Dáil Éireann Debate, Thursday - 14 April 2016
392. Deputy Finian McGrath asked the Minister for Health to clarify who is responsible if there is a side-effect of the human papilloma virus Gardasil vaccine (details supplied); and if he will make a statement on the matter. [6433/16]
View answerThe immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). NIAC is a committee of the Royal College of Physicians of Ireland comprising of experts in a number of specialties including infectious diseases, paediatrics and public health. The committee's recommendations are informed by public health advice and international best practice.
In Ireland, the Health Products Regulatory Authority (HPRA) is the regulatory authority for medicines in Ireland. 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 over 200,000 girls have received this vaccine since its introduction in 2010.
In addition to their desired effects, all medicines (including vaccines) have the potential to cause unwanted side effects (also known as adverse reactions). These effects may be mild and transient, or more serious necessitating treatment to manage symptoms. In the case of vaccination, reporting of experience with use is particularly encouraged, reports may represent true adverse reactions or adverse events that are coincidental to vaccination and may be due to underlying illness/conditions that would also have occurred in the absence of vaccination. Patients/carers should be advised to liaise with healthcare professionals involved in their care for clinical assessment and for any investigation, guidance and advice needed to manage/treat symptoms or conditions they consider may be associated with vaccination.
The HPRA encourages patients (and carers), as well as healthcare professionals to report any suspected adverse reactions experienced to HPRA, so that any possible new risks may be identified and investigated, allowing for any appropriate regulatory action, such as product information updates reflecting the current knowledge of the vaccine and the risks known to occur in association with its use to be implemented and communicated, as necessary.
The HSE provides information for parents about diseases, the vaccines to prevent them and side effects to allow them to choose whether or not to give consent to vaccination. All vaccination information provided to parents is prepared from the available licensed documentation for each vaccine, the Summary of Products Characteristics and Patient Information Leaflet. The information is presented in clear simple language and approved by the National Adult Literacy Agency so that it can be understood by all adults as the average reading age in Ireland is 12 years of age.
Prior to all school immunisation parents receive an information pack in a sealed package which contains an information leaflet, consent form and cover letter. Information packs for all immunisation are standardised nationally. The information booklets include information on the most common adverse events that can occur after each vaccination. 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.
Should parents require additional information about vaccines the immunisation leaflet refers to the HSE’s national immunisation website (www.immunisation.ie ). The national immunisation website has been accredited by the World Health Organisation for credibility, content and good information practices. The website allows members of the public to contact the National Immunisation Office to ask a question if they require further information. These questions, when possible, are answered by the staff of the National Immunisation Office within one working day.
