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Vaccination Programme

Dáil Éireann Debate, Tuesday - 27 July 2021

Tuesday, 27 July 2021

Questions (1741, 1915)

Holly Cairns

Question:

1741. Deputy Holly Cairns asked the Minister for Health further to Parliamentary Questions Nos. 914, 941, 945, 947, 954, 963, 981, 982, 983, 984, 988, 1002, 1003, 1004, 1005, 1041, 1069, 1078, 1083 and 1087 of 28 April 2021, the status of Covid-19 vaccines (details supplied) receiving EMA approval; and if he will make a statement on the matter. [35303/21]

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Patrick Costello

Question:

1915. Deputy Patrick Costello asked the Minister for Health if he will work to obtain European Medicines Agency approval of a vaccine (details supplied) given it is already approved by the WHO and many Irish persons in particular those residing in the Middle East have already received this vaccine. [35861/21]

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Written answers

I propose to take Questions Nos. 1741 and 1915 together.

Ireland is participating in an EU Procurement process with a view to accessing a portfolio of candidate vaccines against COVID-19 which are being negotiated with vaccine manufacturers by the Commission acting on behalf of Member States. Emergency Support Instrument (ESI) funding has been leveraged by the Commission to facilitate its negotiations with vaccine manufacturers, including with regard to production costs and securing a reduced per dose cost for Member States.

This process has provided Ireland with access to vaccines (at a reduced cost) that it would find it difficult to access otherwise within a year after the declaration of a Public Health Emergency of International Concern by the WHO. Four of the vaccines in the EU portfolio have already been awarded Conditional Marketing Authorisation (CMA) by the Commission.

Ireland supports efforts made by the Commission to safeguard the production and delivery of doses of vaccine in the quantities agreed with vaccine suppliers and to ensure that up-front funding provided through ESI has been properly used.

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 quality, safety and efficacy.

The EMA has started a rolling review of the Sputnik V COVID-19 Vaccine but it has not been awarded a CMA to date. The Sinopharm vaccine has not been awarded a CMA to date.

Question No. 1742 answered with Question No. 1541.
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