Michael Fitzmaurice (Roscommon-Galway, Independent)
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172. To ask the Minister for Health if the National Health Service App from the United Kingdom or a certificate as proof of full vaccination will be accepted here thus allowing persons from Britain with proof of double vaccination to travel freely to Ireland without having to face mandatory hotel quarantine; and if he will make a statement on the matter. [30510/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Under the current public health travel measures vaccinated persons arriving into Ireland from overseas, including from the UK, are required to present evidence of a negative / non-detected pre-departure RT-PCR test taken within 72 hours of arrival and to observe mandatory home quarantine.

The UK is not currently a designated state. Further, as provided by SI No. 183/2021, persons who are fully vaccinated by an EMA approved vaccine are exempted from requirements to quarantine at MHQ.

International travel policy is kept under continuous consideration and Government is responding proactively to balancing the risks associated with increased travel with the re-opening of society and non-essential overseas travel. Changes to the current travel policy are intended to come into effect on 19 July, subject to prevailing public health situation.

Jim O'Callaghan (Dublin Bay South, Fianna Fail)
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175. To ask the Minister for Health if the European Medicines Agency is assessing a Covid-19 vaccine (details supplied) for validation; and if so, the status of any such process; and if he will make a statement on the matter. [30513/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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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 also not been awarded a CMA to date.