Vaccination Programme.

Dáil Éireann Debate, Tuesday - 30 November 2004

Tuesday, 30 November 2004

Questions (161, 162, 163)

Denis Naughten

Question:

204 Mr. Naughten asked the Tánaiste and Minister for Health and Children, further to Parliamentary Question No. 789 of 29 September 2004, the progress to date on the issue; if a detailed examination of the schemes has taken place; the reason for the delay in performing this examination; and if she will make a statement on the matter. [31118/04]

Written answers

Tánaiste and Minister for Health and Children (Ms Harney)

A preliminary review of the vaccine damage compensation schemes in place in a number of other countries was undertaken by my Department. This review was done to establish general details of schemes already in existence. Further investigation is required to identify the most relevant models from a clinical, administrative and fairness point of view. My officials have begun this process in recent times. I will be in a position to consider the available options on completion of this investigation. I have asked my officials to prioritise the completion of this work in the context of the Department's 2005 business plan.

Denis Naughten

Question:

205 Mr. Naughten asked the Tánaiste and Minister for Health and Children, further to Parliamentary Question No. 790 of 29 September 2004, when the information will be furnished; and if she will make a statement on the matter. [31119/04]

Tánaiste and Minister for Health and Children (Ms Harney)

The information requested by the Deputy has now been received and collated.

The Irish Medicines Board, IMB, which has the statutory responsibility for licensing all pharmaceutical products for use in Ireland, collects data from health care professionals on suspected adverse effects and quality defects in relation to each publicly funded vaccination programme.

The following tables provide information on the numbers of adverse drug reactions, ADR, reports notified to the IMB in respect of publicly funded vaccines from January 2000 to October 2004, which is the most recent period for which figures are available from the IMB. It should be noted that these tables reflect the total number of reported cases and cannot be considered as incidence figures as the total number of ADRs occurring is not known.

The term "severe" is a subjective one and as such is not used in a regulatory context for classifying suspected ADRs which are either serious or non-serious. A serious ADR is defined as one which is fatal, life-threatening, results in persistent or significant disability-incapacity, results in or prolongs hospitalisation. This definition also includes congenital abnormalities or birth defects and serious adverse clinical consequences.

The tables therefore include the total number of cases for each of the vaccines and the total number of serious cases, many of which are classified as such because they required some level of treatment or intervention and thus fall into the category of "adverse clinical consequences".

The number of ADRs received are within the expected frequency of occurrence of the reactions. However, it should be noted that a high number of ADR reports for meningitis C vaccines were received following active encouragement by the Office for Health Gain and the IMB for notification of all ADRs observed following administration.

Reports of suspected ADRs notified to the IMB associated with use of publicly funded vaccines in the period referred to are set out in the following tables:

2000

Single vaccines	Total Number Reports	Serious Reports
BCG	9	6
Three-in-one vaccines	5	1
Five-in-one vaccines	0	0
MMR	24	13
Hib	7	1
Four-in-one vaccines	0	0
Men C vaccines	404	71
Influenza vaccines	14	4
Hepatitis B vaccines	24	11
Pneumococcal vaccines	10	4

Vaccines used in combination	Total Number Reports	Serious Reports
Three-in-one/ Hib/OPV	7	2
DT/OPV	11	2
Three-in-one/Hib	1	0
Three-in-one/OPV	1	0
MMR/Men C	3	2
Hep A/Hep B	1	0
Flu vaccine /Pneumococcal vaccine	2	1

2001
Single Vaccines	Total Number Reports	Serious Reports
BCG	12	4
Three-in-one vaccines	3	3
Five-in-one vaccines	1	1
MMR	25	12
Hib	0	0
Four-in-one vaccines	15	4
Men C vaccines	1,044	104
Influenza vaccines	21	11
Hepatitis B vaccines	17	6
Pneumococcal vaccines	10	5

