There has been "a marked increase" in the number of children developing complications after being administered a new, stronger strain of BCG, according to a new report which will be published in the Archives of Paediatrics and Adolescent Medicine in the coming months.

The report, conducted between 2002 and 2004, studied reactions to the new vaccine, which was introduced on a national level in 2002 and continues to be administered today.

Fifty-eight children were reported to have had adverse reactions to the vaccine, resulting in multiple surgeries for three patients. The overall complication rate was estimated at one in 931.

One of Ireland's leading consultant paediatricians, Dr Karina Butler . . . who was involved in the study . . . said the report raised a serious question about this vaccine strain's suitability for use in a national immunisation programme.

"BCG is definitely an imperfect vaccination, and it must be questioned whether the kind of reactions reported in this study are acceptable, " she said.

"Some countries have stopped using the BCG vaccine completely, and it would be a wonderful situation if we could do that. The problem is that we do not have the support out there in terms of dealing with TB if we stopped immunising against it. Therefore, we are trying to balance the side effects of the vaccination against the risks involved in leaving people vulnerable to TB."

Butler said the new strain of BCG was introduced to protect people against TB meningitis.

It is 15% more effective than the strain previously used, but as a result must be administered with extreme care.

While the reported rate of complications was high, Butler said there were no long-term side effects for any of the patients reported to have had adverse reactions in the study.

A National TB Subcommittee is currently considering the possibility of no longer using the vaccination. The BCG vaccine is usually given to newborn babies, and HSE figures estimate its uptake at 93%.