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Health and Community Care Committee

These are the conclusions and recommendations of the Health and Community Care Committee’s Report on Petition PE 145 calling for an inquiry into issues surrounding the alleged relationship between the combined Measles, Mumps and Rubella Vaccine and Autism. The published report will follow.

  
     

CONCLUSIONS

Further research is required into the causes of autism, in order to prove or disprove any connection with the combined measles, mumps and rubella vaccine. There is, in this regard, a need to investigate ways in which the coincidence factor can be ruled out, because it may give rise to the impression of a causal relationship between the vaccine and the onset of autism.

There also appears to be a lack of co-ordinated information and statistics on the increase in rates of diagnoses of autism. Scotland has a comprehensive records system which covers a raft of health care issues which should provide a secure launch pad from which to conduct research into the ways in which the incidence of autism and the prevalence of vaccination uptake may be inter-related.

There is a need to have a consistent test for autism at an early age. This should be done to record the stages of both development of the child and progression of any symptoms the child may be showing.

Parents do not need more reassurance; they want more clear and consistent information. An example of the sort of comprehensive information which may be of benefit to parents in enabling them to make an informed decision regarding their child's health is the South Edinburgh LHCC Memorandum, Measles, Mumps and Rubella (MMR): Information for Parents contained in the annexe.

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. Uptake of the MMR vaccine is considered to be the best way to prevent diseases which could lead to epidemics and loss of life. At present, uptake is satisfactory to ensure herd immunity. However, parental fear of a causal connection between the vaccine and autism may result in a fall in vaccination uptake rates. However, it is noted that uptake decreases along with deprivation category: the higher the degree of deprivation, the lower the uptake of the vaccine. This suggests the need to target the general population in a more strategic way.

 

Recommendations

  1. The Committee recommends that the Scottish Executive ensures that existing statistics be integrated and linked, (at an estimated cost of £110,000 (1)) in order to more accurately view vaccination, autism and bowel disorders relative to one another. This should include the Scottish Immunisation Recall System statistics, Continuous Morbidity Recording, health visitor records and information on whether the child shows symptoms of autism and/or special needs. Funding from the Scottish Executive should be directed towards conducting research into the issue, based on Scotland’s existing comprehensive medical records system.
  2. The Committee recommends that all Health Boards commit to a Special Needs Register. (This is currently optional.) A uniform approach would provide a clearer picture of children with autism and would allow recognition of adverse events as part of routine surveillance. The register would include information on the child’s age at which a diagnosis of autistic spectrum disorder was made.
  3. The Committee is agreed that parents, health visitors and general practitioners be given more extensive and accurate information and training than is available at present and calls upon the Scottish Executive to implement these proposals. This would be in line with the NHS Plan to offer more information on inherent risks in medical treatment.
  4. The Committee recommends that the Scottish Executive implement the introduction of a system of accurate and consistent assessment and diagnostic checks, for symptoms and signs of autism and autistic spectrum disorder as a standard part of child health surveillance. Such checks should precede the MMR vaccination.
  5. The Committee recommends that the Scottish Executive target the immunisation of children from more deprived backgrounds such as depcat. 7, as uptake is lowest among those groups.
  6. To address many of the unanswered concerns raised by this report the Committee recommends to the Scottish Executive that it establish an Expert Group. The membership of the group will be decided by the Scottish Executive but should include representatives from the Scottish Society for Autism. The remit of the group should be as outlined from page 19 to 22 below and aim to provide answers to the questions raised by the Committee. The Expert Working Group should make its initial report within 6 months of commencing. The findings of the Expert Group once available to the Scottish Executive should also be referred back to the Committee for consideration.
  7. The Committee believes that on the basis of currently available evidence, there is no proven scientific link between the MMR vaccine and autism or Crohn’s disease and therefore the Committee has no reason to doubt the safety of the MMR vaccine. The Committee does not recommend any change in the current immunisation programme at this time. However, the Expert Group in liaison with the Committee for Safety of Medicines and the Medicines Control Agency should endeavour to deal with the unanswered questions raised by the Health and Community Care Committee and determine what effect there would be on ‘herd immunity’ in offering single vaccines on a pragmatic basis for those children whose parents remain unconvinced by the evidence of MMR safety

The Remit of the Expert Group

  1. Offering single vaccines, public perception and herd immunity
  2. The main concern (of Wakefield et. al.) in considering the link with autism, is with the measles virus. In a report by the Scottish Centre for Infection and Environmental Health (volume 35, no. 2000/8), on the issue of single measles, mumps or rubella vaccines, it was noted that the Urabe mumps strain was withdrawn from the UK in 1992 due to an association with mumps meningitis post vaccination and the Rubini strain has been shown to be of low efficacy and has been associate with mumps outbreaks in Portugal, Spain and Switzerland. The current strain used is Jeryl Lynn.

