Report of the MMR Expert Group
6 Questions, Answers and Next Steps
Questions and Answers
6.1 The "matters raised by the Health and Community Care Committee" are largely defined by a series of questions posed by the Committee, which broadly underpin the formal remit of the Expert Group. In considering how best to provide "answers", the Expert Group recognised both the underlying complexity of the questions (and therefore any response) and the value of brief, factual statements in plain language.
6.2 The Expert Group considers it important to stress that the relatively brief answers set out in the following pages build on the more detailed information and comment set out in earlier chapters. Appropriate cross-references to relevant sections are therefore provided.
1.1 What is the scientific basis for the recommended time period between vaccines?
The HCCC report noted that there was a divergence of opinion (among those who presented evidence) on the recommended time period between the proposed administration of separate vaccines for measles, mumps and rubella, ranging from
6 weeks to 12 months.
JCVI recommends simultaneous administration or an interval of 3 weeks between live vaccines. However, the Expert Group found no scientific evidence to support any specific time period between the administration of separate vaccines for measles, mumps and rubella. Therefore, the best time interval to leave between doses, and the related risk of vaccine associated adverse events, are simply not known.
See also paragraphs 5.13et seq , and 5.40, and 5.40et seq ..
1.2 Would a choice of single vaccines increase or decrease the full uptake of the MMR vaccines, and what would the effect be on population immunity?
The Expert Group's framework of immunisation principles includes a commitment to vaccinating the greatest number of children possible, to ensure population immunity and protect the population as a whole, and in particular the very few, very vulnerable children who cannot take a particular vaccine on health or philosophical grounds.
The extent to which population immunity would be affected by making single vaccines available as an option within the childhood immunisation programme, would depend in our view on four factors:
i) the extent to which this would result in increased vaccine uptake by those who do not currently accept reassurances over the safety of MMR and currently thus leave their children unprotected;
ii) the extent to which this would result in decreased MMR vaccine uptake by those who currently accept the safety of MMR, thus leaving their children temporarily unvaccinated and unprotected against two of these three diseases;
iii) the extent to which leaving a space between vaccines, rather than using concurrent administration, would open up a window within which temporarily unvaccinated children would be at significantly elevated vulnerability to infection; and
iv) the extent to which multiple visits would result in increased default from some or all of the vaccines being administered.
In the 1970s there were concerns - later shown to be unfounded - about the safety of pertussis (whooping cough) vaccine. Parents then were offered a choice of vaccines, with or without the pertussis component. Uptake of whooping cough vaccine fell to 48% in Scotland and the control of pertussis took 15 years to recover. It is estimated that there were 100,000 cases of whooping cough in Scotland during this period, thousands were admitted to hospital, and there were up to 75 deaths.
As such, based on current MMR uptake levels, it is reasonable to conclude that population immunity would suffer as a result of a decision to make single vaccines more widely available on demand. Such a fall in population immunity inevitably increases the risk of an outbreak.
See also paragraphs 5.13et seq and 5.40-49.and 5.40-49.
1.3 Is it administrative convenience or best clinical practice to administer three vaccines in one visit?
The HCCC report stated that 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. That is not wholly correct. The policy, which we understand may be under review, is described below.
First, however, it is important to note that the aim of vaccination in the individual is to produce long-lasting immunity so that if a person is subsequently exposed to wild viruses he or she is able rapidly to prevent the virus multiplying and thereby avoiding illness. If a mother has been vaccinated against measles, mumps or rubella, or has experienced natural infection, her blood will contain antibodies designed to target and eliminate these specific viruses. During pregnancy, these antibodies enter the unborn child, but they usually decline between 6 and 12 months of age. If MMR vaccine is given when a baby's blood contains these antibodies, the vaccine will effectively be inactivated before the baby is able to mount its own long-lasting immune response.
The French policy is to offer MMR at 12-15 months and a second dose at 3-6 years.
In addition, single measles vaccine is offered at 9 months to children in crèches because they may be at greater risk. This is designed to protect those children whose maternal protection has worn off, but it is recognised that some children will not get long-lasting immunity. This is why all French children are offered MMR at 12-15 months and again at 3-6 years.
