More than 40,000 children used in vaccine trials, Mother and Baby Home Commission found

There may have been a sixth vaccine trial carried out at St Patrick's but the commission was unable to confirm details of a possible oral polio vaccine trial there in 1965. Picture: Larry Cummins 

There were at least 13 vaccine trials carried out on more than 43,000 children, according to the Mother and Baby Homes Commission of Investigation.

None of the mothers — some of whom were as young as 15 — involved appears to have given consent for their children to be involved in the trials.

Some of the mothers involved were known to have "mental health issues" or "psychiatric disorders".

In addition, a number of the infants involved did not have their mothers with them at the time they were involved in the trials.

Of these trials, seven were carried out in six of the homes the commission investigated.

There were believed to be at least four different vaccine trials carried out in St Patrick's, Navan Rd, (Pelletstown) and three at Bessborough in Cork.

There may have been a sixth vaccine trial carried out at St Patrick's but the commission was unable to confirm details of a possible oral polio vaccine trial there in 1965.

Although two vaccine trials took place in Cork between 1930 and 1936, the commission was unable to determine whether they took place in institutions within its remit.

Of the children who took part, at least 1,135 of them were from institutions, and the rest were from “the general population”.

At least 223 of the children from institutions came from mother and baby homes or county homes within the commission’s remit.

The commission stated: “It is clear that there was not compliance with the relevant regulatory and ethical standards of the time." Picture: Larry Cummins 

The commission stated: “It is clear that there was not compliance with the relevant regulatory and ethical standards of the time.

"Consent was not obtained from either the mothers of the children or their guardians and the necessary licences were not in place.

“There is no evidence of injury to the children involved as a result of the vaccines.”

At least one child is known to have died of cardiac and respiratory failure two weeks after receiving the first injection in one of the vaccine trials.

The commission said: “The available medical records do not suggest that this child’s death was in any way linked to the vaccine.”

Dublin Union

In 1934, Dr Denis Hanley, assistant medical officer for the City of Dublin, administered Wellcome’s APT anti-diphtheria vaccine to 24 Dublin Union resident children, varying in age from seven months to 14 years.

An examination of the institutional records of the Dublin Union and Pelletstown failed to identify the 24 children involved in Dr Hanley’s initial APT trial.

However, the commission said, it is more than likely the children selected for inclusion were "illegitimate" and unaccompanied, as most children resident there at the time were categorised as such.

In January 1935, with the "consent and co-operation of the medical superintendent and staff" of the Dublin Union, Dr Hanley administered Wellcome’s APT vaccine to another 24 children in the Dublin Union.

Working on the results of his own investigations, and with the full support of the Dublin municipal health authorities, Dr Hanley administered Wellcome’s still experimental, and not commercially available, one-shot APT vaccine to 39,267 schoolchildren in Dublin.

The commission noted Dr Hanley emphasised the importance of obtaining written consent prior to treatment and provided a breakdown of the number of consent forms returned in each school.

No child was immunised unless a written parental consent form was produced.

“However, Dr Hanley made no mention of consent, written or otherwise, in respect of institutional children,” the commission stated.

Bessborough, Co Cork

At least three trials were carried out on children at the Cork home.

The first of these, between 1960 and 1961, was for the Wellcome Laboratories' Quadruple (4 in 1) vaccine ‘Quadrivax’ on 58 infants and children resident in a number of institutions, including Bessborough.

Documentation shows that 25 of the children were living in Bessborough and 23 of them were living with their mothers in Bessborough at the time.

One child involved in the trial was “an abandoned child resident” in the institution.

The Bessborough institutional records show that at least five mothers of children resident there who participated in the trial had mental health issues.

In the second of three trials believed to have taken place at Bessborough, seven children “may” have been involved in a Glaxo Laboratories ‘Mevilin-L’ measles vaccine trial carried out between 1964 and 1965.

All seven children were over eight months old and match the age profile of children involved in this measles vaccine trial.

The commission stated: “As so little is known about this trial, it is difficult to know whether or not it complied with the regulatory and ethical standards of the time.

“Nothing is known about what consents, if any, were sought or obtained.”

In the third trial, in 1965, for the ‘Quintuple’ 5 in 1 vaccine, 16 Bessborough infants were involved.

