Roll-out of Covid-19 Vaccination: Discussion

I welcome all the witnesses who will be presenting to us this morning by video link and who will provide us with a briefing on the roll-out of the Covid-19 vaccination. As members are aware, the High-Level Task Force on COVID-19 Vaccination published its national Covid-19 vaccine programme strategy and its accompanying vaccination programme implementation plan yesterday afternoon.

I welcome Professor Brian MacCraith, chair of the High-Level Task Force on COVID-19 Vaccination; Dr. Colm Henry, member of the High-Level Task Force on COVID-19 Vaccination and chief clinical officer with the Health Service Executive; Mr. Fergal Goodman, assistant secretary, Department of Health; Dr. Ronan Glynn, deputy chief medical officer, Department of Health; and Professor Karina Butler, chair, National Immunisation Advisory Committee, Royal College of Physicians of Ireland.

Before we hear their opening statements, I need to point out to the witnesses that there is uncertainty as to whether parliamentary privilege will apply to their evidence provided from a location outside of the parliamentary precincts of Leinster House. Therefore, if the witnesses are directed by me to cease giving evidence in relation to a particular matter, they must respect that direction. The witnesses are all very welcome this morning. I call on Professor MacCraith to make his opening remarks.

Professor Brian MacCraith

I thank the Deputies and Senators and welcome this opportunity to give my opening statement. It is a little longer than five minutes but not too much longer. I will try to shorten it as much as I can to make it more accessible for the members of the committee.

The Government established the High-Level Task Force on Covid-19 Vaccination on 10 November 2020 to ensure that the right oversight and specialist input is available to support the HSE and the Department of Health in the effective, efficient and agile delivery of the Covid-19 vaccination programme. I was appointed chair of the task force, which has met three times to date. A fourth meeting is scheduled for this afternoon.

The agreed terms of reference are: to support the Department of Health and Health Service Executive to deliver a Covid-19 immunisation programme, that meets best practice and provides good governance, as a critical public health intervention in the prevention and control of Covid-19; working with the Department of Health and the HSE, to develop a national Covid-19 vaccination strategy and implementation plan for the safe, effective and efficient procurement, distribution, delivery and recording of Covid-19 vaccines when approved vaccines are ready to be distributed; to provide a focal point for engagements with sectoral and specialist expertise as may be needed to support the development, implementation and agile iteration of both the strategy and the plan; and to monitor progress and report to Government, as may be required, on the development and implementation of the strategy and plan.

When the task force was established, there was already significant work on a vaccination programme ongoing across both the HSE and the Department of Health, and implementation of the strategy will rely in the normal way on the governance structures and statutory responsibilities of a range of existing bodies. Given the range of responsibilities and actors, and the level of responsiveness that will be required as the programme rolls out, there will be a need to augment and support existing arrangements. It is useful in that context to be clear about the role of the task force in the context of those existing roles and responsibilities.

In respect of immunisation programmes and policies, the role of the Department of Health includes making policy decisions based on advice from the National Immunisation Advisory Committee, NIAC. These are then implemented by the HSE through the National Immunisation Office, NIO. In the context of this vaccination programme, the Department of Health has responsibility for overall public health policy, legislative and regulatory arrangements, and EU co-operation arrangements, and it is also leading on communications for the programme. The HSE has ultimate responsibility for the delivery of the Covid-19 vaccination programme through its NIO, which designs and implements all vaccination programmes in Ireland. The role of the NIO in the vaccination programme includes vaccine procurement and distribution; immunisation training; certain communications to the public; and logistical considerations for vaccine storage, and distribution and return where appropriate. The HSE’s Health Protection Surveillance Centre, HPSC, is responsible for compiling and publishing data in respect of uptake and coverage of Covid-19 vaccines, liaising closely with the European Centre for Disease Control, ECDC.

Where medicines are licensed centrally for all EU member states, as in this case, the Health Products Regulatory Authority, HPRA, works closely with the European Medicines Agency, EMA, including participating in the EMA assessment process and post-marketing benefit-risk monitoring. The HPRA operates the national safety monitoring and risk management system and oversees quality defect reports on vaccines and other medicines. It also licences the facilities that carry out related manufacturing and distribution.

The National Public Health Emergency Team, NPHET, oversees and provides national direction, guidance, support and expert advice on the development and implementation of a strategy to contain Covid-19 in Ireland.

It advises the Government on the public health aspects of the cross-Government response to Covid-19, including on the vaccination programme and, in particular, prioritisation in the context of pandemic management.

Both the HPSC and the Department of Health work closely with the European Centre for Disease Control, ECDC, and the Department is represented on the Health Security Committee, HSC, of the European Commission, which co-ordinates the EU response to infectious disease threats. These will continue to provide advice on the vaccination programme and its impact in terms of pandemic management, the sequencing of the roll-out of the vaccine and the response to any emerging issues.

The challenge in devising and implementing a vaccination programme of this scale, complexity and desire for speed is unparalleled here and around the world. Successful roll-out of the vaccination programme is dependent upon careful and precise co-ordination across Government, several State agencies, the HSE and a wide range of advisory, regulatory and delivery partners across the health sector and private sector providers.

The high-level task force I chair is ensuring that all of this ongoing work is co-ordinated within a single integrated work programme and supporting the Department of Health and the HSE to deliver a Covid-19 vaccination programme that meets best practice and good governance and it will play an ongoing role in the oversight and monitoring of programme implementation, harnessing the wide range of high-level expertise and experience of task force members. The task force includes senior representatives from across the Department of Health, the HSE, the Health Products Regulatory Authority, the HPRA, the Office of the Government Chief Information Officer, the Office of Government Procurement, IDA Ireland, the Department of Enterprise, Trade and Employment and the Department of the Taoiseach. It includes expertise in the areas of public health, supply chain logistics, cold chain logistics, and programme management.

A programme office has been established to support the high-level task force in its ongoing oversight and support role. An integrated work programme, comprising seven work streams, has been established by the high-level task force, HLTF, which fully integrates the work that is ongoing across the Department of Health and the HSE. The programme is using a structured programme and project management approach to manage and deliver all the core elements. I will not list all of the work streams but I am happy to talk about them at any stage, as they affect all the core elements of the end-to-end vaccination process.

Each work stream is led by a senior responsible officer, SRO, and is supported by programme and project professionals as well as subject matter experts. The SROs, the programme director and a number of subject matter experts form a programme working group, which has been established to co-ordinate, integrate and to report progress on work.

I must stop Professor MacCraith. We have the rest of the statement. We are under time pressure as we must leave the committee room within two hours. I apologise for cutting him off.

Professor Brian MacCraith

I appreciate that. I have made the text available to members.

I now invite Professor Butler to make her contribution.

Professor Karina Butler

The national immunisation advisory committee, NIAC, welcomes the opportunity to contribute to the discussion regarding the roll-out of Covid19 vaccination. I am here today in my capacity as chair of that committee. It is less than one year since any one of us first heard of Covid. Since then, globally, more than 72 million people have been infected and just over 1.6 million have died. In Ireland, there have been more than 76,000 cases and 2,000 deaths. Spurred by the urgency of the problem, it has taken scientists less than one year to develop effective vaccines. We are now preparing for the roll-out of potentially three, but likely six, different Covid vaccines over the coming year.

Even just two to three years ago, the speed at which this has happened was inconceivable. However, although rapid, it has not been rushed or reckless. Rather, the speed is a reflection of the extraordinary advancements in the vaccination field that were under way before Covid19, harnessed together with unprecedented scientific co-operation and financial and human resource investment. In the case of Covid, there was already much vaccine research that could be built on to facilitate rapid development of the vaccines and compress usual timelines. Covid19 vaccine development was a single common global priority. Large-scale investment both in human resource and finance enabled many steps to be undertaken in parallel and with much greater efficiency. As Covid19 was, unfortunately, all too common and people were eager to help in finding a solution, recruitment to clinical trials was rapid. Similarly, as symptomatic Covid19 and severe Covid disease were also very common, clinical trial endpoints, that is, reaching the point in a trial where one is able to tell if there was a difference between the vaccinated and unvaccinated, were quickly reached.

Vaccine safety is an overriding concern. With vaccination, a higher safety bar is required than for most other medical interventions, as vaccines are administered to healthy individuals or those with stable underlying medical conditions. Most adverse events following immunisation have onset within six weeks of vaccination. Thus, a minimum median follow up of two months was required prior to evaluation of the clinical trial data by the regulatory agencies. As with all newly licensed vaccines, it is possible that some rare or very rare, less than 1:10,000, adverse events following immunisation, AEFI, particularly those unique to specific populations, may not be known when the Covid19 vaccines are authorised. Thus, it is critically important that, as planned, continued surveillance in the post-marketing phase is undertaken when vaccines will be administered not to tens of thousands but millions of individuals.

The Pfizer-BioNTech vaccine is likely to be the first Covid19 vaccine administered in Ireland. Data from the randomised phase 3 trial based on more than 36,000 participants demonstrated vaccine efficacy of 95% in those aged 16 and over. There were nine cases of Covid19 in almost 20,000 vaccinated participants compared with 169 cases in a similar number of placebo recipients. These results far exceeded what had been hoped. It can be anticipated however that, as the vaccine is rolled out in the real world, the effectiveness is likely to drop a little compared to the very controlled clinical trial situation.