Taking account of the answer at 1.2 above, it is both administrative convenience and best clinical practice to administer MMR (three vaccines in one visit) because it:
provides protection against all three diseases, and avoids a window within which temporarily unvaccinated children would be at significantly elevated vulnerability to infection; and reduces the risk of missing a dose completely;
minimises the trauma to the child;
minimises the risk of local reactions at the injection site.
Expert medical advice, both here and internationally, confirms that MMR remains the safest and most effective way to protect children from these very serious and potentially fatal diseases.
See also paragraphs 5.13et seq and 5.40and 5.40et seq ..
2.1 Is there any benefit in deferring the MMR vaccine until the immunity system is better developed?
2.2 If so, and taking into account the presence of the "coincidence factor", what is the optimal time for administration of the combined vaccine?
The HCCC report highlighted a "coincidence factor" arising because the first parental concerns in children subsequently diagnosed with ASD are generally recognised at 14-20 months, and this coincides with the administration of the MMR vaccine.
There are some children who should not have MMR, for example, because they have untreated cancer or diseases of the immune system, are receiving immunosuppressive therapy or high dose steroids, have allergies to specific antibiotics (such as neomycin or kanamycin) or have reacted severely to a previous MMR.
There are also clinical reasons for postponing MMR, such as if the child is unwell with a fever, has been given an injection of immunoglobulin in the last 3 months, or had another live vaccine (including BCG) in the last 3 weeks.
There is, however, no substantive case for deferring immunisation until the immunity system is "better developed". The scientific evidence currently available confirms that component viruses do not either interfere adversely with each other, nor weaken nor overwhelm an infant's immune system, and the immune system is reliably able to cope with the multiple vaccines. The scientific evidence currently available does not support a link between MMR and autism.
Similarly, there is no compelling case for deferring immunisation to allow evidence of standard development (or otherwise) to become more apparent. Notwithstanding the scientific evidence of no link between MMR and autism, on average ASD is diagnosed at around 4 years of age in the UK. Deferral beyond that age would leave children unprotected for an extended period of time, and put such children, and others, at greater risk of infection.
The Expert Group recognises that deferring MMR immunisation is now a choice that some parents are making of their own accord. That decision leaves their child, other children (including those too young for immunisation) and other vulnerable members of the wider community, at greater risk of infection (taking account of the answer at 1.2-3 above and the more detailed account at paragraph 5.36et seq ).).
See also paragraph 5.13et seq ..
3.1 Which countries allow single vaccinations?
3.2 What are the different uptake rates of the MMR vaccine across Europe and how have these affected population immunity and the threat of an epidemic?
The World Health Organization recommends MMR and does not recommend single vaccines where MMR is available. Single vaccines are in use in a number of countries, particularly those in the developing world where economic, social and other factors combine to produce a different assessment of the interaction between risk, benefit and cost. Put simply, some countries cannot afford MMR. In most of the developing world, monovalent or bivalent MR vaccines are more typically used.
Prevention and control of measles, mumps and rubella are an important element of the routine childhood immunisation programme in most of the developed world. Annex 2 contains details of immunisation programmes in 17 European countries (the 15 EU Member States plus Norway and Switzerland), taken from the Scientific and Technical Evaluation of Vaccination Programmes in the European Union - known as the EUVAX Project Report. As indicated above (in response to 1.3) in France children are given a single measles vaccine at around 9 months old if they are in a nursery. Those children are then offered two further MMR vaccinations.
In Japan, from 1992 to 1997, there were 79 measles deaths 67. MMR vaccine was introduced in Japan in 1989, but withdrawn in 1993, as it contained the Urabe strain of mumps. Japan currently recommends single measles and single rubella vaccines to be given at the same time, as, unlike in the UK, no suitable alternative MMR vaccine is available. Uptake of measles vaccine in Japan was 75% in 1996, increasing to 81% in the year 2000. These low vaccine uptake rates have led to small-scale epidemics consistently occurring in some regions. For example, in Okinawa, 675 children were hospitalised with measles during the period September 1998 to October 1999.
98% of these children had not been immunised, and there were eight deaths. In Japan overall, there has been an increase in the number of measles cases since 1993. In the year 2000, there were 22,497 notifications for measles, compared to 3,259 in 1990 and 13,219 in 1980. There was also a year on year increase in the number of deaths from measles in Japan in the years 1995 to 1999, following a pattern of general decline.
