Cormac Devlin (Dún Laoghaire, Fianna Fail)
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607. To ask the Minister for Health the status of a vaccine (details supplied) in the European Union; if it is being considered for authorisation by the EMA; when persons vaccinated with the vaccine will be officially considered vaccinated for the purposes of mandatory hotel quarantine and other such restrictions; and if he will make a statement on the matter. [23064/21]

Marian Harkin (Sligo-Leitrim, Independent)
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636. To ask the Minister for Health if he is considering exemption from mandatory hotel quarantining for those fully vaccinated with a vaccine (details supplied); and if he will make a statement on the matter. [23175/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 607 and 636 together.

As of 17th April, passengers who are fully vaccinated and have the documents to confirm this are no longer required to complete mandatory hotel quarantine on arrival in Ireland. Dependents, including children, will also be exempted from the requirement to complete mandatory hotel quarantine in this instance.

Please note that the 4 EMA approved vaccines currently accepted have specific definitions for when a person would be considered fully vaccinated.

The following table sets out the definition of ‘fully vaccinated’;

Fully vaccinated travellers are still required to have a negative pre-departure RT-PCR test and complete a period of self-quarantine at home or wherever specified in their passenger locator form.

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.