Colm Burke (Cork North Central, Fine Gael)
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I am asking the Minister for Health to initiate a health technology assessment for an RSV vaccine following recent National Immunisation Advisory Committee, NIAC, approval, particularly in light of the large increase of hospital admissions of patients with respiratory infections. Respiratory viruses are reportable since 2012 and the figures are frightening. Last year, for the 2022-23 winter months, 7,759 cases were reported; 2,231 of those were people over 60 years and over 636 ended up in emergency departments in our hospitals. Across Europe, over 274,000 hospitalisations for RSV have been identified and there have been 20,000 fatalities over the last 12 months.

The vaccine has been approved by the European Medicines Agency since June. The question now is whether we take a decision to make vaccines available. There are two very vulnerable groups, namely those under two years and those over 65. There is a question about assessing cost and implementation but it is also about saving lives. In real terms, it will save huge money because there would be fewer admissions to hospitals and fewer people needing to go to their GPs and requiring care. I ask that the Minister prioritise this issue, that vaccines would be approved and that we would set out a clear programme on their delivery over a very short timeframe.

Ossian Smyth (Dún Laoghaire, Green Party)
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I thank Deputy Burke for raising this matter. Both Minister for Health, Deputy Donnelly, and the Chief Medical Officer share these concerns in relation to the high levels of RSV that are circulating in our community.

To begin with, I can confirm that following receipt of NIAC advice on RSV immunisation options in October, and the Office of the Chief Medical Officer having considered that advice, the Department of Health has requested HIQA to undertake a health technology assessment, HTA, in relation to RSV.

RSV is a common winter respiratory virus that generally leads to mild respiratory symptoms. It can, however, lead to severe illness among infants, young children aged less than five years and in people aged 65 years and older. Symptoms of RSV include a cough, wheezing, runny nose, difficulty feeding or decreased appetite as well as a fever and a sore throat. RSV associated deaths among children in Ireland and other high-income countries are thankfully rare.

Since last month, RSV has been circulating at very high levels. The highest rates are in those aged less than one year old, followed by the one to four year age group. In the last two weeks, we have seen the highest number of recorded cases and hospitalisations due to RSV. The majority of hospital cases are in those aged less than one. This surge in the rate of RSV cases is stretching healthcare capacity by placing a significant burden on the hospital system.

The numbers of notified RSV cases and hospitalisations decreased slightly in the last week but remain at very high levels. The number of RSV cases notified to the Health Protection Surveillance Centre in the week ending 9 December is 829. This compares to 985 cases notified during the previous week. The number of hospitalised cases notified to the Health Protection Surveillance Centre in the week ending 9 December is 335. This is a decrease of 9% over the previous week when 370 cases were notified. However, despite the decrease in RSV case numbers it is anticipated that the healthcare system will continue to come under increased strain in the coming weeks due to an expected rise in the transmission and co-circulation of respiratory viruses including Covid-19, influenza and RSV.

It is worth noting that certain infants at high risk of infection are offered a form of immunisation, licensed in Ireland for the prevention of serious lower respiratory tract infection caused by RSV. The NIAC advice notes that in relation to infants, there are two forms of passive immunisation against RSV. First is a long-acting monoclonal antibody which can be administered to the infant directly and second, a maternal vaccine which can provide infant protection through transplacental antibody transfer. Passive immunisation is when a person is given antibodies to a disease rather than producing them through his or her own immune system. Active vaccination involves administration of a vaccine to stimulate the production of an immune response in the form of the production of antibodies. Based on a small number of clinical trials carried out to date, both products have acceptable safety and efficacy profiles.

The NIAC advice also noted that further analysis of cost effectiveness and programmatic considerations is required to determine the most appropriate RSV immunisation strategy for infants. In relation to the over 65 age group, the advice stated that there are two vaccines which NIAC recommends to protect against RSV. The advice also noted that based on clinical trials carried out to date, these products also have similar safety and efficacy profiles and again, further analysis of cost and product availability is needed to determine which product is more suitable for use in Ireland.

As I mentioned earlier, following consideration of the NIAC advice, the Department of Health asked HIQA to carry out a HTA to determine first whether infant or adult immunisation would provide the greatest benefit in reducing healthcare utilisation due to RSV infection and second, what the most cost-effective RSV immunisation strategy for Ireland would be. The outcome, when available, will inform whether or not RSV immunisation will be added to the national immunisation programme.

Colm Burke (Cork North Central, Fine Gael)
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I thank the Minister of State for a comprehensive reply. As he noted, there were 370 admitted to hospital in the last few days of November and early December and for the week ending 9 December there were 335 admissions. That is a huge demand on our health service.

Therefore, everyone will agree at this stage that we need to identify the best way forward with the use of these vaccines and whether we should have a nationwide programme, in particular for children under the age of two or under the age of five, but also for the older age group. Certain people aged over 65 have certain vulnerabilities and we need to identify those as well and have a vaccine available.

The way forward is to have a vaccine programme available. The medication is there, the drugs are now there and they have been approved. It is now about moving on and using them effectively. In real terms, doing a vaccination programme means there are real cost savings for the State. Fewer people will have to attend their doctor and hospital or to need that care. I have come across a number of cases and recently heard of someone who was only 56 and got a very bad viral infection. That person had no prior medical conditions but actually died. They were very healthy but picked up a virus and despite all of the efforts of the medical team dealing with them, unfortunately they were not able to bring them through the difficulties they had. It is therefore important that we fast-track this and move forward with the introduction of a vaccine at the earliest possible date.

Ossian Smyth (Dún Laoghaire, Green Party)
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I will refer briefly to the timeline in this regard. It is hoped the results of the HTA will provide important clarity on this matter and will assist in determining the most appropriate course of action. It is expected that the key components of the HTA will be completed by the second half of next year.

It is important that parents are vigilant of their children's symptoms, that they trust their instincts and contact their GP if they are worried, especially if the symptoms get worse quickly. There are things parents and caregivers can do to help curb the spread and to keep their children safe. Parents with babies should try to cocoon them and avoid having them in large crowds or spending time with those who have colds or respiratory symptoms. While we are sick ourselves or have children who are sick, we must keep away from other children where possible and ensure we all wash our hands regularly and use respiratory etiquette for coughs and sneezes. It is vital we keep children with cold or flu-like illnesses home from crèche or school until they are feeling better to avoid spreading these viruses.

With regard to winter viruses more generally, we know that vaccines, where available, are the best means of protection available for us and for those who are vulnerable in our communities. All who are eligible for the flu vaccine and have not yet received it should make an appointment to receive it without delay. Those who are eligible for a Covid-19 booster should ensure they receive that also.

We are dealing with three winter respiratory infections now, namely, RSV, Covid-19 and flu. It is a significant burden on the health service. We have seen that we have managed to greatly reduce the effects of Covid-19 through a broad vaccination programme. I hope we can achieve the same with RSV. The fact that RSV particularly affects babies and children is all the more reason to prioritise it but as the Deputy noted, RSV can also lead to death in older people. I thank the Deputy for raising the issue and the Minister, Deputy Donnelly, has spoken to me about RSV in the past and is absolutely concerned about it, as is the Chief Medical Officer. It is something they are working on and it is a priority for them.

Verona Murphy (Wexford, Independent)
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I thank the Minister of State and the Deputy. That is the end of the Dáil session but before we rise I will take the opportunity to wish everybody a very happy holiday and happy Christmas. I thank the staff, the ushers, those on sound or security in general and all of the staff here in the Dáil.