Committee Reports > List of Committees > Joint > 2001 > Committee on Health and Children > Report - Report on Childhood Immunisation

HOUSES OF THE OIREACHTAS

Joint Committee on Health and Children

Report on Childhood Immunisation

July 2001

Report on Childhood Immunisation

Table of Contents

Introduction by the Chairman, Batt O’Keeffe T.D.

The Joint Committee on Health and Children was established in November 1997. As part of its work programme for 2000 and 2001, the Joint Committee decided to examine the issue of childhood vaccination, 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 July 2000, the Joint Committee invited written submissions from members of the public, the medical profession and other interested parties. In excess of 100 submissions were received. During the period November 2000 to March 2001, the Committee held a series of public meetings and heard evidence from a number of invited groups, organisations and individuals.

In April 2001, the Joint Committee appointed Mr. John Kissane to assist it in reviewing the written and oral presentations received and to assist in the preparation of a draft report. The draft report was considered by the Joint Committee at its meetings on 5^th July 2001 and 11^th July 2001. The report, as amended, was agreed.

The Joint Committee is grateful to Mr. John Kissane for his efforts in assisting the Joint Committee. The Committee would also like to sincerely thank the many parents, medical professionals and support groups who made written submissions. In particular, the Committee would like to express its appreciation to the following individuals and groups who gave evidence at public meetings of the Committee -

Ms. Frances Howlin and Ms Marguerite Ronayne

- representing a group of parents who are also parents

The Hope Project

- Ms. Caroline McCabe and Ms. Miriam Twomey

Allergy Induced Autism

- Ms. Cecilia Young and Ms. Rosmary Kessick

The Department of Health and Children

- Dr. Jim Kiely, Chief Medical Officer

- Dr. John Devlin, Assistant Chief Medical Officer

- Dr. Michael Mulcahy, Mental Handicap Advisor

- Ms. Dora Hennessy

- Mr. Fergal Goodman

The Public Health Directors of the Health Boards

- Dr. Kevin Kelleher, Director of Public Health, Mid-Western Health Board

- Dr. Patrick Doorley, Director of Public Hea;th, Midland Health Board

- Ms. Maureen Windle (representing Health Board CEOs)

The Irish Pharmaceutical Healthcare Association

- Ms. Anne Nolan, CEO

- Mr. Brian Murphy, Commercial Affairs Manager

- Dr. Mike Watson

The National Disease Surveillance Centre

- Dr. Darina O’Flanagan, Director

- Dr. Derval Igoe, Specialist in Public Health Medicine

The Irish Medical Organisation

- Dr. James Reilly, IMO General Practitioner Committee

- Dr. Declan Bedford, IMO Public Health Doctors Committee

The Irish College of General Practitioners

- Dr. Brian Coffey, Chairman

- Dr. Rita Doyle, Chair of ICGP task Group on Immunisation

Royal College of Physicians in Ireland – Sub-Committee on Childhood Vaccinations of the National Immunisation Advisory Committee

- Dr. Kevin Connolly, Chairman

- Professor Brian Keogh, Committee member

- Dr. Karina Butler, Committee Member

Professor Denis Gill, Consultant Paediatrician, Childrens Hospital, Temple Street

Dr. AndrewWakefield, Royal Free and University College Medical School, University of London

Professor John O’Leary, Department of Pathology, Coombe Womens Hospital, Dublin

The Joint Committee requests that the issues raised in this report be the subject of a debate in both Houses of the Oireachtas.

_________________

Batt O’Keeffe T.D.

Chairman

July 2001

Summary of Recommendations:

1.The Joint Committee recommends that the achievement of a 95% uptake in the Primary Childhood Immunisation programme while respecting the rights of parents to make an informed choice on immunization should be a key priority of the Department of Health and Children in view of its potential to protect the health and well being of children and to provide considerable return on resources invested.

[Chapter 1.13]

To achieve the objective of a 95% uptake the Joint Committee recommends that:

2.The Department appoints a co-ordinator to oversee the Childhood immunisation programme, to ensure a common approach by all Health Boards and to monitor progress.

[Chapter 5.21]

3.Each Health Board appoints a co-ordinator in its area to ensure the necessary resources and procedures are put in place to reach the target.

[Chapter 5.21]

4.Each Health Board provide dedicated administrative and nursing staff to maximise the delivery of the Childhood Immunisation programme.

[Chapter 7.3(xiv)]

5.The Modernisation of the Civil Registration Service process be used as a basis for giving each child a personal public services number (PPS) at birth which will be his / her personal number in all dealings with the State.

[Chapter 7.3(ix)]

6.Information technology be used to:

-record all relevant information in relation to each child’s immunisation

-to prepare / issue reminders to parents /guardians at each stage of the childhood immunisation programme for issue by Health Boards

-to link Birth Registers with each Health Board

-to link Health Boards, the Irish Medicines Board and GPs to childhood immunisation records

-to link Health Boards to Childrens Allowance payments in an effort to tackle the mobility problem.

[Chapter 7.3(ix), (xi), (xii)]

7.A once off payment be made available to participating GPs to update / install appropriate computer technology and that GPs be encouraged and facilitated to operate the technology.

[Chapter 5.21]

8.Consideration be given to providing parents with a smart card record of each child’s immunisation record.

9.The Department produce a booklet on Childhood Immunisation after consultation with the relevant agencies, which should be given to each parent while in Maternity Hospital or failing that on the first visit by a Public Health Nurse. This booklet could perhaps address such issues as:-

-the six common misconceptions about immunisation

-the risks of each disease versus the risks of immunisation

-the contra-indications to immunisation

-the nature of the consultation which should take place when they visit the GP

-information relating to reporting adverse reactions (see rec. 16 also)

[Chapter 7.3(xvi); 12.11]

10.The Department produce Vaccine Information statements, relevant to the vaccines being given at each visit, which should be issued by each Health Board with the reminder to parents to attend for immunisation.

[Chapter 7.3(xvi)]

11.Each Health Board have a vigorous procedure in place to follow up on children before they enter crèche or primary school, who have not participated in or completed their Primary Childhood Vaccination Programme in their first two years. This could include the setting up of clinics to provide free immunisation for the group.

[Chapter 7.3(iv)]

12.Each Health Board put a procedure in place to check with parents that GPs are complying with the consultation procedure agreed under the Primary Childhood Immunisation Programme.

[Chapter 7.3(xvi)]

13.The National Immunisation Steering Committee established recently to draw up a quality assurance programme to deal with issues including:

-the monitoring of the aspects of the Primary Childhood Immunisation Programme dealing with handling, storage and disposal of vaccines

-a two way feedback system to meet the needs of both Health Boards and GPs

-adverse reaction reporting and recording

-appropriate training of existing health professionals on immunisation risk communications.

[Chapter 7.3(xiii), (xvi), (xviii)]

14.There should be continuous immunisation promotion campaigns on television and radio until such time as an uptake approaching 95% is reached and until a satisfactory computer and administrative system is in place.

[Chapter 5.21]

15.A free phone call in service to the Irish Medical Board be set up to which parents / guardians could report adverse reactions as there are suggestions that there is under reporting in this area.

[Chapter 5.21]

16.Doctor / General Practitioner and Nurse training programmes provide for immunisation risk communications.

[Chapter 5.21]

17.The Irish Medical Board should include in each annual report information relating to:

-the number and nature of adverse reaction reports relating to childhood immunisation

-the procedure for dealing with adverse reaction reports

-the number and nature of Periodic Safety Update Reports from manufacturers

-its exchanges with other regulatory authorities world wide on childhood immunisation issues

-recent activities of the Immunisation Safety Priority Programme

-on going research into possible link between immunisation and autism.

[Chapter 9.34; 11.23]

18.Legislation to provide for a National Vaccine Injury Compensation scheme should be drawn up at the earliest possible date.

[Chapter 13.9]

19.Further research into methods of childhood immunisation including MMR and the pros and cons of the single vaccine be encouraged.

[Chapter 11.23]

1. Introduction

1.1This report draws on information contained in the various submissions received by the Joint Committee. These included literature regarding immunisation in the US and Canada, the UK and Australia. Irish information is included where available. The report concentrates on the vaccines included in the current primary immunisation schedule, particularly those that have been associated with some form of controversy in recent years.

Case for Immunisation

1.2Immunisation against infectious disease has probably saved more lives than any other public health intervention, apart from the provision of clean water. Improvements in living standards have reduced the mortality from infectious diseases, but immunisation has also played a large role in the reduction of disease incidence. It would not have been possible to eradicate smallpox without vaccine, and the near eradication of polio from the Western Hemisphere is largely due to immunisation ⁽¹⁾. The reductions in Haemophilus Influenza B, diphtheria, pertussis and measles are also evidence of the value of immunisation ⁽²⁾. In Ireland, the introduction of Hib vaccine as part of the primary immunisation scheme has been accompanied by a marked reduction in the number of reported cases of disease caused by Haemophilus Influenza B.

1.3Bedford and Elliman ⁽¹⁾ state that in the UK, according to a government information film, before the introduction of diphtheria vaccine in 1940 one child caught diphtheria every 15 minutes and one died every hour. In the UK, since 1970, only 9 deaths have resulted from diphtheria, the last in an unimmunised child in 1994 ⁽³⁾. Between 1970 and 1983, of the 270 people who died from measles in the UK 144 (53%) were healthy children with no predisposing illnesses ⁽⁴⁾.

1.4Immunisation has contributed greatly to the reduction in mortality and disease incidence. This is outlined in table 1 below:

Table 1: Reduction in mortality and disease incidence after introduction of immunisation ⁽⁵⁾

Source: Office for National Statistics, Public Health Laboratory Service, and National Congenital Rubella Surveillance Programme.

1.5The pattern of communicable diseases in Ireland has changed substantially over the past fifty years. Communicable diseases accounted for the deaths of almost one in four Irish people approximately 50 years ago. These diseases included not only tuberculosis but also conditions such as typhoid fever, scarlet fever, whooping cough, diphtheria, influenza, polio and measles. In children aged between one and five years, the vast majority of deaths were caused by infectious diseases including pneumonia, tuberculosis, whooping cough, measles, gastro-enteritis and diphtheria. In older children aged between 5 and 15 years, the most common cause of death was tuberculosis. Tuberculosis was also the leading killer among adolescents and young adults under 45 years of age.

1.6In recent years, improved economic and social conditions, together with public health action, have virtually eliminated the pandemics of communicable diseases. Medical advances, including the development of vaccines and new drugs, have reduced the threat of infectious diseases to the Irish population. More recently, however, infectious diseases which were well controlled have begun to reappear and are reaching epidemic proportions in some countries. A combination of factors including the slackening of vaccination programmes, poor living conditions, anti-microbial resistance and scarce health care resources, have contributed to the resurgence of these infections in these countries.

1.7Worldwide, infectious diseases remain a majority cause of mortality, accounting for approximately 17 million deaths annually in developing countries and 500,000 in the industrialised world. In developing countries, they represent more than 70% of the global burden of disease and in industrial countries are a major cause of school and work absenteeisms. The major poliomyelitis and tuberculosis epidemics which affected thousands of people and resulted in significant morbidity and mortality in the 1950s are no longer a problem in Ireland but continue to affect developing countries. New threats have emerged, however, in the form of AIDS, vCJD, meningitis, anti-microbial resistance, hepatitis and E.Coli which, together with the re-emergence of measles, represent a significant challenge for health-care providers for many years to come. The great increase in international travel also has the potential to enable disease to spread rapidly between countries and continents.

1.8As immunisation rates increase, though, the disease becomes scarcer and eventually a point will be reached at which risk from the vaccine approximates the risk of contracting the disease. It is important, if high immunisation rates are to be obtained, for this ‘conflict’ between the individual (risk of immunisation) and society (benefit of herd immunisation) to be acknowledged⁽⁶⁾. Paradoxically, the success of immunisation programmes means that many parents and health professionals have no experience of many of the diseases preventable by immunisation and so do not appreciate how damaging these can be.

Case against immunisation

1.9Infectious diseases were conquered by the provision of cleaner drinking water and better sewerage facilities. The introduction of immunisation programmes came along either just at the same time or later when death rates from the major infectious diseases had already fallen. There really is not any evidence to show that immunisation programmes have ever been of real value either to individuals or to communities.

1.10Viruses and other organisms do not sit still and remain the same year after year. They are constantly changing and new organisms are being formed all the time. Infectious diseases are least likely to effect those who have healthy immune systems and individuals should put their trust in building up their immune systems.

1.11Things can go wrong whatever you do. If you choose not to have your child immunised and he/she develops a serious illness which you believe might have been prevented by a vaccine he/she did not have you will feel guilty. But if you choose to have your child immunised and he/she ends up with brain damage you will feel guilty about that too.

Conclusion

1.12The Joint Committee considers that immunisation has played, and will continue to play, a major part in reducing or eliminating illness and deaths from communicable diseases in Ireland and strongly support the immunisation objective to achieve and maintain an uptake of not less than 95% of the total child population.

Recommendations

1.13The Joint Committee recommends that the achievement of a 95% uptake in the Primary Childhood Immunisation programme while respecting the rights of parents to make an informed choice on immunization should be a key priority of the Department of Health and Children in view of its potential to protect the health and well being of children and to provide considerable return on resources invested.

2. Immunisation

What is Immunisation?

2.1Immunisation is the process of inducing or providing immunity artifically. This may be done by the administration of a vaccine, toxoid or externally produced antibody in order to stimulate the body’s immune system.

2.2The aim of an immunisation program is to reduce the incidence of, or to eliminate a particular disease. Immunisation has both a direct and an indirect effect. The direct effect is the protection induced in the individual receiving the immunising agent. The indirect effect is the reduction of the incidence of the disease in others – so called ‘herd immunity’.

2.3Deciding whether a particular immunisation program is successful depends upon a comparison of the number of cases of disease prevented with the range, severity, and incidence of adverse effects (i.e. a comparison of the risks and the benefits).

2.4The implementation of immunisation programmes faces many challenges. Immunisation safety (i.e. ensuring and monitoring the safety of all aspects of immunisation including vaccine quality, vaccine storage and handling, vaccine administration and the disposal of sharps) is one such challenge that those who advocate the use of vaccines must find ways to address⁽⁷⁾.

2.5Vaccination is expected to be a safe medical intervention that will not lead to harm⁽⁸⁾. It is important, however, to make the following points unambiguously clear:

•Vaccines are not 100% safe.

•Vaccines are not 100% effective.

•Parents have a right to objective information prior to deciding whether to immunise their children⁽⁶⁾.

Efficacy of Vaccines

2.6Before a vaccine is introduced it undergoes trials to ensure that it has reasonable efficacy. Trials of routine vaccines in use today have shown them to be highly efficacious. Before the introduction of whooping cough vaccine, studies have shown that it provided a high degree of protection. Recent trials have confirmed its efficacy^(9)(10). Table 2 outlines the efficacy of childhood vaccinations.

Table2: Efficacy of Vaccinations

Vaccine Failure

2.7There are two main reasons for failure of immunisations:

•Failure of the vaccine delivery system to provide potent vaccines properly to persons in need; and

•Failure of the immune response, whether due to inadequacies of the vaccine or factors inherent in the host.

The first category is by far the most important worldwide. The major factor contributing to failure of the delivery system is failure to vaccinate; in the developing world this is commonly a result of inadequacy of the vaccine supply. Other important factors include barriers to immunisations, improper use of vaccines, vaccine ineffectiveness at the time of use and factors relating to client attitudes and knowledge. Failure of the immune response may be either primary or secondary (loss of protection after initial effectiveness). The shortcomings of existing vaccines must not deter us from taking maximal advantage of their benefits⁽¹¹⁾.

Aims and Objectives of Immunisation

2.8In Ireland, communicable disease control is organised through the health-care system and based on effective epidemiological surveillance, education, prevention, treatment and care. Vaccination of people against eradicable diseases and other communicable diseases that can be contained with vaccination is central to this strategy.

2.9Vaccine-preventable diseases represent one area of communicable diseases for which highly effective and cost beneficial measures exist for prevention and control. In Europe, public health programmes have included vaccines against such diseases for over 40 years. The Primary Childhood Immunisation Programme in Ireland is intended initially to control and ultimately to eliminate or eradicate the communicable diseases in question.

2.10The Irish targets to reduce communicable diseases are in accordance with the following recommendations:

•"Health 21: The health for all policy framework for the WHO European Region"

Target 7 – Reducing Communicable Diseases

By the year 2000, the adverse health effects of communicable diseases should be substantially diminished through systematically applied programmes to eradicate, eliminate or control infectious diseases of public health importance.

In particular:

Elimination of Disease

-By 2000 or earlier, poliomyelitis transmission in the region should stop and by 2003 or earlier this should be certified in every country.

