Is Mass Vaccination with B.C.G. always warranted in the Scandinavian Countries?
Is Mass Vaccination with B.C.G. always warranted in the Scandinavian Countries? Is Mass Vaccination with B.C.G. always warranted in the Scandanavian Countries? Reprinted from "The Medical Review" Published by the National Anti-Vaccination League 1957 INTRODUCTION After upholding inoculation with B.C.G. for nearly thirty years, Prof. Wallgren and other Scandinavian tuberculosis experts have come to the conclusion that mass vaccination with B.C.G. should be stopped. Prof. Wallgren would do this gradually; Dr. Heimbeck and others would do it at once. Dr. E. Carrol Palmer, a United States expert, opposes the introduction of mass B.C.G. inoculation into the States. In Gt. Britain there was, for many years, considerable reluctance to introduce tuberculin testing and B.C.G. inoculation, but pressure from groups of doctors who based their support of B.C.G. on claims made by Prof. Wallgren and other Scandinavian doctors induced the Ministry of Health and the Department of Health for Scotland to permit a limited amount of tuberculin testing and B.C.G. inoculation. In November 1953 testing of school-leavers and inoculation of those giving a negative reaction, were sanctioned. In February 1956 a committee of the Medical Research Council issued what appeared to be a favourable report on the use of B.C.G. which was, however, severely criticised by a Northern Ireland doctor. In view of these facts it is of the greatest importance that Scandinavian doctors who were the pioneers of B.C.G. inoculation are now advocating the cessation of mass inoculation and appear to be looking forward to the general discontinuance, eventually, of the whole system. The debate on this subject which took place towards the end of 1955, was reported in Nordisk Medicin for January 6th, 1956. The whole of the debate has been translated into English and the following pages contain a summary of the arguments put forward by the experts who took part in this debate. It is of vital importance that medical officers of health and others should be made aware of this development in Scandinavia. Dr. Wallgren’s conclusion that the almost universal use of B.C.G. inoculation in Sweden has not been an important factor in bringing about the decline of tuberculosis mortality, will be noted by those who read this brochure. Dr. Wallgren also intimates that while only five cases of B.C.G. disease have been reported, four of them fatal, there may have been others which have not been reported. In France and Germany there have been reports of children dying from the effects of B.C.G. vaccination. These cases have not been admitted officially, but parents, and in some cases medical advisers, have been convinced that the fatal illness had been caused by B.C.G. inoculation. Indian doctors in letters to Indian newspapers have reported many instances of injury to health caused by B.C.G. inoculation. There is every reason to believe that the inoculation has done a great deal of harm. There is still time for English and Scottish medical officers of health to discontinue the whole system of tuberculin testing and B.C.G. inoculation of tuberculin negatives. An unprejudiced study of this brochure should convince them that there should be no delay in revising their opinions on this matter.L.L. Is Mass Vaccination with B.C.G. always warranted in the Scandinavian Countries? Professor Wallgren, introducing the discussion on Mass Vaccination with B.C.G. in the Scandinavian Countries (Nordisk Medicin 5.1.56) said that when the Calmette vaccination was introduced into Sweden about a quarter of a century ago, the tuberculosis situation in that country was quite different from what it is at present. Mortality from tuberculosis was high. The number of cases of pulmonary tuberculosis was high in relation to the beds available, the waiting period for entry to hospitals being in consequence very long, the number of sources of infection was high and cases of infection abundant for all. Infants and young children became infected, often with fatal consequences, meningitis and miliary tuberculosis often occurred in early childhood, and primary pulmonary tuberculosis was also a cause of death in that age group. About 35% of all children infected in the first year of life died. Thereafter the mortality dropped very rapidly, being hardly 1% for children of school age, after which it rose again as from puberty. The Calmette vaccination came as a way out of the difficulties. Professor Wallgren shows how tuberculosis mortality dropped among babies after Calmette vaccination and when measures taken in conjunction therewith were applied. (In this connection it may be pointed out deaths from tuberculous meningitis in Denmark dropped from 420 (13 per 100,000) in 1921 to 185 in 1935 (5 per 100,000) without any claim that the drop was due to B.C.G. For England without B.C.G. deaths from tuberculosis of meninges and central nervous system dropped from 5,467 in age class 0—4 in 1931—35 to 218 in 1952.