SEMINAR ON EXPANDED PROGRlWlME OF IMMUNIZATION

Transcription

1 REPORT ON SEMINAR ON EXPANDED PROGRlWlME OF IMMUNIZATION ALCXANUKIA, 8 14 DECEMBER 1977

2 The views expressed in this Report do not neoeaaarily reflect the official policv of the World Health Organization.

3 WHO EMRU EM/IMZ/4 EM/SEM.EPI./~B TAHLE OF CONTENTS l'nfic INTRODUCTION OnJECTIVES (a) (b) PRESENT STATUS OF IPlMllNIZATION ACTIVITIES IN THE PARTICIPATINi; CUUNTKIYS INCIDENCE OF THE SIX IPIMUNIZABLE DISEASES IN THE REGION (a) DASIC CONCEYTS OF EPIDEMIOLOGY (h) SPECIFIC F:PII)EMIOLOGY OF THE DISEASES; THE VACCINES CURRENTLY AVAIIARLE I)IISIKnHl.E SCHEDULE OF IPMUNIZATION; HAZARDS AND CONTRAINDICATIONS (a) IiEPATITIS B IN THE KEGION 11 (b) ECONO>lICS AND LOGISTICS OF STERILIZATION AND DISPOSABLE SYRINGES 12 (c) JET INJECTOR APPARATUS 12 \'I VII COLD CHAIN TECIINOLO(;Y, SUI'EKVISION AND DEMONSTRATION 13 (a) PAST EXPERIENCE AND RESIJLTS OF OPERATIONAL RESEARCH ALTERNATIVE STRATEGIES AND THE ROLE Or PILOT STUDIES 15 (13) MANIIFACTUKI: AND PROCURCPfENT OF VACCIIiKS (c) (i) CObfilUNITY PARTICIPATION (ii) IIEALTll I(1IUCATION 17 (iii) TKAINING 18 (iv) SUPERVISION 19 VIII (a) (i) MONITCIRING AND REFORTING 19 (ii) EVALUATION 20 (iii) SENTINEI. IINTTS IN SURVEILLANCE 21 (iv) REGIONAL AND GI.OBA1. REPORTING 21 (b) THC ROLE OF INTERNATIONAL ASSIS'I'ANCE RECOMMENDATIONS 22 CONCLUSION 2 '3

4 EM/IMZ/4 EMISEM.EPI.118 page ii ANNEX I ANNEX I1 ANNEX I11 ANNEX IV ANNEX V ANNEX VI ANNEX VII LIST OF PARTICIPANTS TABLES OF IMMUNIZATION PERFORWED 1975, 1976 AND FIRST HALF INFORMATION SUPPLIED BY PARTICIPATING COUNTRIES INCIDENCE OF THE SIX IHRRJILABLB DISEASES IN TliE REGION TABLES CONCEBNI?G HEPATITIS B PROPER INSTALLATION AND.PREVENTIVE MAINTENANCE OF A COWRESSOR TYPE PEFHIGEKATUR FORMS RECOWNDED FOR GENERAL USE (WITH SUITABLE COUNTRY ADAPTATION WEN NECESSARY) BIBLIOGRAPHY

5 WHO EMRO I INTROUULTION FMfIM7,/4 EM/SEM.EPI/lS page 1 IIi~ The Seminar on the Expanded Programme of Immunization (EPI) was organized by The Regional Office for the Eastern Medite~ranean of WHO and hcld at the Regional Office in Alexandria from 8 14 December Dr G. Rifka, Public Health Administrator (Health Organilation), Acting Regional Director, opened Lhr Semlrlar and delivered a message on behalf of Dr A.H. Taba. Director, EMR, in which he welcomed the participants and pointed out that the Seminar will make available and discuss technical and scientific knowledge about the six diseases concerned, their epidemiolopx and the vaccines ~~lrrently available. Hc further pointed out that crucial mistaken decisions on strategy and methods, arising from lack of such knowledge, could cause such a disappointing wastage of resources of time and money and urged participants to learn from each other, particularly conoerning reoent advancco in the subject. t'! ;O I., He then mentioned the Manual on EPI, and hoped that the participants would discuss it and become thoroughly familiar with its contents. He also reminded the participants of the commitments which were specifically made in Resolutions of the 27th, 29th and 9th World Health Assemblies, the last of which aommit.t.ed the cn>.mtries and the world to makc available by the yea' InununizatlOn against tuberculosis, diphtheria, pertussis, tetanus, measles and polioniyelitis to all children. He hoped that some lives could be saved each year in the Region if the Programe was reasonably successful or, in other W~~rds, two million llves In we decade ly8u/.ly~. I1 OE!JECI'IVES i! The purpose of the Seminar is to bring together participants from selected countries in the Region, mainly officers responsible for WHO and UNICEFassisted EPI, to review the present situation and to review and discuss the elements ncccssnry to establish and operate a national EPI The participants are listed in Annex I. The general objective is tc enable participants to acquire sufficient uptodate technologiaal and scientific information on immunlvltion for the six diseases covered by EPI (diphtheria, pertussis, tetanus, polio, measles. tuberculosis), in order to plan, organize and implement a national EPI. The detailed objectives are: ' I 1. To acquire uptodate knowledge necessary for the successful conduct of EPI; 2. To improve present knowledge regarding inununizatim against the above six diseases; 3. To gain experience in solving local logistic and administrative problems by selecting appropriate options and strategies in EPI; 4. To be briefed on essential features and to be able to conduct adequate monitoring and evaluation of EPI using the EPI Manual guidelines.,, I

