Michael Healy-Rae
Question:332. Deputy Michael Healy-Rae asked the Minister for Health the status of the administration of the human papilloma virus vaccine (details supplied); and if he will make a statement on the matter. [2014/16]
View answerTuesday, 19 January 2016
Questions (332, 380)
Finian McGrath
Question:380. Deputy Finian McGrath asked the Minister for Health to support a matter (details supplied) regarding vaccine concerns; and if he will make a statement on the matter. [2254/16]
View answerWritten answers
I propose to take Questions Nos. 332 and 380 together.
The 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.
Immunisation is regarded as one of the safest and most cost-effective of health care interventions. The HPV vaccine, which was introduced in 2010, protects girls from developing cervical cancer when they are adults. The vaccine is available free of charge from the HSE for all girls in 1st year of secondary school. This is in accordance with the recommendation received from the NIAC which indicated that the HPV vaccine should be offered on an annual basis to all girls aged 12. The advice, based on public health considerations and supported by the cost-effectiveness analysis, is that HPV vaccines confer maximum benefit both individually and on a population basis if administered prior to HPV exposure. The vaccine protects against two high risk types of HPV (16 & 18) that cause 73% of all cervical cancers. Vaccinated women and girls will still be at risk from other high risk types of HPV that can cause cervical cancer and will therefore need to continue to have regular cervical smear tests.
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 100,000 girls have received this vaccine since its introduction. Decisions on the supply of vaccines into the market are undertaken by specific expert agencies rather than being the responsibility of the Minister of the day.
Gardasil is a fully tested vaccine which was licensed by the European Medicines Agency in 2006. No medicine, including vaccines, is entirely without risk, there is therefore on-going pharmacovigilance and monitoring of medicinal products once they are authorised for use. The safety profile of Gardasil has been continuously monitored since it was first authorised.
As part of its monitoring of the safety of medicines, the HPRA operates an adverse reaction reporting system, where healthcare professionals and patients are 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.
As of the 8 January, the HPRA has received 961 reports of suspected adverse reactions or events notified in association with the use of HPV vaccines. Of the 961 reports received, 958 were associated with use of Gardasil and three were associated with Cervarix. The vast majority have been consistent with the expected pattern of adverse effects for the vaccines, as described in the product information, such as gastrointestinal symptoms, malaise, headache, dizziness and injection site reactions.
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) where further information is available. 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.
Parents of any child with a suspected adverse reaction following administration of a vaccine are advised to contact the HSE vaccination teams or their general practitioner for advice and are referred for further management if required.
In November 2015 the European Medicines Agency completed a detailed scientific review of the HPV vaccine. The review which the HPRA participated in, specifically focused on rare reports of two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome associated with heart rate increase. The outcome of the review which was carried out by the EMA Pharmacovigilance and Risk Assessment Committee (PRAC) found no evidence of a causal link between the vaccine and the two conditions examined.
The European Medicines Agency has advised healthcare professionals that available data does not warrant any change to the use of HPV vaccines as there are no new safety concerns regarding HPV vaccines. Healthcare professionals should therefore continue using the vaccines in accordance with the current product information.