—Ed.) Wallgren claims that B.C.G. vaccinated children showed greater resistance to virulent infection than those not vaccinated with B.C.G. Gradually the mass vaccination of children came into being. Tuberculin testing for school children was made compulsory, babies at maternity clinics and children at the beginning and end of school age were inoculated after being tested. They justified the B.C.G. vaccination of tuberculin negative pupils in the upper forms by the belief that there was reduced resistance to tuberculosis in adolescent years, and by the assertion that when they left the parental roof a large proportion of the children would be exposed to infection with tuberculosis. (Note: They always assumed, without proof, that B.C.G. would protect.) Wallgren then shows how the tuberculosis situation has changed. Children, even in the youngest age group, rarely die of tuberculosis. Tuberculosis morbidity is also rare in young children and generalised forms of tuberculosis, meningitis and miliaris have become very uncommon. A few cases of clinically fresh primary tuberculosis occur in children’s hospitals, but the sanatorium departments for children which are still open are mainly social and not determined by real hospital needs. Wallgren then took up the problem for discussion, at the request of the Editorial department of the journal, and asked the following three questions: 1. What can B.C.G. vaccination be deemed to perform in the most favourable case? 2. What part can mass B.C.G. vaccination be deemed to have played in the occurrence of the present low tuberculosis mortality and morbidity? 3. What are the prospects for the future of B.C.G. in our country? 1. What can B.C.G. vaccination be deemed to perform in the most favourable case ? In answering this question Wallgren started by emphasizing the fact that natural resistance is a significant factor in the course of tuberculosis, a number of human races possessing high resistance, and others, particularly primitive people, possessing low resistance. Resistance also varies in different sections of the population of a country. Age affects it and also heredity. The dearth of sensitive individuals should, after many generations, bring about a general rise in general resistance. Wallgren believes that a tuberculous primary infection produces specific immunity against further tuberculous infection, but, he says, experiments on animals have shown that the acquired immunity is only relative and cannot prevent a powerful new infection from attacking. He himself has never seen a case of clinical primary tuberculosis that occurred as a direct consequence of superinfection in a child who had previously been primarily infected. On the other hand, he has had occasion to treat "no small number of children vaccinated adequately with B.C.G., who sickened during the appearance of primary tuberculosis directly following upon a virulent infection." However, Wallgren does not wish to minimise the significance of B.C.G. vaccination in this connection in view of the observations of Heimbeck, Hyge and Dickie, showing how small is the number of cases in those vaccinated with B.C.G. compared with the large number in whom manifest primary tuberculosis has been absent after definite virulent exposure. He thinks it probable that B.C.G. vaccination plays a part in reducing the risk of meningitis and miliary tuberculosis, but while he has not observed a single case of T.B. meningitis in children adequately vaccinated with B.C.G., he admits that various instances of this have shown that it can occur. He refers to Difs and Dahlstrom’s investigations which show that pleurisy occurs less often in B.C.G. vaccinees than in others, and to their conclusions which show that early post-primary pulmonary tuberculosis is less prevalent in the B.C.G. vaccinated than in unvaccinated soldiers. Coming to the ability of B.C.G. vaccination to prevent late post-primary ailments, he says that as T.B. of the legs, joints and urogenital organs is so relatively uncommon, it is hard to obtain comparative material. Moreover, all doctors with experience of these ailments have encountered these localisations of tuberculosis even in the B.C.G. vaccinated. "Of greater significance," says Wallgren, " is late post-primary pulmonary tuberculosis which continues to be common. That this not infrequently occurs in B.C.G. vaccinees is a well-known fact in tuberculosis doctors’ circles. Of 5,000 tuberculous patients admitted in January 1935 to Swedish hospitals, 5% had previously been vaccinated with B.C.G." Wallgren has no records of the distribution of B.C.G. vaccinated and unvaccinated within the same age groups of the population, so he cannot say whether the inoculation played any part as a prophylactic among those who did not sicken. "Nor," he says, "is it possible to draw any conclusions as to whether a reduction in mortality and morbidity, which has been taking place over a long period, is or is not