Regarding safety, local site reactions and, less commonly, more general shortterm systemic reactions such as fatigue, flu-like symptoms and fever, can be anticipated. These events occurred at increased frequency following the second vaccine dose and were more common in the younger rather than older age groups. These effects are partly a result of the efficacy of the vaccines in stimulating the immune response. We will know more detail about the side effects when the licence documentation is published by the EMA. Reports from the regulatory agencies in the United States, the United Kingdom and Canada raised no significant safety concerns. Reports of anaphylactic-type reaction in two vaccines in the UK outside of the clinical trial naturally draw attention. Vaccine-associated anaphylaxis or severe immediate allergic reaction is extremely rare. It is estimated to occur at 1.31 per million vaccine doses. Its occurrence in the UK is being investigated. Continued surveillance data is needed to determine whether this was a chance occurrence or whether the Pfizer-BioNTech Covid19 vaccine is associated with a higher risk of allergy compared with other vaccines.

It is standard practice for vaccinations to be administered by trained health professionals who are appropriately trained in the management of anaphylaxis and have the appropriate equipment available. Where there is doubt, rather than forgoing the benefits of vaccination, appropriate advice should be sought from the relevant specialist or the local immunisation team. NIAC was asked to advise regarding prioritisation for vaccination, given that there will be limited vaccine supply in the initial phases of the rollout. Recommendations were informed by local epidemiology, focused on the key objectives to prevent Covid19 associated disease and death, while striving to ensure equitable access with attention to the ethical principles of moral equality, minimising harm, fairness and reciprocity. Recommendations are based on the currently available evidence and are subject to updating and refinement as data pertaining to risk groups is refined, vaccine availability increases and as even more data regarding the different vaccines is collated and analysed. The document should be regarded as a living document and subject to updating. In summary, this is an exciting time when we can be filled with hope that we are being equipped to begin a path back towards a more normal lifestyle. This will not happen overnight.

There are many challenges ahead, including providing clear, accurate, and up-to-date information to potential vaccine recipients such that they can feel fully informed of the potential benefits, the direct benefit in preventing Covid19 for themselves, the benefit of reducing the case numbers for our communities and to accurately balance that against any small but as yet unknown risks that might be associated with vaccinations.

A further challenge is to finalise the development of a national injury redress programme to provide support and care in the event that any vaccine recipient develops a serious vaccine reaction as recommended by the WHO. We have been relatively lucky in Ireland. Our case numbers are remarkable given what has happened in many other countries in Europe and elsewhere. Data have shown that in early autumn we were on an identical trajectory to other countries. Significant restrictions impacting how we live and causing significant economic hardship for some, have brought relief from spiralling case numbers. However, we cannot continue to depend indefinitely on those measures.

Vaccination is the key that will help open that pathway back to normality. It is very much our hope that in time, this virus will be listed along with other infections such as diphtheria and polio as organisms that vaccination has controlled, if not completely conquered.

On behalf of the committee, I thank everyone for the work they have done and continue to do to address the challenges of Covid-19. Today's meeting is evidence of the first glimmer of light. Professor Butler spoke of it being an exciting time filled with hope. There is a glimmer of light that might, with an effective roll-out and take-up of the vaccine programme, see us emerge from the scourge of the pandemic, into 2021.

I concur with the Chair's comments and thank Professor MacCraith, the task force, Professor Butler, and the team at the national immunisation advisory committee at the HSE and the Department of Health for their work to date in developing the strategy and implementation plan. From reading the strategy and the plan, it is clear the guidance and advice received from the European Commission in October has been used to develop these and that the plan is in line with international best practice outlined by the EU, such as ensuring that we view the vaccine as an addition rather than a replacement for other measures, target at-risk groups, resource the deployment properly, and that there is co-operation and consultation with our European partners and neighbours.

What engagement has there been with GPs and pharmacists on the roll-out of the plan?

The most important part of the plan is the immense need to build confidence in the vaccine programme and in the safety and effectiveness of the vaccines. Five companies have been signed up so far. It is vital that people are given accurate, factual, objective information about the importance of the vaccine but also its safety and effectiveness. We saw this in the early stages of Covid when there was a lot of explaining what it was, how it operates, how it spreads, how it effects the body, the signs to watch for and, most importantly, what one needs to do to protect oneself and others. That is what is needed now. To what extent has there been engagement in implementing the most effective communication and public awareness campaign? Have we identified the organisation or agency most responsible for this? The European Medicines Agency approved the vaccine, while the HPRA advises on the regulation and safety of medicines and vaccines. Which organisation will lead the information and public awareness campaign? It is not enough to react; we must actively build and maintain confidence. False claims and misleading information can spread faster than the virus itself and be just as lethal.

What is the view of the witnesses on actions such as an information booklet being sent to every household with details on vaccines, how they work, what they do and details on the sources of the research and engaging with social media companies including Facebook and Twitter so that inaccurate, misleading or scaremongering claims are marked as disputed in a similar way to some of President Trump's tweets claiming he had won the election are marked as being disputed, and so on? People could then be directed to an impartial, verified accurate account providing that information.

I wholeheartedly agree with the assertion in the implementation plan that vaccines are a proven and cost-effective intervention to protect public health, second only to the provision of clean water. However, I worry about the impact of campaigns to discredit vaccines. I fear they will cost lives if we do not prepare properly and proactively. I am interested in our guests' comments.

Dr. Colm Henry

The role of general practice has been key to our response throughout the pandemic from the very beginning through testing, tracing and the rapidly evolving case definition. We have build solid alliances with general practice, both in the HSE and within NPHET. They have established a central role in provision of vaccine, particularly to preschool children, but also a wider role as advocates of public health and vaccination. We are building on those existing links with general practice. We have established a group within our own governance structure with David Walsh and the workforce, which met as recently this morning, building our links with the Irish College of General Practitioners, ICGP, with key general practice leads to furnish them with the real-time information in what is a very uncertain environment as it comes through and also to ensure that they are equipped with the information they require to advocate for vaccination among the priority groups as they come through.

General practice is key to us. It has been from the beginning of the pandemic and will be key to our response to the roll-out, particularly in the larger phases of roll-out as greater numbers of the batches and provision of vaccine come through to vaccinators.

Professor Brian MacCraith

On the other half of the Senator's question, we absolutely endorse everything he said about a communications strategy. He had specific questions. There is one full work stream on communications and public engagement. It is led out of the Department of Health. The senior responsible officer is Deirdre Watters who is head of communications in the Department. In the implementation plan, it is one of the areas that has had our particular attention in our planning in recent weeks. On pages 25 to 27, inclusive, of the plan, a section sets out the core messages and key communication activities during December. In light of recent developments and potential announcements next week, those activities will have to be accelerated. That reflects something stated throughout both documents, namely, that we have to be agile and able to adapt to changing circumstances in a very fluid situation.

To reinforce the Senator's point, one could get everything else right about the vaccination programme, but if the communications strategy and implementation is not right, everything else will not have the impact that we all need to see happen. It is essential and will be rolled out in greater detail.

Dr. Ronan Glynn

A key part of the strategy over the past year on Covid generally has been communications. Specifically on immunisation, it is worth reflecting that significant work was done in the area more generally in regard to the HPV vaccine and the establishment of the Vaccine Alliance back in September 2019. Hopefully all that will come to fruition - and the alliance has met in recent days - so that we can move this forward. Significant information is up online both on the HSE website,, and, which has specific information on Covid vaccines.

As a general point, while obviously we are concerned about misinformation and the extent to which that might influence people's intention to get vaccinated. It is important we do not give a perception that is a majority view. We know that 70% to 80% of people in Ireland either definitely or probably will get the vaccine when they are offered it. Perhaps rather than focusing on vaccine hesitancy per se, we should promote and build even better levels of vaccine confidence.

What we need to do is continue to build on the basic information materials that were sent out over the past year and, hopefully, over the coming weeks as we get more information from the European Medicines Agency but also in consultation with NIAC, the HPRA and the HSE national immunisation office. Between those different organisations, hopefully, people will get the information they need.

On top of that, we know that when it comes to making decisions on vaccination, the most important source of information for people is what their local GP or pharmacist tells them when they have questions. To echo Dr. Henry's comments, a key part of what we will be doing around this over the coming weeks is ensuring healthcare professionals on the ground around the country have the information they need to answer those questions when they are asked.

I know Dr. Henry mentioned GPs. He did not reference pharmacists unless I missed it. I agree that there be a communications strategy but I ask that the witnesses look at and engage with Twitter and Facebook in terms of the possibility of misleading information because these things can grow rapidly and go viral very quickly if they are not challenged and corrected.

Dr. Colm Henry

Our work does involve engaging with pharmacists through their important part in existing vaccination programmes, including the influenza vaccination programme. To echo Dr. Glynn's comments, with regard to the key role of medical professionals and healthcare professionals broadly in promoting vaccination, as Dr. Glynn referenced, we have seen significant improvements in the uptake of the HPV vaccine to upwards of 75% where the figures were much lower previously. There is a key role for healthcare leaders here, including not just GPs but pharmacists and others in advocacy and promotion of safe and effective vaccines, as well as of the roll-out, as we go from relatively small provision at the beginning to the wider population.

Dr. Ronan Glynn

To answer Senator Kyne's specific question on social media, there has been engagement previously on this issue, in other words, false information around vaccines, with social media companies, including Twitter, Google and Facebook. There are particularly close relationships between the HSE national immunisation office and those companies so I fully expect that those engagements will continue over the coming weeks as we try to counter misinformation.

