Dáil Éireann Debate, Thursday - 2 March 2017
250. Deputy Robert Troy asked the Minister for Health the role of the HSE and his Department regarding the Gardasil vaccine; if it is proactive or reactive to the claims made by persons (details supplied); and if he will make a statement on the matter. [11130/17]
Amharc ar fhreagra251. Deputy Robert Troy asked the Minister for Health his views on the national awareness of an ever increasing number of persons whose health may have been chronically damaged in the aftermath of the Gardasil vaccine (details supplied); and if he will make a statement on the matter. [11131/17]
Amharc ar fhreagra252. Deputy Robert Troy asked the Minister for Health his views on the Health Products Regulatory Authority statements on a television programme (details supplied). [11132/17]
Amharc ar fhreagra254. Deputy Robert Troy asked the Minister for Health his views on a matter (details supplied) concerning Gardasil; and if he will make a statement on the matter. [11134/17]
Amharc ar fhreagra255. Deputy Robert Troy asked the Minister for Health his views on a statement (details supplied) concerning Gardasil; and if his Department has taken all these findings into consideration while deciding to continue with the vaccination programme. [11135/17]
Amharc ar fhreagra256. Deputy Robert Troy asked the Minister for Health his views on the numerous Gardasil safety studies including one released recently (details supplied). [11136/17]
Amharc ar fhreagra259. Deputy Robert Troy asked the Minister for Health his views on matters (details supplied) relating to the HPV vaccine. [11139/17]
Amharc ar fhreagra260. Deputy Robert Troy asked the Minister for Health his views on the role of sodium borate in the HPV vaccine. [11140/17]
Amharc ar fhreagra261. Deputy Robert Troy asked the Minister for Health his views on the role of sodium borate in the HPV vaccine; if his attention has been drawn to the fact that the US Centres for Disease Control and Prevention vaccine excipient and media summary lists four vaccines (details supplied) that contain sodium borate; and if he will make a statement on the matter. [11141/17]
Amharc ar fhreagraI propose to take Questions Nos. 250 to 252, inclusive, 254 to 256, inclusive, and 259 to 261, inclusive, 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. The Health Products Regulatory Authority (HPRA) and the European Medicines Agency (EMA) in Europe continually monitor adverse events to vaccination. All relevant and appropriate information is taken into account when deciding to make changes to the State's immunisation programmes.
Each year in Ireland around 300 women are diagnosed with cervical cancer. The HPV 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. NIAC recommended that the human papillomavirus (HPV) vaccine be given to all girls aged 12-13 in 2009 and in September 2010 the HPV vaccination programme was introduced for all girls in first year of second level schools.
Gardasil is the HPV vaccine used in Ireland in the context of the HSE schools immunisation programme. In Ireland more than 660,000 doses of Gardasil have been administered and almost 250,000 girls have been vaccinated against HPV. Over 205 million doses of the HPV vaccine Gardasil have been distributed worldwide, either as part of national immunisation programmes or by private doctors. Gardasil is currently used in over 25 European countries, the United States, Canada, Australia and New Zealand.
No medicine, including vaccines, is entirely without risk, there is therefore on-going pharmaco vigilance 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 both nationally and at EU level. In Ireland, the HPRA is the statutory regulatory authority for medicines in Ireland and, along with the EMA in Europe, continually monitors adverse events to vaccination.
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 booklets include information on the most common adverse events that can occur after each vaccination. Seizures, muscle weakness, leg pain, joint pain and chronic fatigue are not mentioned as known side effects to Gardasil in the Patient Information Leaflet. There are no known long term side effects to the vaccine Gardasil. 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. The Patient Information Leaflet does not state ovarian failure, painful and chronic severe daily headaches, seizures, neurological condition, chest pain, paralyses, onset of auto immune conditions, muscle weakness, joint and leg pain, heart problems, systemic inflammation, short term memory. 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.
I am aware of claims of an association between HPV vaccination and a number of conditions experienced by a group of young women. An illness that occurs around the time a vaccine is given and is already known to be common in adolescence does not imply the vaccine caused the problem. It appears that some girls first suffered symptoms around the time they received the HPV vaccine, and understandably some parents have connected the vaccine to their daughter’s condition. As there is no scientific evidence that the vaccine causes long term illnesses, the HPV vaccine cannot be held responsible for these illnesses. It is important to reassure people that anyone who is suffering ill health is eligible to seek medical attention, and to access appropriate health and social care services, irrespective of the cause of their symptoms. The individual nature of the needs of some children may require access to specialist services and the HSE are currently working to put in place a clinical care pathway appropriate to the medical needs of this group.
The HPRA which monitors the safety of all medicines in Ireland has received 1072 spontaneously reported adverse reactions and events associated with use of the HPV vaccines from doctors and members of the public since 2006. The vast majority of reports received by the HPRA have been consistent with the expected pattern of short term and self limited adverse effects for the vaccines, as detailed above from the Patient Information Leaflet. Though the Irish media report that anti-vaccine groups report there are several hundred girls suffering chronic fatigue like conditions adverse events after the HPV vaccine, the HPRA has received less than 30 reports of chronic fatigue like conditions and autoimmune disease together and one report of suspected premature ovarian failure after HPV vaccine administration since 2006. These numbers are much less than the estimated prevalence of chronic fatigue syndrome likes conditions and premature ovarian failure occurring by chance among a population of almost 250,000 Irish girls who have received the vaccine. One would expect to see at least 300 cases of chronic fatigue syndrome like conditions and more than 20 cases of premature ovarian insufficiency reported in a group this size. However this has not been seen despite all the media attention given to this vaccine. This HPRA surveillance data provides evidence supporting the good safety profile of the HPV vaccine and is consistent with data from international regulatory bodies. Consequently, there is no scientific biological or epidemiological evidence of the HPV vaccine causing chronic medical conditions.
The focus for the HPV programme in 2017 is to counter misinformation in relation to the safety of the HPV vaccine, and to increase the uptake rate in girls as part of the schools immunisation programme. The benefits of HPV vaccines outweigh the known side effects. The safety of these vaccines, as with all medicines, will continue to be carefully monitored and will take into account any future new evidence of side effects that becomes available. I encourage the parents of all eligible girls to ensure that their daughters receive this important cancer preventing vaccine.
