The Irish Medicines Board, IMB, is responsible for the monitoring and safety of all pharmaceutical products in Ireland. The monitoring of vaccine safety is ensured through clinical trials prior to licence and post-licence surveillance by the IMB. The IMB liaises closely with international bodies, including the European Medicines Evaluation Agency and the World Health Organisation.
Extensive research has, and continues to be, conducted world-wide in relation to the MMR vaccine. The World Health Organisation has indicated that MMR vaccine does not cause autism and that there has been no new scientific evidence that would suggest impaired safety of MMR.
The WHO strongly endorses the use of MMR vaccine on the grounds of its convincing record of safety and efficacy. The international consensus from professional bodies and international organisations is that MMR is a safe and effective vaccine and that the existing research and medical evidence do not support a causal link between MMR vaccine and autism or inflammatory bowel disease.
The institutions include the Medical Research Council Expert Committee of the UK, the UK Committee on Safety of Medicines, the Centres for Disease Control and Prevention, USA, and the American Academy of Pediatrics. Recent studies by the United States Institute of Medicine concluded that there is no link between the vaccine and autism or inflammatory bowel disease. This consensus is based on large-scale epidemiological studies and more specific studies done in the laboratory setting. A large Finnish study involving 1.8 million individuals demonstrated that no case of inflammatory bowel disease or autism was linked to the MMR vaccine. A similar Swedish study found no increase in cases of autism in the ten years during which MMR vaccine was introduced. A recent UK study where researchers analysed some 2,000 studies from 180 countries found no evidence of a causal link between MMR vaccine and autism or inflammatory bowel disease.
In recent weeks, the New England Journal of Medicine published details of a study of more than 500,000 children born in Denmark between January 1991 and December 1998 which indicated that the risk of autism was the same for children regardless of whether or not they were vaccinated with MMR. On this basis, there are no plans for pre-testing children or delaying vaccination.
Additional informationEarlier this year, newspaper articles alleging a link between MMR vaccine and autism referred to a study by Professor John O'Leary into measles virus. In response to these articles, Professor O'Leary issued a statement indicating that the research referred to in no way establishes any link between the vaccine and autism. He further indicated that he and his research team have consistently advocated the use of MMR vaccine to protect the nation's children from measles, mumps and rubella.
MMR vaccine is in use world-wide. Most countries implement a two-dose MMR vaccine programme and this policy has been very successful in controlling measles where high uptake of the vaccine has been achieved.
The primary concern of my Department in relation to immunisation is that the vaccines in use are safe and effective. The Irish Medicines Board and the Royal College of Physicians of Ireland support the use of MMR on the grounds that it has been demonstrated to be a safe and effective vaccine. There is sound evidence for the use of MMR in the national programme.
The report of the Joint Committee on Health and Children on childhood immunisation, published in July 2001, concluded that there is no evidence of a proven link between the MMR vaccine and autism and that there is no evidence to show that the separate vaccines are any safer than the combined MMR vaccine.
In order to reassure the public as to the safety of MMR vaccine and to address the negative coverage on this issue, which adds to the confusion of parents in deciding whether or not to vaccinate their children, I launched a document earlier this year entitled Measles, Mumps, Rubella Vaccine Discussion Pack – an information guide for health professionals and parents. The pack was produced by the National Disease Surveillance Centre and the department of public health, Southern Health Board, and was published by the Health Boards Executive on behalf of the health boards. This document sets out the facts in relation to the most common concerns about MMR in a way that will help health professionals and parents to explore these concerns together, review the evidence in relation to MMR and provide the basis for making an informed decision. The pack addresses such issues as the alleged link between MMR and autism, the safety of the vaccine, combined versus single doses and contraindications to the vaccine.
Medical experts in my Department, in conjunction with relevant experts from the Irish Medicines Board, the immunisation advisory committee of the Royal College of Physicians of Ireland and the National Disease Surveillance Centre review the latest developments and studies in relation to this and other vaccine issues. These bodies also provide expert advice and guidance to my Department on an ongoing basis on all vaccine-related issues. To date, there have been no reputable and validated studies which indicate a proven linkage between MMR and autism. I am not aware of any studies that have demonstrated a causal relationship between other vaccines and autism.
The schedule of immunisation for the childhood immunisation programme is based on the recommendations and expert advice of the immunisation advisory committee of the Royal College of Physicians of Ireland. The committee is made up of experts from associated disciplines in paediatrics, infectious diseases, general practice and public health. The committee launched its revised Immunisation Guidelines for Ireland in October 2002 in which it addressed this issue and it has stated that there is no evidence to support any link between the MMR vaccine and the subsequent development of either inflammatory bowel disease or autism.
The guidelines are an invaluable source of information to general practitioners and contain a substantial amount of detail regarding age for administration of vaccines, contraindications, etc. General practitioners are aware of the contraindications to the recommended childhood immunisations and parents should discuss any concerns they may have with their general practitioner before making a decision about their child's immunisation. Where parents feel they would like to discuss their concerns further, their general practitioner may refer them to a paediatric consultant.
I urge all parents to have their children immunised against the diseases covered by the child hood immunisation programme to ensure that both their children and the population generally have maximum protection.