Guest guest Posted January 15, 2002 Report Share Posted January 15, 2002 > I too wonder about my RA & my MMR shot as a child. I was very ill from it and > in the hospital. Even Mayo Rheumatologists have mentioned the possible > connection. From ALLY (216.221.108.26) http://www.mall-net.com/cgibin/chat.cgi/arth.log http://www.autismuk.com/index1sub4.htm#our S.F.T.A.H. Society For The Autistically Handicapped. Vaccines. FACT SHEET Vaccines. FACT SHEET (Measles/Autism.) Also see Treatments Pages Also see BREAKING NEWS. Vaccines. FACT SHEET. Mumps, Measles and Rubella (MMR) Vaccines and Measles Rubella (MR) Vaccines. Under construction. FACT SHEET By: Barr, Kirsten Limb. Solicitors. 1 Dyers Buildings, London. EC1N 2TJ Telephone: (+44) (0)171 430 5555 Fax:0171 430 5500 Email: info@... This factsheet concentrates on the medical, scientific and ethical issues relating to the MMR/MR vaccines. It is regularly updated. This version was updated on 3rd June 1997. Nothing in this factsheet should be taken to be medical advice. Vaccination decisions should be made only after proper consultation with your medical adviser. Contents Also see treatments A personal comment. Introduction. Background: Setting the illnesses in context. The vaccines. Safety and effectiveness of the vaccines. Side effects: the official view. Side effects: our investigations. Conclusion. A Personal Comment. Top of Page We came to this subject with an open mind. Like everyone else, we had our children vaccinated, and believed that the assurances given about vaccine safety were accurate. Then one day, as sometimes happens in a solicitor's office, we had a new case which changed everything. One anxious mother contacted us because her son had developed meningitis after receiving the MMR vaccine. We investigated the claim, found that vaccine had indeed caused the meningitis, but fortunately for that child, we also established that there would be no long term consequences. Then in 1992 there were " changes in supply " (see later) in relation to two of the brands of the MMR vaccine, and we were contacted by a number of families over the safety of the vaccine. After some early difficulties over legal aid, we then started to do some serious investigation. What we found (particularly in relation to the lack of long term safety studies for these vaccines) is really quite astonishing. Gradually a picture emerged which was far more complex than we expected, and which slowly led us to believe that there are some serious questions which need to be answered about these vaccines. We know of hundreds of children who were fit and well before being vaccinated but who are now chronically ill or seriously mentally or physically disabled. We would be relieved if it could be established conclusively that the vaccines were not implicated in any of these injuries or illnesses. It would vindicate those who have formulated vaccine policy and it would reassure parents.. We know that many parents find it difficult to come to terms with the fact that their child might have been damaged by a vaccine. If the damage is caused by some natural illness then it is something over which they have no control; but if it was caused by a vaccine then inevitably many parents will feel guilty for agreeing to have their child vaccinated. In reality they had very little control over this decision either, because of lack of information given to parents. Far from clutching at straws to find an excuse for their child's illness, for many parents the realisation that the vaccine which they allowed to be given to their child might have caused injury is very hard to cope with. Nonetheless, IF there is even a small possibility that the vaccines are causing the type of damage we discuss later in this factsheet, then it is right that the concerns should be brought out into the open. But that is easier said than done. There is enormous secrecy surrounding vaccines. It is not even possible to obtain a copy of the Product Licence for any of the vaccines. An example of this secrecy can be shown in this exchange of Parliamentary Question and Answer. Q. To ask the Secretary of State...... if he will list for each of the nine MMR vaccines for which the product licences has been cancelled, the date on which the product licence was granted; whether the licensing of the vaccine was on the advice of the Committee on Safety of Medicines; on what date each cancellation took place; what safety concerns had been identified for each vaccine by the Medicines Control Agency and under whose direction the licence was withdrawn. A. With reference to the dates of granting of the nine Measles Mumps and Rubella vaccines I refer the hon. Member to the reply I gave to the hon. Member for Southwark and Bermondsey (Mr ) on 12 March at column 263. Information regarding the cancellation of product licences is commercially confidential. The recommendations of the Committee on Safety of Medicines are confidential (1) (Our underlining) 1 Parliamentary questions written answers. 19 March 1997 PQ 2313/1966/7 So much for open government. Indeed informed debate appears to be discouraged and -- we have to say it - even suppressed (but, as this latest version is being prepared, we have a change of Government. Perhaps things will change). Those who in any way challenge the safety of vaccines are publicly discredited. We have ourselves been accused of being " ambulance chasers " of being fanatically anti-vaccine. ITN News at Ten filmed and edited a news item about the vaccines, but it was shelved after representations from the Department of Health. One of the leading medical journals in this country has forbidden us to quote directly in this factsheet from peer reviewed articles about vaccine safety, again apparently because of pressure from the Department of Health. This is so despite the fact that these articles are published scientific studies. What follows therefore is an attempt to air an issue of serious concern to the parents of hundreds of injured children. Solicitors do not normally give many details of their cases outside the court room; but in this fact sheet is some (not all by any means) of our evidence. We want to get to the truth of the matter. We invite comments from all quarters. If we are wrong, then we want it to be shown that we are wrong. So far there has, for instance, been no significant challenge to our assertion that there have been no long term (2) safety trials of these vaccines. FN 2 i.e. where the condition of the vaccinated children is monitored over a period of years after vaccination. Apparently it just has not been done. There has been very little research into the causes of autism (numerically the largest side effect reported). We want to encourage doctors, the Department of Health and of course parents to think about the issues; to consider possibilities and to look dispassionately at what seems to many parents to be staring them in the face. It is just not good enough for parents of children who had no disability before being vaccinated to be told that the permanent brain damage they now suffer was just coincidence. Their cases merit serious scientific investigation. At the same time we acknowledge that there could be coincidences, particularly when huge numbers of children are being vaccinated. In spite of what is sometimes said about us, we have a completely open mind. It may be that our research (and the research of the experts we have spoken to) is flawed and that these vaccines and not implicated in any way in the widespread injury reported to us. But if the reverse is true, then the public and the parents of damaged children should know about it. Proper compensation (as opposed to the pitiful vaccine damage payment - see later) should be paid; and proper research should be carried out. Barr, Kirsten Limb. Return to Vaccines. FACT SHEET (Measles) Contents. Introduction. Background: Setting the illnesses in context. The vaccines. Safety and effectiveness of the vaccines. Side effects: the official view. Side effects: our investigations. Conclusion. Return to menu Top of Page Introduction. In this factsheet we give specific information about the MMR and MR vaccines and their side effects. Our objective is two-fold. Primarily we have to operate within the English Legal System, which in this context functions only in terms of financial compensation. Our aim therefore is to help families whose children have been affected by the vaccines to obtain proper compensation for their injuries. We hope to be using law that was introduced into this country in 1988 as a result of European Community directives. This new law (the Consumer Protection Act 1987) imposes strict liability on the manufacturers of products which are unsafe. However, because vaccines are such an emotive issue, we have gone further and tried to set the whole subject in context. What follows is an overview of the vaccines, which we hope will give full information not only to the families we are seeking to help but also to those (including medical practitioners) who have found it difficult to obtain detailed information about these childhood diseases and immunisation against them. We have tried to keep a balanced view about the benefits and risks of immunisation, but as we have researched deeper into the issues it has become harder to do so. We have read and heard many harrowing accounts of the injuries that children (and adults) have suffered after the vaccines have been administered. We have listened to the dismissive comments from representatives of the Government and some members of the medical profession. We are now worried that the safety information about these vaccines may not be entirely accurate. We are also seriously concerned that safety monitoring for these vaccines appears to fall far short of what the public is entitled to expect. On top of that, the information given to parents is certainly lamentably incomplete. We are concerned that risks associated with the actual illnesses may have been exaggerated, perhaps to frighten people into having their children vaccinated. We have also included references to and quotations from source material. This represents a tiny fraction of the information we hole, which runs to hundreds of papers on MMR and vaccines generally. Feel free to show this factsheet to your medical advisors. We believe that we can substantiate every statement made in this factsheet from mainstream medical literature. Where possible we have given the source material in footnotes. It is quite significant that many of the medical and scientific findings we have researched are not new: the information about the mechanisms which cause side effects was available to the medical and scientific community years ago. We will be happy to supply more information either to you or to your doctor. Return to Vaccines. FACT SHEET (Measles) Contents. Background: Setting the illnesses in context. The vaccines. Safety and effectiveness of the vaccines. Side effects: the official view. Side effects: our investigations. Conclusion. Return to menu Top of Page Background: Setting the illnesses in context. Something curious has happened to the " official " perception of the childhood diseases which are the subject of the MMR or MR vaccines (Measles, Mumps, Rubella). They have all officially become more serious since vaccines were introduced. It is instructive to put the three diseases into perspective. The following extracts and summaries are from two family health guides published 13 years apart: The MacMillan Guide to Family Health, and authoritative health manual edited by Dr Tony the deputy editor of the British Medical Journal and published in 1982 (3); and 3. The version we quote from is a 1985 reprint the British Medical Association Complete Family Health Encyclopaedia published in 1985 (first published 1990). This is also edited by Dr Tony . We have chosen the first publication because it came out some years before MMR vaccines were introduced into this country. It has been observed by Dr Viera Scheibner (4) that diseases inexplicably appear to become more dangerous at about the time when new vaccines are introduced. Contrast the entries in the two publication. 4. An Australian PhD who has made a considerable study of vaccines. She is the author of " VACCINATION The medical assault on the Immune System " . Mumps From the MacMillan Guide to Family Health 1982: " Mumps is a common infectious disease caused by a virus. After an incubation period of 2-4 weeks the salivary glands swell, the parotid gland (just in front of the ear) is particularly infected. Swelllings are usually accompanied by a raised temperature and a general feeling of illness. It is probably the most common childhood infectious disease but not as contagious as measles. " A fairly common risk of mumps is the swelling of testes in a boy or the ovaries in a girl. This is much more common in an adult. Invariably the swelling goes down after a few days leaving no ill effects. It is excessively rare for the swelling to cause sterility. A rare complication is acute pancreatitis which passes within a few days. " Mumps is generally a mild disease. The usual outcome is complete recovery within about 10 days " In contrast 1995 -- From the British Medical Association Complete Family Health Encyclopaedia 1995: " Mumps is an acute viral illness mainly of childhood.... Serious complications are uncommon. However, in teenage and adult males, mumps can be a highly uncomfortable illness in which one of both testes become inflamed and swollen.... Most infections are acquired at school or from infected family members. In the U.S., where many states required proof of mumps vaccination for school entry, the incidence has dropped markedly over the last 20 years. In the U.K. by contrast, before routine immunisation was introduced in 1988, mumps affected a large proportion of the population at sometime in their lives, usually between the ages of 5 and 10. An occasional complication of mumps is meningitis----- A less common complication of mumps is pancreatitis which causes abdominal pain and vomiting. In males after puberty, orchitis (inflammation of the testes) develops in about a quarter of the cases. Subsequently the affected testis may shrink to smaller than normal size. In rare cases, mumps orchitis affects both testes leading to infertility. " (The book also contains strong warnings about the consequences of older people coming into contact with those infected with mumps.) Rubella (German Measles) From the MacMillan Guide to Family Health 1982 " This is a very mile infectious disease - in the majority of children who catch it, it causes no more inconvenience that a common cold. The incubation period is 14-21 days and the first symptoms are a slightly raised temperature, swollen glands behind the ears and a rash appearing on the first or second day first on the face and then spreading to the rest of the body. By the fourth or fifth day, all symptoms have faded away. " It is slightly less common than measles and not as highly contagious so does not occur in epidemics in quite the same way. " Like other childhood diseases, German measles carries the risk of encephalitis though this occurs in only one case in 6000. A more common complication, particularly in adults is stiff swollen joints (infectious arthritis). " Because German measles is such a mild disease, little specific treatment is required but the disease is known to cause damage to babies developing in the uterus. It is therefore essential to contact any pregnant woman who has been exposed to German measles. " The British Medical Association Complete Family Health Encyclopaedia 1995: The book does not emphasise the seriousness of the illness as much as it does in respect of measles and mumps but does state that vaccines are long lasting in their effect. Measles From the MacMillan Guide to Family Health 1982 " Measles is a highly contagious disease which chiefly affects the skin and respiratory tract. It is a notifiable disease. The incubation period is 10-14 days. The first symptoms are raised temperature, runny nose, red watering eyes, dry cough and sometimes diarrhoea. By the third day the temperature falls and tiny white spots like grains of salt appear inside the mouth. On the fourth and fifth days temperature rises again and the characteristic measles rash appears, starting on the forehead and behind the ears and gradually spreading to the rest of the body but not usually the limbs. By the sixth day the rash is fading and by the seventh day all the symptoms have gone. " In the vast majority of children who catch measles the disease disappears within 10 days and the only after effect is lifelong immunity to another attack.