Brendan Griffin (Kerry South, Fine Gael)
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153. To ask the Minister for Health the up-to-date position regarding the provision of the tuberculosis (BCG) vaccine for infants, the current anticipated timelines; and if he will make a statement on the matter. [35007/15]

Leo Varadkar (Dublin West, Fine Gael)
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Ireland is not the only country affected by the worldwide shortage of BCG. 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. The licensed supplier has informed the HSE that the BCG vaccine will be delivered into Ireland in late October.

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.

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.

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