caused by a universally carried out B.C.G. vaccination. W.H.O’s Tuberculosis Research Office at Copenhagen has given attention to this question which has been studied in Finland. Since 1948 a mass vaccination has been carried out in Finland of persons under the age of 25, and vaccination has since proceeded according to the same principle. The conclusion of W.H.O’s investiga tion is that the reduction in tuberculosis mortality after the introduction of B.C.G. vaccination is not greater than in countries where little or no B.C.G. vaccination has been conducted. Dahistrom writes in his book: "The morbidity in post-primary pulmonary tuberculosis showed no statistically probable or significant difference between the two groups of the vaccinated and unvaccinated." He could not find any significant difference in the prognosis of the pulmonary tuberculosis occurring in the vaccinated and that occurring in the unvaccinated. On theoretical grounds also Professor Wallgren doubts whether B.C.G. inoculation could have had any major significance in the decline of morbidity of post-primary pulmonary tuberculosis. He comes to the conclusion that B.C.G. vaccination may affect the occurrence of primary tuberculosis, pleurisy, meningitis and miliary tuberculosis, as well as early post-primary tuberculosis, but with regard to the most usual form of tuberculosis, namely, late post-primary pulmonary tuberculosis, it is uncertain whether mass vaccination with B.C.G. is of any great significance in the fight against tuberculosis. 2. What part has B.C.G. vaccination played in the present fight against tuberculosis and in the reduction of mortality and morbidity? In answering this question Professor Wallgren first discusses what other factors can be deemed to have collaborated. The most significant factor is the increased general resistance to tuberculosis and not merely the biological increase in resistance, but an increased natural resistance brought about by a raised standard of living and social-hygiene improvements. If anything happened to lower the standard of living, the acquired natural resistance might be expected to decrease and the morbidity and mortality of tuberculosis would presumably rise again. The second factor is the earlier diagnosis and more effective early treatment of tuberculosis. With regard to tuberculosis in children, Wallgren thinks the most important factor in its reduction is the shift of the time of primary infection from the sensitive childhood years up towards higher age groups. He accounts for this shift in various ways, and for the absence of meningitis and miliary tuberculosis, mainly diseases of the youngest children, by the elimination of the risk of exposure. "B.C.G. vaccination need not have had anything to do with the disappearance of these ailments," he writes. He pays a tribute to modern chemotherapy in saving most children if they are treated sufficiently early. His concluding statement on this question runs as follows "As to the part which voluntary B.C.G. mass vaccination may be deemed to play as a factor of importance for the reduction of morbidity, I can put the question in a nutshell. The value of the other factors is very obvious, and they are sufficiently effective to be able to explain the improvement that has taken place in tuberculosis mortality. The vaccination of children menaced by tuberculosis has definitely prevented a large number of the direct consequences of primary infection. It is, however, unlikely that there will now be a trend (rise) in the mortality curve if all B.C.G. mass vaccination were suddenly to stop in our country. It might perhaps lead to an increase in the number of cases of clinical primary tuberculosis, especially in the more resistant school age. It would probably also be possible to find some increase in miliary tuberculosis and pleurisy. Since, as is apparent from the above, the unknown ambulant sources of infection are now very few, and infection, especially in the delicate early childhood stage, is quite rare, the number of children saved by mass B.C.G. vaccination cannot be remarkably high. We have in the Scandinavian countries, with the mass vaccination in force here, a very low tuberculosis mortality, but equally low, or even lower, mortality occurs in certain countries without any B.C.G. vaccination at all, e.g., in certain portions of the United States. I am, therefore, obliged to conclude that mass B.C.G. vaccination has played a very small part in the reduction of tuberculosis mortality. In any event, the other factors have dominated entirely." 