(5) 5. Contrast with the vaccine, which clearly does not give lifelong immunity. In contrast 1995 -- From the British Medical Association Complete Family Health Encyclopaedia 1995: The following are quotations from the book. Note the difference in emphasis and detail. " A potentially dangerous viral illness that causes a characteristic rash and a fever... Measles was once very common throughout the world occurring in epidemics. It is now less common in developed countries due to immunisation " . " Prevention of measles is important because it can have rare but serious complications... It can also be serious, and sometimes fatal, in children with impaired immunity (such as those being treated for Leukaemia and those affected with AIDS virus). In developing countries measles is still common, accounting for more than one million deaths every year, especially in malnourished children whose defences against infection are seriously impaired. " " The most common complications are ear and chest infections. Diarrhoea vomiting and abdominal pain also occur. Febrile convulsions are common with measles and are not usually serious. A serious complication, occurring in about one in a thousand cases is encephalitis (inflammation of the brain),,, Seizures and coma may follow sometimes leading to mental retardation or even death. Very rarely (in about one in a million cases) a progressive brain disorder, known as SSPE, develops years after the acute illness. Measles during pregnancy results in the death of the foetus in about one fifth of the cases. " " Immunisation against measles is usually offered at about 15 months of age and produces immunity in about 97% of the cases. Side effects of the measles vaccine are generally rare. " [No mention of the serious side effects of the vaccine] Measles viewed in 1967 Another example of the apparent change in the nature of measles is this extract from a paper by BM B.Ch, of the National Institute for Medical Research London published in 1967 one year before the measles vaccine was introduced on a wide scale. " Measles is not the commonest infectious disease of childhood in the United Kingdom. It occurs in biennial epidemics in which the total number of cases exceeds half a million, and between these peaks there is a continuous substantial incidence. There is no doubt that most of these cases in England today are mild, last only for a short period, are not followed by complications and are rarely fatal, but this is not the whole picture and other factors have to be considered. " OPPOSING VIEWS: Measles is always a social nuisance whenever it occurs and nearly always an unpleasant episode for the child and the family. Most children develop measles during pre-school or early school life, and when more than one child is infected at the same time it is an exhausting and trying period for the mother, especially if she goes out to work. Outbreaks in schools and hospital wards also cause waste of time and inconvenience, and there have been severe outbreaks in the Armed Forces. To the doctor and epidemic of measles means an increase in work in the late winter and early spring when he is already especially busy. A recent survey in a number of areas in this country (unpublished) showed that the majority of measles cases are visited at least twice by the general practitioner, and in many cases more than twice. This is a heavy burden on the National Health Service, which also bears the cost of antibiotics with which most cases are treated. " In spite of these factors, some physicians consider that measles is so mild a complaint that a major effort at prevention is not justified. On the other hand, others believe that, on the whole, the implications of an epidemic are serious and that the disease should be prevented if possible. These opposing views are of topical importance in considering what use should be made of measles vaccines " (6). The Practitioner November 1967 pg 607. [in fairness, the article still goes on to argue that children should be vaccinated against measles, but it is interesting that the emphasis seems to be much more on the poor overworked doctor than the dangers of the disease]. Measles viewed in 1979. In the well respected publication The Theory and Practice of Public Health(7) it stated 7. The Theory and Practice of Public Health Edited W Hobson. 5th Edition. Oxford University Press 1979 " While the infectivity of measles is still very high in all types of population and environment, the results of infection vary greatly. In Britain and many other developed countries today measles has lost much of its severity, but the disease can still sweep through virgin populations with great ferocity... On the other hand immunity is probably lifelong, and when measles has invaded an isolated community, older members have been protected by immunity acquired over sixty years earlier. In developing of underdeveloped countries measles may still cause serious complications and carry a fatality rate of up to 25 per cent. " (8) 8. Ibid. at page 236 In contrast 1994 -- From: MEASLES why every child in school needs to be protected from measles this autumn. 1994 [Health Education Authority/Department of Health Publication] (9) 9. This booklet was issued to millions of families in the autumn of 1994 before that start of the Measles Rubella vaccination campaign. See later. " Unfortunately, measles can be much more serious than most people think. School-age children who get it are likely to be very ill. These children will have a high temperature, a rash, a cough, a cold and sore eyes. Other symptoms are headaches and not liking bright light. Measles can cause pneumonia, blindness, deafness and even brain damage. Measles can also be fatal. In fact it is the disease most likely to cause inflammation of the brain. This is known as 'encephalitis'. Worryingly, four out of five children who get this kind of encephalitis will suffer long-term brain damage. " Our reason for emphasising this apparent change in the perception of the illnesses is to raise a question-mark over the rationale for MR or MMR vaccines. Vaccination is an invasive procedure. Children, once vaccinated, are inevitably put on direct risk (however large or small that risk might be) of vaccination side effects. On the other hand, if nature is allowed to take its course, they may never catch all or any of the illnesses; and if they do, the evidence suggests that their immunity to further attacks will be far greater than is provided by any vaccine. Furthermore, there is some evidence that catching measles actually protects children against some conditions, such as allergies. A recent trial in Guinea-Bissau found that 25.8% of participants who had the measles vaccine suffered from allergies, as opposed to 12.8% who had the wild measles. (10) 10. S O Shaheen, P Aaby et al. Lancet 29 June 1996. Vol 347 pp 1792-1796 In the Immunisation Awareness Newsletter of December 1991, other advantages of catching measles are considered, as this passage shows: " The advent of complications during these diseases essentially depends on the age and the health of the child, as well as on treatment. We have lost the common sense and the wisdom that used to prevail in the approach to childhood diseases. Too often, instead of reinforcing the organism's defences, fever and symptoms are relentlessly suppressed. This is not always without consequences over the development of the disease. On the other hand, given the depth to which the child's organism is affected by the disease measles, for example, there can also be positive consequences. For the child's organism to defeat a disease by its own means, enables it to mature its immune system and develop increased resistance. The latter will be useful for the organism against other diseases during childhood, and likewise in adulthood. Over many generations, parents, doctors, and educators have noted that children may go through an important stage of their development thanks to a childhood disease. Conditions in which heredity is a factor, such as eczema, asthma, or recurring infections of the respiratory system, may be improved or even cured after measles. " This 'cure potential' of childhood diseases can be demonstrated by an example. There is a serious childhood disease affecting the kidneys, nephrotic syndrome, in which the kidneys lose their vital excretion function as a result of disturbed immunological processes. Up until the 1960s, at the Bale University Paediatrics Clinic, artificial infection with the measles was used to treat this syndrome; this brought about at least an improvement in most cases. " (11) 11. Immunisation Awareness Society Incorporated PO Box 56048, Dominion Road, Auckland, New Zealand. (ISSN 1170-7208), Vol 4 No 3, Page 7. Those in the medical profession might regard this passage as being " on the fringe " , but the assertions made are backed up by several references to medical literature (as does the Lancet paper we have just cited). We will be happy to supply details of those references. The process of vaccination involves submission to a medical procedure for the benefit of a community, not just for oneself or one's immediate family. Therefore, for a vaccination to be justified, there must be: -- a serious threat from the disease(s), and -- a significant benefit from the vaccine. If the diseases are not as serious as they are now claimed to be (and we have found no indication that any of them has become more serious in the past 15-20 years - quite the reverse) (12) and if the vaccines are more dangerous than they are admitted to be, then the risk/benefit ratio is altered. At the very least, parents should know about it. 12. Live measles vaccine: a 21 year follow up. BM. The British Medical Journal, 1987 Jul 4. 295(6589, pp 22-24. Note the following extract: " During the 21 years doctors assessed more cases of measles as being mild in vaccinated than in unvaccinated participants. The difference was highly significant (p<0.001) between 1964 and 1972, but as reported cases became fewer the difference was no longer significant. During the 9 years only five cases (three of them in the unvaccinated group and two in the group vaccinated with killed and live vaccine) were described as severe, and no complications or deaths were reported. " Behind the scenes, it is acknowledged that vaccines are indeed not as safe as they could be: " The goals of immunisation are to eradicate infectious diseases while minimising morbidity caused by the vaccine, particularly to prevent neurological damage. The object of the study is to evaluate neurological complications associated with the immunisation. Immunisation is an important public health measure. Acute reactions warrant support for development of improved vaccines " . (13) 13. Immunisations and brain damage, Iannetti P, Spalice A, Terenzi S, Raucci U, Parisi P, PEDIATR-OGGI-MED-CHIR, 14/3 (31-36) 1994 If vaccines are so safe why do they need to be improved? Return to Vaccines. FACT SHEET (Measles) Contents. The vaccines. Safety and effectiveness of the vaccines. Side effects: the official view. Side effects: our investigations. Conclusion. Return to menu Top of Page The vaccines. MMR Vaccines The MMR vaccines were introduced in October 1988, as part of a campaign to reduce childhood illness. They are a triple vaccine, using the mumps, measles and rubella live viruses. Problems with MMR vaccines Until September 1992 there were three types of MMR vaccine available: IMMRAVAX Manufactured by Merieux UK Ltd PLUSERIX-MMR Manufactured by Kline Beecham MMR (11) Manufactured by Merck Sharpe & Dohme distributed by Wellcome. (On recent data sheets this product is now shown as being distributed by Pasteur Merieux MSD Ltd) Pluserix and Immravax vaccines contain the Urabe strain of mumps vaccine virus; MMR (11) vaccine contains the Jeryl Lynn strain of mumps vaccine virus. On 14 September 1992 the Chief Medical Officer announced that there were to be " changes in the supply of vaccine " . From that date onwards, only MMR(11) would be available. The following is an extract from his letter giving the reasons for withdrawal: " This change in vaccine supply arrangements has been considered prudent following reports of generally mild transient meningitis caused by the mumps vaccine virus in some children who recently received the Urabe mumps vaccine containing products, Pluserix-MMR or Immravax. The rate of post-immunisation meningitis following Jeryl Lynn mumps vaccine (which MMR (11) contains) is much lower. " Incidence of mumps virus meningitis: " Meningitis after natural mumps has been reported to occur at a rate of approximately 1 per 400 cases. " Studies recently undertaken in one Public Health Laboratory, and supported by similar studies in several other Public Health Laboratories, suggest that the incidence of virus positive post-immunisation meningitis from the Urabe strain of mumps vaccine virus may be approximately 1 in 11000 immunised children. (14) 14. See later under the heading " Under-reporting of side effects " . The Chief Medical Officer seems to have got this wrong. One investigation found the incidence of side effects to be as low as one in 4000. See also notes at the end of this section. This rate of vaccine-associated meningitis is appreciable (sic) lower than that reported after natural mumps infection. " Vaccine-associated meningitis occurs around three weeks after immunisation generally. In those instances reported so far it appears to be a milder and more transient illness than meningitis from wild virus. This is what one might expect with an attenuated virus. The risk benefit ration therefore remains strongly in favour of the immunisation of all children with any MMR vaccine. However the MMR(11) vaccine is preferred where this is available because of the much lower risk of vaccine associated meningitis. " (15) 15. Letter date 14 September 1992 to all doctors in England from Dr K C Calman Chief Medical Officer. Even though the Chief Medical Officer mentioned only " changes in supply " , both Immravax and Pluserix have subsequently been withdrawn altogether. (16) 16. Announcement made in British National Formulary March 1993. The Department of Health has told us that the products are still licensed. Nonethe- less they are not being used at all in this country. We are troubled that there seems to be a certain amount of massaging of the figures. In the passage just quoted, side effects of one in 11,000 are mentioned. Later, it will be seen that they were brought down to 1 in 4000. But even that is not the end of the story as this extract from a Japanese study about the safety of MMR vaccines (with the Urabe mumps strain) will show: " During the 8-month period extending from April to October, 1989, in Gunma Prefecture, 11,750 children received MMR vaccination according to information supplied by the prefectural health center. The incidence of MMR meningitis was estimated to be 0.11% in the virus-positive group and 0.30% in the three groups. 2640 and 1320 children received MMR vaccination in September and October, respectively. Twelve children in the virus-positive group, 10 in the serum-positive group and 6 in the clinical group received vaccination in these two months. The incidence of virus-positive, serum-positive and clinical meningitis was 0.3%, 0.25% and 0.15% respectively Total 0.71% " (17) 17. A prefecture-wide survey of mumps meningitis associated with measles, mumps and rubella vaccine. TAKASHI FUJINAGA, MD. YOUICHI MOTEGI, MD, HIROSHI TAMURA, MD ANDTAKAYOSHI KUROUME, MD. Paediatric Infectious Disease Journal ® March 1991 Vol 10 No 3. We have a letter from the Japanese Department of Viral Disease and Vaccine Control which indicates that from April 1993 the use of the MMR vaccine (all types) was stopped in Japan and that vaccines would be available only in their monovalent form (i.e. single virus) (18) 18. Letter dated 26 October 1994 from Akin Yamada of Department of Viral Disease and Vaccine Control. Comment The Japanese finding indicate that adverse reactions to these types of MMR vaccine were up to 78 times as frequent as our Government Chief Medical Officer of Health has admitted (19). 19. 