See also paragraph 5.13 et seq.
3.3 What is the effect on the community/public health if MMR vaccine rates fall?
If the rate of vaccination against measles, mumps and rubella falls, the effect on community/public health will be the return of these diseases in significant numbers with major consequences in terms of morbidity and mortality.
There have been several recent measles outbreaks in Northern Europe that illustrate the serious adverse implications of low uptake of MMR vaccine. With low vaccine uptake, the number of unvaccinated susceptible children builds up until the epidemic threshold is reached which, in the presence of measles or mumps or rubella virus, will allow for an outbreak.
In The Netherlands, there were 2961 notifications of measles in the period April 1999 to January 2000 68. Cases occurred throughout the country, but were concentrated in areas where many parents object to vaccination on religious grounds. Almost all of the cases (95%) had not been vaccinated. Serious complications were reported for 17% of cases, with 2.2% (68) requiring hospitalisation. There were three deaths. The most prevalent complications were pneumonia (193) and otitis media (196). The majority of cases (77%) occurred in the 1-9-year age group, with an average age of 6 years. There have been previous measles epidemics in The Netherlands involving these religious communities in 1987/8 and 1992/93. Nationally, the figure for uptake of one dose of MMR vaccine is 96%. However, this outbreak illustrates that even with good overall population uptake; if there are "micropopulations" of unvaccinated children, of sufficient number to allow virus transmission, outbreaks will still occur.
The Republic of Ireland had an outbreak of measles in 2000, with over 1,600 cases 69. Action taken to curb transmission included a vaccination awareness campaign, which was actually planned before the start of the outbreak, and a lowering of the age for MMR vaccine administration from the routine of 15 months to 6 months in the North Dublin area, and to 12 months in the South Dublin, Kildare and Wicklow areas. The figure for uptake of MMR vaccine in the Eastern Health Board, the area with most cases, was 74.4%. There were over 110 hospital admissions and three deaths.
There have been several recent mumps outbreaks in Europe: in Northern Ireland in 2001; in Switzerland in 1999; and in Spain and Portugal in 1998 and 1996 respectively.
In 1993 an epidemic of rubella in Greece was followed approximately 6-7 months later by an outbreak of congenital rubella. Twenty-five cases were recorded (24.6 per 100,000 live births). All had serious symptoms, and seven died within 12 months 61. In Greece, there had been a "mixed" immunisation schedule for MMR, whereby the private sector provided MMR and the public sector provided single measles vaccine and rubella for teenage girls. The epidemic of rubella and the related outbreak of congenital rubella have been attributed to shortcomings in the public immunisation programme.
There have, of course, been measles outbreaks in the UK early in 2002: 95 cases in England, the majority (73) occurring in London; and three in Scotland - the first such cases for 2 years. See also paragraph 5.2et seq ..
3.4 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?
No - few studies of population prevalence of autism have been carried out in France, and those that were done did not consider MMR.
4.1 If not caused by the MMR vaccine, then why the steep rises in autism?
4.2 Is the rise in autism as a result of better diagnosis?
4.3 Does it reflect the adoption of a much broader concept of autism?
4.4 Is it the case that autism is now identified at a much earlier age?
4.5 Why is autism rising, while the vaccine rates remain constant?
The HCCC report acknowledged that there is little dispute that there has been a rise in diagnoses of autism, but there is uncertainty about why there has been this rise.
As indicated, more substantively, in both the MRC Review of Autism Research and the PHIS Needs Assessment, in part this uncertainty exists because diagnosis is based on behavioural criteria and there is no biological confirmatory test for ASD (although in some cases genetic testing can be helpful). The MRC Review of Autism confirms that the likely causes of apparent increases in prevalence are:
changes in diagnostic practice; and
changes in public and professional awareness; and
methodological differences between studies.
Whether these factors are sufficient to account for increased numbers of identified individuals, or whether there has been a rise in actual numbers affected, is as yet unclear. See also paragraph 2.8 et seq.
4.6 Are health checks and Health Visitor Records as presently held and updated, adequate to pick up signs of autism?
Diagnosis is based on behavioural criteria, and there is no biological confirmatory test for ASD (although in some cases genetic testing can be helpful).
