Introduction

1. The Department of Health is aware that, as a result of reports in certain newspapers, many parents have become concerned about the safety of MMR vaccine. Many are unclear about the facts concerning the vaccine and want to have accurate, scientific information. These pages aim to provide that information.

Background

2. MMR contains three separate vaccines in one injection. MMR vaccine protects children against measles, mumps and rubella (German measles). It is given to children at 13 months of age and again before they go to school. The second dose protects anybody who did not respond to the first dose. Since 1988 when MMR was introduced in the UK the number of children catching these diseases has fallen to an all-time low.

3. Children who have MMR vaccine do sometimes experience side effects. These are most usually mild forms of the diseases the vaccine protects against. Very rarely, children can have severe allergic reactions straight after any immunisation (about 1 in 100,000 immunisations for MMR). If the child is treated quickly, he or she will recover fully. People giving immunisations are trained to deal with allergic reactions. For more information visit the Health Promotion England website.

4. The suggestion of a link between measles vaccine and/or vaccines containing measles (such as MMR) and inflammatory bowel disease or autism have largely come from one source, a team at the Royal Free Hospital, London, led by Dr Andrew Wakefield. Autism was well known long before MMR was ever used in this country. Autism, a disorder causing behavioural and language problems, is recognised more often now than in the past and the increases in the cases of autism were going on before MMR was introduced. Parents often first notice the signs of autism around the time MMR is usually given. This does not mean that one causes the other.

How the Government has looked at the suggested link between MMR, inflammatory bowel disease and autism.

5. The Government takes extremely seriously any concerns raised about the safety of medicines and vaccinations. Whenever any such concerns are raised we are determined that they should be properly investigated. That is why we have referred every claim and allegation made about the safety of the MMR vaccine to two expert committees for thorough investigation. The JCVI (Joint Committee on Vaccination and Immunisation) and the CSM (Committee on Safety of Medicines), who advise the Government, are made up of independent experts. Committee members have a wide range of expertise. Most of them work in the NHS and many have everyday responsibility for the care and treatment of children.

6. The evidence and reports about the safety of the MMR vaccine have been considered carefully by the JCVI and the CSM. They have looked at the work of the Royal Free Hospital team many times and the Chairman and senior members of the JCVI have visited the Royal Free Hospital to hear their theories first hand. They have also looked at other research on this issue from around the world, including research from the UK, USA, Sweden and Finland. On all the evidence available, thethe USA, JCVI and the CSM have agreed that there is no link between MMR and autism. This view is supported by experts from around the world, including the World Health Organisation.

The research about MMR, inflammatory bowel disease (IBD) and autism

7. Many leading independent groups and researchers from around the world have looked at the theories of Dr Wakefield and the Royal Free Hospital team. Here are the findings of some of those who have found no evidence to support a link:

• In March 1998 the UK’s Medical Research Council called together a meeting of over 30 experts in all relevant fields. They reviewed all the evidence and heard full presentations from the team at the Royal Free Hospital. They concluded: "There is no evidence to indicate any link between MMR vaccination and bowel disease or autism".

• In June 1999 an independent expert Working Party of the Committee on Safety of Medicines made a detailed evaluation of over 100 children’s records referred to them by a firm of solicitors where the parents believed their autism or bowel disease was due to MMR. The Working Party concluded that: "The information available did not support the suggested causal associations or give cause for concern about the safety of MMR or MR [measles, rubella] vaccines".

• In June 1999 a study was published in the medical journal, the Lancet, reviewing the cases of nearly 500 children born in north London between 1979 and 1994 who had been diagnosed as having autism and examining possible associations between their condition and MMR vaccine (which was introduced in 1988). The study found:

- No increase in autism associated with the introduction of MMR in 1988.

- No difference in age of diagnosis between MMR immunised and unimmunised children.

- No difference in MMR immunisation rates between children with autism and the rest of the population.

- No link between the timing of MMR and the onset of autism.

• In April 2000 a further independent expert group was brought together by the Medical Research Council, which had met regularly since 1998 and considered all available evidence including further presentations from the Royal Free team. Again, the group concluded that there was no evidence of a link between MMR vaccination and autism or bowel disease.

• In February 2001 a study by Kaye et al was published in the British Medical Journal showing more evidence of no link between MMR vaccine and autism. The study reported:

- That there was a notable rise from 1988 to 1999 in the diagnosis of autism recorded by UK general practitioners in their records.