7.1/1000 = 78.1/11,000 If these figures are correct, then the vaccine is more dangerous than the illness; and it does not give a great deal of confidence that the Government has got its figures (or information about safety or side effects) right. Note also that this article was published in March 1991. Yet the two brands of MMR implicated with these side effects were not withdrawn until September 1992, some 18 months later. Indeed TRIVIRIX (a MMR vaccine containing the Urabe strain virus) was withdrawn in Canada in May 1990. (20) 20 Canada Diseases Weekly Report December 15 1990 Vol, 16-50 p253. Why did the UK Government take till 1992 to withdraw it? The arrival on the scene of the MR Vaccine In the autumn of 1994 it was announced that the Government feared an epidemic of measles and it was aimed to vaccinate all children between the ages of 5 and 16 with the Measles/Rubella vaccine. Not everyone agrees that an epidemic was imminent or that such a widespread vaccination campaign was necessary. (21) 21. See Bulletin of Medical Ethics No 110(July/August 1995); See also response from the Public Health Laboratory Service in the Bulletin of January 1996, pages 16-23. The story goes back further than that - to the MMR vaccines. The two brands of MR Vaccine which were used in the schools campaign are produced by the same manufacturers as were the two brands of MMR Vaccine which have now been withdrawn (see above). Merieux UK Ltd (Measles Rubella Vaccine Live Pasteur) and /Kline Beecham (Eolarix) As far as we can tell the active constituents of these two vaccines are exactly the same as those in their withdrawn MMR vaccines, except that the mumps component has been removed. Both brands of MR vaccines each contain 2 viruses - to provide protection against Measles and Rubella. Return to Vaccines. FACT SHEET (Measles) Contents. Safety and effectiveness of the vaccines. Side effects: the official view. Side effects: our investigations. Conclusion. Return to menu Top of Page Safety and effectiveness of the vaccines. Safety We deal below with side effects, but we are disturbed at the lack of evidence of long-term safety trials. At the risk of repetition we set out again the extract from the publication referred to in our vaccines general information factsheet: " In the course of its review, the committee encountered many gaps and limitations in knowledge bearing directly and indirectly on the safety of vaccines. These include inadequate understanding of the biologic mechanisms underlying adverse events following natural infection or immunisation, insufficient or inconsistent information from case reports and case series, inadequate size or length of follow-up of many population-based epidemiologic studies, and limited capacity of existing surveillance systems of vaccine injury to provide persuasive evidence of causation. The committee found few experimental studies published in relation to the number of epidemiological studies published. Clearly, if research capacity and accomplishment in these areas are not improved, future reviews of vaccine safety will be similarly handicapped. " (22) 22. From Adverse Events Associated with CHILDHOOD VACCINES Evidence Bearing on Causality (ISBN 0-309-04895-8). National Academy Press Washington DC. 1994: p316. So far, most of the safety trials which we have identified, have monitored the children for just 3 weeks after the vaccine was administered; and the longest we have so far been able to find is a monitoring period of six weeks. It means that any adverse effect which occurred after the monitoring period would not have been observed. The safety trials, in the main, have been of the separate components of the vaccines. (i.e. Mumps, Measles and Rubella). Trials of the combined vaccine appear to be even thinner on the ground. this is admitted by the Committee on Safety of Medicines: " Before measles, mumps, rubella (MMR) vaccine was introduced in this country, we carried out a large scale study where adverse events were monitored in the three week period following vaccination in approximately 12,000 children. " (23) 23. Extract from letter dated 9 January 1990 from Dr D M Salisbury at the Committee on Safety of Medicines. This is troubling because there are special considerations which should be given when more than one live virus is admistered as a vaccine at the same time. There is evidence that the measles virus (or vaccine) can cause immunosuppression (24) which in tuen might allow opportunistic infection to develop from one of the other viruses (such as rubella). 24. See Paediatric Infectious Disease Journal ® June 1993 Volume 12, Number 6 Increased mortality after high titer measles vaccines: too much of a good thing. By Halsey, Neal A., Other concerns have also been expressed: " Modern vaccine programs seem to ignore the high potential for mutation of viruses. It was established in 1986 that a mixture of non-virulent viruses can produce a disease by means of complementation or recombination. A team from the University of California (Los Angeles) innoculated mice with two strains of non-virulent herpes simplex virus type 1. Most of those that received a 1:1 mixture of viruses died. But the animals which received a 100 fold higher dose of one strain of virus survived. Virulent recombination had been produced. As early as 1984, R de Long warned that mass immunisation with several live viral vaccines might increase the probability of genetic recombination and might result in new diseases. " (25) 25. Long term effects of early vaccinations. Dr Odent. Publication: Primal Health Research Vol. 2 No 1. p 6 Date: Summer 1994. The two studies he refers to are: R T, Sedarati F, J G, Two avirulent herpes simplex viruses generate lethal recombinations in vivo. Science 7 November 1986 234: 746-47; De Long R, A possible cause of acquired immune deficiency syndrome and other diseases. Medical hypothesis. 1984; 13: 395-97. If anyone can help us to identify longer-lasting safety trials we would be grateful to receive details. We have asked the Committee on Safety of Medicines to supply us with details of long term safety monitoring of vaccines and they have so far been unable to supply them. Effectiveness of the vaccines When the vaccine was first introduced, one of the stipulated criteria was that it should be long lasting in its effect (26). Yet children are now being offered their second and even third dose of the vaccine. We have to ask: is it doing its job? " Before measles vaccination, immunity to measles was acquired by natural infection or by passive protection of infants by maternal antibody transferred in utero to the foetus.... " Revaccination of persons whose antibody levels have waned to low or undetectable levels (from a previous vaccination) appears to offer only transient benefit. In such persons, although antibodies boost after revaccination, they subsequently fall to previous levels. " In the United States, although greater than 50 percent of counties remained free of measles for a decade or more, two main patterns of measles transmission continued. First, outbreaks occurred among highly vaccinated school-age populations in which measles transmission was documented among children who had received a single dose of vaccine.... " The second pattern, observed in large epidemics in 88-91 was transmission among unvaccinated ethnic and racial minority pre-school children, particularly in the inner cities. Vaccination levels among school-age children were high... " (27) 27. Successes and Failures in Measles Control. Felicity T Cutts and Lauri E Markowitz (Communicable Disease Epidemiology Unit, London School of Hygiene and Tropical Medicine and CDC Georgia) The Journal of Infectious Diseases 1994. Vol 170 supplement 1. S32-41. See also the passage we quoted from The Theory and Practice of Public Health which gave details of the protective effect of measles itself (28). 28. The Theory and Practice of Public Health page 236. There is also another worry over the effectiveness of the vaccines. Normally a mother who is immune to illnesses confers that immunity to her children for the first six to twelve months of their lives by " maternal antibodies " , but there is evidence that this protection is reduced where a mother has been vaccinated, as opposed to catchine the natural measles: " The data presented here demonstrate that vaccination against measles in one generation opens a window of opportunity for infection in infants of the next generation. Infants become susceptible to measles as transferred maternal antibody is catabolized. In this study population this phenomenon occurs earlier in infants of vaccinated mothers than in infants of mothers who had natural measles. Furthermore in a well-vaccinated society where measles outbreaks are suppressed and boosting does not occur, even mothers who had natural measles have less antibody to pass to their infants compared with mothers in the past. Consequently the majority of infants will be susceptible to measles many months before the recommended age for vaccination. In other words good preventive and outbreak control measures ultimately lead to a lower age limit of susceptibility. " (29) 29. Reduced measles immunity in infants in a well-vaccinated population. Paediatric Infectious Disease Journal ® July 1992 Volume 11, Number 7 11: 525-9, 1992 Return to Vaccines. FACT SHEET (Measles) Contents. Side effects: the official view. Side effects: our investigations. Conclusion. Return to menu Top of Page Side effects: the official view. There is a concept in medical cases called " informed consent " . In simple terms, has a patient been given adequate information to be able to make an informed decision about whether or not to have a particular type of treatment? Because a child does not need to be vaccinated there may be a duty to give very comprehensive information, so that parents can decide. Even chances of several thousand to one against side effects may be unacceptable, particularly as a child is put at risk of side effects as soon as the vaccine is administered. Yet little information is made available about the side effects of vaccines. They are always played down, and in the booklets encouraging parents to have their children vaccinated, they are hardly mentioned at all. In the booklet given to families at the time of the Measles Rubella campaign in 1994 the following is the entire information relating to safety of the vaccines: " Will my child have any side effects after the injection Side effects are uncommon. They are usually very mild and disappear quickly. A few children may get a mild fever, a rash, sore or aching joints, or feel a bit 'off-colour' a week or ten days after the jab. But this should only last two or three days. Children with these symptoms cannot give anyone measles or rubella. " (30) 30. From: MEASLES why every child in school needs to be protected from measles this autumn. 1994 [Health Education Authority/Department of Health Publication] No other information giving details of side effects is contained in any part of the booklet. By any standards this is grossly inadequate information for concerned parents. As can be seen, side effects do certainly exist: " Reactions from the live [measles] vaccine are usually mild, although convulsions and rare cases of encephalopathy (31) have occurred in connection with vaccination campaigns, but with the improvement in vaccine production reactions are becoming less common. The risk is certainly acceptable in countries where measles is still a killing disease. " (32) 31. Any disease or disorder affecting the brain, including chronic degenerative conditions. 32. from: The Theory and Practice of Public Health Edited W Hobson. 5th Edition. Oxford University Press 1979. page 241. We realise that this passage was written in 1979, but by then measles vaccine had been widely used in this country for more than ten years. It is rather odd, therefore, that the author is talking about an " acceptable risk " in countries where measles is still a killer disease. The same argument can be applied (justifiably) about vaccination against AIDS, where the risks from the illness are very severe. But deaths from measles in country have remained low since the 1950s. The following is the list of side effects taken from the datasheet for one of the brands of MMR vaccine (MMR(11)). It should be emphasised that this too plays down the incidence of vaccine side effects, but it does give much more information than is generally available to the public: From MMR datasheet " Because the vaccine is slightly acidic (pH 6.2-6.6), patients may complain of burning and/or stinging at the injection site for a short time. " Adverse reactions associated with MMR(11) are similar to those to be expected from administration of monovalent vaccines given separately. These may include malaise, sore throat, headache, fever and rash, nausea and vomiting; mild local reactions such as erytheme, induration, tenderness and regional lymphadenopathy; parotitis, orchitis, nerve deafness, thrombocytopenia and purpura; allergic reactions such as wheal and flare at the injection site of urticaria; polyneuritis; and arthralgia and/or arthritis (usually transient and rarely chronic). Cough, coryza and pharyngitis have also occurred. " Moderate fever (38.3'C/101'F) or high fever (above 39.4'C/103'F) may occur following vaccination, predominantly between days 5 and 10. On rare occasions, children developing fever may exhibit febrile convulsions. Rash occurs infrequently and 'is usually minimal, but rarely may be generalised. " Forms of optic neuritis, including retrobulbar neuritis, papilitis and retinitis have infrequently been reported one to three weeks after inoculation with some live virus vaccines. " Very rarely, encephalitis and other CNS reactions have been associated with measles, mumps, and rubella vaccines when given individually. These reactions might be reported with MMR (11) " Experience from more than 80 million doses of all live measles vaccines given in the USA up to 1975 indicates that significant central nervous system reactions such as encephalitis and encephalopathy, occurring within 30 days after vaccination, have been temporally associated with measles vaccine approximately once for every million doses. In no cases has it been shown that reactions were actually caused by vaccine (33). The risk of such serious neurological disorders following live measles virus vaccine administration remains far less than that for encephalitis and encephalopathy caused by natural measles (one per two thousand reported cases). 33. The American version of this datasheet add more here: " The Center for Disease control has pointed out that 'a certain number of cases of encephalitis may be expected to occur in a large childhood population in a defined period of time even when no vaccines are administered'. However the data suggests the possibility that some of these cases may have been caused by measles vaccines " There have been isolated cases of both the Guillain-Barre syndrome being seen after vaccination and ocular palsies occurring 3-24 days after vaccination with a live attenuated measles virus vaccine, but no definite causal relationship between the vaccine and the disease syndromes has been established. Isolated cases of polyneuropathy, including Guillain-Barre syndrome, have also been reported after immunisation with rubella-containing vaccines. " There have been reports of subacute sclerosing panencephalitis (SSPE) in children who did not have a history of natural measles but did receive measles vaccine. Some of these cases may have resulted from unrecognised measles in the first year of life or possibly from the measles vaccination. Based on estimated nationwide measles vaccine distribution in the USA, the association of SSPE cases to measles vaccination is about one case per million vaccine doses distributed. This is far less than the association with natural measles: 6-22 cases of SSPE per million cases of measles. " A study suggests that the overal effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent higher risk of SSPE. " Local reactions characterised by marked swelling, redness and vesiculation at the injection site of attenuated live virus measles vaccines, and systemic reactions including atypical measles have occurred in vaccinees who had previously received killed measles vaccine. " Rarely, there have been reports of more severe reactions, including prolonged high fevers and extensive local reactions requiring hospitalisation. Panniculitis has also been reported rarely following vaccination with measles vaccines. " Arthralgia or arthritis, or both, are usually transient and rarely chronic features of natural rubella. Like the polyneuritis that is also a feature of natural infection, their frequency and severity vary with age and sex, being greatest in adult females and least in prepubertal children. This type of involvement as well as myalgia and paraesthesiae have also been reported with the separate use of rubella vaccine. " The chronic arthritis associated with natural rubella has been related to virus and/or viral antigen found in body tissues. Only rarely have vaccinees developed chronic joint symptoms. " Following vaccination in children, reactions in joints are uncommon and generally of brief duration. In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (children: 0.3%; women: 12-20%) and the reactions tend to be more marked and of longer duration. Symptoms may persist for a matter of months or, on rare occasions, for years. In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and in adult women. Even in older women (35-45 years) these reactions are generally well tolerated and rarely interfere with normal activities. " (34) 34. Taken from 1990-91 Data Sheet Compendium. In a letter to doctors (not released to the general public) the Government's Chief Medical Officer gave details of the expected side effects of the Measles Rubella Vaccination. (35) These are reproduced here: 35. Letter dated 27 September 1994 to Doctors and Nursing Officers from Dr C Calman and from Miss Y s. ...........................ADVERSE EVENTS ASSOCIATED WITH ...........................MEASLES MUMPS RUBELLA VACCINE Adverse Event....Expected following...........Expected following.........Reference ..................................First dose*...........................Second