6 WHO EMRO page 2 Dr L.mt.fi El Sayad, DirectorGeneral of MCH Services, Central Department, Ministry of Health, Cairo, Egypt, was elected Chairman; Dr Abdul Mohammed Darmanger, President of Preventive Medicine, Ministry of Public Health. Kabul. Afghanistan, was elected as ViecChnirrmn; Dr Abdullahi Dcria, Director, Control of Gomuniaablc Dioeaoco, Ministry of Health, Mogadishu, Somalia, was elected as Rapporteur. I11 (a) PFtESEN'I STATUS OF IMMLINI7ATION ACTIVITIES IN THE PARTICIPATING CCOTJNTRJES It is a most welcome indication of gathering momentum in the Expanded Programme of Immunization in the Region th?';, whereas in the Report of the Damascus EPI Seminar of ly(5 it,.ins $osslble to Inclllde only general descrlptlons of Immunlzazion facllltles, and n;,i:il:,t~ <if vaccines produced or imported, all the eight participating countries have bet::;.ii>le to :rovide information for this Seminar about the numbers of children receiving the various vaccines in the period, often by ane group and always by lst, 2nd and 3rd dose where applicable. As not all countries are yet presenting the data with the same age breakdowns, summary tnblrs are prrsrntrd 1iel.e for the eight countries (Tables I, I1 and 111). Comparisons cannot be made because of the differing policies and circumstances of the countries. It can be seen that the data are much more helpful now that breakdown by lst, 2nd and 3rd dose is provided. This enables us to reckon (a) the dropout rate between first and third visit, and (b) the number of children who complete the courses of immunization compared with the number of births in the country. These are two very uscful indices. To calculate them year by year tells the Ministry and the responsible officers whether they ars. gaining or losing ground. We musteventunlly~efine our tables to give us not only breakdown by 1st. 2nd and 3rd or booster dose, ~ u also t breakdown by age, which for some vaccines such as measles, pertussis and. polio is an extremely delicate and important factor in obtaining the greatest possible effectiveness from them.?::+,icipating countries presented summaries of the information about the immuniza +;,.L *_,.. i:.:t:vities in their countries identifying the major constraints and obstacles which, up to now, hindered the achievement of high coverage, as well as favourable factors which were adopted to help increase coverage and efriciency. These constraints were more or less similar for most of the participating countries. They included inaomplete cold chain system. difficulty in transportation system, poor knowledge of the Programme at basic health units, lack of proper statistics, low level of public awareness, and absence of legislation in some countries. I11 (b) INCID!XNCE ;,F THE SM IMMUhTIZABLE DI3EA3E3 IN THE FUXlION (Annex 111) Because of the lack of sufficient information on the incidence of the six immunlzable diseases, it is not possible to assess the size of the problem in the count;ics of this Region. In order to have some baseline information, experience gained in other countries of the world has been utilized to estimate the incidence of these diseases in the Region (see Table 4). It must be emphasised that rnaqy of the figures and ~nsqy vf the upiniuns expressed below are baaed on amlogy with othcr countries rather than on notifications. The whole paper of which this section is an abstract is given as Annex 111.

7 WHO EMRO Measles: It is sald that almost everyonc getsmeasles urlce in his life and appro*imately 80 per cent of children get it before three years of age. Since there are about nine million children who survive past the age of twelve months each year in the Region, it is estimated that there must be on averaae each year abuu~ seven mllllon cases ot' measles in the Regionin children of preschool aqe, about 27 per thousand of the total population. Assuming a case fatality rate as low as 1 per cent, the number of deaths from measles will be over annually. Whooping cough: Whooping cough can be a difficult disease to diagnose, especially in young infants. Moreover, most children with whooping cough do not come to health institutions, The incidence of the disease can therefore be estimated only approximately. If one assuines an inaidenoe of' ny cams per 1M) 000 population, this would mean about cases annually in the Region; but if one accepts that 70 per cent of people have whooping cough at some dime during their life, this would mean an average of over 6 million cases annually in the Reginn. Since the case fatality rate depends on a number of factors, including age of incidence, it is thus not lolow. If it is not less than 1 per thousand and not more than 1 per cent then the average number of deaths per annum is likely to be between and Tetanus: Tetanus is common in the agricultural and underdeveloped countries where contact with animal excreta is more comn. A substantial number of cases or tetanus are amongst the newborn; this is a result of the lack of obstetrical care: the fatality rate in tetanus neonatorum approaches 100 per cent. It is estimated that over cases of tetanus at all ages occur annually in the Region; assuming a case fatality rate of 45 per cent, which is probably much too low, thls would mean about deaths in the Region from tetanus. Other studies would suggest that over JO 000 deaths from tetanus neonatorum alone may occur in the Region annually. (See Annex 111). Diphtheria: The highest incidence recorded is about 40 per population. Even if an attack rate of 15 per population is taken, it will result in over cases with over deaths nnn~~nll~ in the Region. Poliomyelitis: One of the studies put the incidence rate of paralytic polionlyelitis at about 28 per population. A t this rate, there will be over paralytic poliu~~(y~1llls oases with about 7 OOU deaths annually in the Region. Tuberculosis: Based on information obtained during tuberculosis prevalence surveys in various countries of the Re~ion. it is estimat.rd thnt a prev~lenoc ratc of 2.58 per cent and an incidence rate of 0.66 per cent may apply to the Region as a whole. This will result in over six million cases in the countries of the Region, with an annual incidence of over 1.5 million cases.

8 WHO EMRO " 'a) BASIC CONCEFTS OF EPIDEMIOLOGY It was pointed out that before embarkiw on a control progmmmc, the following basic concepts are required: (1) Knowledge of the diseases With regard to time, place and persons. This is essential, not only to Justify the programme but also to plan it. Knowledge of these diseases is also essential to serve as haeltne informatinn whinh wnlhd a.aist. in the final cvalt~atinn of the success of We programme. In view of the absence of the required epidemiological data, it was receommended that the programe should include a system whereby more accurate information on the occurrence of the six immunizable diseases would become available. (11) The methodology of We Progranune The methodology adopted should be one which has already been tried in the field. Experience gained in previous mass campaigns may be used with or without modification, according to the needs. It was, however, felt that the child population to be covered should have been up to two years of age, as this was perhaps the epidemiological requirement of the Region and would also provide a better chance of success for the Program. (ill) Evaluatitln of the Programe This should form an important element of We Progralnme and may consist of two componcnto: (a) 3 builtin system of evaluation whioh will help the administration to check if the various inputs are working satisfactorily; (b) an independent assessment which would evaluate whether the Programme was achieving its objectives. IV (b) SPECIFIC EPIDEMIOLOGY OF TEE DISEASES; THE VACCINES CURRENTLY AVAILABLE; DESLRAPLE SCHEDULES OF IMMUNIZATION; HA2ARDS AND CONPRAINDICATIONS (1) Tuberculosis of childhood Tuberculosis is caused by Mycobacterium tuberculosis. Some atypical wcobacteria may cause skin sensitivity to tuberculin and varyiw degrees of BCGlike effects. The source of infectidn in a child is usually an adult in his own family 3r immedlatr envlrunmanl. The organisms are conveyed by droplet spread; the dose of infection depends on the type of disease in the adult, the amount of sputum and whether he has been treated with antituberculosis drugs. Childhood tuberculosis is usually not infectious; children tend to swallow sputum, so that culture of the germ is difficult except by gastric lavage. Primary tuberculosis means the primary complex and any local progression; the focus in the lung and in the lymph nodes usually heals as hypersensitivity develops. Rarely the lung focus breaks down and causestuberculous bronchopneumoniaj or the