I welcome all the witnesses. We have very limited time so, unfortunately, we are limited to ten minutes. As the witnesses can imagine, there are a lot of questions we would want to put so we will not get through all of them. I start by commending Professor MacCraith on the work he has done along with his team. He has presented an excellent framework to the Government and this committee so I commend him and his team. I also commend Dr. Henry and Dr. Glynn, who did some work in this area. I know that in his opening statement, Professor MacCraith spoke about the work that was already done by the HSE when his team was put in place. It is a really good and strong start and a good framework and I commend everybody involved. Obviously, we have questions relating to the substance so I hope they are taken in the constructive spirit in which they are put.

We have advanced purchase agreements with a number of different companies. In his presentation, Professor MacCraith said that it totals 14,355 potential doses. That will obviously depend on approval by the regulators. Has Professor MacCraith had any interaction with any of the manufacturers in terms of their advance manufacturing? My understanding is that many of these companies have already produced tens of millions, if not hundreds of millions, of doses that are simply waiting for regulatory approval. I will start with the Pfizer-BioNTech vaccine. Do we have any idea how many of the 2.2 million doses we are in line to get under the advanced purchase agreement as part of the European Commission's proposals? Do we have any idea how many of those will come on stream when or if regulatory approval is given? Let us just say that the regulator signs off on this vaccine on whenever date it is. Do we know how many of those 2.2 million doses we are likely to get in the first phase of delivery?

Professor Brian MacCraith

I thank the Deputy for his positive comments. It was certainly a massive team effort to put together the strategy and implementation plan over a period of just over four weeks. In respect of the Deputy's questions about the pharmaceutical companies, most of the dialogue in recent weeks has been with Pfizer-BioNTech, all of it mediated through the country manager here, who also happens to be called Paul Reid. We have seen indicative schedules. Things have been shifting as other factors have shifted. Regarding the potential imminent granting of conditional marketing authorisation, CMA, possibly as early as 23 December, the only strong indication we have is that a small supply of an initial quantity of vaccines is likely to be delivered to us before the end of December but we do not have confirmed details of exactly what we will be getting and when. There are indicative amounts but those have changed over the period of the past number of weeks as other circumstances have changed. The expectation is we will have a small quantity before the end of December. Things are typically shipped in what are called shipper frozen containers of just under 5,000 doses per shipper - 4,875 to be exact - that is, five containers of 195 vials each with each vial having five doses. The team we have working on logistics as one of the work streams is in regular contact with Pfizer-BioNTech so the team from the HSE national immunisation office and the logistics team are in regular contact. As of today, we do not have absolute confirmation of-----

Can I stop Professor MacCraith there? We have very limited time and when we put a question, we really need it to be answered very sharply. I was trying to get back in a couple of times. I say that to other members of the committee who will be coming in as well. I know it is difficult with this exchange. The question I asked was how many we anticipated. Professor MacCraith said it was a very small amount. Does he have even an estimated number out of the 2.2 million that will come in the first phase?

Professor Brian MacCraith

I will try to be brief. We expect a very small amount before the end of this calendar year that will be in small multiples of the numbers I gave the Deputy if we take that figure of 4,875 doses per shipper and we expect a small number of shippers. It may be one or two - we do not know exactly. That has not been confirmed. We expect to be dealing with hundreds of thousands of those in quarterly allocations but I need to be very careful as these have not been confirmed. Perhaps colleagues in the Department of Health can comment on that more generally in terms of signing off on the advanced purchase agreements at national level but-----

In his opening statement and his own vaccination programme, Professor MacCraith talks about the vaccine supply chain. It is very helpful. I found the graph to be very straightforward and useful. It talks about supply from manufacturer to storage, distribution and then vaccine location. What is an estimated end-to-end turnaround time for whichever vaccine comes on stream first such as, for example, the Pfizer-BioNTech one? What is the estimated end-to-end turnaround time for the 2.2 million doses to arrive, be stored and distributed and used to vaccinate people? Do we even have an estimation of how long that journey will take?

Professor Brian MacCraith

I can give the Deputy the answer relating to the turnaround time in terms of vaccines that arrive and are distributed through the hub and spoke model but the Deputy is asking for details of when all of it will arrive from Pfizer. That has not yet been confirmed by Pfizer.

Do we have any idea? When I talk to some of these manufacturers, they tell me they have already manufactured huge numbers of doses. If that is the case, we should have some sense from them as to how many doses we are likely to get, say, in the first half of next year if there is positive news on regulatory approval. There must be some indication of how many doses we would have acquired in the first six months after positive approval.

Let us consider, for example, just six months. What would be the likely number of vaccines coming on stream, and possibly administered?

Professor Brian MacCraith

Mr. Goodman may have the more accurate figures than I would have.

Mr. Fergal Goodman

I do not have that information to hand. We will see whether that information is available in the detail the Deputy seeks. Some of the manufacturing is taking place on a global scale, and Pfizer is operating globally and dealing with markets outside of Europe also. While we have advance purchase agreements with indicative schedules for delivery of the quantities being contracted - and I must be careful in what I say here - we are starting to find that in the discussions that then take place with the company as to what it can facilitate in the initial period, it is not yet certain.

I have to put my next question to Professor MacCraith because the time is very limited. How many proposed mass vaccination centres are we potentially looking at? In the programme, Professor MacCraith said quite rightly that all the vaccinators will be fully qualified healthcare professionals, as it should be. How many staff are we looking at? Notwithstanding how quickly we will get the vaccines doses when they come, how quickly these are administered will come down to the capacity and resources we put in. How many of these pop-up mass vaccination centres are we looking at? What is the estimated number of staff required? Reference was also made to training. How long will it take to train that staff?

My next question is for Professor Butler. Since this is a matter of public commentary, I will ask it in that sense. Some concerns have been raised around indemnity for manufacturers. Will Professor Butler respond to that question? Is this now the norm or standard for new vaccines coming on stream? It has been the source of some conversation and debate inside and outside the Dáil. It would be useful if Professor Butler could answer that question.

My question to Professor MacCraith is how many mass vaccination centres there will be and the levels of staff required.

Professor Brian MacCraith

At least 15 such mass vaccination centres are under consideration by the team in the HSE at the moment. The exact details on how many staff will be required at vaccination centres is still being worked through. The current focus is on being ready for the initial roll-out of the top two cohorts in the provisional priority sequencing. These figures will be developed in time, for example, as has happened in large-scale testing centres, and much learning is coming from that.

The number of staff is an important question. I asked how many staff are likely to be needed for these centres.

Dr. Colm Henry

In the initial phase we are looking at small batches and it will be leaning on the schools vaccination programme for the administration of the vaccine to people in long-term residential care settings and staff. As we get more information on the volume and type of vaccine coming through and the timeline, we will then develop the plan for timing and staff from all those healthcare professions as referred to earlier, for the mass vaccination centres, hospitals and the other locations. Those plans have not yet been finalised. The principal determiner of those plans is the volume and timeline of delivery of the successive types of vaccine, those for which we have advance purchasing approval and those for which we are awaiting approvals from the European Medicines Agency.

Professor Karina Butler

The issue of indemnity is not a question for the National Immunisation Advisory Committee. That would be more a question for the Department of Health.

Again, someone might come back with a response.

I think it is an important one to put on the record.

Mr. Fergal Goodman

Ireland is involved in the process with the European Commission where the option for us is to either go with the terms of the agreements that have been negotiated between the Commission and each company, or not. That is a difficult call in the sense that it means the terms of the indemnities the companies have sought, in the context of the rapid development of these products, is a call on which Ireland as an individual State does not have much choice if I am honest. That is the situation on that. I am not aware of the general proposition in relation to vaccines. I believe it is these ones in particular.

My question was whether this is an outlier or is it more the standard now in new vaccines, that there would be an indemnity?

Mr. Fergal Goodman

I can only refer to these Covid vaccines, which I think we would all accept are a particular category because of the rapidity of development and so on, which admittedly, as we have all said, is an extremely welcome situation to be in. Those are the terms that have been negotiated for these products.

I thank Professor MacCraith and his team. It would be reasonable to say that a nation holds its breath, if I can borrow that phrase. There is a huge weight of public expectation and a huge burden on Professor MacCraith's shoulders. I wish the professor and his team the very best. They have the best wishes of the country and of the Oireachtas.

Who is the boss? It is a straight question, and perhaps Professor MacCraith would answer that.

Professor Brian MacCraith

I thank Deputy Lahart. The normal decision making is across all the key positions, such as I read out at the start of my introduction, and all of these structures in place still remain. With regard to the boss of the integrated programme, we have appointed a programme director who sits above the whole integrated work programme. That person reports into the high-level task force. If there are issues to be escalated or addressed, I now attend the Covid-19 oversight group weekly, chaired by Mr. Martin Fraser. The decision making and putting detail in the documents, especially the strategy of the document, of the Government's arrangements are across into the Department of Health and the HSE, as appropriate, and with an emphasis on making decisions in as agile a way as possible. The implementation plan is a living, agile document that was accurate up to last Friday. Even the circumstances and the information we have received in the past few days changes things. Its adaption is ongoing.

I have just eight minutes left. I have ten questions. The guests will not be able to answer all of them in detail here, but they are ten questions that need to be answered. They are reasonably searching and reasonable to ask. Perhaps we will meet the witnesses on a regular basis, but these questions need to be answered.