- That over the same period, there was no change in the proportion of children who had been vaccinated with MMR which remained at over 95% for the age groups and children in this study.

- The study therefore provides good evidence that MMR has not caused the large increase in diagnoses of autism that has taken place since 1988.

The study authors conclude that: "These data provide evidence against a causal association between MMR vaccination and the risk of autism".

• In March 2001 a paper by Dales et al in the Journal of the American Medical Association compared time trends in autism and in MMR immunisation coverage in California. The paper concludes: "These data do not suggest an association between MMR immunization among young children and an increase in autism occurrence"

• In March 2001, the British Journal of General Practice published a paper by De Wilde et al. The authors looked at whether children who go on to be diagnosed as autistic are more likely to see their GP in the six months after MMR than other non-autistic children. If MMR were causing the sudden loss of skills reported by the Royal Free Hospital research team, then such a study should pick up an increase in GP consultations in the months after MMR. The authors concluded: "there is no change in consultation behaviour in autistic children and matched controls in the six months after MMR".

• In April 2001 a major review of the evidence relating MMR and autism was conducted under the auspices of the American Academy of Pediatrics (AAP) (published in ‘Pediatrics’). The review concluded that "the available evidence does not support the hypothesis that MMR vaccine causes autism or associated disorders or inflammatory bowel disease". It also concluded that "separate administration of measles, mumps and rubella vaccines to children provides no benefit over administration of the combined MMR vaccine and would result in delayed or missed immunisations". In arriving at their conclusion, the writers of the report reviewed over 200 references and heard oral evidence presented by researchers at a two-day scientific meeting.

• The AAP review followed closely on the publication of the United States Institute of Medicine Safety Review of MMR that reached similar conclusions about the postulated causal relationship between MMR vaccine and autism and the importance of continuing with the current MMR programme. Their main conclusion was that "the evidence favors rejection of a causal relationship at the population level between MMR vaccine and autistic spectrum disorders."

• A report published in Vaccine (2001) found "further evidence against a causal association between MMR vaccination and autism". The report is of a reanalysis of the data collected for a study of those diagnosed as autistic who were born over a 15 year period in the North Thames region (Lancet, June 1999, above). This latest study concluded "the results presented here, combined with those we obtained earlier, provide powerful evidence against the hypothesis that MMR vaccine, or indeed any measles-containing vaccine, causes autism at any time after vaccination."

• A leading article and commentary in Archives of Disease in Childhood (September 2001) – the journal of the Royal College of Paediatrics and Child Health - provides further support for the vaccine. It reviews the evidence on MMR safety and identifies the arguments why separate vaccines are not an alternative to MMR. The authors conclude: "There is no good scientific evidence to support a link between MMR vaccine and autism or inflammatory bowel disease; indeed there is mounting evidence that shows no link. There is considerable evidence of the effectiveness and safety of MMR vaccine. Using separate vaccines is an untried and untested policy and, as far as protecting children from infectious disease is concerned, a backward step. While the final decision rests with the parents, the evidence of the safety and efficacy of MMR vaccine is so overwhelmingly conclusive that health professionals should have no hesitation in recommending its use".

• A study which looked at the postulated link between MMR and a form of autism that is a combination of developmental regression and gastrointestinal symptoms that occur shortly after immunization (ie. as suggested by Dr Wakefield) (Pediatrics, October 2001), concludes: "No evidence was found to support a distinct syndrome of MMR-induced autism or of "autistic enterocolitis." These results add to the recent accumulation of large-scale epidemiological studies that all failed to support an association between MMR and autism at population level. When combined, the current findings do not argue for changes in current immunization programs and recommendations." The study compared groups of children with developmental disorders who had had MMR; with autism who had had MMR; and with autism had not had MMR.

8. In short, no independent groups – including those independent of Government and those independent of Dr Wakefield and his colleagues – have been able to confirm Dr Wakefield’s clinical research findings and all have concluded that there is no link between MMR and autism or inflammatory bowel disease.

9. All this evidence has led :-

• The World Health Organisation (WHO) to conclude: "WHO strongly supports the use of MMR vaccine on the grounds of its convincing record of safety and efficacy" (January 2001).

• The All Party Parliamentary Group on Primary Care and Public Health to conclude that: "MMR is safe and … concerns about alleged links with various conditions such as inflammatory bowel disease and autism were unfounded" (August 2000).

