Gerry Adams (Louth, Sinn Fein)
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436. To ask the Minister for Health the progress he has made in conjunction with the Health Service Executive in examining evidence-based changes to the primary childhood and schools immunisation schedule; the stage these examinations are at; and if he will make a statement on the matter. [5478/16]

Gerry Adams (Louth, Sinn Fein)
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439. To ask the Minister for Health the progress he has made in introducing Bexsero, the vaccine that protects against meningitis B, into the primary childhood and schools immunisation schedule; the status of his announcement that the vaccine will be offered to babies for free as part of the primary childhood immunisation schedule from September 2016; the way in which and when he will implement this roll out; and the way in which it will impact on children born prior to September 2016. [5481/16]

Leo Varadkar (Dublin West, Fine Gael)
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I propose to take Questions Nos. 436 and 439 together.

The HSE Service Plan included additional funding for the expansion of the Primary Childhood Immunisation Schedule in 2016. Consequently, there will be two evidence-based changes made to the Primary Childhood and Schools Immunisation Schedule later this year. Meningococcal B and Rotavirus are to be introduced in Quarter 4 and Ireland will be the second country in Europe to provide the Meningitis B vaccine to children as part of a national immunisation programme. The HSE has commenced work on the necessary preparations for the introduction of the new vaccines, and children will begin receiving the new vaccines later this year. The age of administration of the vaccine is under consideration. All vaccines administered through the Primary Childhood Immunisation Schedule are provided free of charge.

I hope this clarifies the matter for the Deputy.

Gerry Adams (Louth, Sinn Fein)
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437. To ask the Minister for Health the progress he has made in plans to re-establish tuberculosis, BCG, vaccination programmes for newborn children and infants; if he has resolved the shortage of the vaccine; and if he will make a statement on the matter. [5479/16]

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. 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 the HSE receives the vaccine, they will arrange appointments for vaccination clinics ensuring that those at high risk are offered vaccination first.