9 WHO EMRO mcdiaatinal lymph nodes may enlarge and ellher. compress areas or lung or erode into the bronchus. Sometimes bacilli escape from the primary focus into the bloodstream: this may lead to miliary tuberculosis or tuberculous meningitis. Primary tuberculosis is usually a selflimiting, silent infection. In poorly nourished children exposed to heavy infection it can be a serious disease. The commonest symptoms are failure to thrive, loss of weight, failure to galn weight even on a eood diet, and fever. Miliary tubcrculoaio and tuberculous n~enlrills are fatal complications unless treated with antituberculosis drugs. BCC vaccine protects against tuberculosis and is recommended where the risk of infection in childhood Is nigh. It may be given at birth or at age 3 months with the first Dm vaccine. here the risk is high it may be repeated at school entry and possibly in school leavers. It is, however, only= part of an antitubercu campaign. Case finding and tr.atrn~nt nf patients with aotive tubo~~uloaia are also essential. (ii) Measles Historically, measles was a major cause of infant morbidity and mortality in all countries. In the developed world there has been a remarkable decline in mortality in the last few decades. The decline ~receded and seems to have been little influenced by the introduction of antibiotics. It is attributed to the cumulative effect of the improved standard of living and the greater access to medical care. In addition, in the last decade, live measles vaccine has proved ito valuc and cfficocy in the temperate iliclusl~~1allzt.d countries. It is possible that measles causes more suffering, malnutrition and death in the developing world than any other specific infectious disease. There is now reasonable laboratory and epidemiological evidence that only a single strain of measles virus exists, and the greater severity of the disease cannot be attributed to a diffcrcncc in the virus; inleaslea 1s IIUL slgnlilcantly different in different ethnic groups suggesting that inherited immunity is not important. However, in the developing world, some of the attitudes and beliefs that have accumulated over the years actually have a harmful effect on the course of the disease. Unlike Europe and North America where many children do not catch measles until they reach srhnnl age, the majority of children in tropical and developing oovlltries are infected within the first three years of life. Most deaths from measles occur within the second year of life, i.e. the age or miximum protein enera malnutrition. The synergistic detrimental effect of the two disorders is important, for both contribute to impaired cellular immunity. It has been said that a community is malnourished so long as the children die of measles. Purlhermore, in children with a boderline nutritional status, measles can precipitate clinical malnutrition.

10 WHO EMRO Imizatlon is the only practical means and the one that has an immediate impact on the disease. A safe and hirhlv potent live measles vaccine was develo~ed twelve years ago which has made possible the effective control of measles. The live attenuated measles vaccine commonly in use at present is prepared in chick embryo cell culture. The current vaccine virus strain has been attenuated beyond that of the oi.igina1 Edmon~ton D atrain. Measlea vacoine produces a imild 01. I~~ayyal~a~~L, infection. lulluum~i;llcnble One dose of the vaccine is enough provided it is not given too early in life. The minimum h an dose of the comercially available furtherattenuated live measles vaccine is 1TTCID50. No reinforoing doses are required. The vaccine is given by the subcutaneous route. Operationally the best compromise for vaccination would seem to be 9 15 months of age. Even then a proportion of children will have contracted measles while a small proportion will still be protected by maternal antibodies. However, If a hlgn percentage of chlldren In the age group 9 15 months are vaccinated and the programme is continued for some time, this would llnve the effect of reducing the percentage of children who contract measles before the age of 15 months and thus gradually increase the efficacy of routine vaccination of children of 9 15 months of age. A continuing programme has to be maintained indefinitely. Failure to do so would rapidly result in a return to the current high prevalence of measles in young children. Live measles vaccine has an excellent record of safety. Adverse reactions associated in time with measles vaccination, those of the central nervous system including encephalitis and encephalopathv, have been WDOrted about once in every million doses. The vaccine is lyophilised and usually packed with the diluent. In the lyophiliacd form thc vaccinc cnn be stored at 4 8'~ but it is preferable tu have it stored at below zero degrees. The diluted vaccine loses it potency rapidly (when reconstituting the vaccine care should be taken that the diluent is cold): in two hours at 37'C the potency decreases from 1000 to lower than 100 TCID50 so what is not used within an hour of reconstitution should be discarded. Furthermore, measles vaccine is very sensitive to light and should be protected against direct daylight. Failures of measles vaccination programmes are usually due to either inadequate conditions of storage or handling of the fragile vaccine, to giving the vaccine to the wrong age i:~.oup, or to a low coverage of the target population. (iii) Diphtheria Diphtheria is a disease nf mnn only. Tt is caused by Corynebacterium diphtheriae of which there are three types: gravis, and e: these all produce the same toxin; gravis and intermedius usually produce more toxin in the human body than w, but is often the cause of laryngeal diphtheria. The bacilli are most often found in the nose and throat, but they may also be found on the lips, the conjunctivae, in discharge from the ears and in skin

11 WHO EMRO sores. Skin diphtheria is not uncommon in the tropics: it may look like impetigo or it may cause ulcers, often on the legs. It probably helps to Imize the child population, but it may sometimes cause outbreaks of fauoial diphtheria. C. diphtheriae does not invade the h um body but causes its damage by pi" ducing toxin in the local lesion on the tonsils, and the toxin then enters the bloodstream and causes damage to the heart and the nervous system. Diphtheria toxoid gives very good protection. Its use does not lead to an increase in carrier rates: in fact, carrier rates tend to fall after its widespread use; but the organism does not disappear from the community. A drop in immunization cover may lead to new outbreaks of the disease. (iv) Pertussis The cause is Bordctella pertussis: this organism exists in several types, all of which must be present in a vaccine, as otherwise types not present in the vaccine may Increase in frequency?nd cause outbreaks of disease in the vaccinated children. The organism is most easily isolated from children in the earliest stages of the disease before the typical cough and whoop develop. So the child is most infectious before his illness is diagnosed. Antibody to B. pertussis does cross the placenta but this maternal antibody does not protect the infant; it is probably not the protective antibody. The organism is a complex one and it is still not clear which is the antigen which provokes protective antibody. In its typical stage with cough, whoop and vomit the disease is fairly easy to diagnose, but it can be confus~d vit.h nt.her onuses of persistent cough. It is important to realize that young babies usually do not have the typical cough or whoop but may yet be seriously ill, and mew babies die from the disease without ever having had a spasmodic cough or whoop. Pertussis vaccine is usually given in the triple vaccine, DFT. A good vaccine gives good protection. The main difficulty is timing: the first dose is usually given at three months of age but this one dose gives no protection to young babies. Perhaps the main aim may be to immunize older children so that they cannot convey infection to the youngest infants. Pertussis vaccine may very rarely cause severe encephalopatb. This risk can be Justified while whooping cough remains a severe, dcbilitatiw and, not rarely. n fntal disease in the cl~ilrlrr~i or all area. Three doses of vaccine are required to give good protection. Two doses of more conoentrated vaccines are under trial. (v) Tetanus Tetanus is an environmental hazard: an infection, certainly, but not a comiaitble disease. The inexhaustible rcccrvoir of Cloatridium tetani is the soil. The organism may contaminate wounds in which it produces a highly potent toxin which invades the central nervous system and causes the typical symptoms of spasm and violent contractim of muscles. Often there is no obvious wound or only a trivial one. Tetanus may follow minor operations such as circumcision, earpiercing, smallpox vaccination: or the organism may contaminate burns or sores.