• The major UK health organisations - including the British Medical Association, Royal College of General Practitioners, Royal College of Nursing, Faculty of Public Health Medicine, United Kingdom Public Health Association, Royal College of Midwives, Community Practitioners and Health Visitors Association, Unison, Sense, Royal Pharmaceutical Society, Public Health Laboratory Service and Medicines Control Agency - to issue the following statement following a meeting with the Government’s Chief Medical Officer: "MMR is a very effective vaccine with an excellent safety record … All of the major health organisations in the UK support the MMR programme … MMR is scientifically proven to be the safest and most effective way to protect children from disease … We strongly recommend that children are protected with MMR and not left at risk". (January 2001)

• The Committee on Safety of Medicine to conclude - when suggestions were made by Dr Wakefield that MMR vaccine had been licensed prematurely - "MMR is very safe. There is no question mark whatever over its licensing". The JCVI reported the same conclusion and said: "If there is a question mark, it is over the advice to have single vaccines". (January 2001)

• The Scottish Parliament’s Health and Community Care Committee, which had considered the issue of MMR, to conclude in its report: "On the basis of currently available evidence, there is no proven scientific link between the MMR vaccine and autism or Crohn’s disease. The Committee does not recommend any change in the current immunisation programme at this time." (March 2001)

• The Irish Parliament’s Joint Committee on Health and Children – which reviewed all the evidence, including hearing a presentation from Dr Wakefield – to conclude "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; …giving separate measles, mumps and rubella vaccines would leave children unnecessarily exposed and vulnerable". (September 2001)

Separate (single) Vaccines

10. The suggestion that MMR should be split and given in three separate vaccines spaced by at least a year came from Dr Wakefield at a press conference following the publication of a paper by his team in the Lancet in 1998. The suggestion was not supported by his 12 co-authors nor by any scientific evidence. Such views about immunisation have little or no support in the UK medical profession or among the international expert community, including the WHO. Worldwide, over 500 million doses of MMR have been given in over 90 countries since the mid-1970s. Finland and Sweden started MMR vaccination with the same vaccine as the US in 1982, and have published studies that the 2-dose programme is both safe and effective.

11. There is no scientific evidence to support the safety or efficacy of giving MMR as three separate vaccines at defined intervals. The UK has never recommended three separate injections and we are not aware of any country that recommends three single vaccines rather than MMR. The UK’s policy seeks to ensure children get the best protection. Separating vaccines puts children at risk whilst they wait unnecessarily between vaccines. There is also evidence that using separate vaccines would lessen the take-up of vaccination and hence increase the risk that these diseases will return. It also means that children are subject to unnecessary repeat injections and more risk of adverse reactions – even if mild – at the injection site.

12. At the moment, none of the single component vaccines for mumps or measles licensed in the UK are manufactured for, or marketed in the UK. The Medicines Control Agency (MCA) has restricted the importation of unlicensed single component vaccines on the grounds that under law, unlicensed medicines should not be imported when a safe and effective licensed alternative (i.e. MMR vaccine) is available and meets the patient's clinical needs. There is also concern that some unlicensed single mumps vaccines may be ineffective or less safe than MMR. However, the action by the MCA is not a blanket ban. The MCA will continue to allow unlicensed single component vaccines to be imported to meet the special needs of an individual patient and for which the doctor takes direct personal responsibility. The MCA will object to the import of an unlicensed vaccine if it has concerns about its safety or efficacy (as such, the MCA has prevented the importation of some strains of mumps vaccine).

13. The above restrictions apply equally to the private and NHS sectors.

Immunisation Policy in Other Countries

14. No country in the world recommends MMR be given as 3 separate vaccines. In over 30 European countries, USA, Canada, Australia and New Zealand, MMR vaccine is used. In total, over 90 countries around the world use MMR. Single rubella vaccine is available in the UK as it is recommended for women who are not immune to rubella.

15. A decision was made to stop using combined MMR vaccine in Japan in 1993 solely on the basis of the mumps component of their home-produced vaccine, which was found to be associated with an unacceptable level of adverse reactions (this mumps component is not in MMR vaccine currently used in the UK). As a result the Japanese stopped recommending routine mumps immunisation. They continue to immunise against measles and rubella but do not currently have a suitable MMR vaccine licensed for use in Japan - such as the MMR vaccine used in the UK. They have not split the three components of the vaccine to give them separately. Japan has suffered from endemic and epidemic measles. Between 1992-97, there were 79 measles deaths in Japan, and none in UK. When single measles vaccine was used in the UK before 1988, there were regular epidemics of measles with 10-20 deaths each year. There is no available data on congenital rubella syndrome in Japan. In England and Wales, there was no single case of Congenital Rubella Syndrome between 1997 and 1999, because of MMR vaccine.

