Dáil Éireann Debate, Wednesday - 3 April 2019
183. Deputy Michael Healy-Rae asked the Minister for Health his views on the education available for users of the HPV vaccine; his further views on whether full information should be made available to all persons before they avail of the service (details supplied); and if he will make a statement on the matter. [15661/19]
Amharc ar fhreagra185. Deputy Michael Healy-Rae asked the Minister for Health the reason the Health Products Regulatory Authority, HPRA, is not reporting the figures of adverse effects of the HPV vaccine to the public (details supplied); and if he will make a statement on the matter. [15663/19]
Amharc ar fhreagraI propose to take Questions Nos. 183 and 185 together.
The Health Service Executive is committed to providing accurate information to 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.
It is not the case that parents are being denied the information on the Patient Information Leaflet. 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 account of the available licensed documentation for each vaccine, the Summary of Product Characteristics and Patient Information Leaflet. The HSE parent information leaflet refers parents to the website (www.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 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. Like other countries providing school immunisation programmes, the Patient Information Leaflet was replaced by an information leaflet which provides the same information on the potential side effects of the vaccine in a manner that meets the needs of those with reading difficulties.
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 was 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 or their GP if they have any further questions.
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 and the European Medicines Agency (EMA) continually monitor adverse events to vaccination. 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. HPV is one of the most closely studied and monitored medicinal products. Considering the totality of available information, the benefits of the HPV vaccines continue to outweigh their risks. 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 HPRA has a dedicated section on their website for information in relation to the HPV Schools Immunisation Programme. The HPRA updates this section in relation to reports of suspected adverse reactions relating to the HPV vaccine approximately bi-annually, with the last update covering the period to 31/12/2018. All reports are considered as ‘serious’ if they meet the regulatory definition of a ‘serious’ adverse reaction, which includes any circumstances where patients require intervention (e.g. review by their GP) and/or treatment for their symptoms.