3. The future of Calmette vaccination in Sweden. Professor Wallgren thinks that in countries like Indonesia, where primary infection occurs at an early stage in childhood and meningitis and miliary tuberculosis are common, and where no other measures can be taken to check the spread of tuberculosis, there is definite indication for general B.C.G. vaccination as early as possible. But in countries like Sweden with late primary infections and good natural resistance, most of the mass B.C.G. vaccinations never have an opportunity of exerting any protective action during childhood. In a word, with only few exceptions, they are unnecessary. Only a very small fraction of all children mass vaccinated as a matter of routine really derive benefit from B.C.G. vaccination." So he asks whether mass vaccination in childhood is worth while. He then weighs the gain and advantage of B.C.G. inoculation against the negative side — the cost and the drawbacks. There is the cost of preparing the vaccine and its distribution, medical investigation, tuberculin tests before and a certain time after vaccination, each involving at least two visits, and finally the loss of time entailed by those who accompany the child. The visit to the doctor must in many cases be repeated a number of times, that is, in those cases where the test after vaccination shows no positive result and the test and even the vaccination itself has to be repeated perhaps twice or more frequently, until there is a final "take." Disregarding the economic side, which does not play a decisive part in the discussion of the future status of B.C.G., Dr. Wallgren comes to the argument that such easily conducted processes as B.C.G. vaccination of all newborn babies and of school children in the schools should continue, as it is then convenient to carry out the vaccination which is said to be safe in all circumstances and may do good, especially as one never knows when a child in civilised society may be exposed to infection. All doctors who sponsor B.C.G. vaccination have always stressed its absolute harmlessness, and in the past had every reason to do so, as there were no indications of serious injury or complications. No account was taken of the formation of abscesses at the point of injection or of lymphadenitis liquefaction which occurs now and again for various reasons. In Sweden, ever since B.C.G. vaccination began to become more common, Professor Wallgren says they have kept their eyes open for complications. The Swedish National Tuberculosis Association has paid travelling and maintenance expenses for hospital observation in special wards and in Professor Wallgren’s clinic they have had a number of children with alleged or actual B.C.G. complications which, he says, in all cases consisted merely of abnormally large abscess formation at the point of the injection, or in special cases in regional glands. After a short stay in hospital the children could be sent home cured. Although Swedish experience supported the idea that B.C.G. vaccination entails no risk, experiments on animals suggested that the B.C.G. bacilli were not as non-pathogenic as had been thought. Progressive tuberculosis in hamsters was produced by first injuring the lungs by silicosis or by weakening their general resistance by infection or other injury. In mice under certain experimental conditions (defective nutrition) B.C.G. bacilli became pathogenic. Coming then to the fact that B.C.G. can, in exceptional cases, cause progressive disease in human beings, Professor Wallgren emphasizes the fact that proof of this has come from the Scandinavian countries. "From Denmark, Norway and Sweden," he writes, "information is now available about generalised B.C.G. processes after regularly conducted vaccination, altogether 5 cases, 4 resulting in death." These may not be considered to weigh heavily against the 100 million vaccinations that have been carried out all over the world, but they must not be disregarded. He adds that, "The failures reported are, of course, minimum figures; many more may have occurred." While admitting that in the individual case, such a fatal effect of a prophylactic measure is under all circumstances a terrible misfortune, a catastrophe, he does not, in the cases published, blame the B.C.G. bacilli as such, nor the vaccinator. He considers "that it is the vaccinated persons who in some way were minus variants in resistance to B.C.G." But although he blames the poor victim for not being able to resist the malignancy (for him) of the B.C.G. bacilli, Professor Wallgren has been so troubled over these tragedies that he has come to the conclusion stated by him as follows: "The knowledge that such progressive B.C.G. diseases can occur in man must shake our faith in the harmlessness of the B.C.G. bacilli and perhaps induce us to reconsider the continuance of mass vaccination. We have hitherto encouraged by publicity as many as possible to have themselves B.C.G.-vaccinated, even if there is no obvious risk of exposure. We can no longer accept the non-dangerousness of our propaganda. Reference has been made to smallpox vaccination, which is, moreover, compulsory and is carried out on all children. It cannot be regarded as non-dangerous, as during this century a number of persons have died in our country of post-vaccinal encephalitis, more than of smallpox, yet smallpox vaccination continues. It is… truncated (42,221 more characters in archive)