-By 2005 or earlier, neonatal tetanus should be eliminated from the region.

-By 2007 or earlier, indigenous measles should be eliminated from the region, and by 2010 the elimination should be certified in every country.

Control of Disease

By 2010 or earlier, all countries should have:

•An incidence level for diphtheria of below 0.1 per 100,000 population

•New hepatitis B virus carrier incidence reduced by at least 80% through integration of hepatitis B vaccine in the child immunisation programme

•An incidence level of below 1 per 100,000 population for mumps, pertussis and invasive disease caused by Haemophilus Influenzae type b

•An incidence level for congenital syphilis of below 0.01 per 1,000 live births

•An incidence level for congenital rubella of below 0.01 per 1,000 live births.

By 2015 or earlier:

•Malaria should in any country be reduced to an incidence level of below 5 per 100,000 population, and there should be no deaths from indigenously-acquired malaria in the region.

•Every country should show a sustained and continuing reduction in the incidence, mortality and adverse consequences of HIV infection and AIDS, other sexually transmitted diseases, tuberculosis, and acute respiratory and diarrhoeal diseases in children.

3. Immunisation introduction dates and registered births statistics

3.1The dates of introduction on a national basis of the different childhood immunisations are:

3.2The registered births statistics for the years 1993 to 1999 are:

4. Development of National Strategy

4.1The intention of childhood immunisation has always been to protect vulnerable individuals as early in life as possible from the negative health impact of the disease. In children, the risk of death, disease and long- complications attributable to specific infections is based on the epidemiology of these infections. The Primary Childhood Immunisation Programme confers initial immunity against a range of infectious diseases. Booster doses may be required for some vaccines already given and where protection is waning. Children attending school represent a convenient opportunity for the immunisation services to boost the large proportion of the target group, before young people enter the adult world. Additional immunisation may also be necessary to accelerate control or elimination efforts. The recent epidemic necessitated vaccinating across a wider age range with the purpose of interrupting transmission of this virus in an epidemic situation. Additional immunisation may also be necessary to counter a specific risk, for example, when travelling to a country where the communicable disease is endemic.

4.2The aim of the Primary Childhood Immunisation Programme is to protect children against vaccine-preventable diseases. This is a fundamental element of the primary health services provided for children. In the interests of childrens protection individually and collectively, the health services and parents, as partners in immunisation, have a responsibility to ensure that they receive this protection.

4.3The immunisation strategy also involves the development of national and local epidemiological surveillance, the development of laboratory services and a process to ensure vaccine quality. Epidemiological surveillance and other information systems established the need for vaccination. It is important that vaccination strategy meets the priority needs of a country prior to inclusion into national programmes. Vaccine quality is also important and vaccines should be safe and effective. It is also important that effective surveillance and other information systems at national and regional levels are in place to monitor changes in disease incidence. The development of high quality laboratory services are also an integral part of communicable disease control. The functions outlined above all go hand-in-hand with a national immunisation programme. The changing nature of communicable diseases, together with the development of new vaccines, require that the Primary Childhood Immunisation Programme is updated on a frequent basis.

4.4Sources of Advice on Immunisation

The Department of Health and Children has many sources of expert advice in relation to vaccination issues. These are as follows:

(i)International Advice

The World Health Organisation provides the main source of advice to countries in Europe and worldwide. It has developed a special programme called the Expanded Programme on Immunisation (EPI) which is concerned with immunisation against six diseases, namely, diphtheria, tetanus, whooping cough, measles, polio and tuberculosis. The WHO advice relates to disease control, new vaccines and self-sufficiency in immunisation programmes. This advice is provided in terms of strategy documents and the organisation of scientific and technical meetings on vaccine issues. The Strategy Plan 1998-2001 contains detailed information in relation to the control of these diseases (Strategy Plan 1998-2001, WHO, Global Programme for Vaccines and Immunisation, Geneva 1998). Ireland participates actively in the EPI Programme. Other sources of advice include the International Children’s Vaccine Initiative, UNICEF and the European Union. The European Union has established a communicable disease network which is concerned with the surveillance of communicable diseases and also provides an early warning system in relation to outbreaks of certain communicable diseases in Europe.

(ii)National Advice

The main source of advice to the Department of Health and Children is provided by the National Immunisation Committee of the Royal College of Physicians of Ireland. This expert committee is broadly representative of the medical profession in Ireland and includes specialists in public medicine, national disease surveillance, paediatrics, general practise, microbiology and virology.

A revised report on immunisation guidelines for Ireland was published in 1999 and the Committee is expected to update this information in approximately a years’ time. The Committee meets on a regular basis to review scientific developments in relation to immunisation.

The National Disease Surveillance Centre is concerned with monitoring communicable disease and on measures relating to control, especially in an outbreak situation. The National Disease Surveillance Centre also provides advice on immunisation to the Department of Health and Children.

The Irish Medicines Board is the statutory agency with responsibility for monitoring the safety and efficacy of vaccines and other therapeutic substances. The IMB also provides ongoing advice to the Department on a regular basis. Other source of advice and information to the Department of Health and Children include members of the medical and nursing professions, the Health Boards, the Office for Health Gain, the vaccine manufacturers and the universities.

The changing patterns of communicable disease, together with the availability of new vaccines, indicate the necessity of continuing to review the immunisation programmes.

5. The Primary Childhood Immunisation Programme

5.1The mission statement of the Department of Health and Children is:

“In a partnership with the providers of health care, and in co-ordination with other government departments, statutory and non-statutory bodies, to protect, promote and restore the health and well-being of people by ensuring that health and personal social services are planned, managed and delivered to achieve measurable health and social gain and provide the optimum return on resources invested.”

5.2In line with the Department’s mission statement, the Primary Childhood Immunisation Programme is provided through a range of other agencies and health professionals. Childhood immunisation is seen as a proven safe, effective and relatively inexpensive means of protecting our children and the population generally from a range of potentially serious diseases.

5.3Neonatal BCG vaccine, which protects against tuberculosis, is administered in the maternity hospitals. Subsequently, under the Primary Children Immunisation Programme, parents are offered immunisation for their children to provide protection against Diphtheria, Tetanus, Pertussis (Whooping Cough), Polio, Haemophilus influenzae type b (Hib disease), Measles, Mumps Rubella and Meningococcal C. Apart from the morbidity associated with these illnesses, they can in a small number of cases lead to long-term damage to the child and may occasionally be fatal.

Structure of the Programme

5.4The general practitioner is centrally placed to deliver primary health care, including primary immunisation, to the Irish population.

5.5In November 1993 a Review Group on Primary Childhood Immunisation, chaired by the Chief Medical Officer, Department of Health, was established by the Minister for Health, with the following terms of reference:

“To review the administration of the present programme of childhood immunisation and to make recommendations on measures having regard to both cost and quality issues, on options to improve the present uptake of immunisations”

5.6In its report, published in 1994, the Review Group made detailed recommendations on how to improve upon the existing childhood immunisation programme. It set out a range of elements which it considered necessary for an effective childhood immunisation programme. This was against a background of relatively low uptake of the recommended immunisations in certain areas of the country and amongst specific groups, and a parallel high incidence of certain infectious diseases.

5.7In its recommendations the Group concluded that the General Practitioner is ideally placed to administer the immunisation service and should be the principle health professional involved in delivery. This recommendation was made in the context of the many issues involved in immunisation where the GP would be able to consult with parents, explain the benefits and possible risks and allow them to make an informed decision on this most important aspect of their children’s health. S/he would in most cases already be the family GP and would also be in the best position to provide follow-up advice in the event of parents having any concerns after immunisation. The Group also recognised that health boards, who are statutorily responsible for the control of infectious disease, were free to take the measures necessary to achieve and maintain the target uptake of immunisation.

5.8Following from the 1994 Report, under an agreement reached in 1995 between the Department of Health and the Medical Organisation, health boards enter into contracts with general practitioners for the provision of the primary immunisation programme to children up to the age of two years. Parents can have their children immunised free of charge by the general practitioner of their choice.

Agreement on the Delivery of the Programme

5.9The 1995 agreement between the Department of Health and the IMO on the delivery of the programme states:

“With the childhood immunisations currently available it is possible to eradicate the disease in question, if an uptake level of not less that 95% of the child population is achieved and maintained. The objective of the immunisation programme, therefore, is to achieve and maintain the required uptake of not less than 95% in the total child population...”

The main components of the agreement are:

(i)Each health board (HB) is responsible for compiling an immunisation resister from the birth notification forms from maternity/general hospitals.

(ii)The public health nurse, employed by the HB, on the initial visit to the infant’s home, will identity the GP with whom the parent agrees to immunise their child. The information is entered into the HB’s immunisation register.

(iii)Based on what is entered into the immunisation register, the health board will inform the GPs on a monthly basis of the children who should be immunised. This notification to the GP by the HB is regarded as the “registration” for the purpose of payments. At this point a note is sent to parents from the health board notifying them to attend their GP for childhood vaccinations.

(iv)The GP is responsible for all aspects of managing the immunisation programme, including taking an appropriate history, providing pre-immunisation advice and information, examining the child, record keeping and administration.

(v)The GP is responsible for contacting those parents on their register who do not present for vaccinations, by way of a letter.

(vi)The GP notifies the HB on the 7^th working day of each month who has been immunised, to facilitate routine monitoring of uptake rates. Those who have failed to receive vaccinations or complete a course are also identified to the HB.

(vii)An immunisation record card, is provided for use by the GP to record the child’s immunisation. This is held by the parent, to allow the parent to keep informed as to their child’s immunisation status and also as proof of vaccination.

(viii)The GP is required to adhere to certain procedures to ensure the safety and efficacy of vaccines.

Schedule of Immunisation

5.10The current schedule of immunisation offered through general practitioners is:

Operation of the Programme

5.11The programme operates through the linking of each new-born child with the general practitioner of the parents’ choice. This is done primarily through the public health nurse, who visits parents shortly after a child’s birth, taking the details of the GP whom the parents wish to have immunise their child and the health boards creating a register of children due for immunisation. Public health nurses also have an important role in relation to the following-up of children who have not had their scheduled immunisations.

5.12An industrial relations issue arose after the initiation of the new immunisation arrangements in 1995/6, as a result of which public health nurses’ co-operation with the operation of the programme was not forthcoming. This matter was resolved in 1999 and public health nurses are again fulfilling their role in relation to the programme. It is acknowledged that immunisation uptake suffered during the period of this dispute.

Uptake Issue

5.13Immunisation is voluntary in Ireland, although some other countries have strict criteria for crèche or school entry. So, to protect public health, it is necessary to achieve high uptake rates through the involvement of parents themselves, general practitioners and other health professionals. Parents especially are the partners in immunisation and must be given accurate information by the appropriate health agencies and health professionals about the benefits and possible side-effects of immunisation.

5.14Primary immunisation uptake in Ireland falls short of the target, see table 3. This compares unfavourably with other developed countries and leaves unimmunised children at risk of contracting the infections concerned. The effectiveness of the immunisation programme is compromised when a sufficient uptake level to generate "herd immunity" is not achieved. The attainment of the 95% target is therefore a major objective for the Minister, the Department and the regional health boards.

Table 3. Immunisation uptake rates for children aged 2 years old at 31^st December 1999.

Source: D of H&C

Reasons for Poor Uptake Rates

5.15Although, low immunisation uptake rates among pre-school children have been attributed to difficulties in reaching certain groups, such as the urban poor and racial and ethnic minorities, more recent evaluations suggest that the health-care delivery system itself bears much of the responsibility⁽¹²⁾. A number of membership theses submitted to the Faculty of Public Health Medicine have also identified other factors contributing to poor uptake rates which include: poor interaction between healthcare professionals and poor access to health services. Lack of integrated health information systems may lead to underestimation (not recorded) or overestimation of uptake rates (duplication of records). It is important to eliminate barriers and obstacles which impede efficient vaccine delivery and to encourage providers to take advantage of all health care visits as opportunities to provide vaccination.

International Initiatives to Improve Immunisation Uptake Rates

5.16Several initiatives in the UK, which improve uptake of vaccination, have been described. They include the following:

•Sending written information to parents.

•Specialist immunisation clinics.

•Prompts by health visitors and GPs⁽¹³⁾.

Use of simple interventions e.g. reminder letters and information leaflets have been shown internationally to increase immunisation uptake rates. Hawe, McKenzie and Scurry⁽¹⁴⁾ undertook a randomised controlled trial using a more patient-orientated postal reminder card which emphasised the importance of preventive health behaviour to improve the uptake of measles vaccine. They concluded that 79% of children who obtained the patient-orientated card were vaccinated compared to 67% of those who were sent the usual reminder card. This illustrates how the effectiveness of a minimal and widely used intervention to promote vaccination compliance can be improved with negligible additional effort. Ferson, Fitzsimmons, Christie et al⁽¹⁵⁾ in an Australian intervention illustrated that sending a letter and leaflet to parents of school entrants increased the immunisation uptake by 37%. International schemes in UK and USA have offered financial rewards to parents to encourage childhood immunisation. Groups receiving the incentives were three times more likely to be immunised and the overall immunisation rates were 17% higher than in comparison groups⁽¹⁶⁾.

National Immunisation Steering Committee

5.17A National Immunisation Steering Committee has been established in 2001 to address a wide range of issues in relation to the Primary Childhood Immunisation Programme including the difficulties which are hampering achievements of the 95% uptake target. The Committee is representative of all groups involved with the Primary Childhood Immunisation Programme. Four working groups dealing with the following issues will report to the Committee:

Materials Management

Systems, including IT

Organisation and Planning

Communications.

It is anticipated that the Committee will issue its recommendations in Autumn 2001.

Review of Immunisation Systems

5.18In addition the Department has written to each health board Chief Executive Officer requesting that a review of systems be carried out in relation to all issues concerning the procurement, supply, delivery and administration of vaccines with a view to identifying any shortcomings which exist in the current system.

Introduction of New Combination Vaccines

5.19The Department’s immunisation policy is subject to ongoing review in the light of the vaccines available and the advice of the relevant experts in this field. The recent licensing of a number of 4-in-1 and 5-in-1 vaccines will enable the Department to implement the advice of the National Immunisation Advisory Committee of the Royal College of Physicians of Ireland which is:

-to change from oral polio to IPV; and

-the use of four and five component vaccines as part of the childhood immunisation schedule.

The main benefits of these combination vaccines are the reduction in the number of injections which children receive and the dispensing with the need to give oral polio so eliminating the risk of vaccine-associated paralytic polio (VAPP). It is expected that the changeover to these products will take place within the next few months. The new combination vaccines will reduce the number of separate injections which children receive during their primary and booster immunisations.

Conclusions

5.20 (i)The Joint Committee agrees that the General Practitioner is ideally placed to administer the Primary Childhood Immunisation System.

(ii)The Joint Committee considers that the role of the Public Health Nurse is vital to the success of the Primary Childhood Immunisation System with particular emphasis on the level of co-operation with the General Practitioners.

(iii)The Joint Committee considers that it is the responsibility of the Department of Health and Children to ensure that the obstacles to reaching a 95% uptake are tackled and overcome.

(iv)The Joint Committee welcomes the setting up of the National Immunisation Steering Committee and looks forward to its findings later this year.

Recommendations

5.21 (i)The appointment of a National Immunisation Co-ordinator within the Department of Health to oversee and monitor the effective implementation of Childhood vaccination programme.

(ii)The appointment of an Immunisation Co-ordinator in each Health Board to manage the provision of the Childhood vaccination programme in each Health Board.

(iii)A once off payment be made available to participating GPs to update / install appropriate computer technology and that GPs be encouraged and facilitated to operate the technology.

(iv)There should be continuous immunisation promotion campaigns on television and radio until such time as an uptake approaching 95% is reached and until a satisfactory computer and administrative system is in place.

(v)A free phone call in service to the Irish Medical Board be set up to which parents / guardians could report adverse reactions as there are suggestions that there is under reporting in this area.

(vi)Doctor / General Practitioner and Nurse training programmes provide for immunisation risk communications.

6 Vaccine-Preventable Diseases and the Primary Childhood Immunisation Programme

Measles, Mumps and Rubella

Measles

6.1Worldwide, measles remains one of the major childhood killers, accounting for more child deaths that any other vaccine-preventable disease. The World Health Organisation estimate that approximately a million children die every year from measles infection. Measles is a highly infectious disease. The World Health Organisation estimate that, in communities where immunisation rates are low, virtually all unimmunised children will have been infected with measles by the age of 5 years (Treating Measles in Children. Global Programme for Vaccines and Immunisation, World Health Organisation, Geneva 1996). It has been found to be more common in urban areas and amongst children whose families are in the lower socio-economic groupings. The incubation period is usually 8-12 days. The symptoms may last for a number of weeks.

