Mary Lou McDonald (Dublin Central, Sinn Fein)
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530. To ask the Minister for Health if there are plans under way to assess additional Covid-19 vaccines for validation or accreditation with the European agencies or the European Medicines Agency; and if he will make a statement on the matter. [49434/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Ireland is participating in a Procurement Exercise being operated by the European Commission on behalf of Member States to procure suitable, safe and effective vaccines, in sufficient quantities, to combat COVID-19.

Four vaccines have been authorised by the EU to date; Comirnaty (Pfizer/BioNTech), Spikevax (Moderna), Vaxzevria (AstraZeneca) and Janssen.

A number of vaccine candidates are currently under rolling review by the EMA including NVX-CoV2373 (Novavax), CVnCoV (CureVac) and Sputnik V (Gam-COVID-Vac).

When medicines are under rolling review, the European Medicines Agency’s (EMA) human medicines committee CHMP evaluates clinical trial data as soon as these become available until it decides there is enough evidence for the developer to apply for marketing authorisation

The EMA cannot provide exact timelines as these depend on when developers provide the necessary data for CHMP review. The EMA updates the status of each medicine under rolling review when the developer applies for marketing authorisation.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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531. To ask the Minister for Health if there is a pathway available to Irish citizens to avail of an EU Digital Covid certificate who have been fully vaccinated with a non-EMA approved vaccine outside of the EU; and if he will make a statement on the matter. [49435/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The EU Digital COVID Certificate Regulation allows for Digital COVID Certificates to be provided to Union citizens vaccinated in a third country provided that the Member State has been provided with reliable proof of vaccination.

Ireland is developing the capability for Digital COVID Certificates are to be issued to Irish passport holders vaccinated in third countries with vaccines approved for use in Ireland.

The list of vaccines accepted in Ireland for travel purposes is listed on gov.ie and is kept under continuous review.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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532. To ask the Minister for Health when phase 2 of the implementation of the EU Digital Covid certificate will be open to applications from non-EU countries; when it is estimated this portal will be open to persons to apply; and if he will make a statement on the matter. [49436/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The EU Digital COVID Certificate Regulation allows for Digital COVID Certificates to be provided to Union citizens vaccinated in a third country provided that the Member State has been provided with reliable proof of vaccination.

Ireland is developing the capability for Digital COVID Certificates are to be issued to Irish passport holders vaccinated in third countries with accepted vaccines. This does not include non-Irish citizens vaccinated in third countries.

Phase 1 of the online portal began to accept applications from Irish passport holders vaccinated in Northern Ireland who hold a Northern Irish COVID vaccination certificate with a QR code on 29th September. Phase 2 will accept applications from Irish passport holders vaccinated in other non-EU countries with an Irish approved vaccine regimen.

This phase is currently in development.