Thomas Pringle (Donegal South West, Independent)
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459. To ask the Minister for Health the reason there is a shortage in supply of tuberculosis (BCG) vaccines; the issues with the supplier; the reason enough vaccines were not acquired ahead of the next supply which is due in July 2015; and if he will make a statement on the matter. [26231/15]

Leo Varadkar (Dublin West, Fine Gael)
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The BCG vaccine is currently part of the primary childhood immunisation schedule and is provided by the HSE. The vaccine is given to protect babies against Tuberculosis (TB). In Ireland the number of cases of TB has been falling and there were no cases in young children in 2014.

The HSE has a contract with a Danish supplier for the procurement of BCG vaccine. BCG vaccine must be specifically packed for distribution to each country. According to the contract when BCG vaccine arrives into Ireland it should have a shelf life of 6 months. The contract contains a delivery schedule of an agreed amount of BCG vaccine every three months. The delivery volume is more than sufficient vaccine for newborn babies and others requiring BCG vaccination.

Since 2014 the supplier has been supplying BCG vaccine with significant delays due to issues in their production. The last shipment of BCG vaccine due to arrive at the end of October 2014 arrived at the end of December 2014. The delay in delivery meant that two months shelf life was lost and this expired at the end of April 2015. The HSE had sufficient BCG vaccine in Ireland until it expired at the end of April 2015. Had more stock been purchased it too would have expired at the end of April 2015.

In addition delivery of BCG vaccine produced in 2014 were suspended pending an extensive investigation regarding a possible problem with the capping of the vials. This investigation has now been concluded and product produced during 2014 is being released, but it will take some time to release all the batches produced. As a result this BCG vaccine will have very short remaining shelf life until newly produced product becomes available

In addition a number of qualification/validation activities have to be performed following repair of central equipment in the first half of 2015. This means that production of new product will not commence until August 2015 and due to the lengthy analysis and release procedure, vaccine from this production will not become available until the end of 2015 or beginning of 2016.

As a result there are limits to the quantities that can be ordered and delays on all deliveries. The supplier does not expect that the delivery situation will be normalised until 1 quarter of 2016 at the earliest.

The HSE will arrange appointments for vaccination clinics when the BCG vaccine supply is restored.