6.2Measles is not a trivial illness. Approximately 1 in 15 children with measles suffer serious complications. Serious cases require urgent hospitalisation where the average length of stay ranges from 5 to 10 days (European Measles Survey, World Health Organisation, 1996). Common complications include pneumonia, otitis media, mouth ulcers and eye complications. Less common complications include acute encephalitis (inflammation of the brain) and which may result in permanent brain damage or death. Sub-acute sclerosing panencephalitis (SSPE) is a severe complication of measles, usually occurring years after the infection and which may cause progressive brain degeneration leading to intellectual impairment, seizures and eventually death. A list of the complications is included below.

Measles Control and Vaccination

6.3In Western developed countries, strategies to control measles focus on improving routine coverage and ensuring proper case management, particularly in high risk areas, to reduce measles mortality. Many countries have now achieved advanced measles control and strive to maintain high vaccine coverage, continuing to focus on high risk populations, and provide supplementary measles immunisation to prevent potential measles epidemics in non-vaccinated individuals.

6.4North and South America are now committed to eradicating measles. Substantial progress has been made regarding the prevention of importation of the virus and a goal has been set to eliminate measles virus from the region by the year 2010.

6.5In Europe, many Eastern and Western European countries have achieved highly satisfactory levels of measles control whereby in some countries measles is almost unknown. The World Health Organisation conclude that measles elimination the European region is feasible during this decade and even sooner in a number of countries. They have noted that some countries have not met the vaccine uptake targets and commented that this may be due to a belief amongst health professionals and parents that measles is not a severe disease and also to the incomplete implementation of vaccine programmes. The World Health Organisation has now targeted that by 2007 or earlier, indigenous measles should be eliminated from the European region and that this be certified in every country by 2010. The WHO stated that the achievement of this target is dependent on 95% vaccine coverage within the eligible population.

6.6Other factors considered necessary by the WHO are the development of public health systems with effective laboratory-based surveillance to monitor the target diseases. The World Health Organisation has held sub-regional workshops to assist countries in developing national plans for measles elimination. It has published a strategy for measles elimination which is based on achieving 95% coverage with the first dose of measles vaccine, implementing a high quality surveillance programme to monitor disease incidence and the proportion of susceptible people, the establishment of a national measles reference laboratory and the implementation of supplementary immunisation strategies and appropriate surveillance activities to control measles infection (Expanded Programme on Immunisation in the European Region of WHO, World Health Organisation, Copenhagen 1999). It is anticipated that these strategies will lead to the elimination of measles in Europe by 2007.

6.7The World Health Organisation’s strategic framework is evidence based and includes a comprehensive survey of vaccination policies and measles incidence within Europe. The data collected suggest that in many countries, measles vaccination has had a very positive impact on the incidence of measles infection and a dramatic impact on the number of deaths. In some countries, very high coverage has been achieved and the incidence of measles has fallen below a target level of 1 per 100,000 population. Despite the successes, many other countries are failing to reach the operational targets established by the World Health Organisation. The WHO recommend that countries must establish a political commitment to measles elimination and that their strategies are based on the epidemiology of measles in the country.

6.8The strategy recommended by WHO in the 1970s was centred on maintaining high routine coverage of a single dose of vaccine. This approach controlled measles and reduced the morbidity and mortality associated with the disease. The problem, however, related to situations with low vaccine coverage (less than 90%), measles continues to circulate and epidemics occurred, usually every three to four years. This situation applies to Ireland. The size of the epidemics was small by pre-vaccination standards, however.

6.9The use of a second dose of measles-containing vaccine is considered to improve measles control and some countries have now managed to interrupt measles transmission by achieving high vaccination coverage for both doses. Finland has implemented a two-dose MMR vaccination policy since 1982 and achieved high vaccination coverage of over 95%. Measles, mumps and rubella have all but disappeared in Finland since 1993. In Ireland, the second dose offers a second opportunity for vaccinating children who are not vaccinated, and a second chance to protect those children who fail to seroconvert following a single dose of the vaccine (primary vaccine failures). Primary vaccine failures represent less than 10% of children immunised above the age of 2 months, however, these children can contribute to the maintenance of measles transmission. In Ireland, a second dose of MMR is given after school entry so as to prevent the possibility of school outbreaks.

6.10Mass (catch-up) campaigns are also advocated by WHO in order to accelerate measles control by the rapid reduction in the proportion of susceptible persons and can, therefore, be used to avert a threatened epidemic. Many European countries have performed catch-up vaccination campaigns and in 1994 the UK adopted this strategy to prevent a predicted outbreak. Ireland is currently involved in a primary school catch-up programme so as to reduce the numbers of susceptible children to measles disease.

6.11In Ireland, national MMR vaccine coverage is approximately 75% for the first dose of the vaccine. This falls short of the target of 95% uptake rate in the childhood population resulting in reasonable measles control, however, with scope for further improvement because of residual measles infections. Prior to 2000, approximately 100 cases were notified annually. In January 2000 a new epidemic of measles commenced in the North Dublin region. This has spread to other areas in Dublin and to a lesser extent throughout the country. Additional measles control measures were put in place including a lowering of the vaccination age to six months in the outbreak areas, an enhanced MMR programme aimed at improving uptake of the first dose of the vaccine, and a catch-up programme in the school population. To date, this epidemic has resulted in approximately 1,500 cases and two measles-related deaths. The control measures have retarded the transmission of measles virus and appear to have interrupted the epidemic curve of this outbreak. However considerable further efforts will be necessary on a ongoing basis in order to achieve elimination of measles in Ireland by 2007, in line with the timetable set by the WHO.

6.12An outbreak control team, chaired by a Specialist in Public Health, was convened to review the epidemiological data and to institute and review control measures. Membership of the team included, Senior Area Medical Officers, Directors of Public Health Nursing, General Managers Community Services, a representative from the Regional G.P. Unit, the Consultant Clinical Microbiologist and Infection Control Sister from The Children’s Hospital, Temple St, the Director of the National Disease Surveillance Centre and a virologist from the Virus Reference Laboratory (VRL), University College, Dublin (UCD).

6.13The Outbreak Control Team made a submission to the committee in view of their firsthand experience in dealing with this large outbreak. The following is not a comprehensive list of barriers to immunisation but are some of the ideas which the members of the Outbreak Control Team felt might be useful to consider, in the light of their experience in dealing with this large outbreak of measles.

(i)Parental barriers to immunisation

(a)It is felt that a considerable amount of work needs to be done in relation to the immunisation delivery system and in motivating parents and addressing their concerns about vaccination.

(b)The perception of the Outbreak Control Team was that there are two different groups who do not have their children immunised. One group are affluent, educated parents, who make a conscious decision not to have their children immunised. It was felt that this group responded to the publicity about the measles outbreak and presented their children for immunisation. It is felt that the specific concerns of these parents in relation to the safety of MMR vaccine need to be addressed. The other group are those from disadvantaged areas, who because of other priorities in their lives, perhaps do not get around to having their children immunised. The perception is that this group did not respond to the publicity and that these parents need to be specifically targeted and encouraged to have their children immunised.

(c)Linking immunisation to a payment to parents, (perhaps on a differential basis so that for example, 50% of the payment would be made on first vaccination and 50% on completion of the child’s primary vaccinations) might be considered.

(d)It was felt that there should be regular vaccination promotion campaigns on T.V. and radio. While the recent TV/radio ad campaign promoting MMR was effective it was felt that the campaign was too short and that regular such campaigns are required. During the measles outbreak there were regular press releases urging parents to have their children vaccinated. These generated a lot of interest from local, national and U.K. media and a good response from parents. It was fortuitous that a Vaccination Awareness Campaign, which was launched on 12^th March by the Irish Pharmaceutical Healthcare Association (IPHA) in conjunction with the Department of Health and Children, heightened media interest in this outbreak of measles.

(ii)The Immunisation Delivery System

(a)The chronic shortage of staff, medical, nursing and administrative, in all areas is acknowledged.

(b)Establishing health board run vaccination clinics in disadvantaged areas should be considered.

(c)Consideration should be given to additional remuneration of general practitioners in inner city areas for immunisation, to reflect the particular difficulties and additional costs they incur in delivering an immunisation service.

(d)There should be increased co-operation between Public Health Nurses and General Practitioners in relation to follow up of immunisation defaulters.

(e)The option of nurses immunising on an outreach basis should be considered. However, this option would need to be piloted and evaluated before implementation, as parents may not attend for immunisation if they expect the nurse to visit to immunise. There is also an issue in relation to authorisation allowing nurses to immunise without direct supervision of a registered medical practitioner.

Mumps

6.14Mumps continues to be a widespread disease in Europe. In 1995, 33 countries reported approximately 340,000 cases. There is limited surveillance data on mumps, however, this represents a modest decrease over the past 10 years when, in 1985, more than one million cases were reported (Health 21 – Health for All in the 21^st Century. World Health Organisation, European Region, Copenhagen 1999). Approximately one third of cases are without symptoms.

6.15Mumps is an acute viral infection, predominantly a childhood disease. It is transmitted by inhalation of infected droplets and the symptoms are characterised by swelling of the salivary glands on one or both sides.

6.16Mumps can cause significant morbidity. The list of possible complications include:

•Mumps meningitis – this occurs in approximately 1 in 200 cases.

•Encephalitis – Inflammation of the brain.

•Deafness – a rare complication caused by damage to the auditory nerve which may result in permanent deafness.

•Pancreatitis – inflammation of the pancreas.

•Sterility – in males, inflammation of the testes after puberty may lead to atrophy of the testes resulting in impaired fertility. Inflammation of the ovaries is a rare consequence.

Vaccination Strategy

6.17Mumps is less infectious than measles and transmission may be interrupted at relatively lower vaccination coverage levels. The World Health Organisation consider that the vaccine coverage targets for mumps match those for measles and rubella, as the MMR vaccine is used against all three. The WHO consider that the cost effectiveness of immunisation against mumps justifies the inclusion of the disease in the targets.

6.18In Ireland, information on the incidence of mumps was not collected prior to the introduction of MMR vaccine. The expanded use of MMR vaccine has, however, led to very low incidence levels in the past decade.

Rubella

6.19Rubella (German Measles) is a mild infectious disease primarily affecting children. Rubella is not easy to diagnose because the symptoms are similar to those of other viral diseases. It causes a mild transient rash and, occasionally, arthritis in adults.

6.20If rubella is contracted by a woman during the first three months of pregnancy, the consequences for the developing foetus can be devastating. In up to 70% of cases the baby is born with permanent disabilities including blindness, deafness, brain damage and heart defects. There is also a 50% increase in the risk of a spontaneous abortion (World Health Organisation. State of the World’s Vaccines and Immunisation. WHO, Geneva 1996). Congenital Rubella Syndrome represented a significant cause of physical and mental handicap. The rate of Congenital Rubella Syndrome was estimated at 1 per 1,000 live births prior to the introduction of rubella vaccine (World Health Organisation. Guidelines for Surveillance of Congenital Rubella Syndrome and Rubella. WHO, Geneva 1999).

Vaccination Strategy

6.21Rubella vaccine was first licensed in 1969. The primary purpose of rubella vaccination is to prevent the occurrence of Congenital Rubella Infection. It is considered that the Congenital Rubella Syndrome could be eliminated from many countries in Europe. This will depend on high vaccination coverage in young children. The WHO recommend that, in countries using routine MMR vaccine, the measles elimination strategy should be considered at the core of the programme. The WHO has now set a target of an incidence level for congenital rubella of below 0.01 per 1,000 live births. In Ireland, the vaccine strategy is in accordance with WHO guidelines, based on the elimination of measles and rubella by use of MMR vaccine in the Childhood Immunisation Programme. This strategy is dependent on achieving satisfactory routine vaccination coverage in children and a process of ensuring that women of childbearing age are immune. The second dose of MMR vaccine is considered important in achieving high vaccination coverage amongst the target population.

Diphtheria

6.22Diphtheria is an infectious disease which can affect the tonsils, respiratory system and the heart. Although the infection can be treated, approximately up to 10% of cases are fatal. The disease can involve serious complications, affecting the heart (myocarditis) and central nervous system, following the spread of diphtheria toxin to various organs.

6.23Diphtheria was one of the diseases originally targeted for elimination by the year 2000 in Europe by the WHO. However, while there was a substantial decline in reported cases in the 1980s, there was a major setback in Eastern Europe in the 1990s. This was primarily due to a dramatic fall in immunisation coverage in the newly-independent states of the former Soviet Union. In 1990, there were under 2,000 cases and this increased to over 47,000 by 1994. The World Health Organisation and UNICEF declared the epidemic an international health emergency and implemented booster immunisation programmes in close collaboration with the countries concerned. It is estimated that this immunisation campaign may have averted more than 500,000 cases in total and more than 10,000 deaths from this disease. In Western Europe, where immunisation coverage among children is high, only isolated cases of diphtheria have been reported despite increasing movement of people from the former Soviet Union region. In Ireland, there have been no recorded cases of diphtheria for many years. However, the recent epidemic in Eastern Europe underlines the need for ongoing primary and booster immunisations as appropriate.

Immunisation

6.24Immunisation against diphtheria protects by the production of antitoxin which provides immunity to the effects of the toxin. In Ireland, diphtheria toxoid is available as a combined vaccine namely, absorbed diphtheria/tetanus/pertussis (DTaP), absorbed diphtheria/tetanus (DT or Td), or adsorbed diphtheria. The World Health Organisation recommends that at least 90% of children under one year of age are immunised with three doses of adsorbed diphtheria/tetanus/pertussis. Boosters are necessary and are given at entry to primary school and again at school leaving when the low dose diphtheria toxoid (Td) is administered.

Pertussis (Whooping Cough)

6.25Worldwide, pertussis is a major cause of morbidity and mortality. In 1994, there were an estimated 40 million cases of pertussis and 360,000 deaths. In developing countries the death rate can approach 15%. In the industrialised countries the mortality is 4 deaths out of every 10,000 infected children.

6.26The WHO consider that the disease is under reported, with only 1-2% of cases ever appearing in official statistics (World Health Organisation. State of the World’s Vaccines and Immunisation. WHO, Geneva 1996). Pertussis infection, in its mild form, is similar to many other respiratory infections. Laboratory confirmation is also not always possible.

6.27Pertussis is associated with an irritating cough. The typical (whoop) may not develop in young infants and instead coughing spasms may be followed by periods of apnoea and cyanosis. There are many complications including bronchopneumonia and cerebral hypoxia. Seizures, encephalopathy and death occur most commonly in infants under 6 months of age.

Pertussis Vaccine

6.28There are two forms of pertussis vaccine, namely wholecell and acellular pertussis vaccine. Previously, neurological complications have been reported after vaccination with the whole cell vaccine, however, these symptoms can also occur in unimmunised children. There are no tests which can specifically attribute neurological conditions to vaccination. Epidemiological studies are used to establish whether there is a casual link between vaccination and the onset of serious complications. Large epidemiological studies have failed to indicate a casual relationship between vaccination and neurological illnesses. It is extremely difficult to quantify the risk, if any, of neurological complications due to vaccination. Indeed, neurological complications are far more common after pertussis disease than after the vaccine.

6.29Extensive international research has been conducted over many years regarding the possible link between the pertussis component of the whole cell DTP vaccine and chronic brain damage. It was known that in common with all other vaccines and therapeutic substances, adverse reactions to DTP occurred. Nevertheless, it was considered in this country, as in all other countries using the vaccine, that the benefits to children far outweighed any potential risks and helped protect them from the serious consequences of a previously prevalent disease. The identification and use of contraindications to the vaccine helped further to reduce any potential risk. Finally, in those children in whom DTP was contraindicated, it was recommended that they be given DT, i.e. Diphtheria and Tetanus vaccination without the pertussis component.

6.30The consensus of the international literature on this subject is best encapsulated in the following quotation from Paediatrics, Vol 97, No 2, February 1996:

"The Academy* reaffirms its earlier conclusions that whole cell pertussis vaccine has not been proven to be a cause of brain damage and continues to recommend pertussis vaccination in accordance with the guidelines in the 1994 ‘Red Book’".

6.31This view was confirmed in the Immunisation Guidelines for Ireland for the Royal College of Physicians which was published in 1996. The report advised:

"although there has been controversy about pertussis vaccine, the consensus from authorative bodies is that it is a safe vaccine".

6.32Ireland replaced the whole cell vaccine with the acellular vaccine in 1996. The acellular vaccine is now considered to have a 80-90% efficacy rate which is only a marginal reduction on the performance of whole cell vaccines. The acellular vaccine does, however, significantly reduce the frequency of side effects associated with the whole cell pertussis vaccine. The pertussis vaccine is available as the combination DTaP and is a core component of the Childhood Immunisation Programme.