I notice comment on NPHET in both of the documents and we need to remind ourselves, and I want to remind the witnesses, about NPHET. The early days of NPHET were not covered in glory. We think of Cheltenham, inward flights from Italy and the failure to control clusters. The country shut down to protect the vulnerable and yet the most vulnerable died in significant numbers. We never got control of nursing homes. Here is the witnesses' opportunity. I will not engage in monstering or anything like that, but the witnesses may come back in writing on these questions.

Some experts say there is a lack of a vaccine expert on the oversight committee. Will the witnesses address this? The document talks of training for administering the Covid vaccine. Where is this training? Who is doing the training? Who will take the vaccines to the nursing homes?

I now turn to the hierarchy, or what has been referred to as population sequencing. One of the things that struck me, and continues to strike me, is that we talk of vulnerable groups, but there is one vulnerable group that I believe we have ignored which is the areas of socioeconomic disadvantage where figures have been significantly higher. Case numbers are higher in these areas across age groups than in the stereotypically vulnerable groups of the over 70s and so on. Reference was made to hospital leads, but consider hospitals such as Tallaght University Hospital where there are significant numbers. One of the local electoral areas there had significantly higher than the national average numbers. The Mater hospital is right at the heart of areas of economic disadvantage and the numbers there are also really high. I wonder about the hierarchy of the population sequencing with regard to delivery.

Who is going to staff these centres for vaccination? Where are our guests at in terms of the roll-out, the advertising for or recruitment of staff? We have heard reference to the recruitment of retired GPs and medical staff. What processes have been put in place? Where are we going to find the staff to roll out the vaccine successfully? Who is currently recruiting these doctors?

It does not appear that there are clinicians with experience in vaccines included in the committees. There is mention of the national immunisation advisory committee, NIAC, but it does not have a clear leadership role in this from what I can see in the document.

We saw in the early stages of the virus that medical, nursing and healthcare staff were redeployed and that caused significant issues in the areas from which they were redeployed. Is redeployment being planned to cover the roll-out of the vaccine and, if so, how do our guests propose to address it?

I have a couple of questions about the no-fault compensation scheme. What identifiers is the task force using to build up its database? We do not have a universal healthcare identifier in this country. What kind of steps have been taken in that regard?

I have asked a whole load of questions and can supply them in writing, if our guests like. If they want to give me a general response now, I am happy to take it. I am sorry for shoehorning so many questions into my time. I wish our guests the very best of luck with the work that they do.

Professor Brian MacCraith

There are many useful questions there, many of which we can answer quickly. One member of the high-level task force is Dr. Lorraine Nolan, chief executive of the Health Products Regulatory Authority, HPRA, who also sits on the board of the European Medicines Agency, EMA. She is directly involved in the whole issue of vaccines, including vaccine safety, effectiveness and so on.

Some of the questions that the Deputy has asked have answers in the document and we would be happy to provide answers to all of those. We might come back to the Deputy if he provides a written version of the questions. I was trying to take some notes as he was speaking. We are very happy to provide responses.

Dr. Colm Henry

The sequencing that is laid out clearly in the document was informed by a document put together on behalf of the National Public Health Emergency Team, NPHET, and the Government, by way of the national immunisation advisory committee. It is based on the ethical principles delineated as fairness, equity, minimising harm and reciprocity. It is clearly based around the primary aim of the vaccine programme, which is, of course, initially to reduce morbidity and mortality from Covid-19, hence the focus on the residential care facilities the Deputy referenced in his question and the workers within them. The prioritisation framework reflects the degree of virulence of the virus in different settings and the experience we have had of how this virus can be transmitted within those settings. That has informed that sequencing.

The Deputy also asked about the deployment of staff. It has been clearly laid out that we are relying on staff who are already experienced in vaccination programmes, be they GPs, pharmacists and existing vaccination teams, including school vaccination teams. We are planning for this based on what we know and what we do not know. What we know initially is that, as we said earlier, relatively small batches of the vaccine will arrive at first. We are awaiting further information on the first vaccine from the EMA as to what deliveries we will get and on what timeline. That will then inform how we redeploy staff from existing services and how we locate staff who are retired or otherwise as the programme ramps up to a more mass vaccination strategy. The document clearly lays out the staff that we will be leaning on. It will be those with the greatest experience in vaccination, managing rarer side effects and, of course, advocacy, promotion and explanation to patients.

The documents are inspirational and aspirational. Our guests are talking today about their plans and proposals. The next time we meet, the committee will be interrogating where those plans are at.

I have two final questions. If the vaccine arrives tomorrow morning, it is my understanding that there will be a three-week delay before people receive it. That is my interpretation and it may be wrong. What causes that three-week delay?

There has been a heavy emphasis from the Taoiseach, Tánaiste and Government on the hierarchy and population sequencing. I get that. Vulnerable groups, people who have underlying health conditions and age considerations must be prioritised. I am going to ask our guests a straight question and I ask them to try not to be political in their response. I heard the Taoiseach last night say that he will take the vaccine at his appointed place in the line. Do our guests think it would be helpful, rather than exclusively looking at this in a hierarchical way, that sometimes it would be really important symbolically if those who are not included as having underlying health conditions or as being in the vulnerable groups take the vaccine from the point of view of public confidence? Should the Taoiseach and Tánaiste have to wait in line until their time comes or do our guests think it would helpful, from a public confidence point of view, if they were to receive the vaccine initially?

Dr. Colm Henry

The useful thing with the list of patient priorities is that it is a transparent description, not just that there are priority groups but that they are arrived at based on the ethical principles that I described and that are contained in the document. I appreciate that there is much we do not know yet. We do not know the timeline of the delivery of the first vaccine, which we hope will get EMA approval. We also do not know the timeline of the Moderna vaccine, which in a sense lends itself more easily to a mass vaccination programme. Thereafter, other vaccines will come through that will have different licence, training and educational requirements.

I would share the opinion of those who put this document together. Groups were prioritised to reduce the morbidity and mortality of this horrendous virus to the maximum effect and to afford the greatest protection to the most vulnerable groups in society.

Professor Brian MacCraith

I see that Professor Butler's hand is raised. She is in the best position to elaborate on the role of the NIAC in the delay between the granting of a licence and the roll-out of the vaccine.

Professor Karina Butler

I was going to come back to the question about people in leadership positions getting vaccines and the whole concept of prioritisation and laying things out. As I said at the beginning, this is a living document. We have to be pragmatic and flexible. For example, if a vial of vaccine with five doses in it is being opened and four people who are scheduled turn up to receive it and there is a fifth person in the room who is not on the priority list, the vaccine is not going to be wasted if that fifth person is agreeable to getting it. There should be that level of flexibility.

The point the Deputy has made about people in leadership roles is important and we should be able to do whatever helps people and builds confidence. However, that does not apply to a point where people feel that we are holding back or depriving someone else. I am sure that people do not want to be seen as if they are jumping ahead. This is a finely balanced situation. There are people who absolutely want to be up there at the front of the line. We do not want others who feel they should put themselves ahead of the queue. We have got to be reasonable about it. That is all I have to say on that.

The Deputy asked about delays. I am not involved in the logistics of this, but we may get a limited amount of a vaccine. We all need to recognise the time of year we are in. The first priorities are people in nursing homes and healthcare professionals. It is not going to be a matter of completing that as number 1 on the list and moving on to number 2. We will be looking at what is practical and some of those people may be vaccinated in parallel. It may not be reasonable to land suddenly at a nursing home to give vaccinations in the period between Christmas and the new year. People need to have time to get the information and give informed consent. It may be reasonable to start vaccinating a small group who are at the highest risk. Those might be the vaccinators themselves or people in critical care areas and emergency rooms. That kind would be a practical approach to using the vaccine as soon as it becomes available and not delaying anybody's vaccination.

As I said earlier and as is contained in the statement, all of this has to be done rapidly but not rushed. Even during the little delays that are occurring at this stage, we are learning as we go along. We are getting the experience from the beginning of the roll-out in other areas, and all of that is to the good.

I thank all of our guests for their attendance and for the incredible work that they have been doing, particularly in recent times.

I have a number of questions to ask about the practicalities of registration but I will start with one on clinical advice. I would appreciate a response on it. It has regard to the potential impact of the vaccine on fertility. I note that pregnant women are in the 14th category, which is the last, so the question is unlikely to arise for some time. We also need clarification with regard to breastfeeding mothers. At yesterday's launch, Dr. Lorraine Nolan said that there are implications for fertility. Women considering pregnancy or fertility treatment were advised to put that off or, otherwise, to put off having the vaccine. I know it is early days, but it is important that advice be made available for women in these circumstances, who constitute a big part of the population. Is Professor Butler in a position to give clear advice at this point? If not, when does she expect to be in such a position?

Professor Karina Butler

That is a very important question. Such advice will absolutely be needed. It is the exact kind of thing in respect of which we are awaiting the recommendations of the European Medicines Agency, EMA, before giving definite advice. There are no data on pregnancy to date. Pregnant people have been vaccinated. Although pregnant people were excluded from the trials, it is always the case that there are people who do not know they are pregnant or who end up getting pregnant unexpectedly. There were small numbers of pregnant people in the Pfizer-BioNTech and Moderna trials. We do not have data on the outcomes for those pregnant people yet. There is a mood within the State to start trials. It was a matter of balancing risk. Some felt that pregnant women should be included. We will just have to wait for the information. Pregnant women were not prioritised in this list because of the absence of data. With regard to breastfeeding, there is no theoretical risk involved in breastfeeding but, again, we are waiting for the licence documentation before we give final recommendations.