The focus of routine developmental screening is primarily on motor, sensory and other physical aspects of development and is not sufficiently detailed with respect to early social aspects of development to identify reliably early concerns. This role normally falls to Health Visitors, and as many are good observers of social functioning, such difficulties are often detected where they are present. Parental concern is a most useful indicator of such early difficulties.
It is clear that early screening methods are not wholly effective in detecting the early signs of autism. The Expert Group welcomes the (UK) National Initiative on Autism: Screening and Assessment (NIASA), which has been set up by the Royal College of Paediatrics and Child Health and the Faculty of Child and Adolescent Psychiatry, Royal College of Psychiatrists, with the support of the National Autistic Society (NAS) and the All-Party Parliamentary Group on Autism (APPGA).
The Expert Group has endorsed the detailed recommendations set out in the PHIS Autistic Spectrum Disorders Needs Assessment Report, and in particular those relating to improved diagnosis and management of ASD, and the need for a more coherent and systematic approach to training health, education and social care professionals, better and in more appropriate numbers. See also paragraph 2.43 et seq.
5.1 Would the single vaccines, given at intervals, lead to delayed and incomplete courses leading to outbreaks of disease resulting in disease and disability?
The HCCC report acknowledged that, 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.
The Expert Group agrees that with any immunisation policy involving single vaccines there would be a (relative) increase in susceptibility whilst awaiting immunisation and also in the likelihood of vaccinations being missed altogether as six vaccinations would be required, rather than two. Six vaccines would inevitably lead to increased risk of local reactions at the injection site and increased trauma to the child.
However, as indicated above in the answer to 2.1, there is no definitive answer to this question, as the outcome is variable and would depend critically on levels of vaccine uptake and the pattern of population demographics.
The 1970s experience with the pertussis (whooping cough) vaccine may be illustrative of what might happen. At that time there were concerns - later shown to be unfounded - about the safety of pertussis (whooping cough) vaccine. Parents then were offered a choice of vaccines, with or without the pertussis component. Uptake of whooping cough vaccine fell to 48% in Scotland, and the control of pertussis took 15 years to recover. It is estimated that there were 100,000 cases of whooping cough in Scotland during this period, thousands were admitted to hospital, and there were up to 75 deaths.
See also paragraph 5.40et seq ..
5.2 Are single vaccines any less effective than the triple vaccine?
The efficacy of the three individual vaccines in MMR is similar to that of the licensed single measles and mumps vaccines, which are not marketed in the UK and the licensed rubella vaccine, which is.
The imported unlicensed single measles and mumps vaccines currently being administered have not been assessed by the MCA for safety, quality and efficacy.
In theory, the efficacy of MMR would be the same as the constituent single vaccines, in relation to providing protection for an individual, subject to issues of manufacture and quality control (which is, as indicated in Chapter 4, a key feature of UK licensing arrangements, but not the importation of unlicensed medicines. A number of different strains are manufactured, and it is important to take care to compare like with like).
However, all the evidence suggests that single vaccines are less effective than MMR in providing individual and population immunity against all three diseases. There are a number of generally acknowledged drawbacks associated with single vaccines, relating to the issues of both increased susceptibility whilst awaiting immunisation, and the likelihood of vaccinations being missed altogether as six vaccinations would be required, rather than two (and some might not appreciate the importance of giving mumps vaccine to girls, or the rubella vaccine to boys). This would decrease the level of population protection.
The concurrent administration of separate vaccines for measles, mumps and rubella has never been formally tested for either efficacy or safety. Therefore, the best time interval to leave between doses, and the risk of vaccine associated adverse events, are simply not known. In addition, six vaccines would inevitably lead to increased risk of local reactions at the injection site; and increased trauma to the child.
The Expert Group concluded that this alternative immunisation policy is not wholly consistent with key elements of its framework of principles for immunisation policy.
See also paragraphs 4.30et seq , 5.26, 5.26et seq , and 5.43., and 5.43.
6.1 Should single vaccines be made available to patients on a named basis?
6.2 If so, what additional criteria should be used (family history of autism, known allergies, low immunity, existing bowel problems)?
The HCCC report highlighted the importance of advice on whether certain individuals are at risk. It suggested, for example, that because these (both MMR and single) vaccines are cultured using an egg base, it is contraindicated for those with an egg allergy.
