Some of the children who received the vaccine were taking part in a drug trial, carried out on behalf of the multinational drug company Wellcome, in Dublin in 1973.
Instead of getting the 3-in-1 childhood vaccine Trivax, some of the children were inadvertently given a veterinary vaccine with a similar brand name, Tribovax T. The animal vaccine is solely for use on farm stock.
It is not yet clear precisely how many babies were vaccinated with Tribovax T. The commercially manufactured containers of Trivax usually held 10 doses each and numerous containers of vaccine were produced from each individual batch.
Massive quantities of the Trivax vaccine were ordered by the Irish health authorities from Wellcome in the 1970s as part of the State-promoted programme for the vaccination of babies all around the country.
The revelation that some children received Tribovax T instead of Trivax is certain to strengthen the case of representative groups and opposition politicians who have been calling for a public inquiry into drug trials and other circumstances surrounding the use of the 3-in-1 vaccine in Ireland in the 1970s.
Last night Fine Gael deputy Denis Naughten, who has been pressing Health Minister Micheál Martin on the controversy for the last three years, described the new information as terrifying.
He said: "This is an appalling and outrageous development. There have been serious question marks over the production and use of Trivax in the 1970s and the minister must now act to compel Wellcome, the Eastern Regional Health Authority and anyone else, including his own Department, to make public all the facts surrounding this scandal. The case for an independent public inquiry into this issue is now irrefutable."
In the early 1970s, Wellcome it has since merged to become the pharmaceutical giant Glaxo Wellcome wanted to run drug trials comparing the existing 3-in-1 (diphtheria, tetanus, pertussis) vaccines with new formulations of the same product.
A comparative trial was carried out in 1973 involving children in care homes and others in the wider community. The reactions to the vaccines were noted and returned to the UK headquarters of Wellcome.
But extensive investigations have now revealed that a second trial was carried out. This was to further investigate the reactions in children injected with the newly formulated vaccine, compared with those experienced by children given the standard product then widely in use. No details of this trial have been published until now.
This trial solely involved children from the wider community who were routinely brought for infant vaccination to health clinics in Dublin and did not involve any infants in care homes.
The Eastern Health Board, which was facilitating the trial, became concerned at the severity of reactions in children vaccinated at the clinics and forwarded details of more than 80 such cases to Wellcome for investigation.
The Irish Independent has seen these details, which include the vaccine numbers used to inject each child. In almost every case, the vaccine used has been shown by Wellcome's own records to be the standard Trivax infant vaccine.
But one of the vaccines, which has been traced back to its originally manufactured batch, has been confirmed as the veterinary product, Tribovax T. Wellcome's register of its manufactured products shows clearly that the vaccine was part of a consignment of Tribovax T which was produced at the company's manufacturing plant in the UK in early September, 1972.
It is not yet clear just how many other children also received the veterinary vaccine.
Tribovax T is a clostridial vaccine for the treatment of animals only. It is used for the active immunisation of cattle and sheep against diseases such as blackleg, braxy, black disease, bacterial redwater and tetanus.
Those using the vaccine are referred to the package insert which advises them to keep it out of the reach of children and to take precautions against accidental contamination.
A six-month-old Dublin baby who supposedly received Trivax, but instead received the Tribovax T vaccine at a health clinic in the city, had a severe reaction, according to the documents seen by this newspaper. The child vomited for 24 hours.
Under the heading 'Final Outcome', the notation by the doctor who examined the baby reads simply 'Injections Discontinued'.
Our investigations have also revealed that vaccine trials on children in care institutions continued over a longer period than had been believed up to now. The tests were being carried out in at least five care homes up to 1976 and possibly even later.
Drugs firm withheld key results of vaccine test
PHARMACEUTICAL giant Wellcome withheld damaging information about highly reactive batches of the 3-in-1 infant vaccine from the Irish health authorities.
The multinational company, which has since merged to become Glaxo Smith Kline, is at the centre of the controversy surrounding the inadvertent injection of some children in Dublin with the veterinary vaccine, Tribovax T rather than the 3-in-1 vaccine, Trivax in 1973.
The late 1960s and early 70s were a period of greatly increased numbers of adverse reactions in both Ireland and Britain.
In August 1973 the Eastern Health Board expressed its serious concern directly to Wellcome. The EHB drew specific attention to five lots of vaccine from which reactions were appearing most regularly.
The information was sent to the Head of Wellcome's Clinical Immunology Department, Dr AH Griffith who forwarded it to a senior colleague seeking precise details.
A couple of weeks later the results of tests carried out on the lots were relayed to Dr Griffith.
In a memo, thanking his colleague for the results, Dr Griffith said: "I am not sure whether they imply that these batches are abnormally reactogenic or whether, on intensive study, all batches are highly reactogenic.
"There seems to be no point in forwarding information to Dublin at this stage ... "
The following week Dr Griffith wrote back to the EHB stating that he was trying to find a reason why there should be higher reactogenicity in Dublin than elsewhere.
He concluded: "I have received information on the batches of vaccine sent to you but that reveals nothing abnormal."
The information that had been despatched by the EHB to Wellcome included more than 80 detailed cases of adverse reactions noted at health clinics in Dublin in the first half of 1973.
Under a reciprocal arrangement with the National Drugs Advisory Board, Wellcome was due to furnish twice-yearly reports of vaccine reactions to the NDAB. But the Irish Medicines Board, which succeeded the NDAB, has confirmed that only two adverse reactions to the 3-in-1 vaccine Trivax were notified to it in 1973.
In the course of his correspondence with the EHB in August, 73, Dr Griffith had also pointed out that it was significant that between 1964 and 1971, not a single case of hypsarrhythmia (loosely described as high voltage activity in the brain) or infantile spasms were among reactions to DTP (the 3-in-1 vaccine) reported to the UK Committee on Safety in Medicines.
But details of the reactions reported to that Committee during this period included convulsions, screaming attacks, post-encephalitic muscle weakness, an angioneurotic oedema and two deaths.
Last night the Glaxo Smith Kline Corporation was considering these latest revelations.
Yesterday's revelations in the Irish Independent sparked a series of investigations. Health Minister Micheal Martin, in a heated Dail debate, said he was "concerned to get fast answers from those concerned".
And he said if they did not get answers they would have to consider what options they had.
He told how his department contacted the Irish Medicines Board and it was concentrating on securing information from the company. The Board said it had no prior knowledge of an "alleged inadvertent use" of Tribovax T in place of Trivax.