Vaccine Trials

The information on this page is adapted from the Clann Project report, which links to all source materials. If you are reproducing material from this page please use the following citation:

Maeve O’Rourke, Claire McGettrick, Rod Baker, Raymond Hill et al., CLANN: Ireland’s Unmarried Mothers and their Children: Gathering the Data: Principal Submission to the Commission of Investigation into Mother and Baby Homes. Dublin: Justice For Magdalenes Research, Adoption Rights Alliance, Hogan Lovells, 15 October 2018.

The subject of vaccine trials carried out on children in Mother and Baby Homes and similar institutions first emerged in 1991, when three trials which took place in 1961, 1971 and 1973 were brought to the attention of the Minister for Health. The vaccines had been produced by Wellcome Laboratories, and the trials were carried out by Wellcome Laboratories in the UK, the Department of Medical Microbiology at University College Dublin and (in one trial) the Eastern Health Board. The vaccines were given to 211 Irish children, 123 of whom were in children’s institutions. In 1998, the Minister for Health asked Dr James Kiely (Chief Medical Officer at the Department of Health) to produce a report on the vaccine trials issue. This Report (the “Kiely Report”) was subsequently published in 2000.

According to the Kiely Report, 58 infants in 5 Mother and Baby Homes took part in Trial 1, which took place in 1961. The names of the 5 homes are not provided, however the Sacred Heart Home in Bessborough, Cork seems to have been involved. To our knowledge, Clann Project Witness 71 (see below) is the only person to have ever received confirmation of their involvement in this trial as an infant. Professor Irene Hillary of University College Dublin alleged that “the management, medical officers and mothers were aware of the nature of the trial and gave their consent on that basis”. However, the Kiely Report notes that

“In the home in Bessboro, Cork, the mothers of the infants would also have been resident there but there is no written evidence to indicate whether the mothers’ consent was sought or obtained for their children’s participation in this trial. Further, there is no documentation available in Bessboro which describes the arrangements made between management and the researchers for the conduct of this trial”.

In this context it is worth noting that records relating to the vaccine trials carried out at Bessborough were not transferred to the Health Service Executive after the Sacred Heart Adoption Agency closed. Witness 71 says that her mother gave evidence to the Commission to Inquire into Child Abuse that she did not consent to the trial:

“In October 2002, my mother and I were invited to give preliminary testimony to the legal team working under the Laffoy Commission in Dublin. My mother gave clear testimony that she was unaware I was being used in any trials, and that her consent was never sought for my participation”.

A 2016 investigation by Conall Ó’Fátharta in the Irish Examiner revealed that files relating to infants involved in the 1961 vaccine trial at Bessborough were altered in the weeks after the CICA sought discovery of the records. According to the Irish Examiner, changes to the records include:

“The alteration of discharge dates of mothers (by a period of one year and two years);The changing of discharge dates of children;

The changing of admission dates of mothers;

The alteration of the age of a mother (by two years);

The alteration of dates of adoption;

The changing of baptism dates and location of baptism;

The insertion of certain named locations and information into admission books”.

The information obtained by the Irish Examiner correlates with records which Witness 71 requested under a data access request. She says that in her case, the altered information made it appear as though her mother had been discharged much earlier.

These alterations seem to be specifically aimed at obscuring the lack of mothers’ consent. Mr O’Fatharta, knowing I had a rather detailed file as a result of my FOI/DPA request, asked me to check my records and this made it clear that changes were made and a notation made of it in August 2002. I have filed a formal criminal complaint with the Cork Gardaí and Data Protection Commissioner regarding the alteration to my data …As these alterations were made while records were being formally requested by an ongoing statutory investigation, it is my contention that these alterations are both a criminal violation and a data protection breach. The Cork Gardaí have decided not to pursue a criminal investigation and have referred the matter to the Data Protection Commissioner (“DPC”) and the current Commission of Investigation into Mother and Baby Homes. I have had no response as of yet from the DPC”.

Trial 2 took place in 1971, and 69 children who were in a children’s home in Dublin were involved. According to the Kiely Report,

“As regards Trial 2, there is no information available which can clarify one way or another, whether consent was obtained for the participation in this trial of those children who were resident in the children’s’ home mentioned because there are no records”.

Trial 3 took place in 1973, involving 53 children in Mother and Baby Homes and other institutions, including St Patrick’s Home, Navan Road; Madonna House; Cottage Home; Bird’s Nest Home and Bohernabreena. According to the Kiely Report:

“As regards Trial 3, the question of consent is unclear. Available correspondence seems to indicate that the Medical Officer of some of the homes may not have been aware that residents of these homes were being given the vaccines prepared for the trial in use at the time. Professor Hillary asserts that she sought and received permission to use these newer vaccines in the homes as part of a clinical trial”.

