Dáil Éireann Debate, Tuesday - 29 November 2016
548. Deputy Michael Healy-Rae asked the Minister for Health his views on a matter (details supplied) regarding the bacillus Calmette-Guérin, BCG, vaccine; and if he will make a statement on the matter. [37186/16]
View answerThere is only one licensed supplier of BCG vaccine to Ireland and to other countries within the EU. The manufacturer has had difficulties in the production of the BCG vaccine. Since this problem became apparent, the HSE National Immunisation Office has been in regular contact with the manufacturer of the 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 that can provide the vaccine for use in Ireland which satisfies all the HPRA requirements on safety and efficacy. There has been a worldwide shortage for over two years and 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.
