Éamon Ó Cuív (Galway West, Fianna Fail)
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1796. To ask the Minister for Health when the vaccination compensation scheme will be set up for those who have suffered adverse effects from the Covid vaccine and other vaccines; and if he will make a statement on the matter. [18333/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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As the Deputy will be aware, any patient concerned with any possible side-effects following their COVID-19 vaccination should, in the first instance, consult with their medical practitioner who can refer them as necessary to appropriate services following clinical assessment.

Additionally, it should be noted that COVID-19 vaccines can only be approved and used if they comply with all the requirements of quality, safety and efficacy set out in the EU pharmaceutical legislation. Any authorised vaccine will be subject to ongoing monitoring in Ireland by 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. The HPRA and the European Medicines Agency (EMA) continually monitor adverse reactions to vaccination. The HPRA operates a national adverse reaction reporting system, to 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. The latest safety updates from the HPRA regarding COVID-19 vaccinations are available here: www.hpra.ie/homepage/medicines/covid-19-updates/covid-19-vaccine-communications

Regarding a vaccine damage compensation scheme, during the pandemic, all available Department of Health resources were devoted to the Public Health response, this has meant that work in this area could not be progressed. Further scoping work is required to inform decision-making in this area. This remains under consideration by my Department.

Catherine Connolly (Galway West, Independent)
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1797. To ask the Minister for Health further to Parliamentary Question No. 844 of 31 March 2021, the progress of the vaccine injury compensation scheme for the Covid-19 vaccine; and if he will make a statement on the matter. [18337/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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As the Deputy will be aware, any patient concerned with any possible side-effects following their COVID-19 vaccination should, in the first instance, consult with their medical practitioner who can refer them as necessary to appropriate services following clinical assessment.

Additionally, it should be noted that COVID-19 vaccines can only be approved and used if they comply with all the requirements of quality, safety and efficacy set out in the EU pharmaceutical legislation. Any authorised vaccine will be subject to ongoing monitoring in Ireland by 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. The HPRA and the European Medicines Agency (EMA) continually monitor adverse reactions to vaccination. The HPRA operates a national adverse reaction reporting system, to 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. The latest safety updates from the HPRA regarding COVID-19 vaccinations are available here: www.hpra.ie/homepage/medicines/covid-19-updates/covid-19-vaccine-communications

Regarding a vaccine damage compensation scheme, during the pandemic, all available Department of Health resources were devoted to the Public Health response, this has meant that work in this area could not be progressed. Further scoping work is required to inform decision-making in this area. This remains under consideration by my Department.