Denis Naughten (Roscommon-South Leitrim, Independent)
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523. To ask the Minister for Health when children will be called for tuberculosis, BCG, vaccinations which have been missed due to the shortage of vaccines; if priority will be given to children who missed out on the vaccine as infants, and in primary school, as is the case in the west of Ireland, given that there is an upper age limit for the BCG vaccine; and if he will make a statement on the matter. [36609/15]

Denis Naughten (Roscommon-South Leitrim, Independent)
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524. To ask the Minister for Health the Health Service Executive policy for vaccinating children who missed out on tuberculosis, BCG, vaccinations due to production difficulties; when the vaccine will be available; and if he will make a statement on the matter. [36610/15]

Leo Varadkar (Dublin West, Fine Gael)
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I propose to take Questions Nos. 523 and 524 together.

There is currently a worldwide shortage of BCG and Ireland is not the only country affected by this. There is only one licensed supplier of BCG vaccine to Ireland and to other countries within the EU. The vaccine has not been available since the end of April 2015 and babies born after the last day of April have not been immunised. Based on an estimated 5,500 - 6,000 babies born every month this means that 33,000 - 36,000 babies are due to be vaccinated. The licensed supplier has informed the HSE that the BCG vaccine will be delivered into Ireland in late October. The HSE will arrange appointments for vaccination clinics when the BCG vaccine supply is received.

Since this problem became apparent, the HSE National Immunisation Office has been in regular contact with the manufacturer of BCG and with the Health Products Regulatory Authority (HPRA) who licenses vaccines in Ireland as well as with other relevant stakeholders. The HPRA have been seeking to find an alternative supply of BCG that meets safety, quality and effectiveness standards and that could be used in Ireland. To date no appropriate alternative manufacturer of BCG vaccine has been found.

In early 2015 the HSE asked the HPRA to look at extending the shelf life of BCG vaccine from 12 months to 18 months. The HPRA reviewed the necessary documentation and agreed to extend the shelf life of any new delivery of BCG vaccine to 18 months. Any new deliveries of BCG will have an 18 month shelf life.

The National Immunisation Advisory Committee (NIAC) and the National TB Advisory Committee have recommended stopping routine BCG vaccination of newborn babies and instead provide a selective vaccination of babies in high-risk babies groups. The Department of Health have requested the Health Information and Quality Authority (HIQA) to conduct a Health Technology Assessment (HTA) to review the implications of this change. HIQA commenced a public consultation on proposed changes to the BCG vaccination programme in Ireland on September 9th 2015. The HTA will be available by the end of the year.

Tuberculosis (TB) is a notifiable disease under the Infectious Diseases (Amendment) Regulations 2011 (S.I. No. 452 of 2011). In 2014, 328 cases of TB were notified to the Health Protection Surveillance Centre, giving a national TB notification rate of 7.1 per 100,000, the lowest rate reported since surveillance commenced. According to the World Health Organisation, the definition of a low incidence TB country is one with a national TB notification rate of less than 10 cases per 100,000, Ireland is in this category.

In Ireland the number of cases of TB has been falling and there were no cases of TB in young children in 2014. Most European countries, including the UK, Sweden, Norway, Denmark and Iceland do not give BCG vaccine to all babies. Babies are not at risk of TB because of the delay in getting BCG vaccine in Ireland.

BCG vaccination is usually given to newborn babies, but can also be given to older children and adults who are considered to be at risk of developing TB.

Resolving the issue of the shortage of BCG remains a priority for me.

Denis Naughten (Roscommon-South Leitrim, Independent)
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525. To ask the Minister for Health the reason some primary, community and continuing care, PCCC, services are still calling newborn children for the tuberculosis, BCG, vaccine while children are left on a two-year waiting list in other PCCC areas; if the procurement and distribution of vaccines has been centralised, as advised, following previous problems; and if he will make a statement on the matter. [36611/15]

Leo Varadkar (Dublin West, Fine Gael)
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As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy. If you have not received a reply from the HSE within 15 working days please contact my Private Office and they will follow up the matter with them.