Dáil Éireann Debate, Tuesday - 19 January 2016
377. Deputy Thomas P. Broughan asked the Minister for Health the number of cases of adverse side effects of the human papilloma virus vaccine, Gardasil, including the severity of these side effects in each of the years 2010 to 2015 and in 2016 to date; and if he will make a statement on the matter. [2251/16]
View answer378. Deputy Thomas P. Broughan asked the Minister for Health if he is examining cases of adverse side effects of the human papilloma virus vaccine, Gardasil, and the literature provided with the vaccine; and if he will make a statement on the matter. [2252/16]
View answerI propose to take Questions Nos. 377 and 378 together.
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.
At the start of the HSE’s schools immunisation programme in 2010 the HPRA requested reporting of all suspected adverse reactions (side effects) associated with use of Gardasil and since that time 958 reports have been submitted to the HPRA. A breakdown of reports per year is as follows:
|
Year |
Number of reports of suspected adverse reactions/events submitted to the HPRA in association with Gardasil |
|
2010 |
256 |
|
2011 |
255 |
|
2012 |
142 |
|
2013 |
129 |
|
2014 |
58 |
|
2015 |
108 |
|
2016 (to 08/01/2016) |
10 |
The vast majority of reports received have been consistent with the expected pattern of adverse effects associated with use of Gardasil, as described in the product information. These include vaccination related events occurring at the time of vaccine administration, such as:
- syncope (faints) which have been among the most commonly reported effects. Other commonly reported symptoms include malaise, headache, myalgia (muscle pain), gastrointestinal symptoms, dizziness and injection site reactions;
- Reports of allergic-type reactions including skin rashes.
Other reports include experiences of persisting/chronic fatigue or persistent joint/muscle/nerve pain, in some cases with multiple other symptoms (e.g. headache, malaise, drowsiness, nausea, gastrointestinal upset, joint swelling, nausea, flu like illness, menstrual disorders etc.) following vaccination. Some reports have indicated that a diagnosis of Chronic Fatigue Syndrome (CFS) has been made, while in others, follow up and investigations are on-going.
All reports of suspected adverse reactions submitted to the HPRA were transmitted to the EMA's Eudravigilance database and were considered as part of the ongoing EU review. The first and second stage of this review concluded in late 2015 and the EMA recommended that it did not consider there was any need to change the way the HPV vaccines are used or to amend the current product information. The review recognised that more than 80 million girls and women worldwide have now received these vaccines and in some European countries they have been given to 90% of the age group recommended for vaccination. The matter is now with the European Commission for a final and binding decision. Use of these vaccines is expected to prevent many cases of cervical cancer (cancer of the neck of the womb, which is responsible for tens of thousands of deaths in Europe each year) and various other cancers and conditions caused by HPV. The benefits of HPV vaccines therefore continue to outweigh their risks.
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.
