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Covid-19 Pandemic

Dáil Éireann Debate, Wednesday - 14 July 2021

Wednesday, 14 July 2021

Questions (403)

Thomas Pringle


403. Deputy Thomas Pringle asked the Minister for Health the reason a vaccine (details supplied) is not being allowed as an authorised vaccine under the Irish system requiring those who have been vaccinated to spend time in mandatory hotel quarantining despite the fact that this is a WHO approved vaccine and there is no liability to the State in the event of any side effects given that the State has never supplied the vaccine; and if he will make a statement on the matter. [31391/21]

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Written answers (Question to Health)

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 Sinopharm vaccine has not been awarded a CMA to date.

Question No. 404 answered with Question No. 335.