Recall of BCG Vaccine

All health boards in Ireland, including the South Eastern Health Board, have been notified by the Department of Health 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 All stock from this batch has been withdrawn and is no longer in use.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.

The South Eastern Health Board is currently identifying children and others who have received BCG vaccine from the batch in question.  We will be in contact with individuals or with parents of children who received this Batch next week.  We will arrange appointments for them to attend a Health Board Clinic to establish whether the vaccine has been effective in their case.  If it emerges that the vaccine was ineffective they will be offered revaccination. 

Alternative effective supplies of the vaccine are being sought to ensure minimal disruption to the BCG vaccination programme.  The South Eastern Health Board would like to emphasise that there is no concern over the safety of this vaccine and no cause for alarm.