Eugene Murphy (Roscommon-Galway, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

448. To ask the Minister for Health his views on the administration of the Gardasil vaccine to persons who develop types of auto antibodies that were not present before the vaccine was administered (details supplied); and if he will make a statement on the matter. [6048/18]

Eugene Murphy (Roscommon-Galway, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

450. To ask the Minister for Health his views on whether general practitioners should inform persons (details supplied) of post-Gardasil vaccine reactions. [6050/18]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 448 and 450 together.

Vaccination is regarded as one of the safest and most cost-effective of all health care interventions. It is also one of the most effective ways a parent can protect the health of their child. Ireland’s childhood immunisation programmes have had a huge impact in improving the health of the Irish population. Diseases that used to be common in this country and around the world such as polio, measles, diphtheria, whooping cough and many other serious infectious diseases are now preventable by vaccination.

The Health Products Regulatory Authority (HPRA) and the European Medicines Agency (EMA) continually monitor adverse events to vaccination. HPV is one of the most closely studied and monitored medicinal products. The vast majority of reports received by the HPRA have been consistent with the expected pattern of short term adverse side effects for the vaccine, as described in the product information. The most frequently reported side effects are local redness and /or swelling at the point of injection and fever. These are usually mild and temporary reactions to any kind of vaccination. Fainting has occurred after vaccination with Gardasil, especially in adolescents.

The HSE is committed to providing accurate information for parents about diseases, the vaccines to prevent them and side effects to allow them to choose whether to give consent to vaccination. All the information provided to parents about vaccination is prepared from the available licensed documentation for each vaccine, the Summary of Products Characteristics (SPC) and Patient Information Leaflet (PIL).

All medicines, including vaccines are subject to on-going review and evaluation of all available data from a range of sources, including systematic scientific literature review, to consider any impact that their data may have on the overall assessment of the benefits and risks of a medicinal product. Taking into account the totality of the available information, the benefits of the HPV vaccines continue to outweigh their risks. The safety of these vaccines continues to be monitored at EU level through the European Medicines Agency (EMA) and its expert committees, which includes representatives from member state competent authorities such as the Health Products Regulatory Authority (HPRA).

The HPRA is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland and operates a national adverse reaction reporting system, which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions through this system. All Reports received by the HPRA are routinely transmitted to the EMA's adverse reaction database for inclusion in global signal detection and monitoring activities. The Patient Information Leaflet provides information on the vaccine, its uses and on any precautions that require advice from a healthcare professional before it is administered.

Adjuvants (immune potentiators or immunomodulators) have been used for decades to improve the immune response to vaccine antigens. The incorporation of adjuvants into vaccine formulations is aimed at enhancing, accelerating and prolonging the specific immune response towards the desired response to vaccine antigens. Advantages of adjuvants include the enhancement of the immunogenicity of antigens, modification of the nature of the immune response, the reduction of the antigen amount needed for a successful immunisation, the reduction of the frequency of booster immunisations needed and an improved immune response in the elderly and immunocompromised.

The question asks me to comment on academic research concerning the HPV vaccine. It would be inappropriate for me, as Minister, to express views on individual pieces of academic research.

I would urge any parent who has doubts or questions about vaccination to engage with their family doctor, or alternatively to visit the HPV website - www.hpv.ie. This source of information is clear and accurate and will answer any queries that you may have.

Eugene Murphy (Roscommon-Galway, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

449. To ask the Minister for Health his views on the selection of persons for the trial of vaccines (details supplied). [6049/18]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

The efficacy of a vaccine for a specific disease is usually defined as the reduction in the chance of developing the disease after vaccination relative to the chance when unvaccinated, as determined in a prospective randomised controlled trial. Clinical trials submitted in an application for a marketing authorisation to place a medicine on the market are reviewed, including the trial methodology, how biases were controlled, and all aspects of vaccine safety, including allergic reactions. Once the efficacy, safety and quality has been reviewed and the vaccine is considered to have a positive benefit-to-risk balance, it is then authorised. The authorised product information provides information on the safe use of the vaccine, and specifically contraindicates the use of the vaccine in patients with known hypersensitivity to the active substances or other inert ingredients.  

Vaccines may be given in accordance with official recommendations but they are never mandated, and the contraindications and warnings outlined in the product information are taken into account prior to administration to a specific patient; for example, hypersensitivity or a patient’s immune status. Vaccines on the market are continuously monitored and this will provide additional safety data on less frequent and rare adverse events. Additionally, ongoing safety studies from the medical literature are reviewed and further changes to the product information may be proposed or, if necessary, a reassessment of its benefit/risk is performed.  

In summary, a vaccine is rigorously tested in clinical trials before being authorised for use, and regularly reviewed once it is on the market.