Irish Vaccine Injury Support Group
In the late 1960’s and early 1970’s there was an upsurge in the number of severe adverse reactions in children who received the 3 in 1 DPT Trivax vaccine manufactured in the UK by Wellcome.
Because of this upsurge Eastern Health Board records (1973) show that the official in charge of the administration of the vaccine within the Dublin Health Board region was inundated with reports of severe reactions among children. On the 24 September 1972 the official in charge wrote to Wellcome enclosing a list of the LOT numbers of the DPT vaccine that had caused severe reactions and to express her concern. (Child Abuse (Amendment) Bill 2005 Second Stage Speech by Denis Naughten TD Vol 601 28-04-2005 No 4).
In the first 6 months of 1973 more than 80 reported adverse reactions were recorded in the inner city of Dublin.
There were so many reactions to the 3 in 1 vaccine in the early 1970’s that by 1974 only 50% of parents were opting for the 2 in 1 vaccine omitting the whooping cough/pertussis element.
The IMB received notice of 324 suspected adverse drug reactions to the DPT vaccine since 1972. 87 of these were classified as serious in accordance with agreed international criteria (Dail reply No 791-29 Nov 2004).
The EHB co-operated with Wellcome in carrying out a study in 1973 comparing 4 types of DPT vaccine. A total of 116 children were involved – 59 from the community and 57 from two children’s homes in the Dublin area.
Vaccine Trials in the Orphanages
The vaccine trials known as ‘Vaccine Trials In the Orphanages’ were part of the Child Abuse Commission investigation set up by the Government in 2000 to examine child abuse in the State. The inquiry had been looking at three trials of vaccines involving children in orphanages and children in the community in 1960/61 1970 and 1973. On 28 November 2006 Health Minister Harney halted the vaccine inquiry module following ‘a detailed examination of judgments in court cases related to the vaccine trials in both the High and Supreme Courts’.
An Expert Medical Group was set up by Health Minister Michael Woods in 1977 to 1984 to assess whether individuals who presented themselves to it were brain damaged by whooping cough vaccine – the decision was on the ‘balance of probabilities’. 93 people went before the committee – 16 were offered an ex gratia payment of £10,000 – 77 applications were declined.
A DPT vaccine Batch that was administered in the late 1960’s and early 1970’s was Batch No 3741 and a vaccine LOT from this Batch was administer to a child from Co Cork called Kenneth Best. In 1992 this case came before the Supreme Court and it was successfully proven that Toxic Vaccine was used widely in Ireland and caused brain damage. Batch 3741 failed 2 laboratory tests for potency and toxicity. It was 8 times more potent than the recommended strength.
At the conclusion of the Best Case Justice Liam Hamilton described Wellcome as negligent and criticized the company’s quality control procedures.
Following the Supreme Court Judgment Kenneth Best received £2.75M by the vaccine manufacturers Wellcome for the permanent brain damage he suffered when vaccinated with vaccine from Batch 3741.
The ‘Best Case’ was the only successful vaccine damage litigation case in Ireland to-date.
Wellcome withdrew the wholecell pertussis vaccine in Ireland in 1993.
The Government under Health Minister Michael Noonan introduced acellular pertussis vaccine in 1993 because of the adverse effects of the wholecell pertussis vaccine.
TOXIC BATCH 3741
A search for Batch 3741 was ordered by the then Health Minister Brian Cowen after Glaxo Wellcome the drug company now called Glaxo Smith Klyne (GSK) made available the LOT numbers taken from the “Toxic Batch” at the centre of the Best Case.
Health Minister Michael Martin issued a report on the use of 3 in 1 vaccine
The Minister for Health and Children, Micheál Martin, T.D., today (27 February 2001) issued a report on the usage in Ireland of Trivax three-in-one vaccine from the batch which was at issue in the case of Kenneth Best. In 1992 the Supreme Court found that the Wellcome Foundation was liable for the disability of Kenneth Best, who had been immunised with this product in 1969. The particular vaccine batch involved was number 3741, which had been produced in 1968 and is believed to have had a shelf-life of two years.
