Fifth vaccine trial on children exposed

A previously unknown fifth vaccine trial was carried out by Glaxo Laboratories on more than 30 young children here in the 1960s.

The pharmaceutical giant GlaxoSmithKline (GSK), has previously stated only four trials were carried out in the 1960s and 1970s. These trials were carried out by the Wellcome Foundation — a GSK “heritage” company.

However, documents uncovered by Michael Dwyer of UCC’s School of History, shows that a fifth trial of a measles vaccine on 34 children took place in 1965. It was carried out by Irene Hillary and Patrick Meenan of UCD’s microbiology department and AJ Beale of Glaxo Laboratories.

This is the first trial uncovered which specifically references Glaxo Laboratories, as all previous trials carried out in Ireland were done by Wellcome.

A report of the trial was carried in The Lancet in August 1965 and confirms the vaccines “were prepared by Glaxo Laboratories” and were trialled on children aged between “eight months to about two years”. There is no mention of parental consent.

“The duration of temperatures over 100ºF was under two days for both the KL [children given both killed and living vaccine] and L [children just given living vaccine],” read the 1965 report. “Only 3 children (all in the living-vaccine group) had a rash. 1 child (KL) had conjunctivitis, and 1 child (L) had coeliac disease and vomited. The reactions to the vaccines were all considered trivial by the adults looking after the children.”

Although the report does not specify where the trial took place, the reference to the reaction to the vaccines being monitored by “the adults looking after the children” and the fact that follow-ups were done on all the children from day six to day 14 at 6pm seem to indicate that the children were in a group setting.

In a statement, GSK said it did not agree that the above references were evidence that the trial was carried out on children in care. It said any trials it carried out in Ireland were done by independent healthcare professionals to the highest safety and ethical standards to help treat illnesses that were a major public health risk.

“If we had evidence that the study had taken place in a mother-and-baby home, we would have submitted it to the Laffoy Commission — we provided copies of historic documents we had on file that were relevant to that investigation,” said GSK. “Given that these trials took place many decades ago, we have limited archived documentation,” said a statement.

GSK said it was currently “seeking to investigate the facts regarding these studies” and would co-operate with any Government inquiry.

The pharmaceutical giant has previously only admitted to four vaccine trials having ever been carried out in Ireland. In a response issued to RTÉ in 2011, it acknowledged a fourth trial but stated that this was the only other clinical trial sponsored by Wellcome using children in institutions in Ireland.

Earlier this year, UCC’s Michael Dwyer also discovered evidence that Wellcome had carried out vaccine trials on more than 2,000 Irish children in 24 residential institutions between 1930 and 1935.

Writing in today’s Irish Examiner, Mr Dwyer said the issue of the vaccine trials now needed a fresh investigation focusing on the role played by the medical and scientific community in the trials.

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