dose** Rash............................5%.......................................0.2 5%........................1 Fever > 38.5'C...........5-15%..........................0.25%-0.75%................. ....2 Arthralgia...................26%.....................................1.30%.. ........................3 (adolescent or adult females) Arthralgia....................3%.....................................0.15%.. ........................3 (children) Arthritis......................11%....................................0.55%. ..........................4 (adolescent of adult females) Arthritis......................rare..................................very rare........................2 (children) Encephalitis+...1/1,000,000 doses........1/20,000,000 doses......................1 * Assuming all recipients are susceptible (non-immune) ** In unselected vaccine recipients, assuming a 5% vaccine failure rate (i.e. 5% of recipients of the first dose did not respond and are susceptible at the time of the second dose) + Assuming vaccine plays a role in causation. If not, the incidence for both first and second doses is 0. The following is another list of concerns. (36) 36. Table taken from Vaccines and their Future Role in the Public Health. Parliamentary Office of Science and Technology July 1995 page 40 (see below) Table 8.......SOME RECENT CONCERNS OVER VACCINE SAFETY Vaccine.....................................Concern......................... ........Comment Measles/rubella..Linked with Guillain Barre Syndrome (GBS)..No evidence for causal .............................a rare neurological condition............................link MMR.......One strain of mumps (Urabe) linked to high...........Urabe strain no longer ..........................risk of aseptic meningitis....................................used. Raises questions ............................................................................. ..........................laboutlicensing and ............................................................................. ..........................surveillancesystems. Measles................Finding that those immunised against..............Evidence contentious. .............................measles may have higher risk of.......................Raises possibility of .............................inflammatory bowel disease in later life.............long-term risks from ............................................................................. ..............................immunisation. In our view it is very wrong that so little information is given to parents about the extent and severity of side effects of these vaccines. Under reporting of side effects. It is a requirement that side effects to vaccines and other pharmaceutical products are reported to the Medicines Control Agency/Committee on Safety of Medicines using the so-called " yellow card " system. It is widely accepted that the adverse reactions to all pharmaceutical products are seriously under reported, and that possibly only a tenth of all reactions are ever reported. " Reporting to CSM is inevitably incomplete: standardized criteria are not used, and there is no clinical follow-up to determine the outcome of reported reactions " (37) 37. Meningoencephalitis associated with MMR vaccine: H C Maguire et al. Review Volume 1 Number 6. 24 May 1991. page R60 In Vaccines and their Future Role in Public Health. Parliamentary Office of Science and Technology July 1955 further concern is expressed: " Sometimes, concerns over the safety of vaccines have turned out to be justified, as illustrated by recent experience with the Urabe strain of MMR vaccine - one of a number of new strains of mumps virus developed in response to increasing demand in the 1980s. All the strains were based on the wild-type mumps virus, but differed slightly depending on the attenuation process used. The Urabe strain was thought to be slightly more efficient at stimulating immune responses, and was licensed for use in the UK, Canada, France and a number of other countries. Meanwhile, the longer-established Jeryl Lynn strain continued to be used in the USA and Scandinavia and also to a limited extent in the UK. " As the MMR campaigns gathered momentum in the late 1980s and early 1990s, evidence began to accumulate that the Urable vaccine might be associated with a higher risk of meningitis 2-5 weeks after vaccination, and suspicions were raised by the finding that virus particles isolated from cerebrospinal fluid of affected patients were from the Urabe strain. One country (Canada) stopped using the Urabe strain as early as 1989. In the UK however, alternative strains of mumps vaccine were not so readily available, and several studies were set up to establish whether there were increased risks involved. Studies bases on voluntary reports gave reassuringly low estimates in the region of 1 case of meningitis per 143,000 to 250.000 doses of Urabe vaccine (Table 9). But when greater efforts were made to identify cases - for instance by cross-linking laboratory reports of hospital diagnoses to vaccination records - the risk rose to between 1 case per 4,000 doses and 1 in 21,000. These findings suggested significant under-reporting of Urabe vaccine-associated meningitis, and led to the withdrawal of the vaccine from the market in 1992. All UK MMR vaccine now contains the Jeryl Lynn mumps strain... (See table below) " What lessons can be learnt from the failure of the yellow card surveillance system to detect the scale of the problem? This system is inevitably prone to a certain degree of under-reporting because it relies on doctors to make the connection between a particular set of symptoms and recent immunisation, and report it to the CSM as an adverse event. However, the Urabe experience shows that making a connection can be very difficult when there is an extended (2-5 week) delay between vaccination and the onset of symptoms. Attention has thus been turned to finding alternative methods of monitoring for adverse reactions. (39) 39. Table and text taken from: Vaccines and their Future Role in Public Health. Parliamentary Office of Science and Technology July 1995 pages 40-41. This publication seems to contradict itself because elsewhere it appears to accept the evidence of the yellow card system when contending that concerns over vaccine safety are unfounded (page 39) Table 9.......RISK OF MENINGITIS 2-5 WEEKS AFTER VACCINATION WITH URABE ..................MUMPS VACCINE. Type of Study...................................................................Risk estimate (cases of meningitis ............................................................................. ............per doses of vaccine) Voluntary reports by paediatricians.....................................1 in 250,000 Notifications of meningitis by doctors..................................1 in 143,000 Checking vaccine records of hospital cases.........................1 in 21,000 Cross-linking vaccine records with lab reports (4 labs)...........1 in 11,000 Cross-linking vaccine records with lab reports (1 lab).............1 in 4,000 A paper in the Lancet records the failure of passive surveillance to detect an unacceptably high risk of aseptic meningitis with measles/mumps/rubella vaccines that contained the Urable mumps strain. (40) 40. A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines by Paddy Farrington et al. (Public Health Laboratory Service) Lancet March 4 1995 Vol 345, pages 567-569 (Referred to below) Our own clients' experience has been that doctors have declined to report vaccine reactions, even when they have occurred within a very short time of the vaccine being administered. This is a incorrect approach. The guidance given to doctors is this: " Doctors are asked to report all suspected reactions to both new and established vaccines. The balance between risks and benefits needs to be kept under continuous review. " (41) 41. Taken from: British National Formulary - all issues. Our own direct experience is that there has been substantial under-reporting of the side effects following the MR (Measles rubella) schools campaign. The Department of Health reported 80 children had suffered adverse reactions (42), but JABs (43) has 122 cases on its database, and we have 140 on ours. There is some overlap, but our guess is that the incidence of side effects know to us and JABs totals at least 150, and almost certainly these will not include all the cases reported to the Department of Health. It can therefore be safely said that the true incidence of side effects is double the DoH figures and quite possibly substantially more than that. 42. Report in The Times of 21 December 1994 page 5 43. Justice Awareness Basic Support; a support group to help families with .............vaccine damaged children. Address given in our Vaccines General .............Factsheet. Ironically there can also be over reporting of the incidence of measles (which can distort the picture just as much): " In a study of measles notifications in 18 districts during 1991-3 Brown et al. show that surveillance based on clinically diagnosed cases is now inaccurate and that detection of lgM in saliva could provide an effective alternative to using serum samples for laboratory confirmation. " Our findings have implications for vaccination policy. For example, the recent increase in the proportion of notified cases in children under a year old may be spurious as infection was confirmed in only 11% of cases in this group. (44) from: BMJ Vol 308 16 April 1994. pages 1015-1017 (and " This week in BMJ " ) Return to Vaccines. FACT SHEET (Measles) Contents. Side effects: our investigations. Conclusion. Return to menu Top of Page Side effects: our investigations. What you have told us. Clients (and those who have contacted us) have reported to us a number of problems with the vaccine. To date we are aware of more than 600 instances of side effects following MMR and MR vaccines. The figures in [square brackets] give the numbers reported in respect of side effects so far (as at May 1997). Note that some children will have more tthan adverse reaction. The side effects include: Autism [287] Crohn's disease and other serious chronic stomach problems [136] Epilepsy [132] Other forms of brain damage (including meningitis, cerebral palsy, encephalopathy, encephalitis etc.) [77] Hearing and vision problems [81] Arthritis and Arthralgia (including crippling juvenile rheumatoid arthritis) [50] Behavioural and learning problems (in older children) [110] Myalgic encephalomyelitis (ME) and chronic fatigue [41] Diabetes [15] Guillain-Barré syndrome [9] Idiopathic thrombocytopaenic purpura (and other purpura) [6] Subacute Sclerosing Panencephalitis (SSPE) [3] Wegener's Granulamatosis[2] Leukaemia [1] Multiple Sclerosis [1] Death [18] Note: Some of these figures overlap because some children have more than one symptom. What we have found There is ample confirmation in the medical literature of complications caused by vaccines. Curiously, whilst mild reactions are admitted in the datasheets, and in the government leaflets, serious adverse events are always dismissed as having nothing to do with the vaccines. If on the other hand a child develops a serious condition after contracting the natural diseases, there is no doubt in anyone's mind that the disease caused the condition. It is therefore revealing to look in the medical literature which does reveal concerns about serious (as well as mild) reactions. Here is a selection of what we have found. There is plenty more evidence. We now have copies or summaries of thousands of articles and reports on vaccine reactions. Arthritis: The following are extracted from pages on the subject. " The main major complication of rubella vaccination is arthralgia and arthritis... Occasionally articular effects may become both prolonged and recurrent.... since joint symptoms occur at the same time as productions of antibodies to virus, then they could be immune complex radiated and the association with circulating immune complex as demonstrated would tend to support this. Of course it is also possible that local replication of the virus in joint tissues could be responsible for joint symptoms... " " There hae been a number of reports of complications seen in combined vaccines including a rubella component. " (45) 45. Complications of Rubella vaccination. From: " Rubella in Pregnancy " by Nick Sidle MB BS BSc. pages 63-65. " Nevertheless, immunisation with measles, mumps and rubella vaccine carries a risk of first ever episodes of joint symptoms, particularly in children under 5 years and in girls. The most severe cases of arthritis were interestingly seen in older boys. " (46) 46. Joint and limb symptoms in children after immunisation with measles mumps and rubella vaccine. C M et al. BMJ April 25 1992 Vol No 6834. pages 1075-1078. " Rubella immunisation or infection is an uncommonly recognized cause of acute, recurrent, or persistent musculoskeletal manifestations. After routine rubella immunisation, two women presented with the onset of polyarthralgia, arthritis, maculopapular rash, fever, paresthesia, and malaise with persistent of recurrent manifestations lasting longer than 24 months after vaccination. The patients expressed rubella virus RNA in peripheral-blood leukocytes 10 and 8 months after vaccination, respectively, in contrast to repeated negative results in asymptomatic rubella-immunised controls. One patient developed significantly depressed antibody responses to rubella virus after vaccination and experienced a prolonged clinical improvement after a 3-month course of intravenous immune globulin. The second patient had normal antibody responses to rubella virus and underwent no clinical improvement during or after intravenous immune globulin therapy. Rubella immunisation or infection should be considered as additional causative factors in evaluation of acute and continuing musculoskeletal syndromes. " (47) 47. Chronic rubella vaccine-associated arthropathy. -LA; Tingle AJ; Shukin R; Sangeorzan J; McCune J; Braun DK. ARCH-INTERN-MED. 153/19 (2268-2274) 1993 Convulsions: In the paper (referred to above) published in the Lancet, the authors revealed that their studies showed that there was an attributable risk of febrile convulsion of one in 2600 doses attributable to the MMR vaccine 15-35 days after being vaccinated. The same paper recorded that even with the MMR2 vaccine there was still a risk of aseptic meningitis of one in 16000 being attributed to the vaccine. (48) 48. A new method for active surveillance of adverse events from diphtheria/pertussis and measles/mumps/rubella vaccines by Paddy Farrington et al. (Public Health Laboratory Service) Lancet March 4 1995, Vol 345. Pages 567-569. Diabetes A disorder caused by insufficient or absent production of the hormone insulin by the pancreas. (49) 49. From: the Complete Health Guide. It has recently been reported that diabetes is increasing at a rate of more than 10% a year among children under 5, and the the increase has been noticed over the past 10 years. This of course corresponds with the date of introduction of MMR vaccines. (50) 50. Report in the Sunday Times, 19 January 1997 Published papers have suggested a possible link with the vaccine. One paper, published in Finland, has suggested: " Further studies are required to determine if the vaccine virus, like natural mumps, could trigger the clinical onset of Type 1 diabetes in young children " (51) 51. Decline of mumps antibodies in type 1 (insulin dependant) diabetic children and a plateau in the rising incidence of type 1 diabetes after introduction of MMR vaccine in Finland. Author(s): Article: H Hyoti et al. Publication: (Diabetologia Vol. 36 No 12: pp.1303-1308) Date: 1993 " Induction of Type 1 diabetes mellitus: A total of 20 cases had been reported. The earliest case occurred 3 days after the receipt of vaccine and the latest 7 months after immunisation. Twelve cases were diagnosed within 30 days of immunisation. The authors considered the cases of diabetes mellitus to have a temporal relationship to mumps immunisation. For every 5 million children immunised against mumps 50 spontaneous cases of diabetes mellitus are to be expected by mere coincidence within a period of 30 days after immunisation. In fact, only 12 cases were reported within 30 days after immunisation. " (52) 52. Title: The Vaccine Adverse Events Reporting System (VAERS): A single post-marketing surveillance system for vaccines in the United States. Poster presented at: 7th International Conference on Pharmocoepidemiology, Basel, Switzerland, August 26-29, 1991. Author: Mullen JR; Chen RT; Swint E; SW; Rastogi S; Knapp G; Publication Year: 1991; Source: Annual 16, page 389. In Adverse Events Associated with Childhood Vaccines the link between the mumps element of the vaccine and diabetes is considered in detail. Inevitably the book record that there have been no clinical trials, and it concludes that the evidence is inadequate to accept or reject a causal relation between measles or mumps vaccine and