Does Professor Butler expect detailed advice to be given when the EMA decision comes through?

Professor Karina Butler

I expect that advice will be given but I cannot, at this stage, say what that advice will be. It may be that we should wait, on a precautionary basis, because of the lack of information or there may be more definitive practical advice.

It is clear that there are severe shortcomings with regard to registration. I refer, for example, to the underdevelopment of the individual patient identifier and the lack of chronic illness registers. I understand why the decision in favour of self-registration was taken, although I have some questions about it. How is it proposed to establish the health status of people who self-register? How is it proposed to reach out to those who do not register, particularly those in priority categories? How will people who are not familiar with computers register? Informed consent was mentioned earlier. How will that be obtained from people in the various categories and specifically from those in the first category, people living in long-term residential settings? The witnesses may prefer to answer my final question in writing. Can they set out a schedule of the likely timing of the delivery of vaccines to this country after their approval? I ask whoever is most appropriate to respond to those questions please.

Dr. Colm Henry

I will try to answer some of those questions. We have some experience internally because there is significant overlap between the priority groups the Deputy has laid out and the groups that are part of existing vaccination programmes such as the pneumococcal disease and influenza vaccine programmes. In identifying these patients, their health statuses are recorded. The first priority group is defined by age and location but, as one goes down the priority list-----

I hope Dr. Henry does not mind me interrupting but I understand what the groups are. Will he speak to us about the registration process?

Dr. Colm Henry

I cannot give the Deputy definitive information but the registration process is being worked through at the moment. It will cover the process from end to end, from pre-vaccine and booking, through administration and on to reporting and monitoring. Our plan is to capture demographic and health information which will inform not just the provision of the vaccine but the follow-up surveillance and safety monitoring. I cannot give the Deputy more detailed information than that at the moment. We will obviously be using the existing expertise and experience we have from other vaccination programmes.

Is there a plan to reach people who do not self-register, particularly those in vulnerable groups?

Dr. Colm Henry

Yes. It is a clear part of the plan. Given what we have learned about the vulnerability of certain subgroups, including people in congregated settings, homeless hubs-----

Does Dr. Henry have the detail of that plan?

Dr. Colm Henry

Yes. As has been said, this is a live document. All these work streams are progressing in parallel as we await EMA approval. Part of this will be the identification not only of vulnerable settings, such as those covered in the first priority group, but also of vulnerable individuals in other settings. We will be working on how we can maximise-----

Is there a plan at which we can look at this point? Can that be sent to the committee?

Dr. Colm Henry

It is not finalised but, as we said before, we will update the committee on our plans as they are put together while we work through this live document.

What are the arrangements for people who are not familiar with computers to register?

Dr. Colm Henry

Leaning into the experience from our existing vaccination programmes, we will use general practice, pharmacists and other networks of healthcare professionals to identify people who are not used to or comfortable with computers. This has already led to a much-increased provision and acceptance of the flu vaccine in those age groups over recent years. We will rely on many options, and not only computer registration. We have a network of healthcare professionals who will identify people and encourage them to get the vaccine.

I appreciate that but it will be some time before people can go to their local GP or pharmacy for a vaccination. In the meantime, how is it proposed to reach people who do not have access to computers? Is there an arrangement by which they can register in some other way?

Dr. Colm Henry

We are working through that at the moment. I do not have final information on it at the moment. We will come back to the committee with further information. As I said earlier, this is a live document and we are working through each of these work streams in parallel. I cannot give a final answer to the Deputy's questions yet but we will come back with further information as the plans are finalised.

How is it proposed to obtain informed consent from people who register online? More specifically, how it intended to obtain informed consent from people in long-term residential facilities?

Dr. Colm Henry

Vaccination programmes already exist in residential care facilities. I am a geriatrician by profession and I am aware that the first port of call is to get informed consent directly from individuals, unless they lack the capacity to give it. In that case, we work through networks of family members or health professionals to secure informed consent through other means, for example, from a direct relative. In the first instance, we always seek to get consent from the individual concerned if it is possible to do so by any means. Even in the presence of cognitive impairment, we give information in such a way that the benefits and risks of the vaccine can be easily understood.

Does Dr. Henry know what the time lag between approval of the five or six different companies' vaccines and their delivery to this country will be? Can he set that out for us? I am not asking for it now, but does he have that information?

Professor Brian MacCraith

The information available to us changes week by week as circumstances change. As Mr. Goodman mentioned earlier, we have envisaged how the different pharmaceutical companies' vaccines will be delivered on a quarterly basis across next year but nothing is confirmed until conditional marketing authorisation is granted. That is why we do not have final details, even up to the end of this year.

It is important to state that, overall, all the questions being asked by the Deputy and her colleagues are valid. Not all the answers have been established at this stage and, even as we speak, teams of people in other parts of this building we are in are working away on developing those answers regarding the most immediate issues and planning for the longer term issues, as each solution is arrived at.

Moving to the supply of vaccines, we have indicative schedules from several of the candidates which we expect to be first out of the traps in respect of getting approval, but nothing has been confirmed in writing. We have taken the view that we should be honest with the Irish public in respect of providing certainty, when we have absolute details. Speculating and providing just general indications is not something we are sure is always helpful. We are very happy, therefore, to take all the questions we are receiving and to try to provide the detailed answers which are available now and to be as helpful as possible. This is the first version of the implementation plan, however, and there will be many versions of it as we work through it.

That is fine. We would appreciate it if those indicative schedules could be shared with the committee.

I thank everybody for their contributions so far. We are all appreciative of the work which has been done in the last nine months regarding this public health emergency. This situation poses many challenges for our public health system, as well as enormous logistical issues concerning rolling this vaccine out. All the indications are that the majority of the Irish public have confidence in the vaccine and will want to access and avail of it when it is first rolled out.

In respect of the vaccine itself, and oversight, enormous amounts of public money have gone into the research and development of the vaccine. Billions of euro, dollars and many other currencies have gone into private entities conducting research on this vaccine. That is welcome and shows that in today's world the socialising of medicine, when we work together rather than against one another, brings better results than competition.

Regarding the vaccination database, I am not sure who might be able to answer this question. However, on RTÉ's "Prime Time" programme last night, I heard Mr. Paul Reid stating that a vaccination database will be rolled out and there will also be a contingency plan. On the vaccination database, therefore, which I think is the cutting edge of this process and the vehicle with which people will interact, who will be entering the data? Who will be capturing the required data for the database? Will there be an app on people's phones managing how they will engage with their medical professionals and how the vaccine can be accessed? Has that aspect been thought about? How is it envisaged that people will interact with the vaccination database in the civic and the medical spheres?

Professor Brian MacCraith

I will address some aspects of the answers to the questions posed by the Deputy, such as that regarding the statement by Mr. Paul Reid yesterday regarding the IT infrastructure, and the decision made to go with a specific vendor, which in this case is IBM and Salesforce working together. A detailed specification for the functionality of the system is given in the implementation plan, as well as how people will engage with it and what the patient journey will consist of.

Turning to the specific questions from the Deputy, we are happy to provide more specific detail to him. The lead on this project is the chief information officer of the HSE, Fran Thompson. We can get the detailed answers which the Deputy seeks through him, and we are happy to provide them. The important thing is that the decision has been made and the work has commenced with IBM and Salesforce. It is also important that a contingency plan is in place, whatever happens on day one of this vaccination roll-out. If all aspects of the functionality are not ready for that date, for example, there is a contingency aspect contained in the implementation plan.

That is fine. Another question concerns the data in the public trials. Is it usual that trial data for a vaccine would not be made publicly available for scrutiny by other agencies? Is that unusual in respect of this vaccine?

Professor Karina Butler

If the Deputy is referring to the clinical trials' data, basically, that is usually kept in any clinical trial by the investigators. In respect of drugs, when all that data is collated, it is then submitted to the regulatory agencies. It is not usually made public before it has gone through the regulatory submission. Some early parts of it, for example, the first phase trial data, was published. We will get that as it goes on. The bulk of the data which goes for registration, however, will go to the regulatory agencies before it becomes public. I hope that answers the question, and that was the question which the Deputy was asking.

Yes, I think it does. I have one last question, which I will try to not ask and answer myself. In a situation in three to six months, when we possibly have six to eight different vaccines, how will clinical managers, doctors, etc., choose which vaccine will be appropriate for each person? Each vaccine obviously has different efficacies. I am a scientific layperson in respect of these vaccines, obviously, but it seems all of them are generally of the same type, except that they are being made by six or seven different companies. How will medical professionals differentiate between who gets which vaccine? I hope that makes sense.

Professor Karina Butler

It is a sensible and reasonable question. Basically, that will depend on the information which we will get about all the vaccines. It might turn out, as it did with the hepatitis B vaccines, for example, that there will be different manufacturers and different products but that they will do the same thing. Although there may be an attempt to vaccinate the same person with doses of the same product, it does not matter because the vaccines are interchangeable and any of them can be used. When it comes down to it, in respect of giving someone a hepatitis B vaccine, for example, for most things it does not matter which of two brands on the market are given. Whatever is available at the time can be used.

