Dáil Éireann Debate, Tuesday - 13 October 2015
234. Deputy John Browne asked the Minister for Health his views that schools are an appropriate environment for providing vaccinations for first year students, some of whom are only in their first few months in their new school; that this is a safe environment for same; and if he will make a statement on the matter. [35717/15]
Amharc ar fhreagra249. Deputy Michael Moynihan asked the Minister for Health if he is aware of the possible adverse reactions to the human papilloma virus vaccine; if he has evaluated the evidence relating to these potential long-term side effects; the steps he will take to address these issues; if a review has taken place, given the recent decision by the Danish health authorities to cease using this particular vaccine; and if he will make a statement on the matter. [35351/15]
Amharc ar fhreagra304. Deputy John Browne asked the Minister for Health if he is aware that the human papilloma virus vaccine, Gardasil, was fast-tracked on to the market; the reason it is considered appropriate to fast-track this vaccine; and if he will make a statement on the matter. [35595/15]
Amharc ar fhreagra321. Deputy John Browne asked the Minister for Health given that it is medically accepted that there will be issues with all vaccines, the supports he plans to put in place for girls who may become injured as a result of receiving the human papilloma virus vaccine; and if he will make a statement on the matter. [35718/15]
Amharc ar fhreagra324. Deputy John Browne asked the Minister for Health if he will recognise that Pandemrix was at one time considered as safe as the human papilloma virus vaccines, that the benefits outweighed the risks, and the possibility that the many auto-immune reactions being experiences by vaccinated girls are following a similar pattern of neurological disturbances; and if he will make a statement on the matter. [35743/15]
Amharc ar fhreagra330. Deputy Billy Kelleher asked the Minister for Health if he will respond to concerns regarding the Gardasil vaccine; and if he will make a statement on the matter. [35750/15]
Amharc ar fhreagra339. Deputy Maureen O'Sullivan asked the Minister for Health the steps he will take to cease dispensing of the human papilloma virus vaccine until after the review, given the growing international uncertainty over the safety of this vaccine, that some countries have suspended its us, and others currently have criminal investigations taking place [35805/15]
Amharc ar fhreagraI propose to take Questions Nos. 234, 249, 304, 321, 324, 330 and 339 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 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 school based immunisation has been used successfully to vaccinate primary school children for over 30 years to protect children from vaccine preventable diseases and is now reaching the 95% vaccination rate recommended by the World Health Organisation. Vaccinations programmes were extended to second level schools since the introduction of the human papillomavirus vaccination programme in 2010 and uptake rates have exceeded the target of 80% for a three dose course in first year girls.
The National Immunisation Office (NIO) provides and updates Guidelines annually for staff who work in the School Immunisation Programme. The NIO continually liaises with the Department of Education in the implementation of the school vaccination programmes and the local HSE vaccination teams work very closely with the school management and staff to minimise disruption. The school based service also provides an additional clinic service where parents can attend with children if there are difficulties with school vaccination.
In Ireland, the Health Products Regulatory Authority (HPRA) is the regulatory authority for medicines in Ireland. Gardasil® is a medicinal product which has been authorised for use across the European Union since September 2006 following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA). The procedure timelines were not fast-tracked (a US term) or accelerated (the EU term). The procedure started on 28 December 2005, a positive opinion was issued by the EMA's scientific committee on 7 July 2006, and a marketing authorisation was issued by the Commission on 20 September 2006. Allowing for the time period taken by the applicant for responses, the time between start of the procedure and the scientific committee's opinion was 190 days.
While no medicine (including vaccines) is entirely without risk, the safety profile of Gardasil® has been continuously monitored since it was first authorised both nationally and at EU level. This is done by both monitoring of individual adverse reaction reports received by competent authorities across Europe (including the HPRA) and Periodic Safety Update Reports (PSURs) submitted by the Marketing Authorisation Holder (i.e. license holder) for the vaccine on a regular basis.
Up to the 11 September 2015, the Health Products Regulatory Authority (HPRA) has received 901 reports of suspected adverse reactions/events notified in association with the use of HPV vaccines (Gardasil® 899 and Cervarix® 2). The vast majority of reports received by the HPRA regarding both Gardasil® and Cervarix vaccines to date have been consistent with the expected pattern of adverse effects for the vaccines, as described in the product information. Vaccination related events, occurring at the time of vaccine administration, such as syncope (faints) has been among the most commonly reported effects. Other commonly reported symptoms include gastrointestinal symptoms, malaise, headache, dizziness and injection site reactions. Reports of allergic-type reactions including skin rashes, urticaria and flushing have also been received, including isolated reports of more severe hypersensitivity-type reactions.
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 (https://www.hpra.ie/homepage/about-us/report-an-issue). 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. All reports received through the online reporting options receive an acknowledgement and case record number on successful submission of a report. Further information is provided to reporters in respect of any questions/concerns reflected in their reports, in the context of report follow up. In accordance with its reporting obligations, the HPRA provides anonymised details of reports received to the EMA, the World Health Organisation and to the marketing authorisation (i.e. licence) holder for the medicine.
The EMA has commenced a review of the human papilloma virus (HPV) vaccine "to further clarify aspects of their safety profile," although the agency points out that this review "does not question that the benefits of HPV vaccines outweigh their risks ." The review is specifically focusing on rare reports of two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome associated with heart rate increase. Recommendations from the first stage of this review are expected in November. The agency also notes that while the review is being carried out, no change in the use of these products is recommended.
In addition the EMA is currently evaluating data from a new epidemiological study on the safety of human papilloma virus (HPV) vaccines, Gardasil® and Cervarix®. The study conducted jointly by the French medicines agency (ANSM) and the French national health insurance fund (CNAMTS) compared the incidence of autoimmune conditions in girls given HPV vaccines with the incidence in girls not given the vaccines. In the meantime, the EMA have advised healthcare professionals that available data does not warrant any change to the use of these vaccines. Healthcare professionals should therefore continue using Gardasil® and Cervarix® in accordance with the current product information.
It has been confirmed by the Danish authorities that they continue to offer HPV vaccination to 12 year old girls as part of the Danish child immunisation programme.