Tetanus

6.33Tetanus is a neurological disease which is caused by a neurotoxin. The organism exists widely in the environment. Tetanus spores may contaminate a puncture wound and the resulting muscle spasms carry a high mortality rate. Tetanus is a rare disease in Ireland.

Tetanus Toxoid

6.34Immunisation works by producing an anti-toxin which provides immunity against the effects of the toxin. The primary childhood immunisation programme provides tetanus toxoid in the form of DTaP or DT. A booster dose is given at school entry and also at primary school leaving age.

Poliomyelitis

6.35Poliomyelitis infection is endemic in some developing countries. In Europe, the World Health Organisation has targeted poliomyelitis for elimination and this is expected to be certified within the next three years. The most recent case of poliomyelitis notified in Ireland was in 1984.

6.36Most poliomyelitis infections are clinically insignificant. Poliomyelitis does, however, have serious complications including meningitis and paralysis. In previous epidemics, it was well known for causing serious breathing difficulties and even death.

Polio Vaccine

6.37Two vaccines are available for immunisation, namely, a live attenuated oral polio vaccine and an inactivated injectable polio vaccine. In Ireland, the oral polio vaccine is used for routine immunisation. The World Health Organisation consider that the oral polio vaccine is preferable because it induces immunity in the gut – the key site where wild polio virus multiplies.

6.38The process of certifying poliomyelitis elimination has commenced in Ireland. This strategy entails high routine immunisation coverage, together with enhanced surveillance. It is anticipated that immunisation against polio will continue for many years after the certification process has been completed. The use of oral polio and/or inactivated polio vaccine is under consideration and will be determined by the ongoing surveillance of both polio disease and potential adverse reactions to the vaccine.

Haemophilus Influenzae Type B (Hib Disease)

6.39Worldwide, haemophilus influenzae type B is a leading cause of respiratory infections among younger children. It is also one of the leading causes of meningitis, which can lead to brain damage and deafness. It mainly affects children under 5 and in industrialised countries, carries a case fatality rate of approximately 5%. The World Health Organisation has set a target incidence of below 1 per 100,000 population for mumps, pertussis and invasive disease caused by haemophilus influenzae type B.

6.40H Influenzae is an important cause of meningitis, otitis media, septicaemia, septic arthritis and osteomyelitis. The risk of complications is greatest in infancy. Invasive Hib disease usually presents as meningitis which carries a high mortality rate.

Hib Vaccine

6.41The Hib vaccine in Ireland is licensed for use at two-monthly intervals and has been shown to be very effective. The introduction of Hib vaccine into childhood vaccination programmes in recent years in Europe has resulted in a significant fall in the incidence of this condition to the point of eradication in some countries. In Ireland, following the introduction of the Hib vaccine in 1992, the incidence of the disease has declined tenfold (Report of Working Group on Bacterial Meningitis and Related Conditions, Department of Health and Children, 1999).

BCG

Tuberculosis Disease (TB)

6.42The incidence of tuberculosis in Ireland has declined dramatically since the 1900s. Recent trends from some European countries and the USA, however, have shown an increase in tuberculosis notifications. These have been related to HIV, drug abuse, homelessness, immigration and adverse socio-economic conditions. A new problem is the emergence of multi-drug resistant TB in Europe. The incidence of tuberculosis in Ireland is higher than in most European Union countries.

BCG Vaccine

6.43BCG vaccine is available for the prevention of TB and is most effective against TB meningitis and miliary tuberculosis. The Report of the Working Party in Tuberculosis (Department of Health, 1996) outlined a model for the prevention, diagnosis and management of tuberculosis in Ireland. Key concepts were the development of an active surveillance system, with prompt notification, early treatment and thorough contact tracing of all cases of tuberculosis. The development of a national TB reference laboratory facility was also recommended and is now under consideration.

6.44BCG vaccine was generally recommended to be administered to infants in the neo-natal period. The national working party recognised, however, that BCG policy was not standardised across all health board areas. It considered the TB surveillance data which indicated that the incidence of TB has reduced in most areas, including those where BCG was not administered in the neo-natal period. Ireland is approaching the level of TB infection where the discontinuation of BCG vaccination may be considered. The National Tuberculolis Committee continues to monitor the TB surveillance and outbreak information, as well as clinical outcomes including the threat of the emergence of multi-drug resistant TB. This information will determine future TB control strategies including the use of BCG in Ireland.

Group C Meningococcal Disease

6.45Ireland has a particularly high incidence of meningitis, indeed the highest in Europe. In 1999, 587 cases of bacterial meningitis were reported, and it is estimated that about one-third of these involved the Group C strain of the disease. Meningococcal Group C infection is a significant public health hazard, causing meningitis and septicaemia in all age groups from infancy to young adults. It is a devastating condition with a significant mortality rate. It can develop with great rapidity and also cause long-term disabilities in the form of developmental delay, hearing loss and neurological damage. The peak incidence of Group C Meningitis occurs in infants and reduces with increasing age. However the incidence increases again in the 15 to 18 year-old group.

6.46In 1999 the Minister for Health and Children, recognising that meningococcal Group C infection is a significant public health hazard causing Meningitis and Septicaemia in all age groups from infancy to young adults, determined that the new vaccines developed to provide long-term protection against this disease should be introduced in Ireland as soon as they became available. The first suitable such vaccines were licensed in Ireland in July 2000 and the immunisation campaign began in October 2000.

(Vaccines against Group B disease, which accounts for approximately two-thirds of meningitis cases in Ireland, are in development, but it will be some years yet before these are available for use.)

6.47The vaccine has being incorporated into the Primary Childhood Immunisation Programme and is being given through a catch-up programme to the population up to age 22 – approximately one-third of the population altogether.

6.48In order for this vaccine to be introduced, a wide range of issues has had to be considered and a very large planning effort has been required. Among the type of issues which have had to be addressed are:

•the need for the vaccine

•identification and prioritisation of target groups

•availability of licensed vaccines

•vaccine supply contracts and distribution planned

•recruitment of additional health board staff to deliver programme

•negotiation of fees for medical practitioners

•provision of appropriate information for health professionals and the public.

6.49In 1999 the Department of Health and Children requested the health board Chief Executive Officers to establish a working group which would oversee the planning for the introduction of the vaccine.

6.50This group has addressed a wide range of issues in order to ensure that a co-ordinated and effective immunisation campaign can be mounted. Working with the health boards and a range of other agencies, the Office for Health Gain has had a major co-ordination and planning role in relation to much of the operational detail of the programme. Each health board has also established a project group to address in detail the many practical and logistical issues involved in implementing a programme of this scale.

6.51In order to ensure that the catch-up programme is targeted at the highest-risk populations at the outset, it was split into two phases. Beginning in October 2000, Phase 1 targeted those up to five years and the also 15-18 year old age group. This is being followed, beginning in 2001, by Phase 2, which will cover those in the 6-14 and 19-22 age groups.

6.52It is important to stress that only those in the highest-risk groups are being offered vaccinations in Phase 1. The available vaccine supplies would not be sufficient to enable those outside the target groups to be immunised at this stage.

7 The Practice of Immunisation in Ireland

7.1The current guidelines for childhood immunisation in Ireland are outlined in the National Immunisation Guidelines for Ireland (Table 4). A multidisciplinary committee from paediatrics, medicine, general practice, public health and infectious diseases compiled these guidelines. They are based on international best practice and are intended to be used as a guidance manual for all professionals involved in administering vaccines to children.

Table 4 Childhood Immunisation Schedule in Ireland

(1)A single dose of Hib vaccine is also recommended if the child presents after age 13 months and has had no previous Hib vaccine

(2)Omit if two previous doses of MMR have been given

(3)Only for those who are known to be tuberculin negative and have no previous BCG

The vaccine preventable diseases mentioned above are all statutorily notifiable to the National Disease Surveillance Unit since July 1^st 2000 under the 1981 Infectious Disease Regulations.

Contraindications to Vaccines

7.2Contraindications are uncommon and most children in whom there is a true permanent contraindication will be under the care of a paediatrician. When a child has had a reaction to a vaccine that is severe enough to contraindicate further doses this should be notified. Unfortunately several mythical contraindications have spring up over the years and this has prevented some children from being immunised (Table 6).

Table 5: Contraindications to immunisation

Table 6: Mythical contraindications to immunisation

7.3In the USA, the National Vaccine Advisory Committee (NVAC) developed standards for immunisation policies and practice. Eighteen standards were developed and were endorsed by the US Public Health Service and the American Academy of Paediatrics ⁽¹²⁾. The 18 standards are outlined in the following text and applied to the Irish situation.

(i)Immunisation services are readily available.

Under the terms of the Primary Immunisation Programme, immunisation services are readily available. Most general practitioners throughout the country have contracted to health boards to provide immunisation services under the agreement. In addition, it is stated that “nothing in this agreement shall be construed as preventing the health board from making special arrangements where the uptake of immunisation among particular groups or in geographical areas is unacceptably low.” Therefore, health boards may, for example, set up special clinics in health centres or immunise children on an outreach basis in their own homes, if this is deemed necessary in areas where there are particular problems with getting parents to present their children for immunisation.

(ii)There are no barriers or unnecessary prerequisites to the receipt of vaccines.

It is stated in the discussion related to this standard that “appointment-only systems often act as barriers to immunisation in both public and private settings. Immunisation services should be available on a walk-in basis at all times for both routine and new enrolee visits.” The system of delivery of immunisation services in general practice in this country varies, with some general practitioners offering immunisation on an “appointment-only” basis, others providing “walk-in” immunisation clinics and others carrying out vaccinations as part of routine clinics. Each system has advantages and disadvantages for both parents/children and general practitioners. The appointment only system means that parents/children do not have a long waiting time and the general practitioner/practice nurse can arrange to limit the numbers attending the clinic in order to provide enough time to discuss the vaccination of their child with parents in an unhurried way. The walk-in system on the other hand eliminates the barrier of having to make an appointment and keep it, which parents, especially those with other small children, often find difficult to keep.

(iii)Immunisation services are available free or for a minimal fee.

The Primary Childhood Immunisation Programme is provided free of charge to all children in the country under the terms of the agreement.

(iv)Providers use all clinical encounters to screen for needed vaccines and when indicated, vaccinate children.

In relation to the identification and follow up of children who have not been immunised, under the terms of the agreement, contracting general practitioners must “avail of any opportunity to discuss the matter with parents. The opportunity might arise through surgery or domiciliary visits for other purposes and liaison with the public health nurse.” The agreement also states that “every effort should be made to ensure that all children are immunised even if they are older than the recommended age range and that no opportunity to immunise should be missed in the interests of public health.”

The setting up of an immunisation clinic in one of the major children’s hospitals in Dublin was considered in the context of the 2000 measles epidemic in Dublin. It was estimated that about 40% of children who presented to the Accident and Emergency Department at the hospital were fit for immunisation on that day, i.e. were a febrile and did not have any other contraindications to immunisation. Issues to be considered were: hospital might be seen by parents as the appropriate place to bring children for immunisation thus undermining the GP surgery as the appropriate setting for delivery of immunisation services and the recording and notification of health boards. Payment for the service also requires clarification.

(v)Providers educate parents and guardians about immunisation in general terms.

Under the agreement, contracting general practitioners are expected to promote the recommended childhood immunisation to parents. The Department of Health and Children and the health boards are responsible for promoting immunisation on a population basis and for assisting general practitioners in this regard. The Office for Health Gain, on behalf of the Department of Health and Children, co-ordinated a successful vaccination education and promotion campaign on radio and television in the summer 2000 in relation to MMR vaccine and is planning similar campaigns in relation to the other primary childhood vaccinations and the meningococcal C programme.

(vi)Providers question parents or guardians about contraindications and, before vaccinating a child, inform them in specific terms about the risk and benefits of the vaccination their child is to receive.

At some point, almost every person in the Ireland is vaccinated. Therefore, many individuals question how vaccines are made, if they are effective and whether they are safe. Individuals, appropriately, are asking more and more questions about the vaccines being offered to them. However, many are responding to alleged dangers of vaccination that are being propagated by those who oppose immunisation. Although few in number, their messages are dramatic, often misleading or completely false, and there are few mechanisms available to counter the false allegations quickly. Patients are increasingly exposed to them in print, on television and on the internet. It is the responsibility of those who counsel patients or who provide information about vaccination to begin educating the public about the need to be critical about information which is disseminated through an increasingly diverse number of outlets.

People seek answers to these questions from a wide variety of sources including family, friends, health care providers, the Internet, television and medical literature. The information they receive is complex and, at times, inaccurate or misleading. Therefore, health professionals have a responsibility to provide accurate, understandable information and to handle vaccine safety concerns appropriately. All health care providers who administer vaccines are required to discuss the potential risks and benefits of immunisation. In these situations, risk communication is a necessary skill. Communicating risk information about vaccination is one of the most difficult challenges in drug safety research⁽¹⁷⁾.

Risk communication involves a dynamic exchange of information between individuals, groups and institutions. This information must acknowledge and define the risks associated with vaccination in a way the public can understand. This is difficult given the current environment where few people experience the devastation of vaccine-preventable diseases. It is further complicated by the fact that immunisation is associated with some degree of personal discomfort when needles are used to administer vaccines.

In 1996, the Institute of Medicine’s Vaccine Safety Forum held a workshop on risk communication and vaccination. Three key concepts emerged:

•First, risk communication is a dynamic process in which many participate. These individuals are influenced by a wide variety of circumstances, interests and information needs. Effective risk communication depends on the providers and recipients understanding more than simply the risks and benefits; background experiences and values also influence the process.

•Second, the goal that all parties share regarding vaccine risk communication should be informed decision-making. Consent for vaccination is truly ‘informed’ when the members of the public know the risks and benefits and make voluntary decisions.

•Finally, there is often uncertainty about estimates of the risk associated with vaccination. Risk communication is more effective when this uncertainty is stated and when the risks are quantified as much as science permits. Trust is a key component of the exchange of information at every level, and overconfidence about risk estimates that are later shown to be incorrect contributes to a breakdown of trust among public health officials, vaccine manufacturers, and the public. Continued research to improve the understanding of vaccine risks is critical to maximising mutual understanding and trust.

(vii)Providers follow only true contraindications.

The agreement states that in order that consistent advice is given to parents, all health professions should be aware that there are very few contraindications to the recommended childhood immunisations. The agreement further states that where a general practitioner has any doubt, appropriate advice should be sought from a consultant paediatrician, the appropriate medical staff from the health board or other appropriate health professional.

(viii)Providers administer simultaneously, all vaccines doses for which a child is eligible at the time of each visit.

Children are exposed to many foreign antigens every day. Eating food introduces new bacteria into the body, and numerous bacteria live in the mouth and nose, exposing the immune system to still more antigens. According to Adverse Events Associated with Childhood Vaccines, a 1994 report from the Institute of Medicine, “in the face of these normal events, it seems unlikely that the number of separate antigens contained in childhood vaccines would represent an appreciable added burden on the immune system that would be immunosuppressive.” Available scientific data show that simultaneous vaccination with multiple vaccines has no adverse effect on the normal childhood immune system.

A number of studies have been conducted to examine the effects of giving various combinations of vaccines simultaneously. In fact, neither the Advisory Committee on Immunisation Practices (ACIP) nor the American Academy of Paediatrics (AAP) would recommend the simultaneous administration of any vaccines until such studies showed the combinations to be both safe and effective. These studies have shown that the recommended vaccines are as effective in combination as they are individually, and that such combinations carry no greater risk for adverse side effects. Consequently, both the ACIP and AAP recommend simultaneous administration of all routine childhood vaccines when appropriate.

The Immunisation Guidelines for Ireland, (1999) state that live vaccines should be administered at the same time at different sites. There are two practical factors in favour of giving a child several vaccinations during the same visit. First, we want to immunise children as early as possible to give them protection during the vulnerable early months of their lives. This generally means giving inactivated vaccines beginning at 2 months and live vaccines at 12 months. The various vaccine doses thus tend to fall due at the same time. Second, giving several vaccinations at the same time will mean fewer office visits for vaccinations, which save parents both time and money and may be less traumatic for the child.

(ix)Providers use Accurate and Complete Recording Procedures.

It is important that providers of immunisations are required by statute to record the following details in relation to vaccinations:

•Name of vaccine administered, including name of manufacturer and lot number,

•Date of administration,

•The signature and title of the person who administered the vaccine,

•The location where the vaccine was administered,

•Personal vaccination record for each child which should be updated when each vaccine is administered.

