Written Answers. - Vaccination Programme.
Dan Neville
Question:
653
Mr. Neville
asked the
Minister for Health and Children
the details of the circumstances surrounding the distribution of tens of thousands of polio vaccines containing blood contaminated with CJD; the period during which the vaccine was administered; and if he will make a statement on the matter.
[1718/01]
Bernard Allen
Question:
673
Mr. Allen
asked the
Minister for Health and Children
if he has now received the full report on batches of polio vaccine distributed here two years ago which contained serum from a British donor who had recently been diagnosed as having Variant CJD; and the communication which took place with the IMO and GPs to inform the public about this.
[1870/01]
Bernard Allen
Question:
677
Mr. Allen
asked the
Minister for Health and Children
if he has met the Irish Medical Organisation to discuss the fall out of the recent polio vaccine alert and other issues related to the vaccination programme; and the outcome of the meeting.
[1874/01]
I propose to take Questions Nos. 653, 673 and 677 together.
The oral polio vaccine (opv) to which the Deputy refers was manufactured by Evans/Medeva in the UK and distributed for use in Ireland during the period 15 January 1998 to 30 January 1999. Seven batches of the vaccine consisting of 95,890 units were available for use over this period.
On 13 December 2000 the Irish Medicines Board, IMB, informed my Department that a constituent of the vaccine namely human serum albumin (HSA) utilised a blood donation in its manufacture from a UK resident who has recently been diagnosed as having the variant form of Creutzfeldt Jakob Disease, vCJD.
HSA is a product which is made from human blood donations. It is a protein, albumin, obtained from blood serum, hence its name. It is used as a stabiliser in some medicinal products and vaccines. On receipt of the information, relating to this vaccine, from the IMB, I arranged to obtain expert advice from both national and international experts in the field who advised on a wide range of aspects relating to this issue. Their advice indicated that the potential risk, if any, to recipients is essentially non-existent.
This expert advice is based on a number of factors: the dilution factor involved in this case – the persons donation was one of 22,353 used to make a pool. This in turn was combined with another pool to give a final dilution of 1/63,866; the manufacturing process by which albumin, the agent used to stabilise the vaccine, is made from plasma involves a number of stages in the course of which any potential for infection would be removed – in other words, no infection possibility has been associated with albumin and the fact that polio vaccine is administered orally rather than by injection further reduces the theoretical possibility of transmission.
I emphasise that the plasma donation involved in this incident was donated in 1996-97 and the individual concerned has only recently been diagnosed as having contracted the disease. It would not therefore have been possible at the time of this person's donation to "screen it out" on the basis that he/she might later develop CJD. While blood donations are screened for communicable diseases, there are no tests which would enable donations to be screened for CJD or vCJD or which would allow doctors to establish whether any individual is at risk of contracting these diseases.
My Department supplied background information, expert risk assessment and other data to health boards and to the Irish College of General Practitioners so that this could be circulated by them to health professionals and others. The Irish Medical Organisation was contacted on 15 December 2000 and informed on a confidential basis about the issues and that a public announcement would be made the following week.
Each health board was asked to establish a telephone line which parents could call if they wished to discuss any concerns about their child/children arising from their having received the vaccine in question. It also enabled reassurance about the level of risk involved to be given to parents.
There was a high volume of calls to these lines in the days immediately following the announcement and therefore not all callers were able to get through immediately. Where details of the vaccine batch administered were not immediately available to the health board the parent was advised to contact their GP. Additional information was available on my Department's website and on the web sites of the individual health boards and on that of the Irish Medicines Board.
I and my Department greatly appreciate the efforts made by GPs in informing and reassuring parents following my public announcement. There was little opportunity for doctors to be briefed in advance of my announcement but this was inevitable given the urgency of making the information available in an organised and objective manner at the earliest possible opportunity. The proximity to Christmas was an added complication.
Following the examination of vaccination records by general practitioners and health boards information has come to light which indicates that vaccine from the batches referred to above was administered after its expiry date.
At my Department's request, the health boards are currently conducting an examination of records in order to establish the extent to which the vaccine in question was used beyond its expiry date. I requested expert advice in relation to this issue from the Immunisation Advisory Committee of the Royal College of Physicians of Ireland who have advised that the efficacy of the vaccine reduces if it is administered more than one month after the expiry date and that the vaccination should therefore be repeated in such cases.
I have met the Irish Medicines Board on 17 January 2001 to discuss a range of issues relating to the circumstances surrounding their announcement of 13 December 2000. In addition the chief executive officers of the health boards are currently establishing a National Immunisation Steering Committee which will address a range of issues relating to the primary childhood immunisation programme. This will include consideration of the protocols for administration of vaccines, whether new mechanisms need to be developed to guard against possible use of vaccine which has passed its expiry date and to ensure that vaccines are administered in accordance with best practice.
My office has no record of a formal request for a meeting from the IMO. However, officials of my Department are available to discuss the issues with the IMO if it so wishes.
Questions Nos. 654 and 655 taken with Question No. 515.