In fact, as indicated by default in the response to 2.1-2 above, egg allergy is not a contraindication. There are some children who should not have MMR, or indeed single vaccines, namely those who have untreated cancer or diseases of the immune system, are receiving immunosuppressive therapy or high dose steroids, have allergies to specific antibiotics (for example, neomycin or kanamycin) or reacted severely to a previous MMR. See paragraph 5.22et seq . Any decision to extend these contraindications would depend upon advice from the JCVI, CSM and MCA.. Any decision to extend these contraindications would depend upon advice from the JCVI, CSM and MCA.
Existing legislation allows a licensed importer to import an unlicensed monocomponent vaccine and supply it in response to a doctor's prescription to meet the "special needs" of an individual patient, on the doctor's direct personal responsibility. See paragraphs 4.26et seq and 5.24.and 5.24.
The Expert Group recognises that some health professionals and some parents of children with IBD and/or autism have particular concerns about immunising children with IBD and/or autism and siblings. The current evidence base does not provide any substantive case for extending existing contraindications. That said, the Expert Group has recommended that JCVI and CSM should, taking account of ongoing and future research into the causes of IBD and autism, continue to keep these vaccination contraindications under review.
6.3 Could the increased use of antibiotics in children affect the immune system and therefore the response to MMR?
There is no scientific evidence currently available to indicate that component viruses either interfere adversely with each other, or weaken or overwhelm an infant's immune system. See also paragraphs 5.13 and 5.37et seq ..
Similarly, the scientific evidence currently available does not support the conclusion that children taking antibiotics should not be vaccinated. The origin of this concern seems to be the recommendation that immunisation should be deferred in an acutely unwell child 70. Many acutely ill children are given antibiotics, and the taking of antibiotics has become a proxy for a substantial illness. However, it is now a common belief that antibiotics somehow interfere with immunisation. There is no logical reason why a child taking antibiotics cannot be immunised, provided he or she is well on the day of immunisation. Interestingly, even the standard advice is often misunderstood, with people inferring that acute illness interferes with immunisation. The little evidence that exists is ambivalent. The true reason for deferral is to avoid difficulties in diagnosis and management, should a child's condition worsen after immunisation.
6.4 What would be the effect on population immunity of excluding these groups from MMR vaccination programmes?
This question relates back to the examples of possible additional contraindication criteria in the HCCC report (namely, family history of autism, known allergies, low immunity, existing bowel problems).
Any decision to extend current contraindications would depend upon the advice to Scottish Ministers of the Joint Committee on Vaccination and Immunisation, the Committee on Safety of Medicines and/or the Medicines Control Agency. The Expert Group considers that current medical and scientific knowledge would not support or enable existing contraindications to be extended. That said, the Expert Group has recommended that JCVI and CSM should, taking account of ongoing and future research into the causes of IBD and autism, continue to keep these vaccination contraindications under review.
Any decision to increase the relative proportion of children who cannot be vaccinated against measles, mumps and rubella would have some effect on population immunity. The nature of such change cannot be predicted precisely, because it depends on a complex interaction of a number of factors including the proportion of children to be so excluded, and the vaccine uptake rate amongst those eligible to be vaccinated.
It is a truism that the risk of an outbreak increases as the number of unvaccinated, susceptible children builds up.
See also paragraphs 5.13et seq and 5.22and 5.22et seq ..
6.5 What are the arguments for and against adopting the system exemplified in those attending state nursery schools in France?
As indicated above (in response to 1.3) the French policy (which may be under review) is to offer MMR at 12-15 months and a second dose at 3-6 years. In addition single measles vaccine is offered at 9 months to children in crèches, because they may be at greater risk. This is designed to protect those children whose maternal protection has worn off, but it is recognised that some children will not get long lasting immunity. This is why all French children are offered MMR at 12-15 months and again at 3-6 years.
As such, the main argument for the French system is that it seeks to protect very young infants who may be at greater risk of contracting measles by dint of the greater exposure to others.
The main argument against is that it would increase the number of injections here. There is also some evidence that the immune response to MMR is higher at 12-15 months, if not preceded by a single dose of measles vaccine.
See also paragraphs 5.13et seq and 5.22and 5.22et seq ..
