In 1993, following the Supreme Court judgment in the Best case, my Department wrote to the manufacturer and to the health boards requesting information on usage of Trivax batch no. 3741, but it was not possible to establish the extent of the distribution of the batch. At that time the numbers of the lots which had been produced from batch 3741 were not available to my Department.
After further consideration of the matter, in 1997 my Department asked the company for any information it could provide on the lot numbers of vaccine produced from batch 3741, on the basis that it was probably these numbers which would have been noted in individual immunisation records. The company's responses, received in 1997 and 1998, gave details of the lot numbers and quantities of vaccine produced from batch 3741. The vaccine was manufactured in 1968 and the shelf life for both vials and ampoules was two years from the last manufacturing step. The company indicated that it did not have distribution records available in respect of these vaccine lots.
Following receipt of this additional information my Department asked the health boards to re-examine their records to see if the extent of usage of these lots in the 1968-1970 period could be established. Final responses have now been received from all of the health boards. The Southern Health Board has indicated that 107 children received vaccine from two of the lots concerned. My Department has no information to indicate that adverse reactions were reported in recipients of vaccine from the lots concerned.
In February 1999 my Department wrote to the company in question to seek details of certain other batches of Trivax vaccine produced in the late 1960s. The company responded that the results of all tests, mandatory and otherwise, together with expert advice which the company had sought, indicate that no other batch gave rise to the same level of potential concern as batch 3741. The company also indicated that it had made every effort to provide as much information as possible to my Department in response to queries regarding the Trivax vaccine.
My Department is currently considering this whole matter with a view to determining what, if any, further action is required.