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. 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.
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. The introduction of new vaccines is based on the expert advice of the National Immunisation Advisory Committee (NIAC). 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.
The European Medicines Agency (EMA) has recently completed a 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.
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 27 November, the HPRA has received 936 reports of suspected adverse reactions or events notified in association with the use of HPV vaccines. Of the 936 reports received, 933 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. 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.
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.
The EMA 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.
