The pharmaceutical company SmithKlineGlaxo yesterday expressed "deep concern" at a report that an Irish child was given an animal vaccine in a drug trial in 1973.
Health agencies said the report in yesterday's Irish In- dependent was the first they had heard of the allegation. They have asked the company for a response.
According to the article, the child was among a group given the 3-in-1 vaccine Trivax as part of a trial. However, the child, according to the report, was inadvertently given the animal vaccine Tribovax T instead. The child vomited for 24 hours afterwards, the report said. The trials were carried out for Wellcome, which was later taken over by Glaxo, which was in turn taken over by SmithKline.
The company said it first learned of the alleged administration of the animal vaccine in the newspaper report and it was asking the newspaper to help it to establish the facts.
The Irish Medicines Board said yesterday it had not previously been informed of any inadvertent use of an animal vaccine on a child. At the time of the trials there was no legislative control over the conduct of clinical trials.
"The IMB intends to fully investigate this issue with the manufacturer of the product and liaise with the Department of Health and Children and the health boards on this matter," it said.
The Eastern Regional Health Authority said it would be taking the matter up with the company. So far as it is aware, the then Eastern Health Board was never told of any incident of an animal vaccine being administered to a child.
The Department of Health and Children said it had asked the company to provide whatever information it could to allay the concerns raised by the report. If the wrong vaccine was administered to a child it would appear that it could only have happened when the product was being manufactured for the purpose of a trial.
Last November the Minister for Health and Children, Mr Martin, received a report on vaccine trials on children in the 1960s and 1970s. He told the Dail he was puzzled at the lack of documentation on the trials and he found this unsatisfactory. Trials were carried out on 211 children, many of whom were in care and living in institutions. He referred the report to the Laffoy Commission on Child Abuse.