In Ireland, childhood vaccinations are recorded and compiled by each health board using manual and electronic databases. GPs also record this data either manually or electronically. Due to population mobility, the use of a unique identifier for each child would facilitate ease of retrieval of vaccination records. It is also important that electronic databases used for recording vaccinations are standardised and compatible with each other so that data on vaccination status is easily retrievable and transferred between health boards. This will ensure that such data is timely and that each child’s vaccination programme is completed, which will also facilitate in providing accurate coverage data. This is of especially important in relation to high-risk groups e.g. travellers, refugees. The development of such systems should be prioritised under the Civil Registration Service Modernisation Programme.

(x)Providers co-schedule immunisation appointments in conjunction with appointments for other child health services.

In Ireland, immunisations are often administered in the GP surgery when children visit with other child health problems. Point (iv) highlights a recent hospital initiative, the objective of which is to target high-risk children from areas where uptake rates for vaccination are low.

(xi)Providers report adverse events following vaccination promptly, accurately and completely.

Providers should encourage parents or legal guardians to inform them of adverse events following immunisation. Both systemic and local reactions should be reported. Providers should report all such clinically important events. In Ireland all suspected adverse reactions, including the batch number of the vaccine, should be reported to the Irish Medicines Board using the Yellow Card System. The Irish Medicines Board, using a similar “Freepost” Green Card System also monitors quality defects in vaccines. Quality defects include missing labels/label texts, container defects, altered product appearance, particles in product, etc. This allows for surveillance of adverse reactions and helps to identify trends of adverse reactions, which may be caused by specific vaccinations.

(xii)Providers operate a tracking system.

A tracking system should generate reminders of upcoming immunisations as well as recalls for children who are overdue their vaccinations. This system may be electronic or manual. In Ireland, such systems exist in all health boards, however, in the health system it may also be necessary for staff to make home visits, especially in relation to children who are at high risk for failing to complete the immunisation schedule. When children are vaccinated in schools, they are vaccinated by class. Sometimes, it is possible that children may miss out on booster vaccines due to absence, migration etc. Difficulties arise in follow-up, which could be addressed by the provision of integrated health information systems, and using a unique identifier for each child.

(xiii)Providers adhere to appropriate procedures for vaccine management.

Quality management systems should be in place to ensure the following:

•Vaccines are handled and stored as recommended in the manufacturer’s package inserts.

•The temperature at which vaccines are stored and transported are monitored daily and the expiry date of each vaccine is documented.

Such systems exist in each health board and are also employed by GPs. It is important that agreed standards are adhered to post implementation.

(xiv)Providers conduct semi-annual audits to assess coverage levels and review immunisation records of the population, which they serve.

In both health board school immunisation clinics and in general practice, the assessment of immunisation services for children should include audits of vaccination records or else a random sample of records to determine the following:

1.The immunisation uptake rate

2.To identify how frequently opportunities for simultaneous immunisation were missed

3.To assess the quality of documentation

This should be part of an ongoing quality assurance programme. In Ireland, this is currently being undertaken in relation to uptake rates, but the audit process will need to be expanded at all levels to include 2 and 3.

(xv)Providers maintain up to date easily retrievable medical protocols at all locations where vaccines are administered.

The National Immunisation Guidelines were updated in 1999. These are based on evidence-based practice and outline the indications, vaccine dosages and containdications, and the recommended sites and techniques for vaccine administration, as well as possible adverse effects and their emergency management. They also specify the necessary emergency medical equipment and emergency drugs (including dosage) required to safely and competently manage any medical emergency which may arise after the administration of a vaccine. All doctors who routinely administer vaccines, i.e. area medical officers, GPs and paediatricians, use these guidelines and they should be available in all settings where vaccinations are administered.

(xvi)Providers practice patient orientated and community-based approaches.

Providers should provide comprehensive information to patients on vaccinations, in particular contraindications, action and the risk of possible adverse effects. In Ireland, all providers of immunisation should endeavour to attain this objective.

Providers should also undertake focus groups and rolling surveys for their patients in order to obtain their views on immunisation and immunisation practices. These should seek information on the following areas:

•Knowledge of immunisation

•Attitudes towards immunisation

•Experience of the immunisation services

•Response to advertising

It also allows a timely response to issues which are of concern to parents and which may act as a barrier to immunisation and allow parents to make an informed choice. This will provide information for the provider in relation to patients’ immunisation needs and allow them to implement the changes necessary to provide a more user-friendly service. Providers should use all opportunities to encourage patients to avail of vaccination services and so increase the coverage rate. This is essential as without high immunisation coverage levels, no community is completely protected against vaccine-preventable diseases. In Ireland, the need exists to develop the structures to undertake patient surveys and focus groups as recommended by the National Health Strategy 1994. This should be incorporated into the quality assurance programme.

(xvii)Properly trained persons administer vaccines.

In Ireland, trained health care personnel, i.e. doctors and nurses, administer all vaccinations. They are also trained in the management of emergency situations (in relation to adverse reactions) and partake in regular refresher courses, which ensure that they maintain their skills.

(xviii)Providers receive ongoing education and training regarding current immunisation recommendations.

Providers should obtain ongoing training and education which should cover current guidelines and recommendations as well as education in the standards outlined above. In Ireland, this is currently in place in an ad-hoc way dependent on the location. In future, a more structured approach to training and education is planned.

In Ireland, the immunisation policy needs to be formalised and changes in policy must take into consideration the resource requirements, especially in relation to manpower. It is also essential that providers of the vaccinations be given comprehensive information on the changes prior to implementation.

Conclusion

7.4The Joint Committee considers that the following areas need to be improved:

•Integration of immunisation record and information systems to facilitate surveillance.

•Undertake rolling surveys with parents in relation to immunisation.

•Need for more resources to facilitate education of professionals.

•Implementation of more comprehensive quality systems to ensure optimal delivery of vaccinations.

8. “Six Common Misconceptions about Vaccination”

-Edited version published by WHO with kind permission of CDC, Atlanta.

8.1"Diseases had already begun to disappear before vaccines were introduced, because of better hygiene and sanitation."

Statements like this are very common in anti-vaccine literature, the intent apparently being to suggest that vaccines are not needed. Improved socio-economic conditions have undoubtedly had an indirect impact on disease. Better nutrition, not to mention the development of antibiotics and other treatments, have increased survival rates among the sick; less crowded living conditions have reduced disease transmission; and lower birth rates have decreased the number of susceptible household contacts. But looking at the actual incidence of disease over the years can leave little doubt of the significant direct impact vaccines have had, even in modern times.

There were periodic peaks and valleys throughout the years, but the real, permanent drop coincided with the licensure and wide use of measles vaccine beginning in 1963. Graphs for other vaccine-preventable diseases show a roughly similar pattern, with all except hepatitis B showing a significant drop in cases corresponding with the advent of vaccine use. Are we expected to believe that better sanitation caused incidence of each disease to drop, just at the time a vaccine for that disease was introduced?

Hib vaccine is another good example, because Hib disease was prevalent until just a few years ago, when conjugate vaccines that can be used for infants were finally developed. (The polysaccharide vaccine previously available could not be used for infants, in whom most of cases of the disease were occurring.) Since sanitation is not better now than it was in 1990, it is hard to attribute the virtual disappearance of Hib disease in children in recent years (from an estimated 20,000 cases a year to 1,419 cases in 1993, and dropping) to anything other than the vaccine.

Finally, we can look at the experiences of several developed countries after they let their immunization levels drop. Three countries — Great Britain, Sweden, and Japan — cut back the use of pertussis (whooping cough) vaccine because of fear about the vaccine. The effect was dramatic and immediate. In Great Britain, a drop in pertussis vaccination in 1974 was followed by an epidemic of more than 100,000 cases of pertussis and 36 deaths by 1978. In Japan, around the same time, a drop in vaccination rates from 70% to 20%-40% led to a jump in pertussis from 393 cases and no deaths in 1974 to 13,000 cases and 41 deaths in 1979. In Sweden, the annual incidence rate of pertussis per 100,000 children 0-6 years of age increased from 700 cases in 1981 to 3,200 in 1985. It seems clear from these experiences that not only would diseases not be disappearing without vaccines, but if we were to stop vaccinating, they would come back.

Of more immediate interest is the major epidemic of diphtheria now occurring in the former Soviet Union, where low primary immunization rates for children and the lack of booster vaccinations for adults have resulted in an increase from 839 cases in 1989 to nearly 50,000 cases and 1,700 deaths in 1994. There have already been at least 20 imported cases in Europe and two cases in U.S. citizens working in the former Soviet Union.

8.2"The majority of people who get disease have been vaccinated."

This is another argument frequently found in anti-vaccine literature — the implication being that this proves vaccines are not effective. In fact it is true that in an outbreak those who have been vaccinated often outnumber those who have not — even with vaccines such as measles, which we know to be about 98% effective when used as recommended.

This apparent paradox is explained by two factors. First, no vaccine is 100% effective. To make vaccines safer than the disease, the bacteria or virus is killed or weakened (attenuated). For reasons related to the individual, not all vaccinated persons develop immunity. Most routine childhood vaccines are effective for 85% to 95% of recipients. Second, in a country such as the United States the people who have been vaccinated vastly outnumber those who have not. How these two factors work together to result in outbreaks in which the majority of cases have been vaccinated can be more easily understood by looking at a hypothetical example:

"In a high school of 1,000 students, none has ever had measles. All but 5 of the students have had two doses of measles vaccine, and so are fully immunized. The entire student body is exposed to measles, and every susceptible student becomes infected. The 5 unvaccinated students will be infected, of course. But of the 995 who have been vaccinated, we would expect several not to respond to the vaccine. The efficacy rate for two doses of measles vaccine can be as high as >99%. In this class, 7 students do not respond, and they, too, become infected. Therefore 7 of 12, or about 58%, of the cases occur in students who have been fully vaccinated."

As you can see, this doesn’t prove the vaccine didn’t work — only that most of the children in the class had been vaccinated, so those who were vaccinated and did not respond outnumbered those who had not been vaccinated. Looking at it another way, 100% of the children who had not been vaccinated got measles, compared with less than 1% of those who had been vaccinated. Measles vaccine protected most of the class; if nobody in the class had been vaccinated, there would probably have been 1,000 cases of measles.

8.3"There are "hot lots" of vaccine that have been associated with more adverse events and deaths than others. Parents should find the numbers of these lots and not allow their children to receive vaccines from them."

This misconception often receives considerable publicity. First of all, the concept of a "hot lot" of vaccine as it is used in this context is wrong. It is based on the presumption that the more reports of adverse events a vaccine lot is associated with, the more dangerous the vaccine in that lot; and that by consulting a list of the number of reports per lot, a parent can identify vaccine lots to avoid.

This is misleading for two reasons:

1.Most surveillance systems report events that are temporally associated with receipt of vaccine; these reports should not be interpreted to imply causality. In other words, an adverse report following vaccination does not mean that the vaccine caused the event. Statistically, a certain number of serious illnesses, even deaths, can be expected to occur by chance alone among children recently vaccinated. Although vaccines are known to cause minor, temporary side effects such as soreness or fever, there is little, if any, evidence linking vaccination with permanent health problems or death. The point is that just because an adverse event has been reported by the surveillance system does not mean it was caused by a vaccine.

2.Vaccine lots are not the same. The sizes of vaccine lots might vary from several hundred thousand doses to several million, and some are in distribution much longer than others. Naturally a larger lot or one that is in distribution longer will be associated with more adverse events, simply by chance. Also, more coincidental deaths are associated with vaccines given in infancy than later in childhood, since the background death rates for children are highest during the first year of life. So knowing that lot A has been associated with x number of adverse events while lot B has been associated with y number would not necessarily say anything about the relative safety of the two lots, even if the vaccine did cause the events.

Reviewing published lists of "hot lots" will not help parents identify the best or worst vaccines for their children. If the number and type of adverse event reports for a particular vaccine lot suggested that it was associated with more serious adverse events or deaths than are expected by chance, most countries have a system which results in the lot being recalled.

All vaccines purchased through the UNICEF vaccine procurement system meet World Health Organization standards for safety and quality of production.

8.4"Vaccines cause many harmful side effects, illnesses, and even death — not to mention possible long-term effects we don’t even know about."

Vaccines are actually very safe, despite implications to the contrary in many anti-vaccine publications. Most vaccine adverse events are minor and temporary, such as a sore arm or mild fever. These can often be controlled by taking paracetamol after vaccination. More serious adverse events occur rarely (on the order of one per thousands to one per millions of doses), and some are so rare that risk cannot be accurately assessed. As for vaccines causing death, again so few deaths can plausibly be attributed to vaccines that it is hard to assess the risk statistically. Each death reported to ministries of health is generally thoroughly examined to examine whether it is really related to administration of vaccine, and if so, exactly what is the cause. When, after careful investigation, an event is felt to be a genuine vaccine-related event, it is most frequently found to be a programme error, not related to vaccine manufacturer.

DTP Vaccine and SIDS

One myth that won’t seem to go away is that DTP vaccine causes sudden infant death syndrome (SIDS). This belief came about because a moderate proportion of children who die of SIDS have recently been vaccinated with DTP; and on the surface, this seems to point toward a causal connection. But this logic is faulty; you might as well say that eating bread causes car crashes, since most drivers who crash their cars could probably be shown to have eaten bread within the past 24 hours.

If you consider that most SIDS deaths occur during the age range when 3 shots of DTP are given, you would expect DTP shots to precede a fair number of SIDS deaths simply by chance. In fact, when a number of well-controlled studies were conducted during the 1980’s, the investigators found, nearly unanimously, that the number of SIDS deaths temporally associated with DTP vaccination was within the range expected to occur by chance. In other words, the SIDS deaths would have occurred even if no vaccinations had been given. In fact, in several of the studies children who had recently gotten a DTP shot were less likely to get SIDS. The Institute of Medicine reported that "all controlled studies that have compared immunized versus non-immunized children have found either no association… or a decreased risk… of SIDS among immunized children" and concluded that "the evidence does not indicate a causal relation between [DTP] vaccine and SIDS."

But looking at risk alone is not enough — you must always look at both risks and benefits. Even one serious adverse effect in a million doses of vaccine cannot be justified if there is no benefit from the vaccination. If there were no vaccines, there would be many more cases of disease, and along with them, more serious side effects and more deaths. For example, according to an analysis of the benefit and risk of DTP immunization, if we had no immunization program in the United States, pertussis cases could increase 71-fold and deaths due to pertussis could increase 4-fold. Comparing the risk from disease with the risk from the vaccines can give us an idea of the benefits we get from vaccinating our children.

The fact is that a child is far more likely to be seriously injured by one of these diseases than by any vaccine. While any serious injury or death caused by vaccines is too many, it is also clear that the benefits of vaccination greatly outweigh the slight risk, and that many, many more injuries and deaths would occur without vaccinations. In fact, to have a medical intervention as effective as vaccination in preventing disease and not use it would be unconscionable.

8.5"Vaccine-preventable diseases have been virtually eliminated from my country, so there is no need for my child to be vaccinated."

It’s true that vaccination has enabled us to reduce most vaccine-preventable diseases to very low levels in many countries. However, some of them are still quite prevalent - even epidemic - in other parts of the world. Travellers can unknowingly bring these diseases into your country, and if you and your family were not protected by vaccinations, these diseases could quickly spread throughout the population, causing epidemics here. At the same time, the cases you currently have could very quickly become tens or hundreds of thousands of cases without the protection you get from vaccines.

We should still be vaccinated, then, for two reasons. The first is to protect ourselves. Even if we think our chances of getting any of these diseases are small, the diseases still exist and can still infect anyone who is not protected. A few years ago a child who had just entered school caught diphtheria and died. He was the only unvaccinated pupil in his class.

The second reason to get vaccinated is to protect those around us. There is a small number of people who cannot be vaccinated (because of severe allergies to vaccine components, for example), and a small percentage of people don’t respond to vaccines. These people are susceptible to disease, and their only hope of protection is that people around them are immune and cannot pass disease along to them. A successful vaccination program, like a successful society, depends on the co-operation of every individual to ensure the good of all. We would think it irresponsible of a driver to ignore all traffic regulations on the presumption that other drivers will watch out for him or her. In the same way we shouldn’t rely on people around us to stop the spread of disease; we, too, must do what we can.

8.6"Giving a child multiple vaccinations for different diseases at the same time increases the risk of harmful side effects and can overload the immune system."

Children are exposed to many foreign antigens every day. Eating food introduces new bacteria into the body, and numerous bacteria live in the mouth and nose, exposing the immune system to still more antigens. An upper respiratory viral infection exposes a child to 4 - 10 antigens, and a case of "strep throat" to 25 - 50. According to Adverse Events Associated with Childhood Vaccines, a 1994 report from the Institute of Medicine, United States, "In the face of these normal events, it seems unlikely that the number of separate antigens contained in childhood vaccines… would represent an appreciable added burden on the immune system that would be immuno-suppressive." And, indeed, available scientific data show that simultaneous vaccination with multiple vaccines has no adverse effect on the normal childhood immune system.

