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Vaccine Trials

Vomiting and fever among side effects experienced by children who took part in GSK trials

The pharma company has today published information about nine trials it carried out in Irish institutions between 1934 and 1973.

VOMITING AND FEVER were among the side effects experienced by children who took part in trials carried out by Glaxo Laboratories (now known as GSK) in mother and baby homes and similar institutions in the 20th century.

GSK has today published information about nine trials it carried out in Irish institutions between 1934 and 1973.

The documents relate to vaccine trials A to G, as they are referred to in the final report of the Commission of Investigation into Mother and Baby Homes, as well as two infant milk formula trials.

Over 1,000 children in various institutions were selected to take part in pharmaceutical trials carried out by GSK and others.

Earlier this year, Children’s Minister Roderic O’Gorman reiterated his view that GSK has a “moral obligation” in relation to the vaccine trials. Despite a “constructive” conversation in April, GSK said its position remained unchanged and it will not pay compensation to people who took part in the trials.

In the documents released today, GSK notes that in 1935 a trial of an anti-diphtheria vaccine was carried out in the following Dublin locations: St Vincent’s Industrial School, St Joseph’s School for Deaf Boys, St Saviour’s Orphanage, and the Dublin Union (Ireland’s largest workhouse, located on the site of what is now St James’s Hospital).

The purpose of the trial was to “reduce the incidence of diphtheria (a serious infection that can lead to difficulty breathing, heart failure, paralysis and death) and associated child mortality in Dublin”. Diphtheria was “endemic at this time and outbreaks were common”, GSK notes.

Seventy children took part in the trial. The side effects included local inflammation around the injection site; localised cold abscesses (abscesses without the usual signs of inflammation); stiffness; headache; and temperature.

The document notes: “These reactions occurred three days after vaccination and typically disappeared four or five days after vaccination. No reactions were observed among the first 24 infants. The second 46 were noted to develop a painless pea-sized lump at the injection site, which gradually disappeared.”

GSK notes that this vaccine was also given to 39,267 Dublin school children “before it was commercially available”.

“This was done with support from Dublin municipal health authorities as part of an immunisation scheme to address the public health need of the time. The vaccine became commercially available in the UK in February 1935.”

Vaccine trial B examined a quadruple vaccine that targeted diphtheria, tetanus, pertussis (whooping cough) – known as DTP – and polio combined.

Fifty-eight children from the following institutions took part: Bessborough, Cork; Pelletstown/St Patrick’s, Dublin; Manor House Castlepollard, Westmeath; Ard Mhuire Dunboyne, Meath; St Clare’s Home Stamullen, Meath; Mount Carmel Industrial School, Moate, Westmeath.

Group A (30 children) were given the DTP vaccine in their right arm and Polimylex (inactivated polio vaccine) in their left arm; Group B (28 children) were given the Quadrivax (combined DTP and polio combined) in their left arm.

In relation to side effects, the document states: “In January 1961, 18 infants became ill with vomiting and mild diarrhoea at Bessborough. Of these, 15 were involved with the vaccine trial and comprised infants from both groups A and B who had just received their second doses.

“One infant had been adopted from the home and subsequently did not receive his second dose. The other two infants were not involved with the trial at all.

“Some 43 children resident in the other trial locations had been given a dose of vaccine from the same batches and did not fall ill … No reactions, either at the local injection site or general, occurred in any of the infants after the first or third injections with either group A or group B.”

The DTP vaccine and the polio vaccine used in this trial were both made commercially available in the UK in the late 1950s.

Milk formula trials

GSK carried out a milk formula trial in institutions in Bessborough in Cork and Pelletstown/St Patrick’s in Dublin in 1967. Twenty-three children took part.

The purpose of the trial was “to determine whether new formulations of infant milk were well tolerated by babies”.

Babies were split into different groups and fed various formulas: Ostermilk 1; L.14 (half cream milk/half fat); L.20 (full cream milk/full fat).

Every second baby in Group A was to receive L.14, the other babies were to receive the standard half cream (half fat) infant milk used by the home as a control. L.14 babies were to be moved onto L.20 “as the person in charge of feeding saw fit”.

In Group B, every second baby was to receive L.20, the other babies were to receive Ostermilk 1 or the standard full cream infant milk used by the home. Babies in Group C were to be fed as normal.

The document notes: “Six out of seven babies on L.14 experienced vomiting and diarrhoea. Those in charge of the infants reverted to the normal feeds used at the homes due to these reactions and reported the reactions to the supervising doctors.

“The trial was stopped early as a result. It appears from later testing that the high levels of lactose proved too strong for the babies, as those given diluted L.14 had no similar reported reactions.”

Another milk trial on Ostermilk 1 was carried out on around 80 babies from Bessborough and Pelletstown (40 at each site) in 1969.

The document notes that “no information” on side effects is available. It adds: “The draft protocol is the only information GSK retains regarding this trial. No evidence could be found that this trial was conducted.”

The documentation released today has been collated from GSK’s archives in London as well as other published sources.

Information service

GSK has also established “an enhanced information service” for survivors of mother and baby institutions who believe they participated in the trials.

In a statement, the pharmaceutical giant said it “recognises that many survivors are understandably seeking to access their personal information”.

“The company has spent time reflecting on its response to the Commission’s report and has endeavoured to find a meaningful way to assist survivors and their families. GSK believes these measures undertaken to simplify the information request service and publish trial summary documents represents the most valuable way to support those seeking further transparency in relation to the trials.”

If people believe they took part in one of the GSK trials, they can submit a Subject Access Request (SAR) to the company.

To make a request for access to any personal data GSK may hold, people have been advised to email providing as much of the following information as possible:

  • Your full name and address (or that of a relative, as necessary)
  • Name at birth (if different)
  • Date of birth
  • Mother’s name (including her maiden name if different)
  • The name of the relevant mother and baby home(s), if known
  • The approximate year or years the person lived at that institution or institutions
  • Any other information that may help in the search
  • Whether you would prefer to receive a response by email or by post

GSK’s statement noted that the records “are not complete for every trial”.

“While some of the individual clinical trial records do contain important identifying information such as names and dates of birth, this information is not available for all trials. This means it is not possible to verify the identity of every participant and part of the reason why GSK has also published trial summary documents with information about the development and, where applicable, the licensing history of the trial products.”

The company today said it “would like to re-emphasise its sympathies to the women, children and families affected by the issues raised in the Commission’s report and sincerely hopes the work undertaken to enhance its information service and publish trial summaries will better support those searching for more information about their personal experience or that of a family member”.

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