to give consent to vaccination.
The HSE's National Immunisation Office has developed a comprehensive range of materials for parents, schools and medical practitioners as part of the immunisation programme. All the information provided to parents about vaccination takes into account the available licensed documentation for each vaccine, the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL).
The Patient Information Leaflet provides information on the vaccine, its uses and on any precautions that require advice from a healthcare professional before it is administered. Therefore, like other countries providing school immunisation programmes, the Patient Information Leaflet is replaced by an information leaflet which provides the same information on the potential side effects of the vaccine in a manner that ensures that it is easily understood.
The information is presented in clear and simple language which has been approved by the National Adult Literacy Agency, ensuring that it can be understood by all adults. The Health Information and Quality Authority guide ‘Communicating in plain English’ (2015), developed in partnership with NALA, states that “one in six people find reading and understanding everyday texts difficult: for example, reading a health leaflet, bus timetable or medicine instructions”.
Prior to all school immunisations, parents receive an information pack in a sealed package with an information leaflet, consent form and cover letter. The information packs for all immunisations are standardised nationally. The information booklets include information on all the known potential side effects that can occur after each vaccination (as is the case with the HPV vaccine, Gardasil). Parents are also given contact details for their local immunisation office and advised to speak to a member of the school immunisation team if they have any further questions.
It is not the case that parents are being denied the information on the Patient Information Leaflet. In fact, the HSE parent information leaflet refers parents to the HPV website (hpv.ie) where links to additional information including the licensing documentation, the Summary of Products Characteristics and the Patient Information Leaflet for each vaccine can be found. The HPV website has been endorsed by the World Health Organisation.
While no medicine (including vaccines) is entirely without risk, the safety profile of Gardasil has been continuously monitored since it was first authorised in September 2006 both nationally and at EU level.
The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland. The HPRA operates a national adverse reaction reporting system, which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions through this system. All Reports received by the HPRA are routinely transmitted to the European Medicines Agency's adverse reaction database for inclusion in global signal detection and monitoring activities.
The HPRA and the European Medicines Agency (EMA) continually monitor adverse events to vaccination. Gardasil is one of the most closely studied and monitored medicinal products. 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. Mild and temporary reactions to any kind of vaccination are not unusual.
It is important to reiterate that all medicines, including vaccines are subject to on-going review and evaluation of all available data from a range of sources, including systematic scientific literature review, to consider any impact that their data may have on the overall assessment of the benefits and risks of a medicinal product. Taking into account the totality of the available information, the benefits of the HPV vaccines continue to outweigh their risks. The safety of these vaccines continues to be monitored at EU level through the EMA and its expert committees, which includes representatives from member state competent authorities such as the HPRA.
I would also like to reassure 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. As there is no scientific evidence that the vaccine causes long term illnesses, the HPV vaccine cannot be held responsible for these illnesses.
I would urge any parent who has doubts or questions about vaccination to engage with your family doctor, or alternatively to visit the HPV website.