With these vaccines, we do not have the data yet to say that they are interchangeable. Different types of vaccines are being developed. The first two we have heard about, the Pfizer BioNTech and Moderna vaccines, are the same basic type of vaccines. Even within them, however, there are subtle differences. It might be that, ultimately, they will be interchangeable and it will not matter, but we do not know that yet. When it comes down to it, as well, we will be looking at what data we have on the vaccines and what age groups they might be most effective in.

Some of these types of vaccines might be more effective in older people rather than younger people, and we might choose on that basis. It might also be the case that there may be a difference in the side effect profiles which might favour one group of people over another. For now, however, we do not have the data to comment on one versus another. We really only have data, to any extent, on the Pfizer vaccine, a little bit more on the Moderna and then on the AstraZeneca vaccine. There have been no head-to-head studies on those vaccines. That is a reasonable question from the Deputy, and it is something which will have to be worked out as we get the information to hand on the vaccines.

I have another quick question for Professor Butler. Do people have to take two doses of each of the vaccines?

Professor Karina Butler

Yes, that is correct regarding those three vaccines to which I referred. Each of those are dosed on a two-dose schedule. However, another vaccine is coming down the line which may only require a one-dose schedule. Some vaccines, therefore, may require one dose and some two. The first dose of both the vaccines to which I referred seems to be of some benefit, but it is necessary to have two doses to maximise the benefit.

I thank Professor Butler.

Along with other speakers I want to mention the work Professor MacCraith has done but I have a couple of questions. First, the message that the IT system will be ready on the day the vaccine arrives, which Mr. Paul Reid said would be the case, is very welcome but the critical point is public confidence. Does Professor MacCraith believe it is a mistake that the IT system is not ready now in terms of building confidence?

Second, he might elaborate on the certificate because it is inevitable that there will be push-back from some of the anti-vaccine people. My fear is that they will use the confusion around the certificate for people who have taken the vaccine. He might provide some clarity on his thinking with regard to the certificate. Some airlines have said they will require the certificate to allow the passenger fly. I would like to hear his thoughts on those two points initially and I will come back in again with a couple of other questions.

Professor Brian MacCraith

I will start with the second part of the Senator's question about the certificate. Within the work programme we are on the IT infrastructure and so on. Discussions are under way about the nature of any potential certificate but it is a certificate of vaccination and nothing else. That is a record of the fact that one has taken the vaccine, the number of doses and the type of vaccine. There has been a conflation publicly between a vaccination record or certificate and now the immunity passport, which is something quite different, particularly as we do not have anywhere near enough information about the impact of the vaccines on preventing or reducing transmission. That will come in time. Throughout this programme, both at national and European level, there has been a lot of discussion on having a simple record of vaccination, whether that be a hard copy or a digital or both, but those discussions have not concluded yet.

Dr. Colm Henry

If I may add to that, and Professor Butler may want to come in on this, the information is not available. We do not have the information yet, as Professor Butler described earlier. As this vaccine rolls out across European and worldwide healthcare systems, we will acquire more information, not just on the primary aim to reduce morbidity and mortality but on the aim to reduce transmission, which is the aim we all want to see achieved, thereby giving immunity to the population. We do not have information on this yet. That information will evolve and inform what a vaccination certificate actually is for individuals and wider society in terms of the social restrictions that are in place.

The IT system.

I asked about the IT system. It has also been raised here that there are people who are not IT literate due to disability, old age or IT poverty. There is not enough clarity on how the witnesses intend to reach out to those people. It is an equality of access issue as well. When the witnesses talk about the IT system they might also develop that point.

Professor Brian MacCraith

We agree with the Senator on that point. I know that is part of discussions in talking about support pathways for those who might not be digitally literate or have access to digital systems. There must be equitable access and the Senator will see that rolled out in a solution. It has to be so. It is under discussion but the exact modality of that has not been agreed. I know it is part of the discussions.

My final question is to Dr. Ronan Glynn. On a separate note, I commend him on the work he has been doing. There is a lot of media discourse about vaccines. Is he concerned that that will have an effect on people's behaviour now that they know we are on the eve of a vaccine? He might also give us his thoughts on the situation that has developed in Northern Ireland overnight where ambulances were lined up outside almost all emergency departments. Does he believe that will have a direct impact on the Border counties here in terms of the messaging of the witnesses and any assistance they can give the people in Northern Ireland at this very difficult time?

Dr. Ronan Glynn

I thank the Senator. On the first point, there is a real risk that premature complacency will set in over these weeks as people, very understandably, see hope on the horizon but, as I said previously, unfortunately, a vaccine simply will not come soon enough to have any positive effect at a population level. As soon as it is rolled out, it will have a wonderful beneficial protective effective for the individuals who get it in the first instance but we are looking at a number of months before we see a vaccine having a significant effect on how we manage this disease overall in Ireland. Unfortunately, our messaging will not be changing any time soon. Whether a vaccine comes next week, the week after or the week after that, the reality is that, unfortunately, for the next number of months we will ask people to continue with all of the basic measures that have been so important over the past year and to which people have been so good at adhering.

On the Senator's second point, the situation in Northern Ireland is of real concern. NPHET will meet tomorrow and will consider both that situation and the situation internationally. The situation internationally over the past number of weeks can only be described as devastating when we look at the number of people in intensive care across Europe and the number of deaths and hospitalisations. NPHET's primary concern is the situation here in Ireland and while we have avoided to a large extent what has happened internationally over recent weeks, I emphasise again that our situation is very fragile. We have seen numbers tick up in recent days and the indicators are that, unfortunately, we have bottomed out in terms of it being as good as it was going to get and are beginning to see a deterioration once again. NPHET will be considering all of that tomorrow. We have ongoing and very regular engagement with colleagues in Northern Ireland and that will continue over the coming days.

Is it possible that NPHET might recommend, as an immediate response, additional restrictions in the Border counties given the very worrying situation in the North?

Dr. Ronan Glynn

I am not going to speculate. NPHET is a large group. We need to look at all of the information tomorrow, both nationally and with regard to Northern Ireland, and indeed internationally, given the likely impact international travel will have on the trajectory of this disease over the coming weeks. All of that will play into our considerations tomorrow and obviously we will come to our recommendations in the normal way.

I thank the witnesses. I have been scanning through the questions to see which ones have been asked so as to not to waste time asking the same questions. I welcome the local PR campaign that will be launched this Friday. That will be very important in getting the public on board with the concept of getting a Covid vaccine. Hopefully, the public in general are on board with that.

From a brief read of the vaccine implementation plan, I want to give some of my initial thoughts on it and I would welcome any commentary on them. On the definition of "key workers", in the document educated staff such as teachers, special needs assistants, SNAs, and childcare workers are not defined as a key worker, which seems strange. They are in a different category, which comes after key workers. There are many comments online and fun things on Twitter about people being at this or that level on the list but what jumped out at me was our definitions. How flexible or malleable will they be as we go along or are they set in stone?

People aged between 18 and 64 who are living or working in crowded situations will be considered quite high up the list but how will we define that? How will people be able to prove that they are in that position? Those can be quite personal details and I am wondering how a person would go about proving that they deserve to be further up the list because of an unfortunate living situation that may be out of their control. What steps will be taken to deal with that sensitively but also how will that be proven? Do the witnesses have any thoughts on that yet?

Professor Brian MacCraith

I might give the Senator an initial response but others may be able to help with this question. In the document we have the sequence table, as she correctly pointed out. That simply is taken from the Cabinet decision of last week.

As Professor Butler mentioned, that decision was on foot of recommendations from NIAC through NPHET and on to the Government. The high-level task force has no remit in this regard, but Professor Butler, as the chair of the NIAC, is probably the best person to comment on it in more detail. She has referred to it as a living document.

Professor Karina Butler

It is a living document and things will change. The principles underlying it were to prevent morbidity and mortality and to protect those most at risk of infection and, consequently, adverse outcomes. The dominant themes are age, which almost overrides everything, and some underlying conditions.

I will address the first question, which is one that people reasonably ask, on whether teachers are important, given that they are mixing in schools. There are two factors to this, the first of which is how high the risk is for people who cannot maintain social distancing. Teachers have done a fantastic job in schools, in that they are able to maintain social distancing. They are young and in a situation where transmission is not as great a problem as it can be in other settings, but their risk of adverse outcomes is much lower than some of the people who are at higher risk. Second, as the vaccine rolls out and more becomes available, it will not seem like people are going from six to seven to eight to nine. Rather, it may all flow along seamlessly.

The key workers in the document are the logistics people who are essential to keep the vaccination programme up and running. If they were taken out through Covid or restrictions, the programme might fall. That is the type of thinking behind it. However, it is a living document and, as information comes out, elements might have to change. Did that answer the Senator's question?

Yes, although there may be a political matter to be addressed. What about people defining how they live in such situations?

It was mentioned that there were at least 15 locations under consideration as sites for vaccination centres outside Dublin. When will that information be available? We know that there will be vaccination centres outside Dublin, but a person reading this document might be concerned that there will not be.

Questions have been asked and answered around IT infrastructure, accessibility, IT poverty and equality of access, but what about the issue of data protection, which is everyone's favourite topic? How will it be managed and who will be the person responsible for it?

We have discussed staffing. Comprehensive work has been done on the staffing requirements, but how will we meet them? How will we meet the nursing requirements in particular, given that we have a shortage of nurses across the healthcare sector? The use of contracted private vaccination services to roll out the programme raises some red flags in terms of how much it will cost.

