Paul Murphy (Dublin South West, Anti-Austerity Alliance)
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291. To ask the Minister for Health to report on the availability of the tuberculosis BCG vaccine and the measures being taken to ensure it is available to all those who require it; and if he will make a statement on the matter. [4754/16]

Leo Varadkar (Dublin West, Fine Gael)
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There is currently a worldwide shortage of BCG vaccine. BCG vaccine has not been available in Ireland since the end of April 2015.

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. The HPRA has tried continually 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 the HPRA have been unable to find a suitable alternative BCG product. 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.

There have been a number of issues that have delayed the production, release and delivery of BCG vaccine in recent months. Consequently, supplies of the vaccine are not expected to be delivered into Ireland until early 2017. When the HSE receives the vaccine, they will arrange appointments for vaccination clinics ensuring that those at high risk are offered vaccination first.