16. Some European countries still make use of measles vaccine in addition to MMR. For example, the routine recommendation in France is MMR. France also recommends that children are given single measles vaccine from 9 months of age also IF they are in a nursery and there is a risk of a measles outbreak. These children then receive 2 further MMR vaccinations, at the same time as the UK. France does not recommend single mumps vaccine.

17. The Netherlands recommends immunisation with MMR at 14 months and 9 years, but when a religious community that refuses vaccines recently had a measles epidemic there were over 2,300 cases. Almost 20% of cases suffered serious complications, 53 children were admitted to hospital and 3 children died. Also, since the beginning of 2000 over 1,220 cases of measles have been notified in the Republic of Ireland, Eastern Regional Health Authority (Dublin, Kildare, and Wicklow) (only 148 cases for whole of 1999). The outbreak is the result of low uptake of MMR (74.4% in the Eastern Region area). There have been 2 deaths.

Other recent concerns about MMR vaccine.

Thiomersal

18. There have been concerns about the use of thiomersal in vaccines. (Thiomersal is a mercury containing preservative used in some vaccines to prevent microbial contamination or as an inactivating agent to produce killed vaccines. It has been used in vaccines for over 60 years). There is no evidence of harm caused by doses of thiomersal in vaccines, except for hypersensitivity reactions. However, as thiomersal contains mercury, both European and American regulatory authorities have recommended that vaccine manufacturers should phase out their use of thiomersal wherever possible, as a precaution. They have not recommended withdrawing any individual vaccines currently in use.

19. It should be noted that there is no, and never has been, thiomersal in any MMR vaccine used in the UK.

Idiopathic thrombocytopenic purpura

20. Idiopathic thrombocytopenic purpura (ITP), a bleeding disorder, has long been a recognised side-effect of live viral vaccines such as measles, rubella and MMR. A study by researchers from the Public Health Laboratory Service (published in Archives of Diseases in Childhood, February 2001) confirms earlier estimates that the rate of ITP after MMR is around 1 in 22,300. Advice on this known real side effect is already contained in the materials provided for parents and health professionals. It is important to remember that the rate of ITP after natural viral illness is much higher (at about 1 in 3,000 for rubella and 1 in 6,000 for measles) and that the severity of illness in non-vaccine related ITP cases is much greater. Therefore MMR offers protection against this higher risk of ITP due to the natural disease, as well as the other known serious complications of measles, mumps and rubella.

Seizures after MMR vaccine

21. A report in the New England Journal of Medicine (The risk of seizures after receipt of whole-cell pertussis or measles, mumps and rubella vaccines, August 30 2001) concluded that "there are significantly elevated risks of febrile seizures after receipt of DTP vaccine or MMR vaccine, but these risks do not appear to be associated with any long-term, adverse consequences". As compared with other cases that were not associated with vaccination, "the children who had febrile seizures after vaccination were not found to be at higher risk for subsequent seizures or neurodevelopmental disabilities".

22. The results of this study are not new. They confirm the evidence we already have on this possible adverse reaction and the information which is already given to parents in all the Department’s information materials on DTP and MMR. The lack of any adverse outcomes shown in this study is reassuring.

Conclusion

23. There is no doubt that parents always face real dilemmas when it comes to protecting their children’s health. All want to do what is right by their children. That is a parent’s responsibility. However, it is the Government’s responsibility to ensure that the care and treatment it makes available is the best possible. In this case all the experts advise that MMR is the safest and best option for children and that single vaccines are definitely second best. For this fundamental reason the Government does not support the use of separate vaccines.

24. Also, there is absolutely no question that the Government is seeking to patronise or bully parents on this issue. Recommendations on MMR vaccine are not based on financial considerations, nor do they aim to deny parental choice. The health departments must make recommendations based on the best scientific evidence and the advice of experts. The latest scientific evidence shows no link between MMR and long-term problems such as autism and inflammatory bowel disease, that separate vaccines are worse for children than MMR and that MMR remains the safest way to protect children against these three potentially serious diseases. It is on this basis that the Government recommends MMR and does not endorse separate vaccines, a choice which experts clearly believe will put children’s health and lives at greater risk.

25. The UK Health Departments will continue to ensure that any new evidence on the safety of MMR is rigorously and independently reviewed.