Most were adopted and discharged from their respective institutions during the timeframe of the vaccine trial.

The commission said it “did not conform to the regulatory and ethical standards in place at the time”.

It said there was no evidence that one of the main researchers involved held a research licence to conduct such trials.

Also, there is no evidence consent was sought or received from the mothers who were in the institutions.

St Patrick's, Navan Rd (Pelletstown)

At least five, and possibly six, vaccine trials were carried out in this institution between 1960 and 1973.

In most cases, the commission found trials did not comply with the regulatory and ethical standards in place at the time and there was no import licence in place for the vaccine.

It found researchers did not have a research licence which covered research carried out in the home. There was also no evidence that consent was properly sought or received.

Pelletstown institutional records show that 13 of the 14 children involved in the 1960-61 Quadrivax quadruple vaccine trial — known in the report as Trial B — were described as "illegitimate". Five were not accompanied by their mothers at the time of the trial.

The commission found the trial did not comply with the regulatory and ethical standards in place at the time and there was no import licence in place for the vaccine.

There was also no evidence that consent was properly sought or received.

The commission believes, but was unable to prove, that children from the home were also involved in Trial D, which was the 1964-65 Glaxo Laboratories ‘Mevilin-L’ measles vaccine trial.

The 1965 Glaxo Laboratories ‘Quintuple’ 5 in 1 vaccine trials — known as Trial E — involved three infants resident in Pelletstown on August 25, September 22, and October 27, 1965.

The institutional records from Pelletstown and Bessborough show that two of the mothers were under 18 years of age.

Again, the commission found this trial did not conform to the regulatory and ethical standards in place at the time, and the vaccine was not covered by Glaxo Laboratories' import licence.

Of a measles vaccine trial carried out at the home in 1968 and involving 30 children, the commission said it did not conform to the ethical and regulatory standards in place at the time.

In a 1973 Wellcome Diphtheria, Tetanus, and Pertussis (DTP) Trial, 20 children in the home were used. They were described in records as unaccompanied, "illegitimate" children aged between three and nine months old.

Two of the children were recorded as having Down syndrome; one had Crouzon syndrome (facial deformity), one had congenital talipes equinovarus (club foot), while another had congenital heart disease.

Institutional records note that at least seven of the mothers had psychiatric disorders or were recorded as being "mentally handicapped". Another mother was 15 years old.

There is no evidence that the mothers or the authorities in Pelletstown were asked for or gave consent.

Ard Mhuire, Dunboyne, Co Meath

Nine children resident in Dunboyne were involved in the 1960/61 Quadrivax vaccine trial.

All were listed according to documents as "illegitimate".

The mother of one child was under treatment in Mullingar Mental Hospital when the first and second vaccinations were administered and was present in Dunboyne on the date of the third vaccination.

Dr Hillery conducted the Quadrivax 4 in 1 combined vaccine that was administered to five children and the other four were inoculated using routine vaccine and procedure. The commission said there is no evidence that any child who participated in the trial was harmed in any way.

"However, it is abundantly clear that (the trial) did not comply with the regulatory and ethical standards in place at the time."

Manor House, Castlepollard, Co Westmeath

Some six children resident in Castlepollard were involved in the quadruple vaccine trials, which were carried out in Bessborough, St Patrick's, and Dunboyne.

The commission says institutional records do not record the dates involved, but that it seems likely the vaccine was administered at this home between December 1, 1960, and February 10, 1961.

All children were, according to documentation, described as illegitimate, and all were accompanied by their mothers.

Sean Ross Abbey, Roscrea, Co Tipperary

In 1964, a trial of Wellcome Laboratories'  Wellcovax measles vaccine was carried out on 12 children living in the abbey.

Ten of the 12 involved were accompanied by their mothers on the date of vaccination. Three of these women were aged under 18 years, two were 17, and one was 16 years old.

Another woman was, the commission noted, described as "mentally retarded" by a family member.

Another child had been admitted to Sean Ross unaccompanied.

In another case, it was unclear if the child was accompanied or not on the date of vaccination.

Again, the commission concluded that this trial "did not comply with the regulatory and ethical standards in place at the time".

There was also no import licence in place for the vaccine and the researchers did not have a research licence which covered research carried out in the children’s institutions.

There was also no evidence consent was properly sought or received.

In addition, the results of the trial were never published.