12 EM/IMZ/I) hl~/3b~.~h'l/l8 page 8 wnn EMR~ TrLa~ius rrom lnfection or the ear is not a rarity. The most important form of tetanus,because of its frequency and high fatality rate, is tetanus neonatorum. The infant is normal at birth, but is infected very soon after birth, usually through a contaminated umbilical stump. The true prevention of this disease 1s sterile obstetric practice and sterile dressing of the stump. But meanwhile in many areas of the world the best hope is by inummizing pregnant women. Two doses of tetanus toxoid seems to give good protection, protective level persisting in womcn'c blood as lo~w as rlve yearn. Booster doses may be given in subsequent pregnanoies but one must avoid too many doses far there my then bea danger of Arthus type reaction at the site of injection. A booster dose at five years' interval seems reasonable. (~orses highly immunized t.o provide equine tetanuo antitoxin sometimes develop anlyloid disease). It may be good policy to imize all women of childbearing age rather than Just pregpant women. Dm and DT given to girls in infancy and at school may eventually solve the tetanus neonatorum problem, h~~t. sorlnd perinatal practicc must alsv be the aim. (vi) Poliomyelitis only a very small fraction of those infected with a poliovirus show the disease, The younger the age the more frequently is the infection "silent". Man is the only hnvn reservoir for the polioviruaca and faecal aontamlnatlon is the usual souroe of infection. In the developing world, where no organized imunization programs have been institulad, pullon&?elltls continues to present a picture of very high and very early infection with relatively little paralysis. However, in recent years a high toll of infantile paralysis has been coupled with wide circulation of the virus. In contrast to the above, in the highly industrialized countries in Europe, North America, Oceania and the Pacific, where vaccination has been effectively carried out for thc last two decades, pollon(ye1itis has been reduced to zero or near zero. Reoently some of the developing countries have also succeeded in controlling the disease. Both "killed" vaccine given by injection and "live" vaccine administered orally are available. Both are effective but eaoh presents advantages and disadvantages. The killed vaccine can be incorporated in the combination DFT. However, repeated reinforaing doeea are required to keep up the Inmnmlty. The absence of living virus ensures that vaccineassociated cases cannot occur. But by the same token the vaccine does not induce intestinal immunity and therefore the vaccinees can still be infected with and circulate the wild virus. In some countries where It has been exclusively used, killed vaccine appeara to have cut short the circulation of the virus. However, this has been observed in small highly industrialized countries which have been providing repeated doses to nearly the entire target population. The biggest disadvantage of killed vaccine at present is the difficulty in producing large amounts of vaccine with sufficiently high virus titre. so that the uusl of the lulled vacclne is much higher than that of the live vaccine.

13 WHO EMRO The live vaccine colonizes the gut and therefore blocks the circulation of the wild virus. In the face of an epidemic, live vaccine administered on a large scale can stop the spread of the disease within a few days. It grows easily anrl in 1a~ge q~~antities in tissue oultwe~ hcncc it is much cl~eapr~. than the killed vaccine. The disadvantages include sensitiveness to heat but this can be reduced to some extent by using magnesium chloride or sucmr,e as stabilisers. Seroconversion rates are lower in the developing warm countries tun In temperate zones. In rare cases Live poliomyelitis vaccine has been temporarily associated with paralytic disease in vaccine recipients or other close contacts. This does not detract from the fact that live poliomyelitis vaccine is amom the safest vaccines in use at. preseot.! vii) Smallpox The fact thnt smallpox cases were discovered until recently in some parts of the Horn of Africa and may still exist in some hidden foci requires special epidemiological measures. The most critical areas for verification of interruption of smallpox transmission are now considered to be southern Ethiopia, northeastern Kenya and Somalia. These three countries, as well as neighbouring DJibouti, will therefore continue intensive smallpox surveillance and containment activities for one year after the discovery of We last case. Taking into account the still existing risk of an importation, the Sudanese Bnlallyon Eradlcatlon Programe was carried out and extended surveillance control and pockmark surveys in Countries on We other side of the Red Sea, like Yemen Arab Republic, ~eoplek Democratic Republic of Yemen and Saudi Arabia started and will continue at a high level the search for and reporting of rash and fever cases. Such measures wlll not only increase confidence for a complctc interruption of smallpox transmission but will also help considerably to document this fact. The actual epidemiological situation in this part of the world makes it InevitaDle to continue smallpox vaccination in expanded immunization programs in all countries bordering the last outbreak area of the world until final interruption of smallpox transmission is achieved. EPI programnes, certainly different in concept and approach to smallpnx rr~dicrtion progranmes, should novcrthclcso benefit from the experience of former smallpox eradication staff when assisting surveillance and reporting of rash and fever cases is the only chance of eventually detecting still hidden foci. (viii) Combination of the vaccines schedules Although it is now very widely known that many antigens can he given at the same time (though not necessarily physically combined) yet sometimes questions are still asked by our colleagues or our students as to whether it is correct to do this and whether there is no danger of loss of potency of one or more of the sntigcno. Therefore, it seems useful to have a very brief review of some of the more recent literature, since the question does affect strategies and schedules.

14 WHO EMRO Terr.~ssis with Diphtheria and Tetanus Vaccines (Dm) "Pertussis vaccine given simultaneously with tetanus toxoid and diphtheria toxoid in man increases the antibody response to the latter." Quoted from WHO Technical Report Series No. 595, 1976, p. 16, Therefore in this case the effect of pertussis vaccine is actually to increase, not diminish, the efficacy of the two other components of triple vaccine. Long experience also indicates that all three antigens are as potent in triple vaccine as when given separately. :?essles with DIT A paper by F.L. Ruben and 01leagues in the WHO Bulletin of 1973 (V. 48, up. i7j181) rrprtrd that wlleu DFT vacoine was biven tu Ni&r~.llul dlllclrru uvar. 9 months of age, together with measles, smallpox and yellow fever vaccines (but at different sites), the measles seroconversion rate was reduced from 89 to 70 per cent. The authors were not able to offer any explanation for this other than possible interference of the killed vaccine with the "take" of the live vaccine, perhaps through interferon production. They cautioned against using such combinations. However, a special study was then conducted in Guatemala to clarify this important point. imarshal1,r.. et al, 1974). No interference by the diphtheria tetanus toxoid and pertussis vaccines administered at the same time as measles vaccine was found in the seroconversion rate of the msaeles vaccine. We are not aware either of any other study confirming the finding of Ruben 2 & and therefore favour at present attributing the partial failure in this case to other causes. ~ook's study in Uganda found the same conversion to a low dose of measles vaccine when administered with DFT (2nd dose) as a Hong Kong study when the same dnse of measles vaccine was given separately. At tne same time the pertussls component was apparentlv successful. Another study in Central America (Landrigan & &, 1974) confirmed also that the simultaneous administration of DFT and trivalent oral polio vaccine with measles vaccine did not reduce measles seroconversion, nor did the administration of the second DFT and polio doses with BCG reduce tuberculin conversion. Rreman& & (1975) in Nigeria published only one in a series of at least five studies showing no interference between measles and smallpox vaccination. 'i The fact that trivalent polio vaccine does not interfere with DPP nor viceversa is illustrated by polio seroconversion and declining pertussis incidence in Cook's study in Ankole, Uganda (Cook, 1969), as well as by many other studies. Indecd, a quadruple vaccine of DPP and trimlent Oplk (killed) polio vaccine (containing, in fact, six antigens) has been used, and in some countries this quadruple vaccine has been used for many years with complete success in controlling all four diseases.