In terms of follow ups on the children involved in these trials, the Kiely Report says that

“It was not the practice to follow-up vaccinated children for other than very short periods and the participants in these trials were not followed up in the longer term”.

The Kiely Report states that

“The Therapeutic Substances Act, 1932 was the statute governing the importation and use of vaccines in these trials. It has not been possible to locate or identify documentation which would confirm whether or not the legal requirements of this Act were complied with in respect of these three trials”.

Whatever the implications of the Therapeutic Substances Act for the lawfulness of the use of therapeutic substances in the State during the conduct of clinical trials, there was no legislation prescribing the procedure for conducting the trials nor was there any legislation dealing with the issue of consent to participate in a clinical trial before the enactment of the Control of Clinical Trials Act, 1987.

In November 2000, the Minister for Health referred the Kiely Report to the CICA because ‘‘the most rigorous interrogation of the system failed to produce documentary records of the trials’’. The CICA set up a Vaccine Trials Division, which investigated the matter for two years. In June 2004 however, as a result of legal action taken by Professor Irene Hillary, the State’s order to the CICA was held to be invalid by the High Court, and the CICA’s work on the vaccine trials was halted.

The judgment in Hillary v. Minister for Education [2005] 4 IR 333 suggests that the researchers involved in the trials in question confirmed, in a public statement on the 9th of July, 1997 that the researchers had received the consent of some of the parents of the infants involved in the trial. It was recorded in the judgment that in subsequent communications, Professor Hillary asserted that she requested and received the permission of both the management and medical officer of the home in Bessborough to carry out a trial and she understood that all the parents whose infants were participants were informed either by her or the manager of the nature of the vacation being undertaken and they gave their consent on that basis. There is a statement in the published article in relation to the findings of the trial in question that the medical officers in the homes gave permission to carry out the trial on infants under their care. The judgment further records the statement to the effect that this is the only reference to consent in the published article and the question of consent is not addressed in the trial protocol.  Addressing the question of consent, the Chief Medical Officer is quoted in the judgment of the Court as having recorded:

In principle, it appears to be the case that the authorities in whose care children were placed and who, in the absence of parents or guardians, were in loco parentis, were entitled to give consent for medical treatment (including vaccination) on behalf of the children in circumstances where, in their judgment, that treatment was in the child’s interest. It is not clear however, that such authority would extend to giving consent to an intervention which, while it would confer certain benefits on the child by way of protection against a number of infectious diseases, was clearly a clinical trial, the outcome of which or the level of benefit accruing to the child could not be predicted. It is also unclear what standing, if any, medical officers attached to the children’s homes had to give consent”.

In 2011, RTÉ’s Prime Time “Anatomy of a Scandal” programme revealed that a fourth trial had been carried out by Wellcome in 1964 on children resident in Sean Ross Abbey.

In December 2014, a fifth vaccine trial, carried out by GlaxoSmithKline in 1965, was uncovered by Michael Dwyer at University College Cork. While GlaxoSmithKline denied that the trial was carried out on children in institutions, the Irish Examiner notes that

“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 6 to day 14 at 6pm seem to indicate that the children were in a group setting”.

In June 2017 Conall Ó’Fátharta reported in the Irish Examiner that Glaxo Laboratories were also testing lactose and baby formula on infants at Bessborough in 1974. The report says that

“The trial sheets recorded a range of reactions to the products. These included vomiting (slight, moderate, severe, or none), excessive regurgitation, wind (slight, moderate, severe, or none), stools (locae, normal, or constipated) and stool colour (yellow, grass green, olive green, yellow green, no stools, meconium, changing). Other “abnormal conditions” were also noted. These included excessive crying, irritability, napkin rash, thrush, and others”.

The vaccine trials in the 1960s and 1970s sometimes involved children living at home, and thus were not exclusively conducted on children in Mother and Baby Homes and similar institutions. However, it is worth noting that informed consent is more feasible to obtain in the case of the parents of children living at home, as opposed to vulnerable women and girls living in institutions under the control of religious orders and other individuals. Moreover, because these institutions were part of the infrastructure of Ireland’s closed, secret adoption system, it has proven impossible for the vast majority of those who suspect they were involved in the trials to obtain information.

There is a lot of uncertainty amongst witnesses who spoke to the Clann Project as to whether they were the subject of vaccine trials, and there is great suspicion amongst those born in these institutions at the relevant times about the truth or accuracy of any records. The Clann Project is not aware of any instance where a mother resident in a Mother and Baby Home gave consent for her child to be included in a vaccine trial.

