30,000 to get BCG vaccine checks

More than 30,000 adults and children who received the BCG vaccine against tuberculosis between 2000 and 2002 must be checked to see if their dose has been effective.

The move follows confirmation today by the Irish Medicines Board (IMB) that a second batch of the vaccine in question, No. 754576, distributed in Ireland between April 4th and July 4th, may be less potent than those normally administered.

The Department of Health and Children emphasised there is no health threat to the 30,000 people who received vaccines from the batch, other than that they might not have received adequate immunity.

Mr Micheál Martin said health boards will contact those who received BCG vaccines from the batch to attend a clinic to establish whether the vaccine was effective. If this test, which must be carried out three months after vaccination, is negative, people will be offered re-vaccination.

Dr Joan Gilvarry, medical director, IMB stressed here is no cause for alarm as this is not a safety issue - it is simply the possibility of the vaccine not being as potent as it should. "If there is a scar or mark at the vaccination site on the upper arm, parents can be assured that the vaccine has worked."

It remains very important that parents continue to have their children immunised so that children continue to be protected against the diseases concerned Mr Micheál Martin

BCG provides protection against tuberculosis (TB) infection and is normally given to children at birth in maternity hospitals. It is also given to contacts of people who develop TB and who do not have immunity against the disease.

Both sub-potent doses of the BCG have been produced by the British manufacturer Evans Vaccines. Batch No. 761641, made by Evans, was distributed to 2,500 people in the Republic on March 20th and last month it was found to be less potent than normal. The efficacy of the dose received by these people will also be checked.

Evans’ BCG vaccine licence was suspended by the IMB pending investigation of five further batches of vaccines supplied to the Irish market over the last two years - which led to today’s announcement.

In a statement today, the IMB said it was dissatisfied with procedures at the Evans plant.

Mr Martin applauded the IMB’s response to the issue.

"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," he added.

The Midlands Health Board has identified 1,200 cases; the Southern Health Board 1,200 cases; the South Eastern Health Board 2,863, the North Western Health Board 2,380; the Mid-Western Health Board 3,000 and the North Eastern Health Board 1,180.

The majority of the remaining cases are based in the Eastern Regional Health Authority area. Figures for the Western Health Board were not available.

Tuberculosis has declined steadily in Ireland in the past number of years with less than 400 cases reported annually.