Vaccine used in combination	Total Number Reports	Serious Reports
Three-in-one/ Hib/OPV/ Men C	3	2
Three-in-one/ OPV/MMR	2	1
Three-in-one/ OPV/Hib	1	1
Men C/OPV/Hib	1	0
Three-in-one/ Men C	1	1
Men C/Hib	1	0
Five-in-one/Men C	2	0
Three-in-one Hib/Men C	1	0
Four-in-one/MMR	1	1
Four-in-one /Hib	1	0
Four-in-one/ Hib/Men C	1	0

2002
Single vaccines	Total Number Reports	Serious Reports
BCG	17	11
Five-in-one vaccines	12	2
MMR	35	15
Hib	1	1
Four-in-one vaccines	32	12
Men C vaccines	205	18
Influenza vaccine	14	5
Hepatitis B vaccines	24	10
Pneumococcal vaccines	7	4

Vaccines used in combination	Total Number Reports	Serious Reports
Five-in-one/Men C	5	3
Men C/Hep A and Hep B/Rabies	1	1
Four-in-one/Hib/OPV/MenC	1	1
Three-in-one/Men C	1	0

2003
Single Vaccines	Total Number Reports	Serious Reports
BCG	54	45
Five-in-one vaccines	7	4
MMR	15	10
Hib	0	0
Four-in-one vaccines	33	9
Men C vaccines	3	3
Influenza vaccines	13	5
Hepatitis B vaccines	22	11
Pneumococcal vaccines	5	4

Vaccines used in combination	Total Number Reports	Serious Reports
Five-in-one/Men C	7	4
Pneumococcal/Influenza vaccine	1	0
Four-in-one/MMR	3	2
Four-in-one/Hib/Men C	1	0
OPV/Hep A and Hep B/typhoid/yellow fever	1	1

2004 (to end October)
Single vaccines	Total Number Reports	Serious Reports
BCG	54	49
Five-in-one vaccines	3	0
MMR	13	6
Hib	0	0
Four-in-one vaccines	78	22
Men C vaccines	2	0
Influenza vaccines	1	0
Hepatitis B vaccines	11	4
Pneumococcal vaccines	0	0

Vaccines used in combination	Total Number Reports	Serious Reports
Four-in-one/MMR	8	8
Five-in-one/Men C	2	1

In Ireland immunisation uptake is routinely calculated on a quarterly basis among children 12 and 24 months of age. The statistics collected relate to children who have received three doses of vaccines against diphtheria, D3, pertussis, P3, tetanus, T3,Haemophilus influenzae type b, Hib3, polio, Polio3, meningococcal group C, MenC3, one dose of vaccine against measles, mumps and rubella, MMR1; uptake at 24 months only, and one dose of BCG vaccine, BCG: uptake at 12 months only. The following table shows the national immunisation uptake rates for children aged 24 months from Q1-2000 to Q2-2004, the latest figures available from the NDSC. In Q2-2004, the national uptake rates for D3, T3, P3 Hib3 and Polio3 were 88-89% at 24 months. The uptake rate for MenC3 was 87% and the uptake rate for MMR1 was 81%. Uptake statistics relating to BCG vaccine for children aged 12 months was first collected in Ireland in Q3-2003. At present, data are available for five of the eight health boards, covering less than half of the national birth cohort. In Q2-2004 BCG uptake was 90% and over the past year, national BCG uptake has ranged from 87% to 91%. Currently, data relating to other vaccinations recommended in the childhood immunisation schedule are not routinely collected.