    These findings emphasise the need for continual active surveillance of adverse results. The French system suggests the possibility of giving the measles vaccine singly (from 9 months onwards), followed by the Mumps and Rubella vaccines, or indeed by the combined MMR vaccine at a later stage. There is also a divergence of opinion on the recommended time period between the proposed single vaccines, ranging from 6 weeks to 12 months.

    The media interest in this issue has informed public opinion to a certain extent. Among the concerns raised is that if parents think there is a causal link between MMR and autism, they may blame themselves for causing autism in their child by having that child vaccinated. This could be considered a relevant contraindication. This speaks to the need for a clear and effective policy.

    1. What is the scientific basis for the recommended time period between vaccines?
    2. Would a choice of single vaccines increase or decrease the full uptake of the MMR vaccines, and what would the effect be on herd immunity?
    3. Is it administrative convenience or best clinical practice to administer 3 vaccines in one visit?
    4. A clear statement is needed to address public perception and parental fears.

    The Expert Group is asked to report in 6 months’ time.

  3. The timing of administration of the MMR Vaccine
  4. Because autism is generally ‘recognised’ or diagnosed at 14 - 20 months, which coincides with the administration of the MMR vaccine, is it necessary to eliminate what has been called the ‘coincidence’ factor? Would it be worth investigating the deferral of administration of the MMR vaccine in order to eliminate this factor? Opinion remains divided on the optimal administration time, with some arguing for 15 and others for 18 months.

    This is based on the argument that if the population coverage of MMR is high and risk of illness low, then there would seem to be little harm in delaying MMR until the child develops normally or acquires autism. If population immunity is low and or there is the imminent risk of measles or mumps, then parents will have to decide sooner based on a balance of 1) risk of illness and 2) their perceptions of the risk of acquiring autism from MMR.

    Applicable questions within the remit of the Expert Group would be:

    1. Is there any benefit in deferring the MMR vaccine until the immunity system is better developed?
    2. If so, and taking into account the presence of the 'coincidence factor', what is the optimal time for administration of the combined vaccine?

    The Expert Group is asked to report in 6 months’ time.

  5. The comparative experience of other countries.
  6. It is important to consider vaccination regimes and state recommendations abroad, in order to establish the best course of action. The Expert group should set out to answer the following questions:

    1. Which countries allow single vaccinations?
    2. What are the different uptake rates of the MMR vaccine across Europe and how have these affected herd immunity and the threat of an epidemic?
    3. What is the effect on the community/public health if MMR vaccine rates fall?
    4. Have there been any studies done in France on those children who receive measles vaccine only (at 9-12 months) followed by the MMR vaccine in relation to evidence of an increase in the incidence of autism?

    The Expert Group is asked to report in 6 months’ time.

     

  7. The Rise in Autism
  8. There is little dispute that there has been a rise in diagnoses of autism. Where there is uncertainty is in understanding why there has been this rise. This follows the recent study already mentioned, in which it was determined that while the immunisation rate has remained relatively constant, the incidence of autism is on the increase; these relative increases need to be explained (2). It is important, therefore, to reconsider and explain the statistics in the following terms:

    1. If not caused by the MMR vaccine, they why the steep rise in autism?
    2. Is the rise in autism as a result of better diagnosis?
    3. Does it reflect the adoption of a much broader concept of autism?
    4. Is it the case that autism is now identified at a much earlier age?
    5. Why is autism rising, while the vaccine rates remain constant?
    6. Are health checks and Health Visitor Records as presently held and updated, adequate to pick up signs of Autism?
    7. A clear statement is needed to address public perception and parental fears.

  9. Offering single vaccines, public perception and herd immunity
  10. The main concern (of Wakefield et. al.) in considering the link with autism, is with the measles virus. In a report by the Scottish Centre for Infection and Environmental Health (volume 35, no. 2000/8), on the issue of single measles, mumps or rubella vaccines, it was noted that the Urabe mumps strain was withdrawn from the UK in 1992 due to an association with mumps meningitis post vaccination and the Rubini strain has been shown to be of low efficacy and has been associate with mumps outbreaks in Portugal, Spain and Switzerland. The current strain used is Jeryl Lynn.

    These findings emphasise the need for continual active surveillance of adverse results. The French system suggests the possibility of giving the measles vaccine singly (from 9 months onwards), followed by the Mumps and Rubella vaccines, or indeed by the combined MMR vaccine at a later stage. There is also a divergence of opinion on the recommended time period between the proposed single vaccines, ranging from 6 weeks to 12 months.

    The media interest in this issue has informed public opinion to a certain extent. Among the concerns raised is that if parents think there is a causal link between MMR and autism, they may blame themselves for causing autism in their child by having that child vaccinated. This could be considered a relative contraindication. This speaks to the need for a clear and effective policy.

