Dáil Éireann Debate, Tuesday - 3 November 2015
735. Deputy Clare Daly asked the Minister for Health if the case of the 110 teenage girls who having taken Gardasil and who have all presented with the same or similar life-altering symptoms should be investigated, with particular reference to their assessment, diagnosis and treatment; and if he will make a statement on the matter. [37745/15]
View answerIn Ireland the National Immunisation Advisory Committee (NIAC) which comprises experts in a number of specialties including infectious diseases, paediatrics and public health make recommendation on vaccination policy in Ireland. Their recommendations are based on the prevalence of the relevant disease in Ireland and international best practice in relation to immunisation. The NIAC guidance is regularly updated and the latest updates including details of local and general adverse events to each vaccine are available on the HSE website.
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. The vaccine protects against two high risk types of HPV (16 and 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.
While no medicine, including vaccines, is entirely without risk, the safety profile of Gardasil® has been continuously monitored since it was first authorised nationally and at EU level. This is done by monitoring both individual adverse reaction reports received by competent authorities across Europe and Periodic Safety Update Reports submitted by the Marketing Authorisation Holder for the vaccine on a regular basis. The introduction of new vaccines is based on the expert advice of the 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.
All vaccines are licensed by the HPRA and the European Medicines Agency (EMA). No vaccine is or will be licensed by the HPRA and the EMA unless it is has been approved as safe by the Licensing Authority.
As part of its monitoring of the safety of medicines, the HPRA operates an adverse reaction reporting system, with healthcare professionals and patients 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. All reports received through the online reporting options receive an acknowledgement and case record number on successful submission of a report and further information is provided to reporters in respect of any questions/concerns reflected in their reports, in the context of report follow up. In addition, pharmaceutical companies are obliged, as a condition of the authorisation to market a medicine, to submit reports of adverse reactions received directly, to the HPRA. In accordance with its reporting obligations, the HPRA provides anonymised details of reports received to the EMA, the World Health Organisation and to the relevant pharmaceutical companies.
In the context of monitoring the safety of medicines, new information on a possible risk is called a signal. Signals of possible, previously unknown adverse reactions or changes in the severity, characteristics or frequency of known adverse reactions may arise from various data sources, including spontaneous reports, clinical trials and epidemiological studies. Once a signal has been identified, investigations are necessary to confirm and quantify the risk. These investigations consider the likelihood that a medicine may have caused or contributed to the effect, try to identify risk factors and estimate the frequency of occurrence. Following the assessment of a safety signal, a decision on the most appropriate regulatory action is taken by the competent authorities. The regulatory action is communicated to healthcare professionals, patients and the general public through established channels, and timelines reflect the degree of urgency. The established channels include publications on websites, information provided to patient and healthcare professionals and the media as well as direct mailing to healthcare professionals.
The HPRA is participating in the Pharmacovigilance and Risk Assessment Committee's (PRAC) review of HPV vaccines to clarify aspects of their safety profile. As for all licensed medicines, the safety of these vaccines is monitored by the PRAC (an EU level drug safety committee) where the HPRA is actively represented and contributes.
The EMA has commenced a review of the 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 (CRPS, a chronic pain condition affecting the limbs) and postural orthostatic tachycardia syndrome (POTS, a condition where the heart rate increases abnormally after sitting or standing up, causing symptoms such as dizziness and fainting, as well as headache, chest pain and weakness). Reports of these conditions in young women who have received a HPV vaccine have been previously considered during routine safety monitoring by the PRAC but a causal link between them and the vaccines was not established. Both conditions can occur in non-vaccinated individuals and it is considered important to further review if the number of cases reported with HPV vaccine is greater than would be expected. The outcome of the PRAC review is anticipated before the end of this year.
As of the 9 October, the HPRA has received 921 reports of suspected adverse reactions or events notified in association with the use of HPV vaccines. Of the 921 reports received, 918 were associated with use of Gardasil® and three were associated with Cervarix®. This level of reporting for Gardasil® reflects the very positive response to calls for monitoring and reporting of national experience associated with use of the vaccine and the very high level of vaccine uptake, following its introduction into the national immunisation programme which commenced in May 2010. The vast majority of reports received by the Authority have been consistent with the expected pattern of adverse effects for the vaccines, as described in the product information. The fact that a suspected adverse reaction has been reported does not necessarily mean that the medicine has caused the observed effect, which may have also been caused by the disease being treated, a new disease the patient developed, or by another medicine that the patient is taking.
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.
The EMA has advised healthcare professionals that available data does not warrant any change to the use of HPV vaccines. Healthcare professionals should therefore continue using Gardasil® and Cervarix® in accordance with the current product information.