diabetes. (53) 53. Adverse Events Associated with CHILDHOOD VACCINES Evidence bearing on causality (ISBN 0-309-04895-8). National Academy Press Washington DC, 1994: pp 153-159. Inflammatory Bowel Disease (including Crohn's Disease) Crohn's disease is an inflammatory bowel disease which can effect any part of the digestive tract causing mouth ulcers, stomach pains, episodes of diarrhoea vomiting. Surprisingly it can be accompanied by joint pains and swelling, and conjunctivitis of the eyes. It can take many years to develop, but with children the first symptom is often malabsorption and failure to thrive. These is convincing evidence of a connection between the vaccination and inflammatory bowel disease (including Crohn's disease). (54) See: Is measles vaccination a risk factor for inflammatory bowel disease? N P et al. The Lancet Vol: 345 pp 1071-1074, Date: April 29 1995. It is a serious lifelong illness which has affected a large number of the children we are helping. We are working with Dr Wakefield of the Royal Free Hospital London. He is investigating this condition. There is a disturbing increase in childhood Crohn's disease, which seems to coincide precisely with the introduction of the measles vaccines. Autism (or autistic features) A condition which manifests itself in severe difficulties in communicating and forming relationships with other people, in using languages and abstract concepts. It is characterised by repetitive and obsessive patterns of behaviour. Parents also report that their children lose co-ordination or motor skills as well. Its cause is not understood, but it has been associated with brain damage. " Autism is one of the developmental disorders of brain function; as in the others, there are several causes. In most cases the cause is unknown....There may be an inherited susceptibility to some environmentally determined stress. In a few cases, there is evidence of tuberous sclerosis, hypomelanosia of Ito, fragile X, phenylketonuria, congenital rubella, neonatal herpes simplex, hydrocephalus, malformation, or other static encephalopathy " (55) 55. Merritt's textbook of Neurology 9th edition 1995 The word " autism " in relation to its present meaning did not enter the language until about the same time as widescale vaccinations were introduced. (56) About 350 new cases are reported each year. (57) 56. Leo Kanner 1943 57. Source: Children with Autism by Colwyn Trevarthen and others. Publishers Kingsley (1996) page 1. A substantial number of parents have reported that their children have become autistic (or developed autistic symptoms) (58) following administration of the vaccine (notably the MMR as opposed to the MR- vaccine) (59) Autism is far and away the most common side effect notified to us. More than a two fifths of all side effects associated with MMR involve autism. 58. The condition has been described as atypical autism or a disintegrative disorder. It has features of autism but normally the signs of autism manifest themselves at a much earlier age - or at least can be recognised retrospectively once a diagnosis has been made. For the sake of simplicity we shall refer to the condition as autism in this factsheet even through strictly speaking it may not be exactly the same condition as has come to be given that name. 59. If the vaccine is a factor, the reason is probably that the MMR vaccine is given at an earlier age (while the brain is still in the process of myelination), but behaviour problems have been reported among older children given the MMR vaccine. It is important to emphasise that autism (or atypical autism) is the manifestation of a condition. It is not an illness in itself. The descriptions we have received are remarkably consistent. This is what one mother has written to us: (60) has gone from being a happy fun-loving sociable child to a quiet introverted and aggressive child. I have a little person who is locked up within himself. And that person within holds the only key to comprehending what makes the world revolve. Our world is one of confusion to and outside the home environment every place, person and activity sparks off anxiety. 60. Not his real name, but these are the actual words written by a mother to us. Many children with autism are extremely behaviourally deviant even during this first year of life. They may engage in stereotyped hand movements and be completely passive, not interested in exploring their environment, indeed showing no initiative whatsoever, and perhaps already fiercely protesting when demands are made or routines changed. A few reject body contact. Many prefer to be left alont " (61) 61. The biology of Autistic Syndromes: Gillberg and ; Mac Press; 2nd Edition (ISBN) (uk) 0 901260 92 4) page: 57. The same point is echoed in a fact sheet from the National Autistic Society: " In almost all children with autistic spectrum disorders, the triad of impairments emerges in the first 2-3 years of life. Some seem to be developing normally in the first year or two (in rare cases even longer than this) before the unusual behaviour begins. But in many, perhaps most, there are indications of developmental problems within the first year of life. Many parents recall these early indications when interviewed, though they may not have known their significance. " (62) 62. From Autistic Spectrum Disorders an aid to diagnosis by Lorna Wing MD FRCPsych. 1995. p7. Available from the National Autistic Society The picture which is emerging is that the children who have become " autistic " after being vaccinated were doing everything they should before being vaccinated, and were showing none of the signs mentioned in the above extract. Is Autism on the increase Anecdotal evidence suggests that there has been a huge rise in cases of childhood autism throughout the country. Using the rates of autism quoted above (63) there should currently be only about 5600 cases of autism among children up to school leaving age, (64) but we have heard that one county alone has 10,000 cases. One paediatrician exasperatedly asked a client of ours (the mother of an autistic child): " Where are all these cases coming from? " 63. Children with Autism by Colwyn Trevarthen and others. Publisher Kingsley (1996) 64. i.e. 350 per year x 16 years = 5600 We have a copy of an extract of minutes of an extraordinary meeting of an education authority which express extreme concern over the increased numbers of autism cases, and the difficulty in coping with them. A small branch of the Norfolk Autistic Society is reported as having been told to expect only three or four sufferers in their area, but there are already 46 " and the numbers are growing daily. " (65) 65. Eastern Daily Press 5 November 1996 page 25. The Sussex Autistic Society has told us that there appears to be a higher incidence of children on the autistic spectrum being diagnosed. (66) 66. Letter dated 24 March 1997 An American paediatrician, Dr J Goldberg writing on the Internet states: While training as a pediatrician, I was told if I saw one autistc chilld in a lifetime of practice it would be one too many. What I am seeing today is not the autism I learned about in medical school twenty years ago. What was once a relatively rare disorder is now twenty times more likely to occur. Before, " autism " was 1-2 per 10,000 births. Now, current statistics suggest a frequency of 20 per 10,000 births (rates of 40 per 10,000 or higher have been suggested). (67) 67. " Autistic Syndrome " A Medical Problem, Dr J Goldberg, Tarzana, California. Figures published by the National Autistic Society suggest a huge increase in the incidence of autism: " The grand total for the whole autistic spectrum is 518,000, an estimated prevalence of 91 people in very 10,000. These new figures reflect the widening definition of the autistic spectrum. They cannot be taken as evidence for an increase in incidence of these disorders. The question of whether the numbers are rising can be answered only by a large-scale, detailed (and expensive) long term study " (68) Newsletter from the National Autistic Society published in May 1997: page 3 Even though the National Autistic Society seems to ascribe the increase to better diagnosis, we are far from convinced. In any event a figure of nearly one percent of the population with some form of autism is very disturbing. Medical and other carers who have spoken to us appear to be puzzled by this, and are apparently seeking the cause. All our cases occur after October 1988 (the date when MMR was introduced). The first autistic side effect we know about occurred in January 1989. We have details of a smaller number of cases involving the measles (only) vaccine. Our sample is admittedly too small to be statistically significant (10 to date) but it seems curious that there are no autism cases among them, if the measled element of the vaccine alone is implicated. If the link with autism is purely a chance one, then we would have expected there to have been chance connections with other conditions made by parents whose children were vaccinated at around a year of age. We would also have expected parents to blame other vaccines, but they have not (apart from a small number of cases arising from whooping cough vaccines.) In some cases, the onset of autistic features takes months to show, but in others it is only a matter of days before the child develops changes in behavioural patterns. The problem is that the diagnosis of autism is not something which happens instantly, as it would be if it were a case of - say - meningitis. It is usually a conclusion reached after prolonged investigation. Nonetheless, if there really is a substantial increase, it is unlikely that this phenomenon could be explained away (as has been suggested by improved diagnosis of autism, or by a willingness on the part of professionals to diagnose an autistic spectrum disorder. We have used the umbrella heading of " autism " but there are also children who, whilst not coming within the definition of autistic, have developed behavioural and/or learning problems after being given the vaccine. Disturbing reports in the press indicate that in this country and in the USA up to one in twenty school children have some form of educational special need. We would not for a moment suggest (as some have done)(69) that this situation is caused by vaccines but nonetheless if a vaccine can cause low level or diffuse brain damage then it must follow that in some instances behavioural problems or learning difficulties are associated with it. 69. See for instance Vaccines and Social Violence and Criminality by Coulter. If the MMR vaccine is directly linked with autism then there is potentially a very serious problem. We are surprised that (perhaps because there appears to have been no adequate long-term follow up) so little of the current medical literature (apart from that mentioned below) makes the connection with the vaccine. We have seen a memo from Dr of the Public Health Laboratory Service (PHLS) dated 2 October 1996 (70) which is dismissive of a link between autism and the vaccine. The memorandum reviews the " evidence " , but with respect to Dr this evidence is negative: that there are no published studies which show a link with the vaccine. What does not appear to have been carried out is any investigation into whether the vaccine (particularly in its triple form: MMR) does or might cause autism. 70. Memo dated 2 October 1996 to all duty doctors CDSC Re alleged association between MMR vaccine and autism. We have a copy on file. The matter is worse than that. Dr. cites a study in Göteburg as being in complete support of her view that Autism is not on the increase: " However, good data on the incidence of autism is available from one study of autism conducted in Göteburg, Sweden. No change which could be explained by the introduction of MMR vaccine was found. " Sir Calman the Chief Medical Officer, in his memo of 7 February 1997 says: " However there is no evidence to suggest a causal link (with MMR) and good evidence against it. For example the annual incidence of autism was constant over a decade in Sweden, when MMR was introduced at the mid-point. " The study they are referring to is: " Is autism more common now than ten years ago? " (71) 71. " Is autism more common now than ten years ago? " Gilberg C et al. Br J Psych 1991; 158; 403-409. Putting it charitably, these public officials have made serious errors in the interpretation of the data as we hope the following overview will show: 1 Nowhere does the paper discuss or even mention vaccination. 2 The paper does not therefore state the coverage of MMR when it was introduced; or whether it was an " operational safeguard " type of exercise; or whether it was merely introduced into a childhood immunisation schedule. There is no information about uptake or demographic variations: Without such information the paper is entirely irrelevant to the subject of MMR damage. 3. The paper refers to three studies (not one), and all three are retrospective studies. 4. The criteria for inclusion in the studies are all different: Study 1 Screening date 1978 and 1980 Area covered: industrial area of Göteburg only Age group covered: Not stated, but presumably those born 1975-1980. Selection criteria: all forms of autism Study 2 Screening data: 1984 Area covered: The urban area of Göteburg and the rural area of the adjacent county of Bohuslän Age group covered: All children born 1975-1984 Selection criteria: all forms of autism Study 3 Screening date: 1988 Area covered: The urban area of Göteburg and the rural area of the adjacent county of Bohuslän Age group covered: Children born 1975-84 who had not been detected by screening 3 years earlier, but excluding children in the age range 0-3 Selection criteria: Autism and autistic disorders but excluding Aspergers syndrome. 5. The paper obviously does not set out to trace the incidence of autism over three discrete time periods. The last study sets out to include all those missed in the previous study. Therefore, although the paper does give some comparisons, it is essentially the study of one group: children born between 1975 and 1988. 6. It is not even true to say that the paper found no evidence for an increase in the prevalence of autistic disorders. The paper acknowledges that the rate of autism in the area has increased. It seeks to explain the phenomenon by reference to immigrant families (including those from adjoining countries - who may or may not have been vaccinated) and better diagnosis, but the study also excludes Aspergers syndrome (a condition suffered by many children after being given the MMR vaccine) and states that is Aspergers were included, the prevalence of autism would be many times higher. The concluding sentence of the paper reads: " Nevertheless the results of an autism rate about double that previously reported is in good accord with at least one recent study in the field. " 7 It is also wrong to state that the MMR vaccine in Sweden was introduced in the mid point of the study. MMR was introduced in Sweden in 1982, but the study excludes children under 4 (even though the paper acknowledges that " a number of very young cases was reported " (Page 405)). It means that, depending on the month in 1982 when MMR was introduced a maximum of 2 years of MMR vaccinated children could have been excluded, and it could have been much less than that. It is more accurate therefore to say that the vaccine was introduced 7/9ths the way through the study - rather a difference! Bearing in mind that the article acknowledges the difficulties in diagnosing autism in young children, it is highly unlikely that any effect of MMR vaccine would have been reflected in the studies, even if the authors were looking for it (which they were not). 8 In any event the study is very small. A total population of 78,106 children was involved. The technique used was to try to track down autistic children by making enquiries of those who might have been treating them, not to survey each one of those children. 9 Our experience is that the children most vulnerable to developing autism after MMR are under 2 at date of vaccination. Older children (e.g. those who were given the MR vaccination in 1994) are not apparently affected in that way. Assuming an even annual birth rate and that the vaccination was carried out under 2 years of age, only about 17,356 [78106 divided by 9 = 8678 (yearly birth rate) x 2)] children could possibly have had the MMR vaccine. The normal statistical rules of probability are that if a particular event is likely to occur once in every (n) children you would need a cohort of at least 3(n) children to expect even one occurrence. As the maximum number of children in this study given the MMR was 17,356, then to yield just one case that would have to be an incidence of MMR-related autism for every 5785 children vaccinated (i.e. 17,356 divided by 3). Unless it is suggested that the incidence of MMR-related autism is one in 5700, the Göteburg study could never have shown an increased incidence of autism. We make no apology for having dealt at such length with that study. If public officials are going to use the medical literature to support their contentions they should do so accurately and honestly. Bearing in mind the apparent dearth of studies on the vaccines and the autism link, the authorities are just not in a position to say one way or another. A paper was published in the British Medical journal in February 1996 (72) (and is cited by Dr in support of her arguments), but this acknowledges that only two published studies have attempted to examine the prevalence of autism. The first study was published in 1979. The second study was published in 1993 but it concerned children born between 1975-83 in Sweden. No studies appear to have been carried out in relation to the MMR vaccine (which was introduced in 1988) and no information which has come into existence since 1993 appears to have been considered. 