15 WHO E:mO EM/IMZ/4 EM/SEM.EPI/L~ page 11 However, the fullest review of the subjeot is the paper of Foege and Foster of With twenty references they support strongly the case for all combinations likely to be desirable for EPI projects. A l l the papers referred to here are in the list of references (Annex VII). Schedules The effect of these studies as regards the schedules commonly adopted, calling for at most three visits for primary imunization for the six diseases, including that recommended on page 14 of the Report of the Damascus EPI Seminar of 1975 (EyhMZ/2, January 1976), is to give a scientific validity to them. We may be free from anxiety of reduced potency, hut it does not absolve us fruzrt the lleaessity uf keepill6 an upen mind un the subjetit. Thin docs rlol mean rejecting cominations on speculative grounds. It means themost careful surveillance we can manage about the effectiveness of the prcgrame in respect of all the six diseases. V (a) HEPATTFIS B IN THE REGION That the parenteral route is the main mode of spread of hepatitis B infection is a well recognized fact and almost all vaccination campaigns require that the vaccine be administered by injections. Therefore there is a great possibility that during immixation programnes we oould start a rise in the cases of viral hepatitis B. We should arrange for a safe method of injection of these vaccines. It is suggested that any relationship between hepatitis B and imunization be studied during the EPI programnes in the countries of the Region in ordcr to detect whether any increase in hepatitis B can be attributed to immunization methods. One way of avoiding almh n r.=lnt.innshlp vorllrl he to,la* disposable syringes which would eliminate the introduction of the virus from serum and body discharges from one person to the other. The other means of transmission of hepatitis B were also consldered, and quotations were given from studies done in this Region. (See Annex IV). The HBsAg carrier rates were discussed in the different countries of the Region and these rates seem to be higher than in Europe and America. The special t.yprs of HBV were considered and it was noted that almost all the countries of the Region are of the "am" predominant type, except for Somalia which is supposed to be of the "adw" type, but this was based on only 10 tests. It is important that this item be considered in campaigns and safe methods should be used for vaccination in order to avoid the risk of transmission of hepatitis B.

16 ~P.~/'IP,I~./!I EI.~,/SZM, EPI/18 page l? WHO EMRO 'b) E,:nnomics and Logistics of Sterilization and Disposable :;:,rint;es Rlthnuph to a ptrblic health officer t k JustifiuaLlu~i Tor. the rlnhnclne of a health programme is selfevident in its prlmarv "humanitarian objectives", he must nevertheless regard it as part of his duty to consider how best to use the limited resourc.?s available f r the care of the sick and the promotion of r.ealtn. 'The paper on the "Economics of Disposable Svringes and Needles '3s Pr N) and the Conventional Sterilization by Boiling 'S & N)" presented an examination of the computed cost of each of these methods, carried out at 15 ijnrwa re~rosentative healt,h ront.rrs In the five fields of ita opcrotion. Tiie ana1,lsis of the cost of "boiling" and "cleaning" of S & N was 92% for manpower and 8: for supplies and depreciation of equipment. A market research of pr'ines c,f DS B N proved that those of UNICEF were cheaper. Because of the ifferelit sizes uf sv1.1rlges and needles requlred at the KHImmunization Programme 'I\?Cf{IP) and the InJection Room 'IR) of the general clinic, the computed prices wotild he lower for the former than for the latter. If the respective costs for conventional sterilization bv boiling and the use of DS & N are applied to the total number of injections given during 1976 a' IMAWA health centres/points, it was shown that at UNRWA'S terms of cost at tile~ time of the study, the use of DS 8 N would be more economical. Tne expected gain would be 7345? for the KHIF, for the IR and for both, subject to whether UNICEF or market prices of DS & N are respectively quoted. An additional advantage is the avoidance (and saving of the cost) of treatinn complicaunns resulting from improper cleaning and incomplete sterilization of S & N, e.g. tvpe B hepatitis, allergic reaction, abscess formation, tissue damage. The reported findings stirred up interesting discussions of managerial and personnel problems if the use of DS & N were to be adopted by field projacts. 3uch dirflcullles wlll have to be defined through field control studies because the setup in the field differs from that in UNRWA. C ) Jet lnjector Apparatus Jet injectors have been used successfully for many years to deliver a variety of vaccines. In many nlt.iiilt.lnn thnir advantage of permitting one hcalth worker tc deliver over 500 injections per day outweighs the disadvantages of cost and the need'to train one or more staff to operate, maintain and repair them. The maximum number of injections usually depends on the speed with which persons can pass in frurit or Lhe worker. The current cost for a "Ped0Jet" injector, including spare parts, is about $1500 for which over 30,000 disposable syringes and needles could be purchased. Innovations are being made continuously in the design of these injectors with thc ~oal of making them less er~nsive, easier to maintain and repair and of making them more suitable for administering different vaccines to smaller numbers of people. Such innovations promise to make jet injectors increasingly attractive alternatives to the use of the syringe and needle in future years. Programmes should not Include the use of Jet injectors without firat ensuring that time is devoted to training staff in their use, maintenance and repair. 'There should always be a backup system. either in the form of fiyrlng~s and needles or a spare injector.

17 WHO EMRO VI CrT D CIW TN TFFIWOT.OW, SUPERVISION AND DEMONSTRATION The potency of all vaccines declines as a function of time and temperature, so that mishandling a vaccine will shorten Its useful life. The cold chain is a system of vaccine handling and distribution, aimed at minimising the extent of mishandling, in order to ensure that vaccine is potent at tiir tirnr uf adrnlrllslrallon. The presentation began with a discussion of vaccine stability characteristics and the work in hand to standardize manufacturers' data Selating potency to time/temperature. The storage and transit stages of the cold chain from the central store through the provincial store to the district health units were summarized and for each stage the system was then discussed with regard to several of the following aapccto: (a) Management Vaccine distribution Supervision Equipment maintenance Cold chain evaluatiun Cold chain training (b) Equipping Transit. packaging span1 fi cat.< nn Cold box desigo and construction Cold room performance and specification of special features Compression type refrigerators and freezer/poor electricity supplies Absorption type ~erosene/gas/electricity refrigerators Vaccine car.r.iers/flasks fur the field This is a summary of the main points made during the discussion: 1. Efficient vaccine distribution depends on preplanned deliveries based on records of vaccine usage and stocks remaining. Inefficient vaccine distribution is evident from the following indicators: Accumulating surplus of vaccine Vaccine shortage, repeated or followed by surplus Premature or irregular supply points Return or redistribution of vaccine by a low level store ~alsified/incorrect recording

