Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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328. To ask the Minister for Health if he will provide parents in counties Cavan and Monaghan an update regarding the delay in providing the BCG vaccine; if their babies are at risk of TB due to this; if it will become a routine vaccine again when stocks are restored; and if he will make a statement on the matter. [33430/16]

Simon Harris (Wicklow, Fine Gael)
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There is currently a worldwide shortage of BCG vaccine.  In 2015 the United Nations Children's Funds (UNICEF) estimated a worldwide shortage of 65 million doses of BCG. The vaccine has not been available in Ireland since the end of April 2015. The manufacturer has had difficulties in the production of the BCG vaccine. The manufacturer has informed the HSE there will be no supply of BCG until 2017. Consequently, BCG vaccination clinics in HSE Clinics and Maternity hospitals have been postponed until new stock arrives.

There is only one licensed supplier of BCG vaccine to Ireland and to other countries within the EU. Since this problem became apparent, the HSE National Immunisation Office has been in regular contact with the manufacturer of BCG vaccine to ascertain when the vaccine might be available. The HSE has also asked the Health Products Regulatory Authority (HPRA), which licenses and regulates all human medicines in Ireland, to source an alternate supplier of the BCG vaccine. Efforts have been made to find a company who can provide the vaccine for use in Ireland which satisfies all the HPRA requirements on safety and efficacy. To date no suitable alternative BCG product has been found. Therefore the HSE has been unable to procure the BCG vaccine from any other source and still awaits the product from the HPRA licensed supplier of the vaccine.

The supplier has indicated that supplies of the vaccine are not expected to be delivered into Ireland until early 2017. When there is confirmation of the date of new supply a decision will be made, guided by the recommendations of the National Immunisation Advisory Committee, on who should be prioritised to receive the vaccine. Arrangements will then be made to administer the vaccine, including to those prioritised in Cavan and Monaghan.

In Ireland the number of cases of tuberculosis (TB) has been falling. TB is a notifiable disease under the Infectious Diseases (Amendment) Regulations 2016 (S.I. No. 276 of 2016). In 2015, 318 cases of TB were notified to the Health Protection Surveillance Centre, giving a national TB notification rate of 6.9 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. The risk to babies remains unchanged, even allowing for delay in getting BCG vaccine in Ireland.