Leo Varadkar (Dublin West, Fine Gael) | Oireachtas source

I thank Senator Mooney for giving me the opportunity to update the House on this important matter. I acknowledge the concerns of families who believe their daughters have experienced adverse reactions and health issues after receiving the HPV vaccine. The vaccine protects against two high-risk types of HPV that cause 73% of all cervical cancers. It is estimated that the HPV vaccination will save 60 lives annually in this country.The vaccine used in the school immunisation programme is gardasil, a fully tested vaccine which was licensed by the European Medicines Agency in 2006. Following this, the national immunisation advisory committee recommended that the vaccine should be offered to all girls aged 12 years on an annual basis.

The Health Products Regulatory Authority, HPRA, is the regulatory authority for medicines in Ireland. 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. Decisions on the supply of vaccines are undertaken by specific expert agencies rather than being the responsibility of the Minister of the day. This is as it should be as it ensures that decisions are made solely on scientific information and expert advice, rather than being implemented by political pressure or lobbying.

As part of its monitoring of the safety of medicines, the HPRA operates an adverse reaction reporting system, where health care professionals and patients are encouraged to report adverse reactions they consider may be associated with their treatment. All reports received are evaluated and considered for 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. I have been informed by the HPRA that up to 9 October it had received 921 reports of suspected adverse reactions or events notified in association with the use of HPV vaccines. The vast majority have been consistent with the expected pattern of adverse effects for the vaccines, as described in the product information, such as gastrointestinal symptoms, malaise, headache, dizziness and soreness or a rash at the injection site. These are short-lived.

As is the case for all licensed medicines, the safety of these vaccines is monitored by the pharmacovigilance and risk assessment committee, an EU-level drug safety committee, where the authority is represented and actively contributes. I am aware that the European Medicines Agency 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 HPRA is participating in the review, which aims to clarify aspects of their safety profile and is specifically focusing on rare reports of two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome. In the meantime, the European Medicines Agency has advised health care professionals that available data does not warrant any change to the use of HPV vaccines. Health care professionals should therefore continue using them in accordance with the current product information. Any changes to this advice will be made following the outcome of the review.