72 Autistic spectrum disorders No evidence for or against an increase in prevalence. Wing L. BMJ 10 February 1996 Vol 312 pp 327-328 Dr 's concluding point is this: " The diagnosis of autism is generally made in the second year of life when MMR vaccine is given. Temporal associations between diagnosis and prior MMR vaccination are therefore to be expected by chance " It may be that a diagnosis of autism is not made until the second year of life, but with children who were autistic from birth the signs were probably there from an early state: " Wing (1989) has suggested that 'infantile autism' is congenital in approximately 80 per cent of cases. In the remaining 20 per cent there is either too scanty evidence from the medical history, or there are definite clues that the typical symptoms began sometime between 6 and 20 months. " (73) 73 The Biology of Autistic Syndromes; Gillberg and ; Mac Press; 2nd Edition (ISBN (UK) 0 901260 92 4) Page: 22 Important: It may be possible in many cases to prove whether or not children were developing normally if videos of their early life are studied by psychiatrists expert in child development. If you believe you child has become autistic as a result of vaccination, be sure to preserve any videos you have of his/her early life. The descriptions we are receiving from parents (who know their children better than anyone) are of children who develloped perfectly normally until they were vaccinated with MMR, and only then did they regress. Instead of simply dismissing the link between the vaccine and autism as coincidence we take the view that the PHLS has a duty to investigate the possibility that the two occur together because the vaccine might be a factor in the development of autism. We say so particularly because we have not yet had information about cases where the late onset autism preceded the vaccine: virtually all cases we have investigated in depth so far show that the affected child was developing perfectly normally until the vaccine was administered, with absolutely nothing to give cause for concern before the vaccination. Nonetheless, we acknowledge that we have to proceed very carefully. There are many insults to the human body as a result of life in the last decade of the twentieth century. Pesticides, agricultural chemicals, antibiotics, preservatives, pollution or junk food may be responsible for the changing pattern of this serious and distressing childhood condition. We certainly do not wish to cause alarm if it is clear that vaccines are in no way connected with autism. Yet a growing number of parents do believe that to be a link between the vaccines and autism, and have evidence to show that their children were entirely normal before the vaccination; and the the disintegration in their condition ties in closely with the date of the vaccination. This applies not only to children who were vaccinated at around 15 months, but also to children who were older (up to about 4 years old) when they were vaccinated. Biological Mechanisms of the link between the vaccine and autism Damage to children does not just happen. There is always cause, though sometimes doctors are unable to find it. " It is difficult to grasp the plausibility of the biological theory when faced with the apparent contradiction that in many children there may be no apparent medical condition that has caused the autism, and no mental handicap of epilepsy. However when groups of children with autism are studied, various medical conditions are found in association with autism more often that one would expect. The implication then is that in all cases some biological cause is likely to lie behind the autism, although currently this is only identifiable in a minority of cases. " (74) 74 From AUTISM THE FACTS by Dr Simon Baron-Cohen and Dr Bolton, Oxford Medical Publications 1993: p. 27. Indeed with autism the medical experts freely acknowledge that they do not know what causes it. The textbooks also indicate that late onset autism is unusual even within the complexity of the various autistic syndromes.: " Cases with documented set-back after a period of normal development are rare, but their relative frequency within the whole group is not known. " (75) 75 The Biology of Autistic Syndromes; Gillberg and ; Mac Press; 2nd Edition (ISBN (UK) 0 901260 92 4) Page:22 ....And that of course in the problem. As far as we can tell (and this book confirms) there have been very few studies at all into late onset autism. We have therefore been considering how the vaccine can be linked with autism. Our investigations indicate that there are biological mechanisms by which the components of the MMR vaccine can cause encephalopathy which leads to autism. It may be caused by immune complexes (molecules of antigens and antibodies linked together) blocking small blood vessels in the brain (76). See, for instance, this extract from the Practitioner of October 1967. Both the brain and intestine are both richly supplied with blood through a network of very small blood vessels. " Classical immuno-chemistry is based on the property many antibodies have of forming insoluble precipitates with homologous antigens. If a large excess of antigen is added to such a precipitate the mixture becomes soluble. These soluble antigen-antibody (immune) complexes have important biological effects. When injected into animals they can produce necrotizing vascular lesions and severe damage to glomeruli. Immune complexes of this nature can also be formed in vivo by simple immunisation procedures; if the animal does not produce too much antibody and the dose of antigen is correct, soluble immune complexes are elaborated and serum sickness results. The nature of the antigen and antibody may be entirely unrelated to the affected organ: for example, complexes comprised of bovine albumin and anti-bovine albumin can be highly nephrotoxic. Apparently, some physico-chemical property of the immune complex is responsible, at least in part, for the tissue damage. This can be demonstrated quite dramatically by an intradermal injection of soluble immune complexes. Within a few hours, a haemorrhagic, recrotic skin lesion (the Arthus reaction) appears. " Two factors in addition to the immune complex are important in the evolution of this lesion: polymorphonuclear leucocytes and complement. The complexes have powerful chemotactic effects, and, soon after their deposition, attract numerous granulocytes. These cells contribute to the lesion by releasing numerous lytic enzymes from their lysosomal granules. Complement is also drawn to the scene and since it, too, has enzymatic activity, further damage results. This mechanism is extremely important in the production of various forms of glomerulonephritis and vasculitis. The streptococcus may be the antigen in some cases of post-scarlatinal nephritis in man. In systemic lupus erythematosus there is important new evidence that a complex comprised of the antinuclear antibodies characteristic of that disease and DNA can provoke nephritis. There are now ample reasons for believing that any antigen-whether exogenous or endogenous - capable of eliciting the formation of a precipitating antibody, and hence a soluble immune complex, can form a soluble immune complex, can form a soluble immune complex, can for the basis of serious immune injury. Bacteria, viruses, chemicals, and drugs are certainly candidates in this important group of diseases. " (77) 77. Advances in Clinical Immunology by Schwartz Practitioner October 1967 pp. 514- Another Possibility Another mechanism (which may be present at the same time) is the formation of antibodies to myelin basic protein. Myelin basic protein acts like an insulating sheath around the nerve (not unlike the insulation around an electrical cable). Without this insulation, complex neuronal networks cannot be developed (and those that are developed will not work correctly). The process starts soon after birth and continues until ten years of age, but most of the myelin is laid down between the ages of 0 and 5 years. Below is a diagram showing the structure of a neurone (a single nerve cell). The distinguished neurologist Dr M Poser has drawn the link between the vaccines and demyelination. Almost any... vaccine can lead to a non infectious inflammatory reaction involving the nervous system... The commone denominator consists of a vasculopathy that is often... associated with demyelination. (78) 78 Poser C M. Neurological syndromes that arise predictably. Consultant. January 1987 pp 45-46 Myelin basic protein is also found in the chick embryos in which the vaccine is cultured. An inflammatory reaction or the production of antibodies against traces of myelin in the vaccine (79) can set up an autoimmune response against the body's own myelin. The effect of this would be a regression in development: 79 The manufacturers acknowledge the importance of removing the culture medium from the vaccine, and claim that modern MMR vaccine is not contaminated by any trace of the chick embryo (that includes yolk sac and egg albumen). However if this is the case, why would a hypersensitivity to egg be a contra-indication to all brands of the MMR and MR vaccines? " At present, a cause or effect relationship between antibodies to myelin basic protein and autism cannot be defined very well... We hypothesise that the development of humoral immune response to myelin basic protein should be regarded as the proponent of immunopathogenisis in a subset of autism. " ....if an immunological assault perhaps secondary to a virus infection were to occur prenatally or postnatally during infancy or early childhood, it could possibly result in poor myelination or abnormal function of the neuron-axon myelin. The latter may be a critical factor in the development of neurobehavioural problems in some cases of the syndrome and should be worthy of future research for the understanding of a pathological basis of autism. (80) 80 Antibodies to Myelin Basic Protein in Children with Autistic Behaviour. V.K. Singh, P Warren, J Dennis Odell, W Louise Warren and Phyllis Cole: Brain, Behaviour and Immunity Volume 7 pp 97-103 (1993) Similar views are expressed in a fact sheet on acute disseminated encephalomyelitis produced by the Encephalitis Support Group: " The association of the disease with an antecedent infection or immunisation suggests an immunological process and detailed laboratory studies involving measurement of anti-brain antibodies and of cellular immune responses to specific myelin antigens have shown that these patients indeed have mounted an allergic response against their own brain constituents. " (81) 81 Fact sheet 2: " Acute Disseminated Encephalomyelitis " ; Encephalitis Support Group; Paper written by Professor O Behan, Professor of Neurology, Glasgow University. A study of autistic patients made by an immunologist in the USA, Dr. H H Fudenberg included these findings: " Fifteen of the TA (true autism) patients developed symptoms within a week after immunisation with the measles, rubella and mumps vaccine (MMR): 3 had high fevers (up to 106o ) and convulsions within one day of administration; in the other 7 TA the symptoms gradually worsened in severity (e.g. gradual rather than sudden loss of vocabulary) with onset of clinical abnormality beginning between 15 and 18 months of age. " " Antibodies to myelin basic protein were present in 20/22 TA and in 4/18 PAS (Pseudo autistic syndrome) patients. " (82) 82 Dialysable lymphocyte extract (DLyE) in infantile onset autism: A pilot study. By Dr. H H Fundenberg. Biotherapy 9 (1996): page 144. The second extract in our view is extremely significant, because it provides a strong indication that the mechanism put forward in this part of the factsheet could well provide an explanation for the link between the MMR vaccine and autism. Another researcher in the field has reached a similar conclusion: In conclusion the in vivo activation of IL-12 [interleukin-12] and IFN-y [interferon-gamma] in patients provides an important clue to the mechanism of autoimmunity, a pathogenic factor for autism. Based on a regulatory feedback between IL-12 and IFN-y (a cytokine of Th-1 cells) it is suggested that antigenic stimulation of TH-1 cells may be involved in autoimmune pathogenesis of autism. In this respect, brain-derived myelin basic protein (MBP) may serve as a candidate autoantigen since it induces macrophage-inhibition factor (Weizman et al. 1982), autoantibodies (Singh et al. 1993) in many autistic children. This however is one possibility while others remain to be investigated. " (83) 83 Plasma increase of interleukin-12 and interferon-gamma: Pathological significance in autism. Vinjendra K. Singh; Journal of Neuroimmunology 2915 [1996]. We have also found this observation from Dr Sudhir Gupta: " One of the striking features in all autistic patients that we have studied is a strong association between immunisation with MMR and the development of autism (regressive autism) " (84) 84 Immunology and Immunological Treatment of Autism. Conference paper delivered by Dr Sudhir Gupta MD PhD, Department of Medicine, University of California. Dr Gupta has also stated in a paper: " We theorised that the high titers of rubella antibody (>1280 vs. normal <320) present in mothers of children with autism would be transplacentally transferred and may also persist for a prolonged period in the child. When such a child gets MMR immunisation, rubella antigen may complex with pre-existing antibodies and such complexes might play a role in the pathogenisis of autistic features. " (85) 85 Taken from: Dysregulated Immune System in Children with Autism: Beneficial Effects of Intravenous Immune Globulin on Autistic Characteristics by Sudhir Gupta et al. Journal of Autism and Development Disorders Vol 26 No 4. 1996. One possible reason for a child's immune system being incapable of coping with the vaccine might be a genetic deficiency in one of the complement proteins (86) which are essential for the triggering of a normal immune reaction. 86 Complement forms a system of 18 proteins which are an integral part of the immune system reaction to an antigen wuch as a bacterium or virus. " Conceivably, human subjects one ot two C4B null alleles [a deficient form of complement C4B gene] may not be able to clear certain viruses completely or before the viruses affect the central nervous system..... It seems possible that C4B deficiency is associated with a sub-group of autistic patients " (87) 87 Decreased Plasma Concentrations of the C4B Complement Protein in Autism Author9s): Warren R P, Burger R A, et al. Publication: Archives of Pediatrics and Adolescent Medicine Vol. 148 P 180-183) Date: February 1994. The link with disease (particularly rubella) is also acknowledged in The Biology of Autistic Syndromes: " Rubella in utero has been shown to cause an altered immune response in some infants owing to the prenatal viral insult (South and Alford 1973, Fuccillo et al. 1974). Lack of antibody response to a previous vaccination is helpful in diagnosing retrospectively an episode of prenatal rubella. Stubbs (1967) checked rubella titres in 13 children with autism who had had a previous rubella vaccination. In contrast to controls, five of the 13 children with autism had undetectable titres in spite of a previous vaccination. However, in the same study, a rubella vaccine challenge did not differentiate children with autism from the control subjects. " (88) 88 The Biology of Autistic Syndromes; Chtistopher Gillberg and ; Mac Press; 2nd Edition (ISBN (UK) 0 901260 92 4) page: 134 This chapter in the book concludes: " A great deal more work is needed before it is fully understood how the immunological factors in patients or families chould predispose to the infectious aetiology of autism... " (89) 89 Ibid. Page 135. We would agree, but we would also repeat that it is clear the Department of Health are in no position to assert that a vaccine containing the measles mumps and rubella viruses has no link with the late development of autism. Clearly a number of researchers have independently begun to point to immunisation (particularly with rubella) as a risk factor. A US Court case involving autism. We have a copy of the judgment of the United States Court of Federal Claims of Lassiter v Secretary of the Department of Health and Human Services. (90) This case involved the DPT vaccine but the biological mechanism of damage is identical. We quote below from the judgment: 90 Case 90 - 2036V Filed: December 17 1996. " Doctors Steffenburg and Gillberg list many disorders, 22 in all, which have been associated with autism. They conclude that autism is not a disease but 'represents a behavioural syndrome with multiple etiologies.... Autism can be the final common expression of various contributory/etiological factors.' They explain further that genetic factors are in operation in some cases. 