7.1 Was the MMR vaccine adequately tested?
7.2 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?
The HCCC report acknowledges that the "CSM and MCA reviewed the licensing procedures following the critical paper by Wakefield and Montgomery, and concluded 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".
The evidence reviewed by the Expert Group also supports the conclusion that MMR was appropriately and rigorously tested before introduction, consistent with standards and science relevant at the time. The Expert Group notes that the process has subsequently been formally reviewed by the MCA, who confirmed that licensing followed normal procedures, clinical trials met the satisfactory standards of the time and follow-up of patients was in accordance with usual practices on vaccine trials.
The Expert Group recognises that the MCA continually monitors the safety of MMR vaccine in clinical practice and, if necessary, updates the Marketing Authorisation and product information if and when relevant new data become available.
The Expert Group recognises that the identification and analysis of conditions which appear to emerge some considerable time after the administration of any medicine, and which may or may not be connected, may require supporting epidemiological evidence.
The Expert Group recommends that Medicines Control Agency should continue to work closely with the European Union, and appropriate corresponding bodies in individual Member States, to improve collaboration and monitoring of vaccine safety.
See also paragraph 4.19et seq ..
8.1 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?
The Medical Research Council Review of Autism confirms that:confirms that:
"A number of expert review groups have considered the specific question of the potential link between MMR vaccination and ASD (the Medical Research Council, the American Medical Association, the Institute of Medicine, USA, the World Health Organization, the American Academy of Pediatrics, the Population and Public Health Branch of Health Canada, and the Irish Department of Health and Children). All of these groups have analysed the published work.
These reviews were unanimous in concluding that a causal link between the MMR vaccine and 'autistic colitis' and ASD was not proven and that current epidemiological evidence did not support this proposed link."
The Expert Group recognises that the phrase"does not exclude the possibility" correctly identifies the impossibility of proving a negative. The Expert Group recognises that, at any given time, governments, organisations and individuals base decisions on the body of scientific evidence that is available at the time. It acknowledges, like the HCCC, the MRC and others, that on the basis of currently available evidence, there is no proven scientific link between the MMR vaccine and autism.correctly identifies the impossibility of proving a negative. The Expert Group recognises that, at any given time, governments, organisations and individuals base decisions on the body of scientific evidence that is available at the time. It acknowledges, like the HCCC, the MRC and others, that on the basis of currently available evidence, there is no proven scientific link between the MMR vaccine and autism.
See also paragraph 2.15et seq ..
8.2 Is the current "spontaneous" reporting system for vaccines consistent, accurate and "complete" in recognising symptoms of autistic behaviour?
The "Yellow Card" system provides an important early warning of suspected adverse reactions to medicines by collating information required to assess the association between the suspected adverse reaction and the medicine. This scheme may identify previously unknown side-effects or indicate that certain known side-effects occur more commonly than previously believed. It may also identify at-risk groups of patients for particular adverse reactions. Such findings can lead to changes in the marketing authorisation, for example restrictions in use, refinement of dose instructions or the introduction of specific warnings of side-effects in product information, which allow medicines to be used more safely and effectively.
The "Yellow Card" scheme does not act as a register for all adverse reactions (side-effects) that occur. As such, it cannot be regarded as a complete record of symptoms of ASD. The Expert Group recognises that the identification and analysis of conditions which appear to emerge some considerable time after the administration of any medicine, and which may or may not be connected, may require supporting epidemiological evidence.
See also paragraphs 4.10et seq ..
8.3 Is it likely that all parents would accurately identify these symptoms of autism?
ASD is diagnosed on the basis of qualitative abnormalities in social, communicative and imaginative behaviours, and the presence of repetitive and stereotyped patterns of interests and activities. Diagnosis is complicated by the varied manifestation of these core deficits, by wide variation in ability level, and by developmental changes.
Parental concern is likely to be a useful indicator of early behavioural difficulties, and it is important that health professionals recognise that parental concern is, in effect, one of the available diagnostic tools.
See also paragraph 2.43 et seq.
6.3 The Expert Group's task was to:
a) describe the consequences of pursuing an alternative vaccination policy to MMR;
b) review evidence on the apparent rise in the incidence of autism, taking account of the current work of the Medical Research Council;
c) describe the process of vaccine testing and the monitoring of adverse effects; and
d) in all its work, have regard to the role and remit of the Joint Committee on Vaccination and Immunisation, the Committee on Safety of Medicines and the Medicines Control Agency.