Witness 71 says that she

received confirmation from GSK that I was indeed part of the active trial group of a 4‑in‑1 combination vaccine given between 1960/61 at Bessborough”. 

The Department of Health claim[ed] they held no files relative to me, but it is my understanding that they were at that time in possession of records and files pertinent to the Laffoy Commission, a subset of the Commission to Investigate Child Abuse (“CICA”) begun in 1991.  In 2001, I submitted an online questionnaire published by CICA relative to those who believe they may have been part of vaccine trials in relevant mother-baby homes or residential institutions.  In October 2002, my mother and I were invited to give preliminary testimony to the legal team working under the Laffoy Commission in Dublin.  My mother gave clear testimony that she was unaware I was being used in any trials and that her consent was never sought for my participation”.

Witness 70 says

When I was a teenager I was very conscious of the vaccine marks/scars on both my shoulders and left ankle.  I had asked my adoptive mother about these as I was self‑conscious of these and didn’t like to wear vests, etc so these marks could be seen.  My mother told me that when I was placed with her and my father on 27 May 1961 both my arms were bandaged and all the vaccine marks were inflamed and infected.  It took months for these to heal she told me and I had to go to the doctor to get my arms dressed and ointment, etc.  She told me they were in a bad way.  I always wondered where they came from.

I [have] now gotten my birth weight and the chart documenting my weight over time and, most importantly, my vaccine dates, both BCG and smallpox.  I was given both my smallpox and BCG vaccines in Bessborough before I was sent to my adopted parents in Mayfield, but what accounted for all the marks I had?  I had two huge BCG scars on my right shoulder, four smallpox on my left shoulder and two small marks on my left ankle.  I went to my GP and got him to examine my marks/scars very carefully and he said that these many marks were not at all in keeping with marks of vaccines from that time.  There were way too many of these. 

I wrote to GSK [Glaxo Smith Kline] pharmaceutical company and gave my date of birth and my birth name to see was I one of the babies who got vaccinated in the 1960/61 trial while I was there.  I got a letter back stating “no they didn’t have my birth name or mother’s name on that trial which had taken place while I was there”.  I received a letter stating that I wasn’t part of that 1960/61 trial.

I just hope I can get some answers for all the vaccine marks that I have on my body as whether I was in a vaccine trial or not.  I am very badly scarred from these marks and no need for so many of them.  Most people have 2/3 at the most, I have 8 in total.  I just want to know and find out what was done to me”.

Witness 68 says:

“I have five or six inoculation marks on my left shoulder and I had become concerned over the years that I may have been involved in drug trials whilst I was at St Joseph’s. I submitted a Freedom of Information request to Glaxo SmithKline who confirmed that I was not part of a trial”.

Witness 17 says:

I am also concerned that I may have been used in medical research without my consent when I was living at the County Home in Killarney and potentially the Industrial School.  In particular, my medical records show that I was hospitalised for 5 days between 19 and 21 February 1953.  However, no reason for this medical treatment is given.  This is very unusual because, in my experience, the nuns who ran the County Home and other institutions like it were meticulous record keepers.  It simply does not make sense to me that no reason was given in my medical records for my hospitalisation.

I have tried to investigate whether such medical trials were conducted in the County Home in Killarney or the Industrial School during my time in both institutions but, when I contacted someone in Dublin who held themselves out as having information about these trials, they told me that no such trials had been carried out in County Kerry.

Given that there is evidence relating to the medical trials which the courts and the Irish Government have prevented from being subject to public scrutiny and that I have previous personal experience of people attempting to suppress my records, I would not be surprised to find that people are lying to me and there is evidence that I was subjected to medical trials as a child”.

Witness 28 says:

I think it is possible that I was subjected to vaccine trials at St Patrick’s, although I have no way of knowing this for certain.  I think that this is possible for three reasons.  First, the date of my birth in December 1966 coincides with the period when vaccine trials were being undertaken.  Second, I used to be a blood donor, but around the time of the hepatitis C scandal in Ireland in the mid-1990s I received a letter from the Blood Transfusion Service informing me that my blood could no longer be accepted because it contained an anti-virus.  I have no idea how an anti‑virus could have become present in my blood unless it was as the result of a vaccine trial.  Thirdly, I remember that when I was at primary school, another girl and I were taken to be examined by a doctor.  I have never understood what that examination was about but I have often wondered whether it may have been a follow‑up examination for children who had been subjected to vaccine trials”.