A number of studies have been conducted to examine the effects of giving various combinations of vaccines simultaneously. These studies have shown that the recommended vaccines are as effective in combination as they are individually, and that such combinations carry no greater risk for adverse side effects. Research is under way to find ways to combine more antigens in a single vaccine injection (for example, MMR and chickenpox). This will provide all the advantages of the individual vaccines, but will require fewer shots.

There are two practical factors in favour of giving a child several vaccinations during the same visit. First, we want to immunise children as early as possible to give them protection during the vulnerable early months of their lives. This generally means giving inactivated vaccines beginning at 2 months and live vaccines at 12 months. The various vaccine doses thus tend to fall due at the same time. Second, giving several vaccinations at the same time will mean fewer office visits for vaccinations, which saves parents both time and money and may be less traumatic for the child.

9. Safety of Vaccines

Introduction

9.1Since many of the diseases preventable by vaccines are now uncommon, parents have little experience of these diseases and so potential side effects take on a disproportionate importance. Many conditions with an onset in early childhood, such as autism, do not have an obvious cause. As children are immunised at a time when these disorders such as autism, convulsions, and sudden infant death syndrome manifest themselves for the first time it is inevitable that on occasion their onset follows immunisation. It may then be assumed that immunisation caused the problem.

9.2The scare following publication of the mistaken theory that pertussis vaccine was a significant cause of brain damage is an example of what can happen when preliminary research is made public. Some children died unnecessarily because their parents refused to have them vaccinated. Another example is the current controversy over the measles, mumps, and rubella vaccine and autism and bowel problems. This is largely based on one paper in which the authors themselves stated they had not proved a link between autism and the vaccine. More recent data on the pattern of autism in several countries, e.g. Sweden, does not suggest a link between the vaccine and autism⁽¹⁸⁾. This issue will be discussed in more detail later in this report.

9.3Other concerns that have been raised include possible long-term effects such as asthma and overloading or damaging the immature immune system. After birth, infants are constantly exposed to antigens. The number of antigens contained even in the combination of vaccines is small compared with the number normally encountered every day. By giving a vaccine, that is, a carefully controlled dose and antigen, this assault is substantially reduced. A double blind randomised controlled trial carried out in the US in which some children were given diphtheria, tetanus, and pertussis vaccine and others diphtheria and tetanus vaccine showed no difference in the proportions of children with wheezing, itchy rash, or sneezing at two and a half years old^(19)(20).

9.4The Irish Medicines Board (IMB) is responsible for the monitoring and safety of all pharmaceutical products sold in Ireland. The monitoring of vaccine safety is ensured through clinical trials prior to licence and post-licence surveillance by the IMB. Reports of any suspected adverse events are notified to the Irish Medicines Board. As with any drug, monitoring of safety continues after a vaccine has been introduced. As in all passive systems, underreporting can be a major problem and at its best the system can only serve to flag up possible issues for further examination. Studies linking hospital admissions and immunisation records can also be used to look at the relationship between specific conditions and immunisation. In this way the true incidence of adverse reactions can be determined.

Manufacture, testing and licensing of vaccines

9.5There has been much adverse publicity about the development of new vaccines in recent years, with allegations that they are not properly tried and tested. It is important to address these concerns.

9.6Vaccines are legally defined in the EU as “medicinal products” and as such are highly regulated products. Prior to being approved for general use, vaccines are extensively tested by scientists to ensure that they are effective and safe.

9.7The Rules Governing Medicinal Products in the European Union⁽²¹⁾ set out the controls applicable to the manufacture, testing and licensing of vaccines in the EU. Their objective is to provide the highest level of protection of public health. This legislative framework defines a rigorous and transparent approval process, which leads to the granting of a marketing authorisation allowing the pharmaceutical product to be put on the market.

Manufacture of vaccines

9.8Vaccines are difficult to produce and the processes involved are time-consuming. Careful controls on production and very strict quality control procedures exist to ensure the safety and efficacy of vaccines. Tests are undertaken at every stage in the manufacture of vaccines to ensure that the vaccine contains the correct organism in the right amount, that it has the proper level of potency and that it is free of contaminants.

9.9The total production period for a vaccine can take almost 20 months from raw ingredient to the vaccine actually being in the surgery fridge. From the manufacturers point of view, it is therefore vital to have adequate notice of when particular vaccines will be required so that the necessary stocks will be available at the right time⁽²²⁾.

9.10Each country has a national regulatory authority (the Irish Medicines Board in Ireland) that assesses the safety, efficacy and quality of vaccines, whether locally produced or imported, and ultimately authorises or rejects their use by the public. WHO has specified that all vaccines used within national immunisation programmes should, as a minimum, meet the WHO quality requirements⁽²³⁾.

9.11No medicinal product (including vaccines) may be placed on the market unless the manufacturer has a valid manufacturing authorisation granted by the regulatory authority of the country where the manufacturing plant is located⁽²¹⁾.

9.12The manufacturing authorisation certifies that the manufacturing plant has been inspected to ensure that it is capable of manufacturing the medicinal product and/or carrying out the necessary quality control tests specified in the marketing authorisation application and that the manufacturer conforms to accepted standards of best practice known as Good Manufacturing Practice (GMP).

9.13Manufacturers are regularly inspected by the authorities in the Member State in which the product is manufactured. The Irish Medicines Board has responsibility for this task in Ireland.

9.14To sum up, the fact that a product has a marketing authorisation in any EU country means that both the particular product and the manufacturing site have been evaluated and shown to comply with the appropriate regulatory standards (GMP, quality, safety and efficacy).

Clinical trials on vaccines

9.15Before vaccines are licensed for general use, they are extensively tested in the laboratory and in human beings to ensure their safety. First, computer models are used to predict how the vaccine will interact with the immune system. Then researchers test the vaccine on animals. Once the vaccine successfully completes these laboratory tests, it is approved for use in clinical studies by the relevant authorities. During clinical trials, the vaccine is tested on human beings. Participation in these studies is completely voluntary. Many individuals choose to contribute their time and energy for the advancement of science. Informed consent must be obtained from all participants before they become involved in research. This ensures that they understand the purpose of the study, potential risks and are willing to participate. Volunteers agree to receive the vaccine and undergo any medical testing necessary to assess its safety and efficacy.

9.16The licensing of vaccines is a lengthy process that may take ten years or longer. Vaccines undergo three phases of clinical trials in human beings before they can be licensed for use in the general public. Phase one trials are small, involving only 20-100 volunteers, and last only a few months. The purpose of phase one trials is to evaluate basic safety and identify very common adverse events. Phase two trials are larger and involve several hundred participants. These studies last anywhere from several months to two years and collect additional information on safety and efficacy. Data gained from phase two trials can be used to determine the composition of the vaccine, how many doses are necessary and a profile of common adverse events. Unless the vaccine is completely ineffective or causes serious side effects, the trials are expanded to phase three which involves several hundred to several thousand volunteers. Typically these trials last several years. Because the vaccinated group can be compared to those who have not received the vaccine, researchers are able to identify true side effects.

9.17If clinical trials demonstrate that the vaccine is safe and effective, the manufacturer seeks regulatory approval to put the vaccine on the market.

Regulatory approval process for vaccines

9.18The European Union operates a comprehensive authorisation system for pharmaceutical products, which requires applicants to provide evidence in the form of extensive data generated from clinical trials and other studies that demonstrate that the product meets rigorous standards of quality, safety and efficacy. These data must be developed in strict compliance with EU standards such as good laboratory practices, good clinical practices, and good manufacturing practices. This system ensures that only products which have been rigorously tested are allowed onto the market.

9.19The data submitted by the company are subject to in-depth scientific evaluation by appropriately qualified experts in national regulatory authorities such as the Irish Medicines Board. In this process, the evidence for quality, safety and efficacy is analysed and potential risks are assessed and put into context with the benefits of the product. It is only after the regulators decide that a medicinal product has a favourable risk/benefit profile that a marketing authorisation (known as a product authorisation in Ireland) is granted.

9.20Changes in the original marketing authorisation are possible only after informing the authorities and obtaining their approval. In any case, the authorisation has to be renewed every 5 years. As part of the renewal process, data gained on the medicinal product during the previous years, particularly safety data, are reviewed by the regulatory authority. If necessary, the conditions of use of the product can be amended to reflect any information which comes to light from its use in the general population.

Batch release testing of vaccines

9.21Under EU law (Directive 89/342/EEC), Member States must ensure that all processes in the manufacturing of immunological products (which include vaccines) are properly validated and result in batch to batch consistency.

9.22When a manufacturer is granted a license to market a biological medicine in Europe, it is a requirement that samples of each batch of the finished product be sent to a WHO-approved laboratory so that they can repeat quality tests and satisfy themselves that the vaccine is suitable for use in the marketplace. The assessment carried out in such cases is termed a “batch release” and involves review of manufacturing protocols and laboratory testing of samples to ensure potency and purity. This process takes up to two months⁽²⁴⁾.

9.23The task of batch release for the Irish market is undertaken by bodies such as the National Institute for Biological Standards and Controls (NIBSC) in the UK which is one of three WHO International Laboratories for Biological Standardisation.

Monitoring the safety of vaccines in use

9.24Although a vaccine must undergo extensive study before it is granted a marketing authorisation, as with any medicine, its safety is continually monitored after it is put on the market. Side effects may come to light when the product is used in millions of people that did not previously occur within the smaller group which took part in clinical trials on the vaccine.

9.25The process of monitoring the safety of a vaccine (as with all other medicinal products) during its life on the market, is known as pharmacovigilance and is extensively regulated under EU law⁽²¹⁾. Thus, the safety of pharmaceutical products is under continual scrutiny by the EU regulatory authorities, including the Irish Medicines Board.

9.26In the EU, data on side effects or adverse reactions for all medicines, including vaccines, must be collected and collated by the manufacturer and by regulatory authorities. It comes from reports of adverse reactions submitted by healthcare professionals and also from literature reports of adverse reactions.

9.27The Irish Medicines Board operates a yellow card scheme for the reporting of suspected adverse reactions by healthcare professionals. Doctors, nurses, pharmacists and dentists are encouraged to report adverse reactions even if they are not sure whether the vaccine caused the reaction.

9.28The information collected is scientifically evaluated and appropriate action is taken where necessary. For example, if the overall risk/benefit profile for a vaccine is adversely affected because of reports of side effects, it may be necessary to withdraw or suspend its use or to vary the conditions of use. A decision on the appropriate course rests with the regulatory authority. There are procedures in place to rapidly implement measures to ensure the safe use of medicinal products e.g. product recall.

9.29To ensure that health authorities are fully informed of adverse reactions, manufacturers of vaccines are legally obliged to report serious adverse reactions immediately, and in any case, within 15 days. Other information on the safety of medicinal product has to be collected by the manufacturer on an ongoing basis (e.g. literature reports of side effects, data in other countries) and this forms the basis of Periodic Safety Update Reports which have to be submitted to regulatory authorities at defined regular intervals. These records must be accompanied by a scientific evaluation on whether the benefit/risk ratio for the vaccine has changed. All this information is assessed by the regulatory authorities who decide if any action is necessary.

9.30Systems have been established to ensure that reports of adverse drug reactions are exchanged between regulatory authorities worldwide. Therefore, the surveillance of vaccines in the EU market is not only based on experience in EU member states but also on additional data from outside the EU.

Immunisation Safety Priority Programme (ISPP)

9.31It is not surprising that immunisation safety ranks high on WHO’s priority list, resulting in the establishment of the Immunisation Safety Priority Programme (ISPP). The project’s main target is to establish by 2003 a comprehensive system to ensure the safety of all immunisations given in national immunisation programmes. Other agencies such as the CDC are also participating in this project which has four major objectives:

•To ensure vaccine safety from clinical trials, through vaccine distribution, to the point of use;

•To strengthen research and development of safer and simpler delivery systems;

•To establish efficient mechanisms that detect serious or potentially serious adverse effects following immunisation and enable prompt and effective response;

•To broaden access to safer and more efficient systems for vaccine delivery and sharps waste management.

9.32Examples of recent ISPP activities include the establishment of a Global Advisory Committee on Vaccine Safety to provide a reliable and independent scientific assessment of vaccine safety issues. An external steering committee on immunisation safety has also been created to provide technical and scientific advice to ISPP⁽²⁵⁾.

Conclusion

9.33 (i)The Joint Committee is satisfied that:

•vaccines are rigorously tested before being licensed for use.

•every batch of vaccines is independently tested before use.

•the effects of vaccines are continuously monitored.

•the routine vaccines are safe.

•vaccine scares are common.

(ii)The Joint Committee considers that the setting up of the ISPP is an important development to give people confidence about the safety of vaccines.

Recommendations

9.34The Joint Committee recommends that the Irish Medicines Board should in its annual report outlining its activities for each year include information on:

-the number and nature of adverse reaction reports received from healthcare professionals relating to vaccines and the procedure for dealing with these;

-the number and nature of Periodic Safety Update Reports from manufacturers;

-its exchanges with other regulatory authorities worldwide;

-the procedures in place to rapidly implement measures to ensure the safe use of medical products including product recall;

-recent activities of the ISPP.

10. Safety Issues in Relation to Specific Vaccines other than M.M.R.

Pertussis

10.1Because of the decrease in the incidence of pertussis over the course of the twentieth century it is difficult to fully appreciate how serious a condition it can be. At the end of the nineteenth century in the UK one child in every thousand under the age of fifteen died from the disease. In the US in the early 1940’s it caused more deaths in children under two years-of-age than any other acute infection besides pneumonia and diarrhoeas.

10.2One important demonstration of the efficacy of immunisation, including pertussis immunisation, is the observed increase in incidence of diseases that occurs when there is a decline in immunisation rates in a previously well-immunised population. In the UK during the 1970s concern about the efficacy of the pertussis vaccine led to a decline in immunisation rates. There followed two epidemics in 1977-79 and 1981-82.

10.3In Japan in 1974-5 two children died following DTP immunisation. The Ministry of Health and Welfare temporarily halted the DTP immunisation programme, and though this only lasted a couple of months public confidence had been eroded. The DTP immunisation rate, which had reached 85% by 1972 fell to 13.6% in 1976.

10.4The following table shows the figures for the cases of pertussis, and deaths from the disease, for the years just prior to the decline in DTP immunisation (1974-5) and for the years following⁽⁶⁾.

Table 7: Pertussis cases and deaths in Japan 1970-79. Immunisation suspended in early 1975.

10.5Ninety percent (90%) of the cases from 1975 onwards were in unvaccinated children. These figures were thought to clearly demonstrate “the importance and effectiveness of pertussis vaccine”, and also served to provide “convincing evidence that pertussis is still a fatal disease of babies…”

10.6In Sweden immunisation against pertussis was suspended in 1979 in response to concerns about the efficacy of the vaccine then in use. Following suspension of immunisation there was an increase in reported cases of pertussis in Sweden. In many areas of Sweden general immunisation against whooping cough was recommended in 1995. This decision was based upon the results of trials of newer acellular vaccines⁽⁶⁾.

DTP and SIDS

10.7Another expressed concern regarding immunisation, particularly with the DTP, is a possible link with Sudden Infant Death Syndrome (SIDS). The peak time for SIDS is between two and four months of age, which is also the recommended time for the first two dosed of DTP. We would therefore expect many cases of SIDS to occur in close time proximity to immunisation merely by chance.

10.8One of the points frequently mentioned by the anti vaccination lobby is the decline in the SIDS rate in Japan following the shift in age of immunisation to two years. In Japan during the period concerned there was in place a Vaccine Compensation System. Compensation was commonly awarded for events considered possibly due to immunisation, unless there was clear evidence that this was not the case. Approximately two thirds of claims submitted were accepted.

10.9When the minimum immunisation age was moved from three months to two years there were no claims made through the compensation system for vaccine-related sudden death. Claims for vaccine related sudden death stopped, not because children were no longer dying, but because their deaths no longer occurred during a period when they were also receiving immunisation.

10.10During the period 1970-74, when DTP immunisation was begun at three months the incidence of pertussis in children aged under one was approximately four per 100,000. In 1975 the minimum immunisation age was moved to two years, and by 1984 the incidence of pertussis in children aged under one was over 20 per 100,000. These figures demonstrate well the expected change in pertussis epidemiology following shift in immunisation age^{(6) (26)}.

10.11In recent years, however, epidemiological evidence indicates that infants immunised against diphtheria, pertussis and tetanus (DPT) are at a decreased risk of sudden infant death syndrome (SIDS). A recent paper explains the mechanisms through which this may occur⁽²⁷⁾.