    1. What is the scientific basis for the recommended time period between vaccines?
    2. Would a choice of single vaccines increase or decrease the full uptake of the MMR vaccines, and what would the effect be on herd immunity?
    3. Is it administrative convenience or best clinical practice to administer 3 vaccines in one visit?

  11. Disease and compensation
  12. Since MMR was introduced in 1988, over 2000 families are suing the drug manufacturers for compensation. Where single vaccines are used, exposure to infection persists in the intervals between each immunisation and single vaccines may be less effective than the combined vaccine. This applies in particular to certain types of mumps vaccines where the strain used produces a very poor antibody response.

    1. Would the single vaccines, given at intervals, lead to delayed and incomplete courses leading to outbreaks of disease resulting in disease and disability?
    2. Are single vaccines any less effective than the triple vaccine?

  13. At-risk groups.
  14. Given the need for further research, it is also important to focus on whether certain individuals are at risk. For example, because these vaccines are cultured using an egg base, it is contraindicated for those with an egg allergy. It is recommended by the North Wales Health Authority, that the MMR vaccine should be administered in hospital as a day case in children with a history of anaphylaxis to eggs - even although the British National Formulary indicates that it 'can be given safely even when the child has had an anaphylactic reaction to food containing egg.' More advice is needed in relation to: minor infections such as asthma, excema, hay fever, infections requiring antibiotic treatment or those on steroids. Could it be the case that when a child is taking antibiotics, the body is less able to cope with the triple vaccine? This may also be the case among children with an impaired immune system.

    1. Should single vaccines be made available to patients on a named basis?
    2. If so, what additional criteria should be used (family history of autism, known allergies, low immunity, existing bowel problems)?
    3. Could the increased use of antibiotics in children affect the immune system and therefore the response to MMR?
    4. What would be the effect on herd immunity of excluding these groups from MMR vaccination programmes?
    5. What are the arguments for and against adopting the system exemplified in those attending state nursery schools in France?

  15. Safety testing
  16. Wakefield has argued that ‘participants in the tests conducted in Costa Rica, El Salvador, Dominican Republic, Philadelphia and Ohio were only observed for 4 weeks after they received the injections.' Similarly, senior clinicians, including a former medicines regulator at the Department of Health, have argued that the MMR vaccine should not have been licensed in 1988 because there was insufficient evidence of its safety and the decision to licence was premature. And according to the Public Health Laboratory Services MMR safety trials in the UK lasted 3 weeks. Parents were asked to complete health diaries for 21 days after their children were vaccinated. The CSM and MCA reviewed the licensing procedures following the critical paper by Wakefield and Montgomery. They concluded, '[Our] Review has clearly shown that licensing followed normal procedures, clinical trials met satisfactory standards of the time and follow-up of patients was in accordance with usual practice in vaccine trials.' However, this begs the questions,

    1. Was the MMR vaccine adequately tested?
    2. Will the standard of 'the time' and the follow-up meet the concerns in respect of a longer and somewhat newer condition such as regressive autism and autistic spectrum disorder?

     

  17. The alleged link between MMR and autism
  18. Although many children in Scotland are diagnosed before they start school, research suggests there are fewer diagnoses than actual cases. Dr James Le Fanu was quoted in the Sunday Telegraph as saying, "’Regressive’ autism where previous normal children go backwards in behaviour, losing their already acquired communication skills is an entirely new syndrome. The uniqueness of this syndrome and its close temporal relation to the MMR strongly implicates the vaccine as a cause." This indicates the need for guidance on the following points:

    1. Can the absence of an alleged causal link between MMR and autism be conclusive given that changes may be subtle and gradual and that there may be considerable delay in recognising symptoms, with further delay in diagnostic clinics?
    2. Is the current ‘spontaneous’ reporting system for vaccines consistent, accurate and ‘complete’ in recognising symptoms of autistic behaviour?
    3. Is it likely that all parents would accurately identify these symptoms of autism?
    4. Further research is needed to examine possible environmental causes. Future research should also examine the possibility of a biological reason to suspect that ‘interference’ may occur between the component viruses of MMR. This should concentrate on the hypothesis of Wakefield and Montgomery that, 'It is evident from a literature search, prior to 1977, that the outcome from measles infection may be influenced by close temporal exposure to another virus.

 

 

1. According to Dr Ian Jones, Director of the Scottish Centre for Infection and Environmental Health.

2. See Kaye, James A. 'Mumps, Measles, and Rubella vaccine and the incidence of autism recorded by general practitioners: a time trend analysis.' (2001) 322 British Medical Journal 460, and Dales, Loring MD; Hammer, Sandra Jo, RN, PHN; Smith Natalie J., MD, MPH. ' Time Trends in Autism and in MMR Immunization Coverage in California' (2001) 285 Journal of the American Medical Association 1183.
 

   

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