Press Release

Statement by the Minister for Health and Children concerning the recall of one batch of BCG vaccine

The Minister for Health and Children has been advised by the Irish Medicines Board (IMB) that a single batch of BCG vaccine is being recalled from the Irish market due to the possibility of reduced effectiveness. This is a precautionary measure following tests which showed that one batch of the vaccine, distributed in Ireland since late March 2002, was found to be less potent than that which is normally administered.

There is no health threat to persons who received vaccine from the batch concerned other than the fact that they may not have received immunity from the vaccine.

BCG provides protection against tuberculosis (TB) and is normally administered to children at birth in maternity hospitals. It may also be administered to at-risk groups who are known to be tuberculin negative and who have not been previously vaccinated with BCG.

The batch in question, Batch number 761641, manufactured by Evans Vaccines Ltd. was first distributed in Ireland via United Drug on 20 March 2002. All stock from this batch has been withdrawn and is no longer in use. For precautionary reasons the use of other batches of Evans BCG vaccine have been deferred pending testing and confirmation of their effectiveness.

Health boards are currently in the process of quantifying and identifying children and others who have received BCG vaccine from the batch in question. Health boards will arrange appointments in the coming weeks for those concerned to attend a health board clinic in order to establish whether or not the vaccine was effective. If it emerges that the vaccine was ineffective, people will be offered revaccination.

Alternative effective supplies of the vaccine are being sought to ensure minimal disruption to the BCG vaccination programme.

While the IMB already meet the highest international standards in relation to the licensing of medicinal products, the Minister has asked it to confirm that all companies supplying vaccines in Ireland continue to meet international quality standards. He is also establishing an Expert Group to examine and report on the processes in place to ensure the continuing quality of vaccine products licensed for use in Ireland. In addition the Minister has requested the National Immunisation Steering Committee already established by health board CEOs to review the procurement and distribution arrangements for vaccines.

The Minister and the Department urges all parents to have their children immunised against the diseases covered by the childhood immunisation programme, which includes BCG, in order to ensure that both their children and the population generally have maximum protection against the diseases concerned.