Meningococcal C vaccine

10.12This vaccine was introduced in Ireland in October 2000. There were reports in the press of eleven deaths in the UK alleged to be linked to the administration of the MenC meningococcal vaccine during the national vaccination campaign. These cases were examined in the course of a routine follow-up of reporting of suspected adverse events by the Medicines Control Agency (MCA) and the Committee on Safety of Medicines (CSM) and found to be unlikely to be associated with the use of the vaccine. Six cases were Sudden Infant Death Syndrome (SIDS), two had congenital heart disease, two died of Group B meningococcal disease and one had a convulsion 10 days after vaccination. All the deaths are regarded as coincidental rather than causally related to vaccination. The MCA report in June 2000 cited 4764 reports of possible adverse effects in the context of almost 14 million doses distributed, a level defined by the World Health Organisation as ‘very rare’. In a vaccination programme on such a scale it is inevitable that serious illness and death unrelated to vaccination will coincide temporally on a number of occasions⁽²⁸⁾.

Polio

10.13Polio vaccines manufactured from the early 1950s to the early 1960s, which by necessity were produced on monkey kidney tissue cells, were later found to be contaminated by a monkey virus known as SV40, which was not discovered until 1961. Although steps were immediately taken to ensure that subsequent releases of vaccine were free of SV40, vaccine recipients around the world were likely to have been exposed to the virus. Initial work done to determine whether the contamination posed a risk to humans found no increase in cancer incidence in the vaccinated group and found SV40 in rare cancers in both vaccinated and unvaccinated groups. More recent studies, which received considerable publicity, have suggested that SV40 could be involved in the formation of some very rare human cancers.

10.14An international meeting to discuss the study findings and review all historical data concluded that more work should be done in the areas of laboratory testing and epidemiology before more definitive answers could be obtained⁽²⁶⁾.

Rotavirus

10.15This vaccine is not licensed for use in Ireland. Controversy regarding the vaccine was recently reported by the media. There may be an increased risk of intussusception during the first few weeks after receipt of the licensed vaccine. The Centres for Disease Control and Prevention (CDC) received reports of 23 cases of intussusception after receipt of doses 1,2, or 3 of rotavirus vaccine which was greater than the expected number of cases, with the highest rate during the first week after vaccination. These initial data suggest that intussusception occurs at a younger age in vaccine recipients than in unvaccinated children.

10.16As a result of this concern the American Academy of Pediatrics (AAP) made the following recommendations:

-Clinicians should suspend administration of rotavirus vaccine to unimmunised and partially immunised children, pending collection and evaluation of additional information.

-Parents or guardians of children who received the vaccine within a period of approximately 3 weeks should be advised to promptly contact their physician if signs or symptoms compatible with intussusception develop.

-All cases of intussusception that occur after administration of this vaccine should be reported to the relevant agencies⁽²⁹⁾.

Rubella vaccine and arthritis

10.17Infection with the rubella virus is well known to produce joint symptoms in susceptible individuals, especially women. The later the exposure, the more likely the individual is to have joint complaints. In rare cases, chronic arthritis may develop. The rubella vaccine, therefore, was also thought to be responsible for similar effects, though not to the same extent as the disease. Two studies have closely examinied the question of rubella vaccination and joint disease. The first study which was carried out in Canada examined 546 healthy women aged 18 to 41 years. This study revealed that seronegative postpartum women who received the rubella vaccine had a significantly higher incidence of joint manifestations than women who received saline placebo. Eighty-one of the 268 women who received the vaccine experienced acute joint manifestations, while only 55 of the 275 women who received the placebo developed problems. By contrast, in follow-up checks at age one, three, six, nine and 12 months after immunisation, the frequency of recurrent manifestations between the two test groups varied only slightly⁽³⁰⁾.

10.18Additional original research, conducted in the United States found that women vaccinated against rubella do not appear to have a greater risk of developing chronic joint diseases, such as arthritis, lupus, chronic fatigue syndrome or fibromyalgia. The data were based on an examination of more than 400 women, including some who had never been vaccinated against the infection. The authors concluded that despite the fact that previous research had suggested that a link might exist, the new findings support the continued vaccination of rubella-susceptible women of childbearing age⁽³¹⁾.

11. The controversy surrounding MMR, inflammatory bowel disease (IBD) and autism

11.1The recent controversy regarding MMR vaccination, inflammatory bowel disease and autism originated following a press conference called by Dr. Andrew Wakefield of the Royal Free Hospital and his co-workers. At this press conference Dr. Wakefield outlined his hypothesis that MMR vaccine was implicated in the appearance of a new syndrome where children developed inflammatory bowel disease and a regressive development disorder – a form of autism. He had previously tried to implicate measles vaccine in the causation of Crohn’s disease but independent opinion had refuted this.

11.2The investigators had studied a case series of children with enterocolitis who had reported regression of neurodevelopmental skills. All these children were referred to a gastroenterology clinic. 12 patients were in the study and it involved retrospective parental reporting of developmental delay. The investigators suggested that there was a relationship between receipt of MMR vaccine and inflammatory bowel disease. They hypothesised that inflammatory bowel disease prevents absorption of essential vitamins and nutrients resulting in developmental disorders such as autism. However, in at least 4 of the 12 cases onset of symptoms (developmental regression) appeared before the onset of symptoms of inflammatory disease. The authors of the paper actually stated “We did not prove an association between MMR vaccine and the syndrome described. Virological studies are underway that may help to resolve the issue.”⁽³²⁾

11.3Numerous methodological faults are present in this study. Other studies have failed to demonstrate a link between these diseases. However the damage caused by media attention at the time of publication has not been reversed despite subsequent publications which have been unable to show such a link.

11.4At a subsequent meeting in March 1998 organised by the Medical Research Council a worldwide panel of independent experts reviewed all the data surrounding the hypothesis and concluded that there was no association between the MMR vaccine and the development of inflammatory bowel disease or autism.

11.5On the 24^th March 1998 the Chief Medical Officer (CMO) of Health in the UK issued the following statement:

“Based on the views of the experts and on previous material that I have studied I have concluded that there is no link between MMR vaccine or MMR immunisation and either Crohn’s disease or autism.

I strongly advise parents to continue to have their children immunised with MMR vaccine as presently recommended and I am writing to all health professionals with that advice.”

11.6In July 1998, a second paper was published by the Royal Free team which gave the results of the virological study mentioned above. This study was unable to demonstrate the presence of measles virus in the lesions of IBD in the children even though the most sensitive screening techniques currently available were used⁽³³⁾.

11.7A paper, which was published in July 1998 by a Swedish research team, provided further evidence to disprove the alleged link between MMR vaccine and autism. The researchers examined the medical records of a group of children with autism, 55% of whom had not received MMR vaccine and 45% of whom had. In these two groups, 62% of the cases of autism occurred in the unvaccinated children and 38% in the vaccinated⁽³⁴⁾.

11.8In Finland, the National Board of Health and National Public Health Institute launched a vaccination programme against measles, mumps and rubella in 1982. Adverse events were reported after vaccination and follow-up of all cases reporting gastrointestinal symptoms was done. About 3 million doses were administered by the end of 1996. GI symptoms were reported for 31 vaccine recipients. The time of onset of GI symptoms ranged from 20 hours to 15 days. None of these children developed autistic-spectrum disorder. More than a decades worth of data did not support a link between MMR vaccination and chronic inflammatory disease and autistic spectrum disorder⁽³⁵⁾.

11.9A review of children in the East Thames region was also done. Children with autism born since 1979 were identified from special needs/disabilities registers. 293 out of 498 cases of autism could be confirmed using ICD 10 coding. A steady increase in cases by year of birth was seen and there was no sudden “step-up” or change in the trend line after the introduction of MMR vaccination. There was no difference in age at diagnosis between cases vaccinated before or after 18 months of age and those never vaccinated. No temporal association was shown between onset of autism within 1 or 2 years after vaccination with MMR⁽³⁶⁾.

11.10In April 2000 an expert group of scientists and doctors brought together by the Medical Research Council published a report which concluded that there is no new evidence to suggest a causal link between MMR vaccination and autism or inflammatory bowel disease. The group was set up following an ad hoc meeting of experts in March 1998 to steer and monitor research into inflammatory bowel disorders and autism. The group’s main conclusions were that between March 1998 and September 1999 there was no new evidence to suggest a causal link between MMR and IBD/autism (confirming the earlier view of the ad-hoc group) and that much remains unknown about IBD and autism and more research in these areas is needed⁽³⁷⁾.

11.11An editorial in the BMJ commented on similarities between the public concern after the Lancet report linking measles, mumps and rubella (MMR) vaccine with autism and similar scares over pertussis in the 1970s, which resulted in much suffering and many deaths from pertussis both in Britain and internationally.

11.12The authors commented that the WHO found no links between measles, MMR, and inflammatory bowel disease and a survey of conditions associated with autism did not mention inflammatory bowel disease. A rise seen in the incidence of autism started over a decade before the introduction of the MMR in 1998. Unproved theories are no basis for dropping a vaccine of proved global safety and effectiveness.

11.13In the American Journal of Gastroenterology, September 2000 Dr. Wakefield (et al) reported on a total 60 children with developmental disorders (primarily autism) and compared their ileocolonoscopic findings (both macroscopic and historical) with those of 22 “control” children and 20 with ulcerative colitis. In all, 93% of effected children had lymphoid nodular hyperplasia (LNH) in comparison to 29% of “controls” and chronic colitis was identified in 88% of effected children in comparison to 5% of “controls”. The authors concluded that children with developmental disorders frequently exhibit a new variant of inflammatory bowel disease “autistic enterocolitis”.

11.14The Chairman, Rep. Dan Burton, of the Government Reform Committee, US House of Representatives referred to Dr. Wakefield’s and Professor O’Leary’s research as having uncovered a possible connection between inflammatory bowel disorder in children with autism who received the MMR vaccine and have the measles virus in their small intestines when they appeared before that committee to give evidence on “Autism: Present challenge, Future needs. Why the increased rates?” in April 2000.

11.15Drs. A. Wakefield and S.M. Montgomery published an article in Adverse Drug Reaction and Toxicologica Reviews (“Measles, mumps, rubella vaccines: Through a glass darkly”, 29 January 2001) suggesting that the MMR vaccines were licensed prematurely.

11.16The World Health Organisation issued a statement in response to the article as follows:

“WHO has noted that other scientists have not been able to reproduce the results claimed by Dr Wakefield and his team regarding measles virus in the gut. His published observations regarding the onset of autism following administration of MMR vaccine do not meet the scientific criteria required to suggest that the vaccine is the cause. Other studies not cited by Dr Wakefield find no link with autism or Crohn’s disease.”

WHO Position

WHO strongly endorses the use of MMR (measles, mumps and rubella) vaccine on the grounds of its convincing record of safety and efficacy.

The combination vaccine is recommended rather than monovalent presentation when available and the disease burden justifies its use.

There has been no new scientific evidence that would suggest impaired safety of MMR. On the contrary, all results from vaccine trials published reaffirm the high safety and efficacy of MMR vaccine.

11.17The Centers for Disease Control in the U.S. have advised that splitting the MMR vaccine may be harmful because it would expose children unnecessarily to potential serious disease. For instance if rubella vaccine was delayed continued transmission of the virus could result in additional cases of congenital rubella syndrome, which is one of the recognised causes of autism.

11.18In the BMJ (February 2001) James A Kaye et al studied children aged 12 years or younger diagnosed with autism 1988-99, with further analysis of boys aged 2 to 5 years born 1988-93 to estimate changes in the risk of autism and assess the relation of autism to the mumps, measles and rubella (MMR) vaccine.

Results: The incidence of newly diagnosed autism increased sevenfold, from 0.3 per 10 000 person years in 1988 to 2.1 per 10 000 person years in 1999. The peak incidence was among 3 and 4 year olds, and 83% (254/305) of cases were boys. In an annual birth cohort analysis of 114 boys born in 1988-93, the risk of autism in 2 to 5 year old boys increased nearly fourfold over time, from 8 (95% confidence interval 4 to 14) per 10 000 for boys born in 1988 to 29 (20 to 43) per 10 000 for boys born in 1993. For the same annual birth cohorts the prevalence of MMR vaccination was over 95%.

Conclusions: Because the incidence of autism among 2 to 5 year olds increased markedly among boys born in each year separately from 1988 to 1993 while MMR vaccine coverage was over 95% for successive annual birth cohorts, the data provide evidence that no correlation exists between the prevalence of MMR vaccination and the rapid increase in the risk of autism over time. The explanation for the marked increase in risk of the diagnosis of autism in the past decade remains uncertain.

11.19Dr. Wakefield and Professor O’Leary gave evidence on their research before the Joint Committee on 22 March 2001. During his evidence Dr. Wakefield indicated that he was not in any way anti-vaccine. He indicated the researchers believe that there may be a synergetic interaction between the components of the vaccine which increases the risk of an adverse event and that we have the ability with the single vaccines to prevent this interaction between the viruses.

Prof. O’Leary indicated that children must be vaccinated and nothing in his testimony should be considered anti-vaccine.

11.20The following statement of Marie M. Bristol-Power, Ph.D., co-ordinator, Network of the Neurobiology and Genetics of Autism, National Institute of Child Health and Human Development, National Institutes of Health before the Committee on Government Reform, U.S. House of Representatives, 18 June 2000 may give the most up to date position on the controversy surrounding MMR, IBD and autism:

Introduction

Autism is a developmental disorder that affects the most central of human behaviors—the ability to communicate, to interact socially and emotionally with others, and to have the broad repertoire of skills and knowledge needed to easily take one’s place in the worlds of work and leisure. The great variability in expression of autism and related disorders indicates the complexity of the puzzle this disorder presents. Genetic, infectious, metabolic, immunologic, and possible environmental influences have been implicated as possible causes or triggers of autism.

We believe that no single cause will account for all cases of autism (and the range of Autism Spectrum Disorders), nor will any one intervention or treatment prevent or “cure” all its manifestations. Autism might be better understood as a class of disorders. Solving the puzzle of autism will be like peeling an onion, one layer at a time. To date, the gene, protein product, and some understanding of mechanisms have been found for Fragile X, once defined as a form of autism. This past year, a major gene for Rett’s syndrome, one of the Autism Spectrum Disorders, was identified. Genetic “hotspots” for autism have been discovered by independent, international groups of researchers using common diagnostic criteria. Promising work also continues on candidate genes such as on chromosome 15q11-13, and the serotonin transporter gene. The current consensus is that autism probably involves multiple genes that interact in some complex way to make individuals genetically susceptible to Autism Spectrum Disorders. The scientific challenge is to identify both the genetic basis for the disorder and the other influences that might lead to or precipitate autism in susceptible individuals.

Regression in Autism

There are two modes of presentation of autism—one, thought to be true for the majority of children with autism, in which the child has symptoms from birth, and a second, historically considered to constitute 20-30% of all cases, in which the child apparently develops normally and then loses functional communication and social skills, usually between 18-24 months. Recent reports suggest that the relative proportion of early onset to later onset regressive autism may be changing. Further research is needed to verify these reports. In any case, at this time, there is not a proven explanation why some children appear to develop normally and then regress. As with the overall etiology of autism, there is likely to be a variety of causes of autistic regression. In fact, a number of other developmental disorders, caused by a number of different mechanisms—genetic, metabolic, neurologic, immunologic and combinations of these mechanisms—are characterized by periods of normal development followed by regression. At the NIH, scientifically defensible mechanisms will be investigated so that the tragedy of various forms of regressive autism can be understood and ultimately prevented. The NIH supports research in these areas, and encourages the submission of research applications on these different mechanisms. Currently supported studies in these areas include research at the University of Utah/Utah State on a possible immuno-genetic basis for autism and at the University of Rochester on the interaction of genes and environment in at least a subset of cases of autism.

Vaccines and Autism

Recent reports in the literature and testimony before this Committee have raised the possibility of a link between vaccines, especially the MMR vaccine, and regressive autism, a particular concern given the importance of vaccines to the health of America’s children. A related concern has been raised about the possibility of a link between mercury and autism resulting from exposure to preservatives such as thimersol in cumulative infant vaccinations. Since it is clear that vaccines are safe and effective for the vast majority of children, such reports raise the question of whether or not some children may suffer adverse events from vaccines that are helpful to the vast majority of children who receive them.

Even before recent letters to the Secretary of Health and Human Services were received from the Chairman and Ranking Member of this Committee, the NIH was looking very carefully at the suggestions raised by congressional witnesses and others on what causes autistic regression. The results of current studies are inadequate to draw conclusions that would have far-reaching effects on children’s vaccination programs. However, these results are of sufficient concern that they must be addressed. The NIH is taking a number of different approaches to get information needed as rapidly as possible to determine the merit of these recent concerns.

