Dáil Éireann Debate, Tuesday - 15 November 2016
488. Deputy Clare Daly asked the Minister for Health if there is a possibility of aluminium in Gardasil forms of HPV vaccines crossing the blood brain barrier; if he will publish any data held by his Department on this subject; and if he will make a statement on the matter. [34595/16]
View answer489. Deputy Clare Daly asked the Minister for Health if there is a possibility of potential synergistic toxicity of aluminium in HPV vaccines. [34596/16]
View answer490. Deputy Clare Daly asked the Minister for Health if pandemrix was at one time considered as safe as the HPV vaccines and that the benefits outweighed the risks; and if there is a possibility that the many autoimmune reactions being experienced by HPV vaccinated girls are following a similar pattern of neurological disturbances. [34597/16]
View answer491. Deputy Clare Daly asked the Minister for Health the data that the manufacturer submitted to the EMA which indicated that those pre-exposed to vaccine relevant HPV may experience a 44.6% increased risk of pre-cancerous lesions after vaccination with Gardasil; and the steps in place to monitor cervical cancer rates in the HPV vaccinated population. [34598/16]
View answerI propose to take Questions Nos. 488 to 491, 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.
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.
By January 2016, over 200 million doses of Gardasil had been distributed worldwide. In Ireland over 580,000 doses of Gardasil have been administered and over 220,000 girls have been fully vaccinated against HPV since it was introduced in 2010.
Aluminium has been used in vaccines for many decades to improve the body's response to vaccination. It is a component of Gardasil and several other vaccines. The World Health Organisation's (WHO) Global Advisory Committee on Vaccine safety (an expert clinical and scientific advisory body) has concluded that there is no evidence of a health risk from aluminium-containing vaccines.
The safety of the aluminium adjuvant used in Gardasil has been established in clinical studies and the level of aluminium present is tightly controlled as part of the quality control testing of the vaccine. Gardasil which contains amorphous aluminium hydroxyphosphate sulphate adjuvant was tested in nonclinical safety assessment studies where daily monitoring for physical signs did not reveal any notable effects on any physiological function. In addition, the safety of Gardasil was tested in human clinical studies and no signs of concern were identified. Apart from the expected immune response and local injection site reactions, there was no evidence of systemic effects (such as effects on CNS, respiratory, cardiovascular, and renal systems) caused by HPV L1 VLP vaccines such as Gardasil from study data and there is no data to suggest that Gardasil crosses the blood brain barrier. The pharmacological evaluation of Gardasil focused on the evaluation of primary pharmacodynamics (i.e. immunogenicity) as the vaccine did not show any effects apart from the expected immune response.
The European Medicines Agency (EMA) is a decentralised agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. It would not be appropriate to comment on data submitted by manufacturers of a medicinal product to the EMA as part of their market authorisation processes or monitoring of its safety following authorisation for use.
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 both nationally and at EU level. In Ireland, the Health Products Regulatory Authority (HPRA) is the statutory regulatory authority for medicines in Ireland.
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 of suspected adverse reactions submitted to the HPRA are reviewed and followed up as necessary to ensure all relevant information is available, prior to onward reporting to relevant stakeholders, including the EMA. At EU level, regulators continuously monitor this cumulative reporting experience as part of the ongoing assessment of the safety of HPV vaccines. 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 WHO and to the relevant pharmaceutical companies. 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 condition being treated, a new condition the patient developed, or by another medicine that the patient is taking. Further data are usually needed to complete the picture.
I am aware of claims of an association between HPV vaccination and a number of conditions experienced by a group of young women. 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. 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. The HSE are currently working to put in place a clinical care pathway appropriate to the medical needs of this group.
I encourage the parents of all eligible girls to ensure that their daughters receive this important cancer preventing vaccine.