Professor Brian MacCraith

I will take the first two questions. The Senator mentioned mass vaccination centres. The reason for including the two that are mentioned is that, although they are in Dublin, they are already under the HSE's control. As to the 15 or more other sites, discussions and negotiations are taking place. They will be announced in good time for the phase of the roll-out where mass vaccination centres are relevant. We were conscious that there was a potential Dublin-centric interpretation of the mention of the two in question, but I have had discussions on behalf of the HSE with the presidents of Waterford Institute of Technology, which Deputy Cullinane will be pleased to hear, NUI Galway, the University of Limerick and University College Cork regarding their major sports arenas, centres and so on. All four of those institutions were positive in their initial responses. The dialogue will be held over the coming weeks and certainly in good time before there is a need to establish the mass vaccination centres. There is great positivity about the discussions and what was learned during the earlier stages of the pandemic.

Dr. Colm Henry

Regarding data protection, an impact assessment has been developed by the HSE. We are engaging with the Data Protection Commission, DPC, to seek its guidance and advice on that matter.

Professor Brian MacCraith

I sat in on the first meeting with the DPC last week where we went through the specifications, the minimum data set and so on. It was a positive engagement. It was provided without guarantees, but there were considerable assurances in terms of the potential of there being no significant problems in this regard. Obviously, it is a key issue that must be resolved through the formal processes, but they have been initiated.

I wish to put a number of points to the witnesses. Well done on their continued efforts to guide us through this pandemic.

I will discuss mandatory vaccinations first. The Minister has stated several times that this vaccine will not be mandatory, but will there be mandatory vaccinations for people who have to be somewhere, such as those who are imprisoned, those living in direct provision centres or those required to remain in a place of work such as an Army barracks? I do not mind who answers the question.

Dr. Ronan Glynn

I will answer. It is not envisaged that there will be any mandatory vaccination. Our initial research suggests that the intention of the majority of the population is to take up a vaccine when it is offered. I would be cautious about calling out settings such as direct provision centres in terms of mandatory vaccinations. There is no intention at all in that respect at this point. It has been proven across the world that the key to vaccination uptake is information, trust, confidence and engagement on an ongoing basis. We must be clear throughout that we do not know everything about these vaccines and we do not have all of the information, but our job is to continue communicating it as it becomes available to us, not just to GPs and pharmacists, but to all of the groups that have been such a central part of the response to Covid, for example, Pavee Point, Safetynet and the other representative organisations, which will play a fundamental role in advocating for the vaccine's uptake in the months to come.

To clarify, I do not believe it should be mandatory. I hope there will be a significant buy-in, as I am sure Dr. Glynn does.

Does it concern the witnesses that, within the body politic in Leinster House, quite a few Members stated when they were surveyed by newspapers that they would not take the vaccine? Do those who have been elected to the Dáil have a leadership role to play in standing up, getting the vaccine and encouraging their communities to get it as well?

Dr. Ronan Glynn

The experience over the past year has been that our elected representatives at local and national levels have had an important role to play, be that in Kildare, Laois and Offaly or anywhere else in the country where challenges have been met. It has been important that our elected representatives have played a key role in communicating what have been difficult messages. All representatives will have an important role to play over the coming months. I do not have the details, but my understanding is that the vast majority of representatives stated that they would take the vaccine. It is important that we focus on what the majority is intending to do, that being, take the vaccine. There will always be a small proportion of people in every sector of society who refuse to take a vaccine like this regardless of what information is available on it. In contrast, the majority of people will have understandable questions. They will want those questions answered and their uncertainties addressed. The job for us is to ensure that happens over the coming months.

Professor Karina Butler

I endorse everything that Dr. Glynn has said. All Deputies - not just those who are in the room - are leaders in our communities. That is important.

If there is information they do not have that they feel they need, we will do whatever we can to answer any questions with all the limitations of what we do not know and all we do know. What these vaccines can do and the efficacy they have shown is dramatic. Members are leaders in the community and I hope they have enough information to feel informed and that they have the confidence to share that with the people who support them.

Some months ago, the Special Committee on Covid-19 Response met in this room and I asked a question about zoonosis. We are learning about this day by day. At the time, the possibility that there was a zoonosis or reverse zoonosis risk was dismissed. We have since seen the mink population culled in Denmark and there are articles today suggesting there is a worldwide possibility of a second zoonotic event. Zoonosis was a term I last encountered in leaving certificate geography. I thought I would never use it again. It refers to diseases being transmitted from animals to humans and, in reverse zoonosis, back again.

We are on a push to have most people in Ireland vaccinated and a nationwide vaccine roll-out. There has been little mention throughout the pandemic of the Department of Agriculture, Food and the Marine, herds of livestock or domestic pets. We have seen cases in other countries of domestic pets carrying Covid. Are we sufficiently prepared on that front? We are looking at the human population for the vaccination programme. If there is the risk of a second zoonotic event worldwide, are we in any way equipped to deal with it? Have we had enough dialogue about the risk of livestock and domestic animals carrying Covid into a home? It was not an issue in March and April but scientific evidence worldwide in recent weeks has proven it is an issue. I ask the witnesses to comment.

Professor Karina Butler

Many of our challenges as we go forward will be related to zoonosis. A big one all members are familiar with is flu. That is what we worry about. We worry about birds, avian flu and mutations occurring that facilitate the spread in humans. There are many other areas also. This is ultimately a zoonosis. We do not have any real evidence that there is a lot of animal to human transmission in this. We do not say that could never happen. One of the ways to protect against it is by everyone getting vaccinated.

On the culling of the mink, the information is limited. There was concern that the disease might pass back into humans from the mink but there was not definitive evidence of that. It is an area on which we have to keep a watching brief.

Human pets have not proven to be a huge problem that we know of. Occasionally, cats and dogs have had the virus but they have not seemed to have it to a great degree or to pass it on very much. We are watching that space.

Perhaps the committee will write to the Department of Agriculture, Food and the Marine and the chief veterinary officer because there is a huge focus on human containment. That is natural, makes complete sense and I support everything they are doing. However, we are seeing reports of second zoonotic events and a number of cases in North America of the little dogs people sit on their laps carrying Covid and introducing it to homes. We need to know some of the measures being planned. There has to be a parallel process and I would like the Chairman to seek that information.

We will write to the Department. I am aware that sniffer dogs are being used in Finland as part of an experiment.

I thank the witnesses for the work done over recent months. There are many more challenges in the months ahead. A few issues are coming up. The first relates to a certificate being issued to people who have received the vaccination. Can we get some clarification on that? Some people seem to be not in favour of this.

The second concerns the records of people who have received the vaccine. If someone is suddenly admitted to hospital and is not able to give instructions because of a medical condition, how would the hospital know the person has had the vaccine? Has that issue been considered?

The third issue, which has been raised already, is access to older people. In rural areas especially, there are people who are very much alone, do not have regular contact with others and do not have immediate relatives. What measures are being put in place to ensure these people can be contacted? Will this be done through GPs or public health nurses? What mechanism is being developed for that?

Finally, if the vaccine is physically available in the country on 1 January, what percentage of the population do we expect will have received it by the end of April? I do not want to tie the witnesses to figures but I wonder if there is an estimate at this stage.

Dr. Colm Henry

I will take some of the questions and others can respond to those that are left out. On hospital admissions and cases where people cannot give information, this is a common problem in relation to Covid and other illnesses. In relation to background and medication, anyone who works in hospital will know the challenges of people sometimes coming in with sparse information. Usually, we rely on information from a GP referral letter, from direct contact with the GP on people coming into hospital, their background, their medications and their vaccination history, if it is relevant. In this case, a great enabler will be the universal health identifier, which is used for e-referrals and school vaccination programmes. Its application here will facilitate access to vaccination histories for hospital-based doctors for people being committed to hospitals who are not capable for whatever reason of conveying the information themselves.

On older people in rural areas, the Deputy will know this is a common problem across the healthcare service in terms of providing advice, ensuring access to healthcare and so on. We faced this issue with the influenza and other vaccination programmes among older people. The menu of actions we have includes publicity, communications and advertising but also using clinical networks. The hub of such networks is and always will be primary care. There is a unique relationship between a general practitioner and the people under his or her care, whether they are on the General Medical Services, GMS, list or otherwise. That will be a huge enabler for us in reaching the more inaccessible groups, including older people in rural areas.

What is the estimated figure for vaccinations by the end of April if we have the vaccine available on 1 January?

Professor Brian MacCraith

I can give an answer to that. Going back to what I said earlier, it is not possible to give absolute certainty on these matters, but I will give an example we have been working through on various models.

Residential care facilities are in the number one cohort. We know there are 589 such facilities covering close to 78,000 people, between residents and staff. We have done modelling of different rates of arrival and what we can expect at this stage with some degree of positivity is that the Pfizer vaccine will be approved quickly and that, perhaps, the Moderna vaccine will be too. The rate of arrival of that vaccine could change things. If one looks at those numbers and at the initial cohort of vaccinators, one could think that cohort might complete their vaccinations by mid to late February, for example.

Every time we mention something like that, it becomes a fact. It is not. These are models and scenarios we are working through under various rates of arrival, timings of approval of vaccines and so on. The team working on this is working through all of those. In vaccination strategies and plans around the world, people are showing indications of the curves in these diagrams, but dates and numbers are not given because, at this stage, it is impossible to give certainty around these. As I said earlier, we want to give certainty to members of the public around this and to manage their expectations in as transparent a way as possible.