6.4 In the course of addressing that remit, the Expert Group identified a range of possible and desirable changes to existing arrangements. The Group therefore recommends that:
a) The Scottish Executive and the Medical Research Council should work together to drive forward and fund, as appropriate, the full research agenda outlined in the final chapter of the MRC Review of Autism Research, which was informed by the concerns of parents and consumers. Parents and other representatives of those with autism must continue to play a key role in developing research strategies (paragraph 2.40);
b) The Scottish Executive and the Medical Research Council should, in pursuing that research agenda, seek to maximise international collaboration (paragraph 2.41);
c) The Scottish Executive should consult widely, in order to publish a firm timetable for addressing all of the detailed recommendations set out in the PHIS Autistic Spectrum Disorders Needs Assessment Report (paragraphs 2.48 and 2.49), and in particular those relating to the:
development and implementation of improved evidence-based approaches to the diagnosis and management of ASD;
integrated joint planning, delivery and review of related health, education and social care services, for children, parents and adults, in which context people with autism, or parents and other representatives of those with autism, should have a role;
need for a more coherent and systematic approach to training health, education and social care professionals, better and in appropriate numbers;
development of a database of people with ASD in Scotland.
d) The Scottish Executive and the Medical Research Council should work together to drive forward and fund, as appropriate, further research into inflammatory bowel disorders in children (paragraph 3.16).
e) The Medicines Control Agency should continue to work closely with the European Union, and appropriate corresponding bodies in individual Member States, to improve collaboration and monitoring of vaccine safety issues, and regularly review the operation, management and voluntary nature of the "Yellow Card" system in the light of such developments (paragraph 4.18).
f) The Scottish Executive should ensure that (paragraph 4.35):
vaccination records relating to individual patients should include details of the name and batch number of the vaccine administered;
a national lifelong vaccination record is developed, to allow identification of the immunisation status of an individual throughout the health service - irrespective of age group and independent of setting;
NHS Health Boards put in place adequate quality assurance mechanisms to ensure accuracy and completeness of recording of vaccination data.
g) The Committee on Safety of Medicines and the Joint Committee on Vaccination and Immunisation should, taking account of ongoing and future research into the causes of IBD and autism, continue to keep vaccination contraindications under review (paragraph 5.25).
h) The Joint Committee on Vaccination and Immunisation should (paragraph 5.29):
develop and publish core principles for immunisation policy in order to provide all interested parties with a clear framework against which future policy options might be assessed in an open and transparent manner; and
continue to publish the conclusion of its regular reviews of the scientific evidence relating to the safety and efficacy of MMR, and seek to improve upon existing arrangements for publicising that material.
i) Health Ministers (in the UK Government and devolved administrations) should urgently implement existing plans to extend arrangements for appointing members to the Joint Committee on Vaccination and Immunisation who are non-medical experts and/or members of the general public (paragraph 5.31).
j) The Scottish Executive should take steps to improve the level and quality of information available to parents whose children are due to be immunised against measles, mumps and rubella (paragraphs 5.21 and 5.32), by:
ensuring that all parents receive basic factual information about MMR (for example, contraindications, the risks posed by measles, mumps and rubella, and the risks of adverse reactions) with the invitation to bring their child for vaccination;
ensuring that all parents know that they can and should discuss any related questions with their GP or health visitor in order to make an informed choice about vaccination;
asking HEBS to evaluate and develop "the MMR discussion pack", in order to maintain and enhance the currency and accuracy of the information, training and support provided to GPs and other health professionals, in relation to the medical science underpinning the immunisation programme;
requiring NHS Boards to put in place systematic arrangements for providing further advice to parents who, despite discussions with their GP or other health professional, have concerns and questions about MMR or the particular circumstances of their child.
k) The Scottish Executive should ensure that appropriate resources are provided to allow the Scottish Centre for Infection and Environmental Health to carry forward research, in collaboration with the University of Strathclyde, with the aim of developing mathematical models, which might help demonstrate the range of possible outcomes, for the population as a whole, arising out of immunisation decisions made by individual parents (paragraph 5.47).