Malcolm Byrne (Fianna Fail)
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I thank the Minister of State for coming into the House to address this issue concerning vaccines which have not been approved by the European Medicines Agency, EMA. I acknowledge the enormous success of the vaccination programme to date. We are jabbing more arms in Ireland now for the size of our population than anywhere else in the world. Everybody involved in that operation deserves our thanks and congratulations on that achievement.

The Minister of State will be aware that the European Medicines Agency has approved four vaccines. However, I am raising the question of Irish citizens outside the European Union who may have received a non-EMA-approved vaccine. This includes people who may have received the Sinovac or Sinopharm vaccines, as well as the AstraZeneca vaccine developed in India. This is particularly a problem for Irish citizens working, generally as teachers, engineers or other professionals, in the Middle East and other parts of the world. Those people’s employers arranged for them to get these vaccines very early during the global vaccination process and this situation now represents a difficulty for those people in returning home because Ireland only recognises the EMA-approved vaccines.

This situation will also present a challenge to the roll-out of the digital Covid-19 certificates. The EU is operating on the basis that only vaccines that have been approved by the EMA can be used for certificates. It is up to each of the individual countries in the EU or the European Economic Area, EEA, however, to determine who may enter each respective state. The difficulty which arises then is a discrepancy between the criteria in different European countries. Spain, for example, will accept all EMA-approved vaccines and those approved by the World Health Organization to meet the criteria for entry, which gives a total of eight vaccines overall. Greece and Estonia, then, will accept the vaccines which are recognised in the country of departure. Therefore, if somebody is leaving Dubai to travel to Greece, for instance, and he or she has been vaccinated with a vaccine recognised in Dubai, the Greek authorities will accept that as meeting their requirements for entry. In Iceland, the authorities will allow entry to someone who has been vaccinated with AstraZeneca in South Korea, as well as with the Sinovac vaccine. A similar situation exists in Cyprus and Hungary, because those countries have also administered other vaccines. In Slovenia, meanwhile, people will be permitted to enter once 21 days have elapsed, regardless of the vaccine received.

Across Europe, then, there is a divergence in the approaches which will be taken. Our concern regarding this matter is obviously for those Irish citizens seeking to return home, especially if they have spent much of the time during the Covid-19 pandemic away from Ireland but have now received a non-EMA-approved vaccine. We need clarity regarding what is going to happen concerning this situation, depending on how long it may take for the EMA to recognise those other vaccines. I also raise this matter in the context of a concern regarding international students coming to Ireland in the autumn.It is a crucial issue for our higher education institutions and it is welcome that we will see on-campus activity resume in the autumn. It is essential that we start to see international students coming back. Obviously, many of these international students will have received vaccines. I am thinking in particular of students who may be coming here from China or other parts of Asia. They will have received other vaccines. It will be challenging if we, as an authority, do not provide clarity to them on the situation.

Frank Feighan (Sligo-Leitrim, Fine Gael)
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I thank the Senator for raising this question and providing me with the opportunity to update the House on this matter on behalf of the Minister for Health, Deputy Donnelly.

Covid-19 has created unprecedented challenges for Irish citizens at home and overseas who seek to travel. Public health requirements have been put in place for travellers arriving to Ireland from overseas in order to protect against the introduction of new cases of Covid-19 and newly developing variants across the world. Based on knowledge to date, the safest way to reopen society, including to international travel, is to continue to control disease incidence through a range of public health measures which are continuously reviewed, along with progressing the national vaccination programme to ensure as many people as possible within the population are protected through immunisation.

Under the current measures, travellers to Ireland who are fully vaccinated with European Medicines Agency approved vaccines are exempt from hotel quarantine but are still required to show a negative pre-departure RT-PCR test and to complete a period of self-quarantine at home. The accepted Covid-19 vaccines have received market authorisation from the EMA and, therefore, comply with all the requirements of quality, safety and efficacy set out in the EU pharmaceutical legislation. Authorised vaccines are also subject to ongoing monitoring in Ireland by the Health Products Regulatory Authority, HPRA.

The Government has announced that new travel policies will be introduced from 19 July, subject to the prevailing public health situation. While it is not intended to depart from recognition of EMA approved vaccinations, the measures that apply following travel overseas will be revised and the new travel measures will be publicised in advance of 19 July.

The Senator has raised some issues on which I have received correspondence and which I have passed up the line. In Spain, all eight EMA and WHO vaccines are recognised, as is the case in Greece and Estonia. They are able to bring back from Dubai people who have received vaccinations other than those approved by the EMA. We are conscious of these issues and they are being examined in the Department. I have no answer for the Senator today but it is appreciated that it is an issue that, hopefully, can be addressed.

Malcolm Byrne (Fianna Fail)
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I thank the Minister of State. There is an urgency to addressing this matter. We are speaking about potentially thousands of Irish citizens who, in good faith, took the vaccine their company or the country where they were working offered them. They received it and they want to be fully vaccinated. They want to follow the rules but they also want to be able to come home. It would be very unfair to force them into mandatory hotel quarantining. They may have received a WHO approved vaccine that has not yet been approved by the EMA. They are willing to take a PCR test. We have to create circumstances in which we can allow Irish people to come home. In advance of the autumn, we have to provide clarity for international students who are going to come here. It is an essential part of the higher education experience that we have international students in Ireland. I appreciate what the Minister is saying but with the digital Covid certificate coming into operation from next week, there is an urgency to this issue.

Frank Feighan (Sligo-Leitrim, Fine Gael)
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I restate the importance of decisions we have taken on international travel. Measures introduced in response to the risks posed by Covid-19 are in place to protect the progress we are making in suppressing transmission rates at home while the national vaccination programme progresses. Important developments are under way as we transition to a new travel policy. Ireland has begun to issue EU digital green certificates to vaccinated persons. In the coming weeks, the passenger locator form will be overhauled to provide for smoother boarding and checking of documents. From 19 July, quarantine requirements will be lifted for many travellers. Continuous consideration is being given by the Government to policy on international travel to ensure we strike the right balance between containment of the risks and facilitating safe international travel.

I thank the Senator for his remarks regarding the vaccination progress. It is very good to see we are probably top in the EU for vaccinations to date. I thank all of the front-line staff and everybody who has made this possible.