Uptake at 24 months - HOI
	D3	P3	T3	Hib3	Polio3	MenC	MMR1
Q1 2000	85	82	85	85	85		76
Q2 2000	85	82	85	85	85		77
Q3 2000	87	83	87	86	86		81
Q4 2000	87	83	87	86	87		83
Q1 2001	85	82	85	85	85		79
Q2 2001	86	83	86	85	85		75
Q3 2001	83	81	83	83	83		70
Q4 2001	83	80	83	82	83		69
Q1 2002	83	81	83	82	83		70
Q2 2002	83	81	83	82	82		72
Q3 2002	83	81	83	82	82	71	73
Q4 2002	85	83	85	84	84	79	75
Q1 2003	85	84	85	85	85	81	77
Q2 2003	86	85	86	85	86	83	77
Q3 2003	87	86	87	87	87	85	80
Q4 2003	87	86	87	87	87	86	80
Q1 2004	88	88	88	88	88	87	80
Q2 2004	89	88	89	89	89	87	81

The 2002 census recorded 166,208 children under two years of age. It can be deduced from this that the number of ADRs is low compared to the number of vaccines administered. For instance, the uptake of MMR in 2002 averaged 72.5% which equates to 120,501 vaccine doses administered in that year. This compares with 15 serious adverse drug reactions in the same year.

The same pattern appears in vaccines targeted at older age groups. The following table shows the number of vaccine doses for pneumococcal disease, hepatitis B and influenza. In the case of influenza, for example, no serious ADRs have been reported this year to date, while the average number reported over the previous four years was 6.25.

Year (Sales in doses)	Pneumococcal	Hepatitis B	Influenza
2000	122,434	13,455	308,291
2001	84,933	17,109	452,000
2002	64,117	22,587	522,570
2003	70,196	25,394	577,000
2004 Sales up to November	44,032	30,146	591,309

I take this opportunity to urge all parents to have their children immunised against the diseases covered by the childhood immunisation programme in order to ensure that their children and the population generally have maximum protection against the diseases concerned. General practitioners are aware of the contra-indications to the recommended vaccinations and parents should discuss any concerns they may have with their general practitioner before making a decision about their child's immunisation.

Denis Naughten

Question:

206 Mr. Naughten asked the Tánaiste and Minister for Health and Children, further to Parliamentary Question No. 864 of 29 September 2004, when the information will be furnished; and if she will make a statement on the matter. [31120/04]

Tánaiste and Minister for Health and Children (Ms Harney)

The information requested by the Deputy has now been received and collated.

The State Claims Agency, SCA, established in 2002, manages personal injury claims against the State. Information provided by the SCA indicates that four claims have been received from parents regarding alleged vaccine damage from the State supported MMR vaccine programme. No claims have been received by my Department.

Information provided by the health authority-boards indicates that no claims have been received by the following: Eastern Regional Health Authority, ERHA; Midland Health Board, MHB; Mid-Western Health Board, MWHB; North Eastern Health Board, NEHB; North Western Health Board, NWHB; Southern Health Board, SHB. The South Eastern Health Board has received solicitors' letters regarding three incidents. These claims relate to the BCG, meningitis and 3 in 1 vaccine programmes. However, there have been no further proceedings in relation to these cases. The Western Health Board reports that two claims have been received regarding alleged reactions to the BCG vaccine.

Complaints associated with the vaccination programme have been received by the following health boards: Mid-Western Health Board, two written complaints in relation to meningitis C vaccination programme, one with respect to the management of faintness following vaccination and one because a child had received the meningitis C vaccine twice. Parents are asked to report adverse reactions to vaccinations to the health board. The board is regularly advised verbally of local reactions to vaccinations but these would not be considered unusual or unexpected. The board was made aware in 2003 of a number of BCG alleged reactions which were more extensive than expected. In the South Eastern Health Board complaints received relate to incorrect BCG vaccination and alleged adverse reactions to meningitis, 3 in 1 and BCG vaccination. In the Southern Health Board the board has been contacted by a parent where in their view their child's reaction was caused by a vaccine. In each instance no conclusive evidence was found to support the views. The vaccines involved were 4 in 1, meningitis C, 2 in 1 primary, hib, 5 in 1-meningitis C primary and MMR.

The immunisation programme currently operated in this country has played a major part in bringing serious, previously common diseases under control. It is very important that parents continue to have their children immunised in order that children continue to be protected against the diseases concerned.