Bríd Smith (Dublin South Central, People Before Profit Alliance)
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332. To ask the Minister for Health if he, his Department, or representatives of the HSE have met or will meet with representatives of a group (details supplied) to discuss its concerns on vaccine-related side effects; if he can detail the safeguards and measures taken by the HSE and his Department to monitor and review the effectiveness and health impacts of the ongoing vaccine programme; and if he will make a statement on the matter. [61519/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). 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 European Medicines Agency (EMA) is the body which can authorise vaccines for EU Member States. In relation to COVID19, the EMA and its scientific committees are supported by the COVID-19 EMA pandemic task force, a group that brings together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.

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.

The manufacturer 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 manufacturers are subject to independent assessment and inspection by national medicines agencies.

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 EMA continually monitor any adverse reactions 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.

Whilst I can not answer for the HSE, to my knowledge neither I nor my officials have met with the group to which the Deputy refers. I have asked the HSE to respond directly to the Deputy to answer on their behalf the queries raised in the question.