If it will be mid-February for that cohort, what about healthcare workers? Will they be vaccinated by mid-February as well? I am not trying to tie Professor MacCraith to specific times. The process will start on 1 January, assuming the vaccine is available but obviously if it is not available until 15 January, then everything gets moved forward by 15 days. I am just wondering about the time period for roll-out.

Professor Brian MacCraith

That estimate is highly dependent on the supply of the vaccine. It is based on vaccinating the first cohort on the priority list first and after that, typically one would move on to the next cohort which is the Covid-facing front-line healthcare workers. Again, these are just indicative scenarios and not something we are standing over or making an announcement on at this stage. We are just indicating to the committee that we are working through real data across all of the cohorts and through various potential vaccine arrival schedules. So, for example, if the Moderna vaccine is approved on 12 January, we could start to see a supply of that coming in quite quickly but that is not confirmed yet in terms of any details. All of these factors change the parameters of modelling involved which is why I cannot be definitive-----

I wish to return to the issue of certification. Will a certificate be issued for every person who gets the vaccine? This needs to be clarified.

Professor Brian MacCraith

The group working on this has not come to a decision or conclusion on it yet. Part of the reason is that there are EU-wide discussions taking place on whether there might a common approach taken across the 27 member states. The UK has been giving out hard copy evidence of vaccination but a decision or recommendation from the task force has not been reached yet.

It is absolutely imperative that some certification would issue during the course of the inoculation campaign. It would be simple enough to do. It may take a little bit of extra time, but not a lot. A card could be printed and then filled out and handed to people as they are inoculated. That is hugely important.

It is not the intention of this committee to micromanage the campaign but public confidence in the integrity of the system is hugely important. It will become even more important as this particular vaccination programme progresses. We have seen from the USA and Donald Trump the way fears can be manipulated and the obvious can be contradicted through social media. Professor MacCraith has already said that there will be a campaign to combat any negativity that may arise from certain quarters, including from conspiracy theorists. It is hugely important to be able to rebut their arguments instantly and to do so authoritatively. The scientific evidence and information necessary to rebut them must be readily available. Is that in hand? Has the task force attributed sufficient importance to it? Does it appreciate that the success of the inoculation campaign will depend not only on the logistics of it but on public confidence in it? Who wants to answer that?

Dr. Ronan Glynn

I can respond to an element of that. As the strategy sets out, this is a clear and fundamental component, as Professor MacCraith said earlier. There is no doubt that there will be misinformation and rumour and the reality is that as quickly as we respond, there will be further rumours and more misinformation. What has been proven internationally over time is that as important as responding to misinformation - which is clearly very important, as we have seen over the last year in terms of Covid-19 more generally - is ensuring that the basic correct information is put out regularly, transparently, as quickly as we have it to hand and in a form that is digestible for the public. It needs to be in many different forms because people digest information in many different ways. As I said earlier, there will be a campaign at national level but at local level elected representatives, GPs, pharmacists, healthcare professionals of all types as well as community organisations and others will have a fundamental role to play in addressing misinformation over the coming months. However, I would reiterate that the majority of people in the country at the moment have indicated that they plan to get the vaccine, albeit they have very understandable questions that we need to answer.

Like others in this House, I will be supporting those who wish to take the vaccine.

Another important issue is equity in terms of distribution, access and availability. There is nothing that upsets Irish people more than the possibility of somebody who is less entitled getting in ahead of them. Equal distribution, access and availability is essential in terms of reassuring the public that the process is fair. I ask the witnesses to respond to that point.

Dr. Colm Henry

The priority list was clearly informed by the principles of equity and fairness. It is quite clear from the groups we described in the dialogue we had earlier with Deputy Durkan's colleagues that the roll-out is based on the principles of equity and fairness in the context of reducing morbidity and mortality, as Professor Butler said. I would like to assure people that those principles are reflected in our priority list.

Given that it takes two shots to complete the dose for individuals, at what stage do the witnesses expect it will be possible to determine that the virus has been contained by way of the vaccination programme? At what stage after the double inoculation should we expect to see a visible improvement in our control of the virus? Will we monitor the situation in Northern Ireland, which has already started its vaccination campaign, with a view to identifying the effectiveness of it?

Professor Karina Butler

The Deputy has asked a very good question but the answer is that we do not know exactly. It depends on whether the vaccines not only prevent disease and death but also prevent transmission of infection and that information is just not available yet. If they just protect the person who receives the vaccine, it will take much longer. Essentially, it will take until a large number of people are vaccinated and that will depend on the roll-out and people coming forward for vaccination. If it happens that the vaccines are very good at blocking viral turnover or replication in the nose so that it is not passed on to other people, we may see it happen sooner. It is a very good question but we do not have the answer yet.

Deputy Naughten is our last contributor and he has about two minutes.

I will run through my questions quickly and the witnesses can give me a written response if necessary. My first question relates to the unique health identifier. The eHealth Ireland website speaks to plans for 2019 and obviously we have moved along considerably since that. Do we need any amending legislation on the individual health identifier or are the witnesses satisfied that the legislation already in place is robust enough? Can the witnesses assure us that they will not be pulling front-line staff away from the provision of already-delayed services, such as processing primary medical certificates, to carry out the vaccination programme?

I thank Dr. Henry for his clarification on informed consent in the context of vulnerable settings but I ask him to provide us with a copy of the protocol to which he referred. I also ask him to ensure, as a matter of urgency, that a code of conduct is issued to all of our nursing home settings around the country detailing how they should engage with older people. Naturally enough, older people are going to start asking questions as soon as the first vaccine is approved. It is very important that they are not told that they will not have access to X or Y service if they do not avail of the vaccine so that they are giving proper, informed consent.

Dr. Colm Henry

I will start with the final point first. We have built up experience in informed consent for vaccination programmes among older people with the pneumococcal vaccine and the influenza vaccine programmes. Deputy Naughten is correct that they should never involve a threat, direct, indirect or otherwise, and should involve providing information in a way that a person can best understand the benefits and risks. The principle of informed consent has evolved over the years. It is not a binary concept. It is complex. In this case, it is the duty of the healthcare provider, namely, ourselves, to explain things as best we can, according to each individual situation. That includes people who may have cognitive impairment. They should not be excluded from consent just because they are on a journey of cognitive impairment towards dementia. Our colleagues in nursing and GPs who vaccinate older people have a lot of experience in explaining the benefits of vaccines. They trust that older people, like younger people, are able to ask for the information that is important to them. It is obvious to everybody that they have suffered greatly, not just in terms of the impact of the virus, but from the impact of the social restrictions. I hope we would be leading from the front and providing impartial, correct information to people. My guess is that based on the optics from the influenza vaccine this season, which has been taken up at very high levels among this age group, we would see a big appetite among older people for a vaccine that would reduce what is a very high risk for some of them.

Is there a response on the adequacy of the legislation in terms of the unique identifier?

I asked about the unique identifier amending legislation.

Will anyone comment on that? Perhaps the witnesses would come back with a written response.

Dr. Colm Henry

We will come back on that.

What about redeploying the front-line staff?

Dr. Colm Henry

This is a big priority for people who would otherwise either get very sick or worse with this virus. It is a big priority for healthcare assistants because of the impact we are seeing. Reference was made this morning to the situation in the Antrim hospital in the North. Vaccination is also important in terms of reopening society and the economy. Part of this will involve us deploying staff away from other services where they are currently employed. Since reopening healthcare services, we have a full range, including cancer screening services. Community services have reopened and we are trying to redeploy and keep staff in those services rather than redeploy them away. We will be leaning heavily on those experienced vaccinators, between school vaccination programmes, GPs, nurses and pharmacists. It will involve prioritising this work over other elements of work, and there will always be some pain associated with that.

I must bring the meeting to an end. I had a number of questions myself but, unfortunately, I will not have time to ask them. One of the obvious questions relates to what we started off the meeting talking about, namely, the 76,000 plus people who had Covid. Where are they in terms of prioritisation within the programme? Are they included? Many of them have underlying conditions from Covid and they are really concerned about getting it again. I would welcome a brief reply in a matter of seconds. I apologise for the way the meeting went. Some people got in and others did not. The way we are operating at the moment makes it very difficult. I really appreciate the time and effort involved this morning. Could anyone answer my question on those people who had Covid?

Professor Karina Butler

People who have had Covid are recommended to get the vaccine, but many of them fit into the priority groups and would get it in that way. Many of them are elderly or had underlying disease, but the fact that a person has had Covid is not a contraindication to receiving the vaccine and it is recommended that people in that category would get it.

I thank Professor Butler very much. I appreciate the input of the witnesses into the meeting. It was very useful. It is the start of a conversation. I hope to meet all the witnesses again in the new year. This meeting concludes our work for 2020, thankfully, on a very positive note after a very tough year. The committee will meet again at 11.30 a.m. on Wednesday, 13 January 2021 when we will meet with representatives of the National Public Health Emergency Team, NPHET, and the HSE to review Living with Covid-19, which will provide an update on the trends and the incidence of Covid-19 for this month and early January, as well as an update on the roll-out of the vaccine and on developments in testing and tracing. I wish everyone a very happy and safe Christmas and a happy new year.

The joint committee adjourned at 1.35 p.m. until 11.30 a.m. on Wednesday, 13 Jan 2021.