Written Answers. - Vaccination Programme.
Seán Crowe
Ceist:
1018
Mr. Crowe
asked the
Minister for Health and Children
the steps his Department has taken to reassure parents and the general public that a situation will not recur whereby more than 4,000 children in the South Western Health Board region may not have received effective immunisation against tuberculosis over the past two years and that the continued quality of vaccines will be maintained and monitored.
[15895/02]
The Bacillus Calmette-Guerin, BCG, vaccine is given by injection to protect against tuberculosis. In early July 2002, I was advised by the Irish Medicines Board, IMB, that a single batch of BCG vaccine, batch number 761641, manufactured by Evans Vaccines Limited was being recalled due to the possibility of reduced effectiveness. This was a precautionary measure following tests which showed that this batch of vaccine, distributed in Ireland since March 2002, was found to be less potent than that which is normally administered. All stock from this batch was withdrawn at this time and is no longer in use. This withdrawal took place under the direction and supervision of the IMB. For precautionary reasons, the use of other batches of Evans BCG vaccine, five in total, was deferred pending testing and confirmation of their effectiveness.
Following this withdrawal, the IMB carried out an on-site investigation of Evans Vaccines Limited's facility in the UK; the IMB was dissatisfied with the procedures adopted by the company in producing the BCG vaccine and, as a result, on 31 July 2002 the IMB suspended the BCG licence held by Evans Vaccines Limited. Alternative effective supplies of BCG vaccine were secured from Statens Serum Institute of Denmark and these have been distributed to health boards.
In August 2002, the IMB advised me that following testing a further batch of BCG vaccine, batch number 754576, manufactured by Evans Vaccines Limited, was also found to be sub-potent. This batch was distributed in Ireland between April 2000 and July 2002. The IMB confirmed that the four other batches tested met the licensed potency specification required.
There are no safety concerns associated with these vaccine batch recalls; the problem is one of a possible reduction in effectiveness. However, it is necessary to identify those who have received vaccine from the two relevant batches in order to check if the vaccine has been effective. A period of three months must have elapsed after the BCG vaccine is given before the effectiveness of the vaccine can be determined. Health boards have identified those who received vaccine from the two batches concerned and are now in the process of contacting all relevant individuals to arrange appointments for follow up. The follow up involves an inspection of the injection site for the presence of a scar and, if necessary, testing to see if the vaccine has been effective. If, following this, it is determined that the vaccine has not been effective a further BCG vaccine will be offered.
The IMB is responsible for the monitoring and safety of all pharmaceutical products in Ireland. The monitoring of vaccine safety is ensured through clinical trials prior to licence and post-licence surveillance by the IMB. The IMB liaises closely with international bodies including the European Medicines Evaluation Agency and the World Health Organisation. The IMB has assured me that there is no health threat to persons who received BCG vaccine from either batch 761641 or 754576 other than the fact that they may not have received immunity from the vaccine.
In order to reassure the public as to the safety of vaccine products, I am in the process of establishing an expert group to be chaired by Professor Kingston Mills, Professor of Immunology at Trinity College, Dublin, which will examine and report on the procedures in place to ensure the continuing quality of vaccine products licensed for use in Ireland. I will shortly be announcing the terms of reference and membership of this group.
The immunisation programme currently operated in this county has played a major part in bringing serious, previously common diseases under control. It is very important that parents continue to have their children immunised so that children continue to be protected against the diseases concerned.