18 EM/IMZ/4 EM/sEM.EPI/~~ page 14 WHO EMRO Surplus stocks should be kept to a minimum and low level stores and limited to total storage periods recommended in the WHO hual Vol. SII. Rotation of stocks requires simple ruling throughout the cold chain and close supervision. 2. It is most important to establish cold room facilities for the national central vaccine store with the following characteristics: Prefabricated and assembled locally 2 locally constructed but in either case must be adequately insulated to maintaln internal temperatures below 8 " for ~ two days. Chart temperature recording facilltiei3 and alarm. Standby refrigeration and electricity generation plant. Double door "coldlock" included as packing area. 3. Packaging and cold boxes should be designed and constructed for the periods of "cold life" required on different lengths of Journey within the country. The following points were made: Tne cold llt'e perf'ormance of the cold box/package should be about double the Journey time to allow for breakdown/delays Cold dogs should be 1/3 total oapoity of the box W surround the vaccine Polystyrene insulation up hours "cold life" and polyurethane up to 6 rlaya "cold llfel'. (Polyuretnane In "slab" form for cutting to size or in liquid chemical form for foaming in place). 4. Refrigerators and freezers of two types: Absorption; gas, electrio or kerosene (heat source powered) Comprcoaion; eleotrioity only (mutor/oompressor powered). Absorption types chosen should be the larger capacities, e.g. Electrolux RAlOO ~asblec. or RAKlOO Kerosene (200 litres) and preferably ~ODopening e.g. Electrolux RC65 Refrigerator/Freezer, Gas or Kemaene (155 litres). Compression types chosen should be ordered with automatic voltage regulation#, voltage protectors. Spare protectors, starter relays and thermostats should be ordered one per five items nrdered. All refrigerators and freezers should be Pitted with temperature measuring devices, e.g. dial themmeters with maximum needles. Equipment demonstrations: The following demonstrations and instwotion took place: Compression refrigerator simple fault diagnosis to ensure that local electrical contractors do not mislead inmuniurtion operations officers (See Annex V)

19 WHO EMRO Absorption refrigeration first level maintenance Use of recording charts to diagnose refrigerator performance 2. Selection and fitting of tempnrat.1lve m~nsurillejreaordin~ devioes: Chart recording thermometers, operating instructions and appl5.cations DLal LhrrmomeLel' TlLtlw instructions am applications 3. Construction/design of vaccine cold boxes: Insulation types and their use Rubber seals and fittings External casing design Application of standard pionio boxes. 4. Use of domestic pressure cookers for syringe sterilization: I> minutes at 15 lbs psi. 5. Use of Jet injectors: "PedOJet" ) Operating instructions, maintenance and field "Panjet" ) precautions VII (a) PAST EXPERlEEICE AND RESULTS OF OPERATIONAL RESEARCH ALTERURTIVE SPRATEGIES AM) THE ROLG OF PILOT STUDIES With regard to Expanded Programes of Immunization covering the six diseases specified, there is in fact very little in the way of past experience and results of operational research in developing countries. The experienoe of industrialised countries which guea back fur Just over Leri years, when the latest or the vaccllles, measles vaccine, came into general use, is not really relevant because of the much greater resources which the industrialized countries can command in manpower, infrastructure and finance. Three programmes are reviewed whose description and evaluation are published or in some other way available. First is the programme of operational research described by Mahieu which was conducted in Kenya between 1974 and Valuable points from this are its description of the constraints, the demonstration of how a comparatively simple mobile team approach did raise the immrnization rates considerably in the experimental as compared with the control areas, and finally the most useful analysis of the costs of the programme per fully immunized child.

20 EM/IMZ/4 EM/SEM.EPS/l8 page 16 WHO EMRO The second pro&ramne dealt with is not 00 muoh a prograrm as a valuable account of operationaloonsiderationsgiven by Foege and Eddins in their paper of This in itself draws much on the experience of the measles and smallpox programs in West Africa and the global smsllpox eradication programme. dnd on otner experimental programnes in West Africa. Many of these operational considerations have in fact been incorporated in the WHO EPI Manual in detail. Only one programe is described whiah (a) confoms to what we now understand as an Expanded Program of Immunization, (b) began on a virtually zero baseline, (c) was evaluated from the point of view of coverage, cost, effectiveness of the imunizations in respeot of "take" and also in respect of disease reduction, and (d) was Cullowed up for a perlod of five years. This was the programme in Ankole, Uganda, for whose design and initial conduct Cook was responsible and which has been described partly in publioations and partly in thesis form. This program was described in brief detail, and in s ~ m rwas y suooeecful in respect of coverage and in respect of "take", and in respect of disease reduction excepting measles, where though some reduotion took place it was quite insufficient to prevent the usual cyolioal epidenic. The cost per completely immnized ohild wan, allgwi~ for idlatiu~~, vury similar to tnat of mahleu's programme almost ten years later. The paper concludes with remarks on alternative stratenies and the role nf pilot studies. Some lessons drawn from past experience can be identified; among them is the necessity of a strong government comnitment. Another lesson is the desirability of incorporating both fixed units and mobile outreach from the very start. and nnt velyin& solely either on the "horimntal" or on the "vrrllcal" strategy. Argument as to which of these strategies to adopt is really a bogus issue since both are essential. Pinally, another lesson from the experience so far, limited as it may be, is that it g possible to achieve the objeotives of EPI at a cost wnich is well within the capacity of most developing countries, particularly when we take into account assistanoe available to them. Since each country's cirntlmat.ances differ in soma important degree from those of its neighbours, pilot projeots are essential) or rather, not so much pilot projects as carefully evaluated pilot stages of permanent pr0grb. Therefore an openminded and innovative approach is required prtiaularly in the first five or ten years of the Expanded Pr0grs.m or ation in tho developing countries. VII (b) MANUFACTURE AllD PROCWZMWI' OF VACCDIEB d The problem of the mmuiaoture and procurement of vaccines has bem discussed. They were referred to at the Seminar which ms conducted in Syria in 1975 which skms the national requirements as well as the national pmduction of vaooines and those that are pmcured from abroad. It was stressed that production of vaoeinea at this stage, especially those of polio~clitio and measlea, alluuld Ltr pastponeid beaause it Is an expensive process. However, purchase of these vaocinea In bulk form to be bottled iq the different central laboratories of the Region will be a more economacal process than purchasing them ready bottled.

21 WHO EMRO This brings the problem of control to the fore and control of vaccines becomes a very important item, not only with the vaccines when arriving at the central laboratory but also at the last peripheral stage when used for children. To start control at regional laboratories was suggested and it is hoped that these vaccines could be dealt with in the local laboratories in the different countries of the Region at a later stage. Bilateral aid and UNICEF were also pointed out for supply of vaccines to the different countries of the Region. EPI Unit, WHO Headquarters, is also willing to assist to ensure the quality and quantity of vaccines needed, as far as possible. VTI (c) (i) COMMUNITl PARTICIPATION Because of the limited financial and other official facilities in the developing countries it is essential to encourage community participation. It is essential to study the community its traditions, habits, trends and tendencies towards health programmes and servioe. A suitable worker who knows the language and is socially acceptable should be selected to obtain community participation. He should start to organize the communlt,y, declde what he needs and from whom. He should be very courteous in his approaches, friendly in his relations, punctual in his timing and comitments. The community is expected to assist in finance, accomodation, motivation, organization of vaccination sessions, etc. Community sectors such as teachers, associations, clubs, elders, leaders, religious people, health workers can be utilized, each according to what they can offer. Community participation can be obtained by the different approaches discussed under Health Education. People expect in return to be well treated by health workers. Any incentives such as therapeutic aids, letters of t.hnnks, and other approaches that can raise their prestige will be helpful in encouraging more community participation. VII (c) (11) IKWLTII EDUCATION Health education is of special importance to the Expanded Pmgrame of Immunization. Human factors represent the substantial part of these activities. as was stressed by many participants. The main target groups for health educotirn for immunization have to be oonsidered, consumera ac well as providers of health carej espeoially mthera, parents of small children and the members of the vaccination mobile teams and fixed centres. Health education should be planned, implemented and evaluated as an integral part of the EPI and of the primary health care services in general. The best health educators are health workers providing vaccination and other health care to the respective population. But they should be trained and supervised continuously in order to gain practical experience and skills in field work.

