Written answers

Thursday, 15 July 2021

Department of Health

Vaccination Programme

Photo of Michael McNamaraMichael McNamara (Clare, Independent)
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322. To ask the Minister for Health if he will allow the administration of a second dose of a vaccine (details supplied) to healthcare workers who have received a first dose of another vaccine and are concerned about the overall efficacy of the first vaccine against some variants after two doses in certain circumstances; and if he will make a statement on the matter. [31750/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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Ireland's COVID-19 vaccination programme strategy is to distribute all available vaccine as quickly as is operationally possible, prioritising those who are most vulnerable to COVID-19.

The programme is based on the principles of safety, effectiveness and fairness, with the objective of reducing severe illness, hospitalisations and deaths from COVID-19 infection.

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 the Department of Health. The NIAC review all data relating to COVID-19 vaccines on a rolling basis.

Following the recommendation for use of vaccines against COVID-19 by the European Medicines Agency (EMA) and authorisation for use by the European Commission, the NIAC develops guidance for their use in Ireland which is contained in the Immunisation Guidelines for Ireland. These guidelines are continuously updated and include guidance on all new vaccines as they are approved for use in Ireland.

The current Guidelines state:

There are currently four COVID-19 Vaccines authorised for use in Ireland. The vaccines are not interchangeable. For vaccines that have a two-dose schedule, the same vaccine should be used for both doses. The NIAC will continue to review the evidence concerning the safety and efficacy of a heterologous vaccination strategy (using a different vaccine for the first and subsequent doses of a multi-dose schedule) as it becomes available.

You can read the guidelines at: www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/covid19.pdf.

Photo of Michael McNamaraMichael McNamara (Clare, Independent)
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323. To ask the Minister for Health the system he has put in place to record side-effects of Covid-19 vaccinations carried out in Ireland; if such data is published or the way it can be accessed; and if he will make a statement on the matter. [31751/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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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 in which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions to vaccination. 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 HPRA follows up on reports of suspected adverse reactions received from healthcare professionals and members of the public through the voluntary reporting system, including any deaths notified following vaccination.

The latest safety update from the HPRA regarding COVID-19 vaccinations is available here: www.hpra.ie/homepage/medicines/safety-notices/item?t=/safety-update-covid-19-vaccines-overview-of-national-reporting-experience-17-june-2021&id=f3c50f26-9782-6eee-9b55-ff00008c97d0.

Photo of Róisín ShortallRóisín Shortall (Dublin North West, Social Democrats)
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324. To ask the Minister for Health when he will review the EMA approval of a vaccine (details supplied) for 12-15 year olds; if medically vulnerable children in this age cohort will be included in cohorts 4 and 7 for the vaccine roll-out; the timeline for same; and if he will make a statement on the matter. [31819/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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Ireland welcomes the European Medicines Agency age extension recommendation for the COVID-19 vaccine Comirnaty to include use in children aged 12 to 15. The National Immunisation Advisory Committee is reviewing the matter and will make a recommendation as appropriate. Currently, Ireland's COVID-19 Vaccination Programme is administering vaccines to those aged 16+.

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