The Minister said that in the light of the Best judgement, he and his Department had been approached from time to time on behalf of a number of individuals, whose families believe that they may have suffered damage as a result of receiving three-in-one vaccine, seeking assistance in tracing the batch or lot numbers administered in these cases.
The Department has been in contact with the manufacturer of this product, and also asked the health boards to examine their records to establish what information is available. “Much of the information obtained about the usage in Ireland of vaccine from batch 3741 has already been placed in the public domain. The purpose of this document is to set out clearly and comprehensively the information obtained by my Department about the issues involved”, the Minister said.
The report issued by the Minister indicates that 296 individuals are recorded as having received vaccine from lots produced from batch 3741 in the period 1968-1971. The number of recipients in each of the health boards concerned (the Mid-Western, North-Western, Southern and Western Health Boards) is as follows:
||No. of persons
||Period of usage
|Mid-Western Health Board
||October 1969 – October 1970
|North-Western Health Board
||November 1969 – February 1970
|Southern Health Board
||June 1969 – October 1971
|Western Health Board
Full details are contained in the report. The other health boards did not succeed in tracing any records containing the lot numbers concerned. The report issued by the Minister is available on the Department of Health and Children’s website “www.doh.ie”.
The health boards had undertaken detailed searches of their records for a period which predated the establishment of the health boards. In many cases immunisation records for this period no longer exist, or where they exist do not contain vaccine lot numbers involved. It would appear reasonable, however, to assume that vaccine from the batch concerned was administered more widely than in the 296 cases documented in the records which have been traced.
The records obtained suggest that in some instances vaccine may have been administered after its expiry date. However it is difficult at this stage to be certain about this, as full information on the expiry date of all vaccine lots is not available.
The Minister said that he has written to the Chief Executive Officers of the four health boards concerned, asking them to endeavour to trace the individuals who received this product and to inform them accordingly.
The Minister added that the expert medical consensus is that wholecell pertussis vaccine has not been proven to be a cause of brain damage. He said that this view has been confirmed by the Immunisation Advisory Committee of the Royal College of Physicians of Ireland, which has stated that “although there has been controversy about pertussis vaccine the consensus from authoritative bodies is that it is a safe vaccine” (Immunisation Guidelines for Ireland, RCPI, 1996, p.25).
Joint Oireachtas Committee on Health and Children
As part of it work programme for 2000 and 2001 the Joint Committee examined the issue of ‘Childhood Immunisation’ to include an examination of current vaccination policy and practices – poor take-up rates and public concerns about the risks and adverse effects of vaccination. In excess of 100 submissions were received from the public and the medical profession and other interested parties. In its Report of July 2001 this committee recommended that a vaccine damage compensation scheme be set up at the earliest possible date.
Vaccine Damage Steering Group
Following on from the Report of the Joint Oireachtas Committee on Health & Children on ‘Childhood Immunisation’ the Minister for Health & Children Mary Harney established a ‘Vaccine Damaged Steering Group’ early in 2007. Chaired by Chris Fitzgerald Principal Officer Public Health Division the group’s brief was to examine the issue of vaccine damage including compensation options. Submissions were invited from members of the public or interested groups on the issue of vaccine damage – 124 submissions were received from members of the public and 7 from interested groups up to 15 November 2009.
The Report of the Vaccine Damage Steering Group was released on 17 November 2009
The Group recommended that a ‘no fault’ ex-gratia compensation payment scheme be established and administered by the Department of Social and Family Affairs. A scheme consisting of a three tiered structure depending on the severity of damage is recommended and this applies to all cases of vaccination whensoever they occurred – provided they meet the eligibility criteria.
The Minister for Health and Children Mary Harney and her Department are currently considering the recommendations of the Vaccine Damage Steering Group Report in detail.