In addition to pursuing ongoing research on the various causes of autism, the NICHD, with co-funding from CDC, has begun a study of regression in 1,000 persons with autism through the Network on the Neurobiology and Genetics of Autism of the Collaborative Programs of Excellence in Autism supported by the NICHD and the National Institute on Deafness and Other Communication Disorders. A minimum of 200 children with documented regressive autism will be compared with matched groups of children with early onset autism and 200 normally developing control children. Group comparisons (early onset autism, regressive autism, and normal development) will include presence/absence/duration of normal development, age at regression, vaccination histories of children and of mothers (i.e., maternal vaccination before, during, or after pregnancy), measles antibody levels, and association of vaccine additives and autism. The study provides for independent, blind assessment of laboratory samples. Analyses will re-examine the hypotheses of Drs. Singh, Wakefield, and O’Leary. Initial laboratory assessments will include comparisons of immunity to measles using ELISA and other related tests of antibody levels and presence of measles virus nucleic acids in peripheral white blood cells using Real Time (RT) PCR. Subsequent assessments may include immunity to other components of the MMR vaccine, immune responses to DTP vaccine (including thimerosal), immune responses to host proteins, and transcript profiling using expression arrays representing infectious agents.

Since no one study will be definitive, the NIH is also eagerly awaiting the reports and research recommendations on this topic expected to come from an established blue ribbon panel at the American Academy of Pediatrics, and another panel of experts about to be established by the National Academy of Sciences/Institute of Medicine.

Retrospective research and literature reviews will provide valuable information. However, a prospective, longitudinal study is ultimately needed to determine the contributions of both genes and environments to healthy development and to the onset of developmental disorders such as autism. A national initiative, involving the NICHD and other NIH institutes, CDC, EPA, other federal agencies, and independent research laboratories is needed to study the developmental course of autism and other disorders in the context of normal development. Such an effort would involve following a minimum of 100,000 to 150,000 children and youth from pregnancy through at least 21-years of age, collecting both biological and behavioural measures, including vaccination history and exposure to other environmental toxins, diet, and other influences. The NICHD is working with the other agencies to initiate the planning for such a study. The recent announcement of the imminent completion of the description of the human genome signals the beginning of a new era of genetic medicine. We must pursue knowledge of the role of environmental influences in the course of autism and other developmental disorders with the same diligence we are applying to understand the underlying genetic susceptibility to autism.

At the same time, we must be vigilant that we do not overlook alternative explanations for autism and for regression. For example, recent research by Dr. Karin Nelson of the National Institute of Neurological Disorders and Stroke has identified potential biological markers present at birth that distinguish infants with autism or mental retardation from infants with cerebral palsy and from normal infants. This research, as well as work by Dr. Patricia Rodier at the University of Rochester that suggests onset of autism as early as the first three weeks of gestation, raises questions about the impact of postnatal influences on the onset of autism. Similarly, possible metabolic or other infectious sources of autism etiology must also be explored. All hypotheses must be open to independent testing and researchers held accountable to the rules of evidence and peer review.

11.21In April 2001 the “Measles-Mumps-Rubella Vaccine and Autism Report” was released in the U.S. by the Institute of Medicine’s Committee on Immunisation Safety Review. In this report the Committee concluded that:

•the evidence favours rejection of a causal relationship at the population level between MMR vaccine and ASD.

•the preceding conclusion did not exclude the possibility that MMR vaccines could contribute to ASD in a small number of children.

•because of the limitations of the evidence, the significant public concern surrounding the issue, the risk of disease outbreaks if immunisation rates fall and the seriousness of ASD continued attention should be given to the issue.

The Committee did not recommend a policy review at the time of the licensure of MMR vaccine or of the current schedule and recommendations regarding administration of MMR vaccine.

Conclusions

11.22The Joint Committee considers that:

-there is no evidence of a proven link between MMR and autism.

-there is no evidence to show that the separate vaccines are any safer than the combined MMR vaccine.

-Babies are very susceptible to measles, mumps and rubella, which are killer diseases, so they much be protected as soon as possible and this can only be done with the MMR vaccine.

-Giving separate measles, mumps and rubella vaccines would leave children unnecessarily exposed and vulnerable.

Recommendation

11.23 (i)The Irish Medicines Board should in its Annual Report provide up to date information on funded research by the NIH and CDC in the U.S. and any other agency on all aspects of ASD. Relevant information from private research such as the MIND Institute (Medical Investigation of Neurodevelopment Disorders) at the University of California, Davis School of Medicine and Medical Centre and NIDS (The Neuroimmune Dysfunction Syndrome Institute) in California should also be included.

(ii)Further research into methods of childhood immunisation including MMR and the pros and cons of the single vaccine be encouraged.

12. Risks of Vaccine-Preventable Disease Vs Risks of the Vaccine

12.1The Centres for Disease Control in Atlanta USA have published information on the risks of adverse events after vaccines and also on the risks of complications or adverse events after the disease itself. This data is collated below.

12.2Diphtheria

12.3Pertussis

12.4Tetanus

12.5Haemophilus Influenzae (HIB)

12.6Polio

12.7Measles

12.8Mumps

12.9Rubella

Conclusion

12.10The Joint Committee considers that information as indicated at 12.2 to 12.9 and for Meningococcal C, if available would be useful to parents/guardians in making informed decisions relating to vaccines.

Recommendation

12.11Information comparing the risks of each vaccine preventable disease to the risk of each vaccine should be prepared by the appropriate authority, after consultation with relevant agencies, and circulated by each Health Board to parents/guardians on the first contact.

13. Compensation

13.1Despite all the efforts to make vaccines as safe as possible, a small number of vaccine recipients will experience serious adverse reactions. The issue of appropriate compensation for these children is one that should be addressed by any countries with an immunisation programme in place. The US and Britain are examples of countries which have a programme in place to address this issue.

Britain

13.2The British Government, through the Vaccine Damage Payments Act 1979, has accepted that some children have been disabled to a level of 80% below normality. It is now paying £100,000 as a once-off payment to those so assessed. Up to March 1998 about 900 children had been awarded vaccine damage payments.

U.S.

13.3In order to reduce the liability of manufacturers and health care providers, the National Childhood Injury Act of 1986 established the National Vaccine Injury Compensation Programme (NVICP) in the US. The NVCIP is a Federal no-fault system designed to compensate individuals or families thought to be injured by childhood vaccines. No fault means that people filing claims are not required to prove negligence on the part of either the health care provider or manufacturer to receive compensation. The programme covers all routinely recommended childhood vaccinations. Cases are filed with the US Court of Federal claims, which decides which claims are eligible for compensation and the award amount.

13.4In order to avoid disagreements over what is vaccine-related, Congress created a Vaccine Injury Table as a legal mechanism to simplify such decisions. This table was developed by a panel of experts who reviewed the medical literature and identified the serious adverse events that are reasonably certain to be caused by vaccines. Examples of table injuries include anaphylaxis (severe allergic reaction), paralytic polio and encephalopathy (general brain disorder). The Vaccine Injury Table was created to justly compensate those injured by vaccines while separating out unrelated claims. As more information becomes available from research on vaccine side effects, the Vaccine Injury Table is updated. A vaccine is “presumed” to have caused injury if a listed condition occurred in a specified time frame following vaccination. Since this is not a scientific determination, compensation claims may reflect both medical conditions that occur naturally in individuals (e.g. epilepsy) not necessarily tied to vaccination, as well as, true vaccine-related injuries.

13.5Individuals and their families can qualify for compensation in three ways. First, is to show that an injury found on the Vaccine Injury Table occurred in the appropriate time interval following immunisation. The other two ways to qualify include proving that the vaccine caused the condition or demonstrating that the vaccine worsened a pre-existing condition.

13.6The Advisory Committee on Childhood Vaccines (ACCV) of the Department of Health and Human Services has worked continuously to make a good programme better. The members of the ACCV include parents of children thought to have been injured by vaccines, their attorneys, representatives of vaccine companies, and recognised medical experts in childhood diseases. Together this diverse body developed and approved a series of recommendations that formed the basis for amending legislation proposed in 1999. This legislation included many enhancements aimed at making the NVICP even more streamlined and less adversarial for its intended beneficiaries. The proposals included doubling the statutory time limit for filing a claim, expanding compensation to families and simplifying the process for adjudicating claims. A draft bill titled the “Vaccine Injury Compensation Programme Amendments of 1999” was sent to the Congress in June 1999.

13.7By August 1999 more than 1,400 families had received the benefit of the Compensation Programme through awards totalling in excess of $1 Billion.

Conclusion

13.8The Joint Committee considers that in the light of the huge benefits of immunisation and the small number of children who experience serious adverse reactions a no-fault compensation scheme should be introduced in Ireland as soon as possible.

Recommendations

13.9Legislation to provide for a National Vaccine Injury Compensation scheme should be drawn up at the earliest possible date.

14 Summary of some suggestions and recommendations received by the Joint Committee

References

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19)Odent MR, Culpin EE, Kimmel, 1994. Pertussis vaccine and asthma: is there a link? JAMA; 272:592-3.

20)Nilsson L, Kjellmann N-IM, Storaester J, Gustaffson L, Olin P (1996). Lack of association between pertussis vaccination and symptoms of asthma and allergy. JAMA; 275:760.

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22)Production of Vaccines Factsheet. UK Vaccines Industry Group.

23)World Health Organisation website – www.who.int/vaccines

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29)American Academy of Paediatrics. Possible association of intussusception with rotavirus vaccination. Paediatrics 1999; 104: 575.

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33)Chadwick N, Bruce IJ, Schepelmann S, Pounder RE, Wakefield AJ. Measles virus RNA is not detected in inflammatory bowel disease using hybrid capture and reverse transcription followed by the polymerase chain reaction. J Med Virol 1998; 55: 305-11.

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35)Peltola H, Patja A, Leinikka P, Valle M, Davidkin I, Paunio M. No evidence for measles, mumps, and rubella vaccine-associated inflammatory bowel disease or autism in a 14-year prospective study. Lancet 1998; 351: 1327-8.

36)Taylor B, Miller E, Farrington C, Petropoulos M, Favot-Mayaud I, Li J et al. Autism and measles, mumps an rubella vaccine: no epidemiological evidence for a casual relation. Lancet 1999; 353: 9169.

37)MRC. No new evidence of a link between MMR and autism. Press release April 2000.

Appendix 1

Oral Presentations to the Joint Committee

Appendix 2

Minutes of Evidence

Appendix 3

Members of the Joint Committee

Notes:

¹Senator Kathleen O’Meara was appointed in place of Senator Pat Gallagher on 4 November 1999

² Deputy Liz McManus was appointed in place of Deputy Róisín Shortall on 4 November 1999

³ Deputy Gay Mitchell was appointed in place of Deputy Alan Shatter on 29 June 2000

⁴ Deputy Michael Ring was appointed in place of Deputy Deirdre Clune on 29 June 2000

⁵ Deputy Bernard Allen replaced Paul Bradford on the 29^th March 2001

⁶ Deputy Martin Brady replaced Deputy Michael Ahern on 17^th May 2001

Appendix 4

Orders of Reference of the Joint Committee

Joint Committee on Health and Children

ORDERS OF REFERENCE

Dáil Éireann

13th November, 1997, (** 28th April, 1998),

Ordered:

(1) (a)That a Select Committee, which shall be called the Select Committee on Health and Children, consisting of 14 members of Dáil Éireann (of whom 4 shall constitute a quorum), be appointed to consider such—

(i)Bills the statute law in respect of which is dealt with by the Department of Health and Children, and

(ii)Estimates for Public Services within the aegis of that Department,

as shall be referred to it by Dáil Éireann from time to time.

(b)For the purpose of its consideration of Bills under paragraph (1)(a)(i), the Select Committee shall have the powers defined in Standing Order 78A(1), (2) and (3).

(c)For the avoidance of doubt, by virtue of his or her ex officio membership of the Select Committee in accordance with Standing Order 84(1), the Minister for Health and Children (or a Minister or Minister of State nominated in his or her stead) shall be entitled to vote.

(2) (a)The Select Committee shall be joined with a Select Committee to be appointed by Seanad Éireann to form the Joint Committee on Health and Children to consider—

(i)such public affairs administered by the Department of Health and Children as it may select, including bodies under the aegis of that Department in respect of Government policy,

(ii)such matters of policy for which the Minister in charge of that Department is officially responsible as it may select,

(iii)the strategy statement laid before each House of the Oireachtas by the Minister in charge of that Department pursuant to section 5(2) of the Public Service Management Act, 1997, and shall be authorised for the purposes of section 10 of that Act, and

** (iv)such Annual Reports or Annual Reports and Accounts, required by law and laid before either or both Houses of the Oireachtas, of bodies under the aegis of the Department(s) specified in paragraph 2(a)(i), and the overall operational results, statements of strategy and corporate plans of these bodies, as it may select.

Provided that the Joint Committee shall not, at any time, consider any matter relating to such a body which is, which has been, or which is, at that time, proposed to be considered by the Committee of Public Accounts pursuant to the Orders of Reference of that Committee and/or the Comptroller and Auditor General (Amendment) Act, 1993.

Provided further that the Joint Committee shall refrain from inquiring into in public session, or publishing confidential information regarding, any such matter if so requested either by the body or by the Minister in charge of that Department; and

(v)such other matters as may be jointly referred to it from time to time by both Houses of the Oireachtas,

and shall report thereon to both Houses of the Oireachtas.

(b)The quorum of the Joint Committee shall be 5, of whom at least 1 shall be a member of Dáil Éireann and 1 a member of Seanad Éireann.

(c)The Joint Committee shall have the powers defined in Standing Order 78A(1) to (9) inclusive.*

(3)The Chairman of the Joint Committee, who shall be a member of Dáil Éireann, shall also be Chairman of the Select Committee.

Seanad Éireann

19 November 1997(** 30th April, 1998),

Ordered

(1) (a)That a Select Committee consisting of 5 members of Seanad Éireann shall be appointed to be joined with a Select Committee of Dáil Éireann to form the Joint Committee on Health and Children to consider

(i)such public affairs administered by the Department of Health and Children as it may select, including bodies under the aegis of that Department in respect of Government policy,

(ii)such matters of policy for which the Minister in charge of that Department is officially responsible as it may select,

(iii)the strategy statement laid before each House of the Oireachtas by the Minister in charge of that Department pursuant to section 5 (2) of the Public Service Management Act, 1997, and shall be authorised for the purposes of section 10 of that Act, and

(iv)such Annual Reports or Annual Reports and Accounts, required by law and laid before either or both Houses of the Oireachtas, of bodies under the aegis of the Department(s) specified in paragraph 1(a)(i), and the overall operational results, statements of strategy and corporate plans of these bodies, as it may select.

Provided that the Joint Committee shall not, at any time, consider any matter relating to such a body which is, which has been, or which is, at that time, proposed to be considered by the Committee of Public Accounts pursuant to the Orders of Reference of that Committee and/or the Comptroller and Auditor General (Amendment) Act, 1993.

Provided further that the Joint Committee shall refrain from inquiring into in public session, or publishing confidential information regarding, any such matter if so requested either by the body or by the Minister in charge of that Department; and

(v)such other matters as may be jointly referred to it from time to time by both Houses of the Oireachtas,

and shall report thereon to both Houses of the Oireachtas.

(b)The quorum of the Joint Committee shall be 5, of whom at least 1 shall be a member of Dáil Éireann and 1 a member of Seanad Éireann.

(c)The Joint Committee shall have the powers defined in Standing Order 62A(1) to (9) inclusive.*

(2)The Chairman of the Joint Committee who shall be a member of Dáil Éireann.

Appendix 5

Proceedings of the Joint Committee

AN COMHCHOISTE UM SHLÁINTE AGUS LEANAÍ

THE JOINT COMMITTEE ON HEALTH AND CHILDREN

Imeachtaí An Chomhchoiste

Proceedings of the Joint Committee

Dé Céadaoin, 11 Iúil 2001

1.The Joint Committee met at 12 p.m. in Committee Room 4, LH2000.

2.MEMBERS PRESENT.

The following members were present:

Deputies Batt O’Keeffe (in the chair), Paul Connaughton, John Dennehy, John Gormley, Cecilia Keaveney, Brendan Kenneally, Liz McManus and Dan Neville.

Senators Dermot Fitzpatrick, Camillus Glynn and Mary Jackman.

3.DRAFT REPORT ON CHILDHOOD IMMUNISATION (RESUMED)

Consideration of the draft Report on Childhood Immunisation, brought forward by the Chairman, was resumed. The Report was read and amended. The Report, as amended, was agreed.

Ordered:To report accordingly.

4.ADJOURNMENT

The Committee adjourned at 12.40 p.m. until 12 p.m. on Tuesday 24^th July 2001.

(* American Academy of Paediatrics Committee on Infectious Diseases)