Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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584. To ask the Minister for Health if a version of a vaccine (details supplied) will be considered and accepted as a valid and viable vaccine by the National Immunisation Advisory Council and the European Medicines Agency; if it will be considered in the plans to accept returning vaccinated persons as restrictions are lifted; and if he will make a statement on the matter. [22943/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Ireland supports the EU Procurement Process, the purpose of which is to secure safe and efficacious vaccines for EU citizens.

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. No vaccine will be used until Market authorisation from the European Medicines Agency (EMA) is obtained and any authorised vaccine will be subject to ongoing monitoring in Ireland by the Health Product Regulatory Authority (HPRA).

The delivery of vaccines under APAs that the Commission has negotiated on behalf of Member States are predicated upon a CMA being obtained from the Commission (on the basis of a positive recommendation being awarded by the EMA).

The awarding of a CMA provides a high level of assurance that a vaccine has undergone rigorous testing and has met the requirements of the independent regulatory process as regards demonstrating its safety and efficacy.

The AstraZeneca Covishield ChAdOx1 nCoV-19 Recombinant is not currently approved for use in Ireland.