'Disease entities or pre- and prenatal damage leading to destruction/dysfunction in certain brain areas can cause autism in others.' 'The Etiology of Autism,' (91) 91 P Ex 21 at 65, 73-75 Diagnosis and Treatment of Autism. Gillberg ed, Proceedings of the State-of-the-art-Conference on Autism: held May 8-10 1989 in Goteborg Sweden. " Dr Gerhard Bosh states in his treatise on 'infantile Autism' that various factors or noxae working together can cause autistic symptoms, either triggering the autistic symptoms, either triggering the autistic behaviour or intensifying the effect. (92) 92. P Ex 20 at 130 He explains further that as a result of 'cerebral affections suffered in early childhood a clinical picture could develop that would be indistinguishable from that of infantile autism.' He cites case reports in which insults to the brain were followed by onset of infantile autism.' Autism can occur or be closely simulated in children with known organic brain damage.' Other etiologic factors include complications at birth, prenatal damage, infectious diseases, encephalitis. 'In one case an indeterminate post-natal feverish illness occurred, after which the development of the child is said to have changed.... Symptomatologically equivalent cases of autism [can be caused] by cerebral-organic damage.' (93) 93. Ibid. at 132-134 " In his treatise entitled 'Recent Neurological Findings in Autism,' Luke Y Tsai also lists a similar variety of established neurologic disorders reported in autism including viral infections and other toxic or environmental causes of brain damage. He explains that it is now well accepted that autism results from dysfunction in certain parts of the central nervous system (CNS) that effect language, cognitive and intellectual development, and the abillity to relate. He believes that autism may be 'the commone pathway of a diverse range of organic brain conditions' including both prenatal and post-natal infections or injuries, the latter accounting for those whose autism is manifested 'after a period of apparently normal development " (94) 94. Ibid. at 83-84 P Ex 21. This extract from judgement in Lassiter v Secretary of the Department of Health and Human Services taken from pages 7-8. We currently do not have the texts referred to, but these are on their way, and presumably the judge summarised the medical literature accurately. <,p> Note: the court found in favour of the autistic claimant. The enigma of autism - some thoughts of our own. The apparent link between autism and the MMR vaccine troubles us greatly. It is also controversial, with the Department of Health firmly dismissing any possible link, and the parents of affected children being convinved of it. Certain facts seem undeniable: 1 The children all had the MMR vaccine. 2 Before they were vaccinated they were (according to their parents) developing perfectly normally, passing all milestones, demonstrating norrmal skills, and showing none of the classical signs of autism. Indeed in many of the cases we have studied in detail, the children appear to have been advanced in their development. 3 After being vaccinated they regressed (sometimes within only a few days), losing mental, physical and social skills. Many are so severely handicapped that they have to have constant supervision and are subject to educational 'statementing'. 4 It is quite clear that medical science has, as yet, no explanation for autism. There are plenty of theories, but no answers. Late onset autism seems to be particularly perplexing to those investigating autism, with the strong suggestion that it must have been there from birth, but was simply not observed (or did not manifest itself until later): " The abnormality in the brain which causes autism may well, in certain cases, have been there from before birth, but before a certain age, the nervous system is able to deal with the demands posed by development. Gradually, the brain can no longer fully cope with these demands and the autistic symptoms appear clearly for the first time. In such cases 'autism', even if congenital, will appear to have its onset after infancy " (95) 95. The Biology of Autistic Syndromes; Gillberg and ; Mac Press; 2nd Edition (ISBN 9UK0 0 901260 92 4) page 57 5 It is however acknowledged that autism can be 'caused' by some insult. " In other cases, however, it is clear that the autistic syndrome developed after some particular postnatal brain affliction such as herpes encephalitis " (96) 96. The Biology of Autistic Syndromes; Page: 61. See also the report on the Lassiter case (above) This seems obliguely to be acknowledged even by the Government's Chief Medical Officer: " It is therefore highly unlikely that MMR vaccine plays a part in the development of autism in children who do not have significant neurological manifestations after immunisation " (97) 97. Memorandum to all Directors of Public Health reference EM/CMO/97/3 dated 7 February 1997 from Sir Calman, Chief Medical Officer, Department of Health. The inference is that he concedes that MMR does play a part if there is a " significant neurological manifestation " . Although there is sometimes an immediate reaction to vaccination, our experience suggests that this is not necessary to produce autism or other adverse reactions. Deafness, for instance, is often not accompanied by any noticeable reaction. (98) 98 See, for instance: Sensorineural hearing loss following live measles virus vaccination Author (s): Letter: JG, Publication: International Journal of Pediatric Otorhinolaryngology Vol. 19: pp 189-190) Date: 1990 But, the autism reported to us by parents is showing itself at about the same time as it did in children before the MMR vaccine was introduced. It is also appearing in the same ratio (4 to 1 in favour of boys) as it has always done. If it were happening independently of the vaccinations, then it would show the same pattern. What is there to indicate that autism after vaccination is in any way different from autism which occurred in the general population before MMR and (measles) vaccines were introduced. First of al there is the congenital autism (estimated as occurring in 80 per cent of cases) (99). 99 The Biology of Autistic Syndromes; Page: 22 If this percentage is correct, then the majority of autistic children were doomed from birth to develop the symptoms, which will show themselves in the normal manner. What we are therefore concerned about is the remainder which will include those where some event happened to bring on the autistic symptoms. It is also likely to be a sub-set: we have already noted that it is described as 'atypical' autism. Many of the children do not conform exactly to the classical definition of autism. That may give a clue. Secondly, in this section of the fact sheet, we have highlighted the concerns and findings of doctors and scientists investigating autism and its possible links with MMR vaccine. They have certainly noted a connection with the vaccine, and with the same viruses in the vaccine (especially rubella). Thirdly, we have described ways in which the vaccine might cause autism, in other words, there is biological plausibility. Fourthly, we have noted that there is anecdotal (and sometimes direct) evidence of a significant increase in autism in this country. If the incidence of autism is rising above normally expected levels, then something must be causing it. Fifthly, even though the link between autism and vaccines is rejected by the government, nobody knows what does cause it. No records are kept centrally of the incidence of autism. This state of affairs was the subject of criticism by the House of Commons Health Committee: " We are concerned at the failure of the DoH(Department of Health) to collect information centrally on autistic children and to issue specific guidance on services for such children. " (100) 100 Commons Health Committee: Second Report. The Specific Health Needs of Children and Young People; Volume 1; 10 February 1997; Paragraph 105. What, inevitably, they must therefore be saying is " We don't know what is causing it but we know it is not the vaccine " (a difficult argument to sustain). Sixthly, we have the accounts of more than 280 parents who believe that their children were indeed normal before they were vaccinated, and who can point to nothing (other than the vaccination) which could account for the deterioration in their child's condition. Seventhly, we have the links with inflammatory bowel disease (see below). About half of the vaccinated children with autism have some form of chronic intestinal problem. Furthermore, their autism improves (but is not cured) if the bowel inflammation is reduced. It might well be possible to show involvement with the vaccine virus in respect of the intestinal conditions. But it goes further than that. We know of experts who believe that there is a connection between autism and peptides leaking through the gut wall. " Our results show that in some patients with infantile autism damage to tight junctions of the gut mucosa as evidenced by IPT occurs in the absence of established gastrointestinal disorders. Such alteration could represent a " possible " mechanism for the increased passage through the gut mucosa of peptides derived from foods. " (101) 101. Abnormal intestinal permeability in children with autism: D D'Eufemia et al. Acta Paediatr 85. 107609. 1996. p. 1078 Damage to the gut wall is caused by inflammatory bowel disease, and it looks likely that we will be able to show that the vaccine causes that condition. Therefore, through this route alone, it follows that there is a clear possible link with the vaccine. Our tentative conclusing is therefore this: If after very careful history taking (plus examinations of photographs, videos, medical records and so on) it can be shown objectively that a child was developing normally and had acquired social and other skills which were within normal range (and which showed none of the hallmarks of autism) prior to being vaccinated; and if there as no other event which could account fot he condition, then in all probability the MMR vaccine has played a part in the cause of autism. We emphasise that our views are tentative. But in legal terms we would certainly assert that there is a case to answer. Inflammatory bowel disease and Autism As we have already mentioned, there also could be a link between the two conditions (Crohns and Autism) AND the measles element of the vaccine. Our work also indicates a clear biological mechanism for the two conditions. Indeed many children with autism have chronic bowel disorders. There have been some striking improvements in the autistic condition of some children after their bowel problems have been appropriately treated. If your child has developed persistent stomach problems (including stomach pains, constipation or diarrhoea) following the vaccination, ask us for a fact sheet from Dr Wakefield (who is looking into Crohns disease). Conclusion. Return to menu Top of Page We have gone into the matter in some considerable detail because we feel that it is time to make it clear that vaccine damage is not some capricious concept, but is very real, and is demonstrable using scientific principles. The families with injured children have not been treated well; and it has not helped them to have all their concerns dismissed by those who are responsible for vaccination programmes. The Vaccine Damage Compensation Scheme (see our Vaccines General factsheet, and our factsheet on Vaccine Damage Payments) is a disgrace. It pays a fixed sum of £30,000 but parents have to prove that their children are 80% disabled as a result of the vaccine. In reality it costs more than £30,000 a year to care for a seriously disabled child. This kind of payment is regarded by many as an insult to the families whose children have been seriously injured. Yet the government has no plans to increase it. " The current levels of payment, according to the HEA (Health Education Authority) research do not appear to deter parents from agreeing to immunisation, and the Government recently made it clear that it has no plans to review the scheme, stating that it operates fairly and effectively in its present form... " (102) 102 From: Vaccines and their Future Role in Public Health. Parliamentary Office of Science and Technology July 1995 page 42. We wonder if parents would think the same about the Vaccine Damage Compensation Scheme if they knew its limitations, and had a chance to read the datesheet on the MMR/MR vaccines and to find out other information about the vaccine before having their children vaccinated. One mother (whose child is now autistic) wrote to us recently: " If I knew then what I know now, I would have allowed Sophie [the name has been changed] to take her chance and have measles. " Those exact sentiments were also expressed at a recent meeting of concerned parents by the mother of a sixteen year old boy who died a few days after receiving the MR vaccine. 's moher (see under autism) has also written: " The best way to describe the last 9 months is that I have grieved fo the son I thought I had. In order for the maintenance of my own sanity I have to live for the day and do the best that I can for my own family. I have given up my career of teaching to look after . I do not begrudge giving my children my time. I also do not resent losing my income. What I do resent is the battle I have had to have investigated and the fact that I was not informed about the side effects of the MMR. Parents give their consent to vaccination to prevent illness not to cause their children damage. In hindsight if I had known the side effects of the MMR I would not have had my children inoculated. I would have taken the risk of them getting the diseases. Children are not the Government's guinea pigs and they need to face up to their responsibility that vaccinations can cause damage. " 's mother writes (103) 103 Again the name has been changed. He is 5 years old. He was a really bright little boy before he received the vaccine at three and a half years old. " has severe mental impairment brought about by encephalitis after having the MMR injection. He has no speech, no understanding of language at all, no concentration, bizarre behavioural problems and rarely acknowledges anyone. He has become very strong and aggressive. He is having constant tantrums, screaming and flinging himself to the ground and biting anyone who tried to restrain him. He is very frustrated and agitated most of the time. " When he is at home takes up 99% of my time. I cannot give my two other boys the attention they need. Looking after such a mentally impaired child is extremely wearying and detrimental to family life. " Our son was once a bright, happy, normal child who could speak and love everyone. Now we all suffer the dreadful sense of loss, and the sadness and strain is taking its toll on our marriage. " On the frustrations of persuading some members of the medical profession to accept even the possibility that the vaccines are implicated with damage. 's (104) mother writes. 