Dáil Éireann Debate, Tuesday - 23 June 2020
486. Deputy Niall Collins asked the Minister for Health his views on matters raised in correspondence by a person (details supplied) regarding vaccinations; and if he will make a statement on the matter. [12250/20]
Amharc ar fhreagraIt is important to note that vaccine hesitancy is not unique to Ireland. It is a global issue and was identified by the World Health Organisation as one of the ten leading threats to global health in 2019.
One of my priorities as Minister for Health is to increase vaccination rates across the country and several options in this area are being explored. In this regard, I wrote to the Attorney General to seek legal advice as to the Constitutionality of introducing schemes of mandatory vaccination. The requested legal advice is being reviewed by my Department.
In addition, I launched the Vaccine Alliance in September 2019. Its aim is to increase the uptake of childhood vaccines and reduce vaccine hesitancy. The group includes a wide range of organisations and further organisations will be added once the terms of reference, key target audiences, and priorities for the Vaccine Alliance have been agreed.
The immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). The NIAC is a committee of the Royal College of Physicians of Ireland comprising of experts in several specialties including infectious diseases, paediatrics and public health. The committee's recommendations are based on the prevalence of the relevant disease in Ireland and international best practice in relation to immunisation. It makes recommendations on vaccination policy to my Department. The NIAC continues to revise recommendations to allow for the introduction of new vaccines in Ireland and to keep abreast of changes in the patterns of disease. Therefore, the immunisation schedule will continue to be amended over time.
The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland. The HPRA and the European Medicines Agency (EMA) continually monitor adverse events to vaccination. The HPRA operates a national adverse reaction reporting system, which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions to. 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.
Prior to use in humans all vaccine formulations undergo preclinical testing. These typically involve a range of in vitro tests followed by a comprehensive range of toxicity studies in animals. These studies identify potential safety concerns and serve to avoid possible harm to human subjects. Clinical safety studies are conducted during the clinical trials and the safety data that is collected is based on events reported after each dose of vaccine and also events reported after a longer time post-vaccination. Clinical trials run for a defined period and safety data will be collected from trial participants for a defined period post vaccination. This period of time may differ between trials. In addition, vaccines on the market are continuously monitored to provide additional safety data and to identify adverse reactions. Under the regulatory framework, benefit-risk evaluations continue to be carried out throughout the product lifecycle.
Manufacture of vaccines must also comply with good manufacturing standards and regulatory requirements in EU and national legislation to ensure that the materials and methods used are appropriate. Vaccine manufactures are subject to independent assessment and inspection by national medicines agencies. It is important to reiterate that 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. The safety of these vaccines continues to be monitored at EU level through the EMA and its expert committees, which includes representatives from member state competent authorities such as the HPRA.
