Written answers

Wednesday, 28 April 2021

Department of Health

Vaccination Programme

Photo of Joe CareyJoe Carey (Clare, Fine Gael)
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971. To ask the Minister for Health his plans to approve and to use a vaccine (details supplied) in the current Covid-19 vaccination programme; and if he will make a statement on the matter. [21607/21]

Photo of Dara CallearyDara Calleary (Mayo, Fianna Fail)
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972. To ask the Minister for Health the situation regarding the regulatory approval of a vaccine (details supplied); and if he will make a statement on the matter. [21608/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 971 and 972 together.

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 Sinopharm vaccine has not been awarded a CMA to date.

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