Micheál Martin (Cork South Central, Fianna Fail)
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392. To ask the Minister for Health the position regarding the reported shortages of the BCG vaccine; and if he will make a statement on the matter. [35753/16]

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.

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, the HSE will be guided by the recommendations of the National Immunisation Advisory Committee on its administration.