22 page 18 WHO mo The most effective rs(3tvhwl~ in working wlth the people have been: persontoperson comrmnication, small woups and carefully used mass media. Preparation and distribution of the simple, cheap and effective mteriala (posters, leaflets, hroohures, should take plaoe on We spot and with the involvement of the local ~rolwnteera. Conaunity involvement and aotive partioipation of the people wen~ticularly empnasizea, especially lri rural areae. Interseotoral cooperation was alao stressed as very important for suocesful implementation of EPI. Training of staff is 8 continuous process to keep the level.nd effioienoy of a projeot optimal. The project manager is responsible for the training and. being aware of whiah activities each staff membar has to osprjr out, should prepare dctailcd Job dcucrlptinns whioh will help oo~siderably to ohooao the right person for each positl on withln the projert. Training of centrl&l ntaf f 1s espeaiallj his personal responsibility, while in the training of swglcnal md prcvlilulal offioers as well sr of supportiq oontral staff O. should bs cssiated by a a.sntra1 operations oifioer. Training of health asnereo' or mobile team's otnff needo to be plamed in close cooperation with health ~erviues. Responsible EPI offioers auld take every ohanoe to get the conoerkrr. of tho programin included in training oouraes of basic health services 811d of ajmolal importance of the prinury health oare program. Before starting training ccburses aupemriaors my prepare detailed ourrioula whioh need the approval of the direotor and whioh should be revised from time to time aa We programme daval opt!, Teaohing should never stick to theory only, but praotioe should be given muoh attention. This ia espactally Important if staff get8 Molmsd on teohnioal matters ond averybudy etlould Im given a ohanoe to get Well acpualnted Wlth me tools he is suppoaed to harldie later. With regard to tralnirm Ln health education. staff members ahould not only know how and whom to oonkiot in a oonrmnity but also be praotioally trakred how to get the interest and cooperation of the populations. Teaohing prs~tcally how, for inatanas, to aot during vaooination searions" is of the same iaportanoe as how to give Mooine ourreotly. The problem of rartrainira former Smallpox Eradiaatlon PrograPme staff deserves attention and tmderstmding, It would ba wrow to negleot there devoted field workers and not we them for the ExpMded l r r o of ~ hmmintion. It has already been merationed Uvlt training is a oontinuous process: one ahould therefore always glve utaff inembars a ohmoe to report observations not only on inoonvenienoes and constraints but also on improvements. Suoh elgohulge of ideas may ba vary fruitfw in reviewing training ourrioul.., Finally it my be etreased that tra will only ouooeed if the trsiner is fully familiar with the subject he is trying to teaoh others.

23 A supervisor, leader, manager or administrator at aqy level should be capable and competent. His main tasks are (a) to deoide what is to be done and (b) to get that done with the help of the people placed under him. He must maintain contact with workers in the field. The supervisor snould determine what his objectives/targets are:'epidemiological and operational. And he must give clear directions to the personnel as to the methods of achieving those objectives. There are many types of management, e.g. management by objectives, consultative management, participation management. Experience has shown that to get the people working efficiently and happily they must be selfmotivated. To obtain this state a leader si~uuld be a trainer, helper, consultant ana protector. In other wopds, he n ~st create conditions and establish relations with the personnel that bring out their best. The supervisor has to supervise all aspects of the programne, technical, operational and administrative. Check Lists for the various kinds of supervision should be used. Scvcn rules for good aupervialon 1. No straitjacket rules to suppress subordinates' style. Trust your subordinates and let them use initiative. 2. Don't be vague in giving instructions. Clearcut orders, directives, targets and so on. 3. Don't be inconsistent. Not to make retroactive changes, in policies and prccedures. If change is necessary, explain beforehand. 4. Be impersonal with subordinates. Don't show favowitism. 5. Don't ahuse status privileges. 6. Don't ignore subordinates' potential. 7. Don't be too conservative. Welcome suggestions from the subordinate and accept changes if appropriate. VIII (a) (1) tk)nitoring AND REPORTING For monitoring the various aspects of an imivltion program a recording and reporting system is necessary. In developing the system, the use to which the information will be put at the different echelons should be carefully scrutinized. Only Infomation relevant to the management of the program ahnuld be collected, recorded or reported. Furthermore, before ilatruduui~y rlrw ~rcu~rlti or forms the iorms actuiclly ~n praotice should first be studied.

24 EM/IM'L/4 EN/SEM.EPI/~~ page 20 WHO EMRO The management systen~ should, in addition, provide for early detection of flaws in the programme operations and for idiate remedial actim. It was agreed that the following forms included in the WHO EPI Manual will be adopted (and adapted where iracessa1.y) by LLhr ouuntries in the Region (Manual, 1.9). 1 Vaccination Card p Immunilations Performed Report D. 15 (modified) 3 Vaccine control card P Monthly Vaccine Supplies Status p. 25 (modified) 5 Refrigeratorflreezer record P Cold Cf~sin Component Pcrformacc Report p.. 27 (modified) (These six forms are sat out for oonvcnicnt rcfcrence in Annex VI, modified form recommended by the participants after discussion). in the The other forms presented in the EPI Manual were not considered as applicable to all countries and all progranunes in the Region. They ahould serve as a guide to the countries in developing their' management information system. VIII a (11) EVALUATlUN Evaluation or assessment of the programe should be done by people not directly cnnc~merl with the Implem~ntat,lon of the programne. It is thought that the epidemiologist is the best person to be made responsible for assessing the achievement of We programe. Assessment has to be ongolng; tnls will give an idea to the innnagement as to whether the programme is doing well. Simultaneously assessment can be performed at repeated intervals to determine the extent to which objectives are being met. In EPI the assessment to be done will deal with the condition and history of the vaocine used. Was the vaccine stored and transported properly, and was the^ evidence to believe that the vaccine used was or was not potent? The next thing to be assessed would be the coverage claiwtd to have been achieved by the Programne. The EPI Manual describes a simple and practicable method to assess the coverage. However,in urban areas, if the two aard system is being used, the cards kept at home can be used to assess the coverage. Since the aim of the programne is to decrease the disease incidence of these six diseases, a system of disease surveillance may be established to see the impact of vaccination. Seroconversion l~~thods should nut bz used as a routine, Out to Solve problems which may arise such as the occurrence of disease in vaccinated children. It is hoped to develp micromethods of titrating serum, and a course will be held in the Region to train suitable personnel in these methods.