104 Not the true name. " The paediatrician told me of the neurologist's opinion that the damage to the white matter of the brain had probably occurred before birth. I responded by tellling the paediatrician that this made no sense whatsoever as had been a healthy normal baby up until the age of 16 months when he had the MMR vaccines. He said that he was only stating the neurologist's opinion and went on to agree that it seemed as if were struck down by something at about that age, die to the fact that he was walking and talking. He went on to say that damage occurring in the newborn child usually meant that it was a progressive problem and within the first months of life would generally show itself and continue to progress until such time as it became very serious and often the child would die. Payl's MRI scan had showed a global damage to the brain. " I was upset and told him that in view of what he had just told me it seemed more than ever that it was definitely the vaccine that had caused the brain damage in . I went on to say that I was angry that no one would begin to look at the obvious and examine the possibility that vaccines could cause such damage in children. I stated that there were probably many more cases that have been diagnosed as autistic or autistic tendencies when the reports were made by people like the neurologist who from the very first meeting with had labelled him autistic. I asked him if he thought that the neurologist would agree that the evidence would indicate that there was a possibility that the MMR had been responsible. He stated that he did not see how he could not say that there was a possibility. I said that he would definitely find a way as he was so anti the idea the MMR could cause such damage. He said that he would write to the neurologist and ask him that very question. I said that I needed someone to say that it was possible. I asked him to speak out and report it to the Medical Officer of Health. He began to tell me of the implications involved. That parents would panic, I agreed, and said that I was aware of that. He said that the government wouldn't like it. I agreed and he also mentioned litigation. I said surely if it was to save further children it was necessary that someone speak out. He said that his hands were tied. I said yes but mine are not. He agreed. " I was in tears at this time and said that I needed someone to say that it was possible that the vaccine had caused 's brain damage. He did then say, 'Yes of course there is a possibility.' " We are not saying that all injuries suffered after the MMR or MR vaccination are automatically caused by the vaccine. But we are saying that our own investigations give cause for considerable concern that the vaccines may not be safe (or for that matter measles mumps and rubella are not as dangerous) as they are claimed to be. If we, with our very limited resources, have been able to point to possible links between the devastating conditions suffered by the children we are helping and the vaccines, then it should not have been difficult for the Government or the manufacturers of the vaccines to do so. We are not reassured about the Government's efforts to identify or act on information about the side effects from Pluserix or Immravax when problems occurred with those vaccines. There is no doubt that the children we are helping are now ill or disabled (many very seriously). All have had the MMR or MR vaccine and in the vast majority of cases there is no event other than the vaccination which could account for the injury. If a teenager takes Exstasy and becomes ill or dies, it is Immediately concluded that the illness or death was caused by the drug. Similarly if a child becomes disabled after having measles or mumps, the natural diseases are always blamed. But if a child becomes ill or dies after vaccination, it is dismissed as mere coincidence. We would like to see doctors, health authorities and the Government show a more open mind on the subject of vaccine side effects. Considering the number of children already known to us to be ill or disabled after vaccination, that is not asking a lot. Health professionals must always bear in mind one of the tenets of medicine: " Primum non nocere' " (105) 105 Firstly, do no harm. It may be that vaccination against measles mumps and rubella is justified. If that is the case, then those who suffer the down side should be properly taken care of; and full information about the reality of vaccination risks should be made available to all who require it. But if the risks are greater than we have been told, then the Department of Health has an urgent duty to review its vaccination policy. Measles is always claimed to be a dangerous disease. If it is, why not restrict vaccination to measles only for children? Mumps has never been claimed to be serious. With rubella the risk is generally associated with birth defects. When the Japanese found problems with MMR they changed over to single antigen vaccines. It could be done here too. Alternatively the age of vaccination could be changed. If our information is correct, then the majority of very serious side effects (but not all) relate to the MMR vaccine administered at 15 months (as opposed to the MR vaccine which was given to school children). Would the side effects be less devastating if small children were given MMR at, say, 30 months? We are happy for you to send a copy of this fact sheet to your doctor. It should be made clear that we are investigating claims against the vaccine manufacturers and the government not the doctors who in good faith administered these vaccines. We hope however that what we have said will be of interest to practitioners, and we can supply a copy of any of the references we have given. We repeat that this factsheet does not give medical advice, and nor does it seek to persuade anyone to have, or not have, a child vaccinated. If you believe your child has been damaged: We will be glad to try to help if you believe your child has been damaged by the vaccine. We do not want to raise false hopes. It will not be a easy task. There will be many hurdles to overcome. The only promise we can make is that it will be a long hard struggle. Nonetheless we propose to seek proper compensation in the courts, but we will also help with applications to the Vaccine Damage Tribunal. Alternatively if you have your own solicitor we will be happy to provide assistance to him or her; we are helping a number of firms of solicitors under our contract with the Legal Aid Board to investigate claims arising from the MMR and MR vaccines. The first thing to do is to get the facts, and then to apply for legal aid (parent's finances are not taken into account in applications for children). We (or your solicitor) will take care of the paperwork. Ask us for more details. We have more fact sheets on the tollowing. If you believe your child may have been damaged by vaccines, ask us for copies: Vaccines General (this gives contact addresses) Medical Accidents and claims Consumer Protection Act Vaccine Damage Payments Act claims. In the interests of balance: The Department of Health has now produced its own fact sheet on MMR vaccines. Needless to say, it takes a somewhat different approach from this factsheet. Your GP should be able to supply you with a copy, or alternatively you can contact the Department of Health, Welllington House, 135-155 Waterloo Road, London S.E.1. 8UG. If you need any further information (or further copies of this fact sheet) please feel free to contact: Barr (partner) or Kirsten Limb (Medical/scientific investigator) at Hodge & Solicitors. Return to menu Top of Page ------------------------------------------------------------------------ Sheri Nakken <vaccineinfo@...> wrote: Booster shots for Pertussis and now this...this is an emerging pattern, and unfortunately our health " experts " don't recognize that the increase in adult incidence of these diseases is a direct RESULT of our mass vaccination policy. Apparently the only remedy they can come up with is more vaccines. Follow the money. Dave Nationwide Campaign for Vaccination of Adults Against Rubella and Measles --- Costa Rica, 2001 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5044a2.htm [MMWR 50(44):976-979, 2001. Centers for Disease Control] In 1999 in Costa Rica, a large rubella outbreak occurred among persons aged 15--45 years. In response, the Ministry of Health adopted the goal of eliminating rubella and congenital rubella syndrome (CRS). In 2001, a nationwide vaccination campaign reached approximately 1.6 million (>95%) persons aged 15--39 years. This report highlights successful aspects of the campaign, including effective planning, cooperation among government ministries, social mobilization, the use of house-to-house vaccination teams, daily coverage reports from local staff, vaccine safety monitoring, and strategies for ensuring a sufficient national blood supply. This campaign will strengthen measles eradication and lead to rubella and CRS elimination in Costa Rica. In Costa Rica, measles vaccine was introduced in 1967, the combined measles-rubella (MR) vaccine in 1972, and measles-mumps-rubella (MMR) in 1986 as a single dose for children at age 12 months. Since 1992, a second dose of MMR vaccine has been recommended for children aged 7 years, and nationwide campaigns were conducted in 1992 (targeting children aged 1--4 years), 1997 (targeting children aged 1--14 years), and 1999 (targeting children aged 7--14 years) (Figure 1) [1]. In 1996, a nationwide serosurvey indicated that rubella immunity was lowest (46%) among persons aged 15--24 years [2]. In 1999, a rubella outbreak, in which 906 (84%) of 1,083 cases occurred among persons aged 15--45 years, prompted an MMR campaign among children aged 7--14 years (Figure 2). Figure 1 Figure 2 On the basis of age-specific data on the incidence of rubella, age-specific fertility rates, and the risk for CRS during pregnancy, 30 CRS cases were projected to occur following the 1999 outbreak. In response, the Ministry of Health implemented a national rubella and CRS elimination program that included MR vaccination* for persons aged 15--39 years, in accordance with World Health Organization recommendations [3--5]. Measles-containing vaccine was used in this campaign to maintain elimination of measles in Costa Rica. The last confirmed case of measles was reported in September 1999. During May 2001, the Ministry of Health and the Social Security System collaborated to vaccinate >95% of the adult population. The ministries of education and labor, worker's unions, religious leaders, community associations, student federations, university representatives, entrepreneurs, and local governments assisted with communication and social mobilization. During the 2 weeks preceding the vaccination campaign, news-papers, radio, and television stations informed the targeted adults about the importance of vaccination. During the campaign, vaccine was offered at health units and locations convenient for the target populations (e.g., malls, universities, and workplaces). In addition, mobile teams went house-to-house from sparsely populated areas to densely populated areas. Reports of doses administered were submitted daily by health units and periodically by selected workplace vaccination programs. These reports were used to estimate regional and national vaccination coverage by age group, sex, and canton (i.e., district) of residence. During the 4 weeks of the campaign, coverage of persons aged 15--45 years increased from 30% at the end of week 1, to 61%, 80%, and 98% for subsequent weeks, respectively. A total of 1,635,445 persons were vaccinated, representing 42% of the country's population [6,7]. Vaccination coverage? by age group was 111% (aged 15--19 years), 92% (aged 20--24 years), 93% (aged 25--29 years), 87% (aged 30--34 years), and 106% (aged 35--39 years). Coverage was >100% in the youngest and oldest targeted age groups because of the inclusion of vaccinated persons either younger or older than the targeted age. Vaccination coverage was at least 80% in all 81 cantons and 95% in 60 cantons. Vaccine safety surveillance conducted by the Social Security System using a passive reporting system detected 981 events (rate: 60 per 100,000 vaccinated persons) possibly related to vaccination, including rash (26%), lymphadenopathy (16%), fever (15%), headache (10%), and arthralgias or arthritis (10%). Of >1.6 million doses administered, health-care workers reported five needlestick injuries at the time of vaccine preparation out .. Women aged 15--40 years known to be pregnant (56,634 [7%]) at the time of the campaign were not vaccinated and will be vaccinated after delivery. Vaccinated persons were not eligible to donate blood for 1 month after vaccination, and blood donations decreased 52% in May compared with the previous 12 months. To maintain the blood supply, information about blood donation was distributed to persons not targeted for vaccination; persons aged 40 years had accounted for approximately 25% of blood donations before the campaign. During and immediately after the campaign, this group accounted for approximately 95% of donations. Blood donations returned to normal in July. Surveillance for measles and rubella in Costa Rica is integrated with the surveillance of febrile rash illnesses, including dengue fever and leptospirosis. In conjunction with the MR vaccination campaign, rubella and CRS surveillance protocols were updated, laboratory capabilities for isolating and identifying rubella virus were upgraded, and training programs were conducted for staff at the national epidemiologic surveillance unit. Reported by: Ministry of Health; Social Security System, Costa Rica. Div of Vaccines and Immunization, Pan American Health Organization, Washington, DC, Div of International Health, Epidemiology Program Office; Epidemiology and Surveillance Div; Global Measles Br, Global Immunization Div, National Immunization Program, CDC. Editorial Note Adults are difficult to reach with mass vaccination campaigns possibly because vaccination usually is not considered part of adult health care. Aspects of the design and implementation of this vaccination campaign can serve as a model for other countries that want to eliminate CRS and rubella. Complete demographic information about the target population obtained through an up-to-date census or registry is useful in assuring adequate vaccine and staff, targeting the campaign to appropriate areas, and estimating coverage. Supplemental outreach activities can reach immigrants and persons residing in remote areas. Coordination between national authorities and local campaign organizers can avoid the occurrence of dangerously lowering blood reserves. Strategies include conducting a blood drive before the vaccination campaign, selecting a pool of donors to be vaccinated after the campaign, and offering incentives for blood donation among persons aged 40--60 years. Safety data should be gathered in a timely fashion to ensure the safety of vaccine and to address concerns about adverse events. The low number of needlestick injuries reflects the appropriate biosafety training given to vaccinators before the campaign. To maintain the goals of measles, rubella, and CRS elimination, Costa Rica will need to 1) achieve and maintain coverage 95% with measles- and rubella-containing vaccine at both scheduled vaccination opportunities or conduct periodic mass vaccination campaigns; 2) continue surveillance for measles, rubella, and CRS; and 3) adjust their vaccination strategy in response to new surveillance information. * MR vaccine manufactured by Serum Institute of India. ? Measured by the number of doses of rubella-containing vaccine administered to persons in the age group divided by the total population in that age group and multiplied by 100. References 1.Morice A, Castillo-Solorzano C, Depetris A, et al. Impact evaluation of rubella vaccination on incidence of rubella and congenital rubella syndrome in Costa Rica [technical report]. San , Costa Rica: Ministry of Health, August 2000. 2.Sáenz E, González L, Morice A, Castillo-Solorzano C, Depetris A. Rubella seroprevalence in school age children and women in childbearing age, Costa Rica. San , Costa Rica: Ministry of Health, 2000. 3.Ministry of Health. Plan to eliminate congenital rubella syndrome and measles eradication. San , Costa Rica: Ministry of Health, February 2001. 4.Pan American Health Organization. Expanded Program on Immunization, EPI Newsletter. February 2001;23:1--3. 5.World Health Organization. Control of rubella and congenital rubella syndrome (CRS) in developing countries. Geneva, Switzerland: World Health Organization, 2000; document no. WHO/V & B/00.03. 6.Ministry of Health. Final report of the national immunization campaign against measles and rubella in men and women 15 to 39 years. San , Costa Rica: Ministry of Health, 2001. 7.Pan American Health Organization. Expanded Program on Immunization. EPI Newsletter. August 2001;23:1. << All opinions expressed are mine, not the University's >> =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= National Center for Microscopy and Imaging Research Programmer/Analyst University of California, San Diego dfoster@u... Department of Neuroscience, Mail 0608 (858) 534-7968 http://ncmir.ucsd.edu/ =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= " The reasonable man adapts himself to the world; the unreasonable one persists in trying to adapt the world to himself. Therefore, all progress depends on the unreasonable. " -- Bernard Shaw -------------------------------------------------------- Sheri Nakken, R.N., MA Vaccination Information & Choice Network, Nevada City CA & Wales UK $$ Donations to help in the work - accepted by Paypal account vaccineinfo@b... (go to http://www.paypal.com) or by mail PO Box 1563 Nevada City CA 95959 530-740-0561 Voicemail in US http://www.nccn.net/~wwithin/vaccine.htm ANY INFO OBTAINED HERE NOT TO BE CONSTRUED AS MEDICAL OR LEGAL ADVICE. THE DECISION TO VACCINATE IS YOURS AND YOURS ALONE. Well Within's Earth Mysteries & Sacred Site Tours http://www.nccn.net/~wwithin International Tours, Homestudy Courses, ANTHRAX & OTHER Vaccine Dangers Education, Homeopathic Education CEU's for nurses, Books & Multi-Pure Water Filters Quote Link to comment Share on other sites More sharing options...
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