Statement by the Minister for Health and Children concerning BCG vaccine
The Irish Medicines Board (IMB) has advised the Minister for Health and Children that a further batch of BCG vaccine – batch number 754576 – manufactured by Evans Vaccines Ltd has been found to be less potent than that which is normally administered. The testing of this and four other batches was part of the follow up initiated in early July 2002 when another batch of BCG vaccine (batch number 761641) was found to have reduced effectiveness. The IMB has confirmed that the other four batches met the licensed potency specification required.
For precautionary reasons the use of Evans BCG vaccine had been suspended pending testing and confirmation of their effectiveness. Following the tests and the IMB´s suspension of the BCG vaccine licence held by Evans Vaccines Ltd, the batches will not be used again.
There is no health threat to persons who received vaccine from the two batches concerned, other than that they may not have received immunity from the vaccine.
Health boards are in the process of identifying children and others who have received BCG vaccine from batch number 754576. Initial estimates indicate that approximately 30,000 people have received vaccinations from this batch. The health boards will contact those involved and make arrangements to examine those who received the vaccine in order to determine whether or not the vaccine was effective at the time it was administered. If it emerges that the vaccine was ineffective, revaccination will be offered.
Alternative effective supplies of BCG vaccine have been secured. An immediate order is in the process of being delivered to health boards and further supplies will be available in September. The alternative supplier is Statens Serum Institute of Denmark.
On 31 July 2002 the IMB suspended the BCG vaccine licence held by Evans Vaccine Ltd and it is reviewing all licences held by this company for products supplied to the Irish market. This action followed an on-site investigation by the IMB of the company´s facility in the UK.
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 Minister speaking earlier today said “I want to thank the IMB for the comprehensive manner in which they have responded in this instance. The immunisation programme currently operated in this country has played a major part in bringing serious, previously common, diseases under control. It remains very important that parents continue to have their children immunised so that children continue to be protected against the diseases concerned”.
The Minister is pleased to announce that Professor Kingston Mills, Professor of Immunology at Trinity College Dublin has agreed to chair the Expert Group announced in July. This Group will examine and report on the procedures in place to ensure the continuing quality of vaccine products licensed for use in Ireland. The Terms of Reference and membership of the Group will be announced shortly.