25 WHO EMRO EM/IMZ/~ EM/SEM.EPI/~~ page 21 viii a (iii) SENTINEL UNITS IN SURVElLIANCE Notification in most Regions is most inadequate. Official notifications nay be be lower even than admissions to neighbouring hospitals. Can sentinel units help? With tuberculous meningitis this should be possible for the disease is eventually easy to diagnose. Therefore, if hospitals are chosen and encouraged to ma&e monthly returns these can act as a clue to the incidence of childhood tub rrulosis. Something the same applies to tetanus neonatorum. Many children doubtless die suddenly outside hospital from laryngeal sp sm,etc. from tetanus, but most live for at least a week and the disease is so dramatic that most of these in an urban area reach hospital. So hospital returns agaln may serve as a clue to incidence. The incidence of young childhood poliomyelitis, which is usually mild as regards paralysis, e.g. drop foot, weak shoulder, can be assessed by examining school entrants. Uliversities and schnnl health services can work together using senior medical students as part of their medical training. Vtllage surveys for the incidence of tetanus neonatorum and whooping cuugh are feasible if carried out by village young men or women who have been given a little training. The question they must ask is simple but collaboration depends on understanding and fitting in with the habits, customs and general attitudes in the villages (EPI Manual Book I, Annex ja). In all systems of sentinel reportine. it ic eeeential that somconc, be he the programme manager or someone appointed by him, keep in touch with all the sentinel units and feed back infomtion. The sentinel units must be made to realise that the information they send in is important and vital. VrII a (iv) REGIONAL AND CLOBRL REPORTING IT Is acceptea that perloalc reports from the field are needed by the E?I manager at the national level in order to plan, implement and evaluate the Programme, the need for perludic reportfng fr m country to regional and from regional to global level should also be a~~reciated as far an Rrlfilmmt nf World Henlth Assembly resolutions is concerned. Data systems, perhaps better termed "management information Systems", are now 111 L ~ C procrss of being developed at country level. slnoe tne management information system at regional and global levels will be based on the information obtained at the country level, this too is only now being developed. The goal of WHO 1s to establish, by the end of 1978, a system in at least one nnuntry per region in which data originating at the field level are passed on to national, regional and global levels. The data at each level should serve the particular needs at that level with respect to content and frequency of reporting, the concept being that only a ~ummary of data received by LhaL level would be Sent on to tne level above, and that such summaries would be sent forward at less frequent intervals than We Incoming data were received. Our present concept is that information would be received on a monthly basis at the country level, on a quarterly basis at the Reginnnl Office level and on a semiannual basis at the global level. Mechanisms have to be established. The three levels oountrv, regional and global should organize feedback systems from one to the other. In every capeciolly important. country, feedback from national to field level is

26 EM/IM'Z/~ EM/SEM.EPI/18 page 22 WHO EMRO In the sinallpox prbgr*ainme, fear of exportation of the disease from infected areas and the yrospa,:t of a timeliniited program prompted generous support from donor8. Internatii,rial prcbsure permitted WHO and WHO etnff to play n major role in all phases of the px'ogr'arrme, and an ample "cash reserve" was established at Headquarters whioh perr,litted rapid response to urgent requests from the Field. The EPI has quite a different orientation: it is a program without tlai limit and, at least at present, little pressure is being exerted by countries with good control of the imurliz;ible diseases in those countries where heavy transmission still ornlr.i. No s!~h~tantlal " ~ a reqerve8" ~ h are planned for Headquarters and therefore requests from the field will require orderly incorporation into plans of operation which forecast needs over at least a fiveyear perlod for vaccine requirements. Alttlougn well rolmllatea plans or operation WILL ne me basis on mlch much of the contributions from donors can be sought, plans can only continue to be such a basis for a few years, after nhich the programe results will be the key factor. For this reason. slans of oseration, from the beginning, ahould Rmvida for the development nf adequate management information systems whioh objectively document what inputs went into the programme, what activities were carried out as a result of those inputs, and what impact those activities had on morbidity and aiur.la1lljr. IX RECOMMENDATIONS 1. The WHO Manual on Expanded Programme of Imnunivrtion should be adopted as a basis for the Programe in the Region. 2. Systems for evaluation teams within the partioipating oountries should be developed. Members of teams should themseives be involved in EPI; in this way they too can benefit from the evaluations. Evaluations at lower than natimal levels within countries should be made frequently.. Special training manuals, based on the EPI Msnual, should be provided to suit the different levels of workers In the national program. Basic curricula for training personnel should be drawn up; these can be modified from time to time to suit the needs of personnel attending courses. An Amhtc translatton of the EPI Manunl. provided by 0, would b. weloome. A condensed version, about one fifth the size of the Manual, is particularly requlred, aimed striotly at field level to suit the needs of provinolal operations officers, team leaders or health aentre leaders, There should be a copy rlrst In EngllSh, and m u should tnen produoe a version in Arabic; versions in other langua~es may also be required. Six forms from the EPI Mwual should be used by all partinipating notmtvtrs: 1) For houae to house assessment every child or woman mst have a vaccination card (Manual 1.5, p.16). ii) The Mooination reporting form (Manual 1.5, p.l5)(or Imrmnizations Performed Report) will be used but the breakdown of ages will be 02 months

27 WHO EMRO 4 8 months, 10 to 23 months and 2 20 "I years. Countries may include finer age divisions if they so require. (ill) The vaccine control card (Manual 1.5, p.20) will be used. (iv) The vaccine supply status from, suitably modified, will be used. (Manual 1.5. p.25). Annex IV.1. (v) The reirigerator/freezer temperature record form (Manual 1.5, p.lgj will be used in a modified form; twice daily temperature records will be entered, but not maximum and minimum temperatures; these will be recorded only when dial thermometers or continuous recording charts become available. (vi) The cold chain equipment performance report 'modified) will be used 'Ear~ual, I, y. 27, Aru~ex F?, 2.) X CONCLUSION Dr M.O. Shoib, Director of Health Services, WHO EMRO, concluded the Seminar with brief remarks thanking the participants fur their attendance and commented on the lively discussion to which he had been listening in the final session. He emphasiaed the atrong commitment of tho Orgwizatiun tu uullalor.dlt. wllh Lhr Governments of the Region in Expanded Programmes of Immunization, which he felt were a practicable endeavour which, if properly carried out, could yield important results.

28 WHO EMKO EM/IMZ/4 CX/SEM.EPI./18 Annex I page i ANNEX I LIST OF PARTICIPANTS AFGHANISTAN DEMOCRATIC YEMEN EGYPT Dr Abdul Mohd Darmanger President of Preventive Medicine Ministry of Public health Kabul Dr Mohamed Yacoub Salehi National Director of EPI Ministry of Public Health Kabul Mr Mohd Ebrahim Amin Sanitarian Preventive Medicine Department Ministry of Public Health Kabul Dr Ahmed M. A1 Shaiba Director MCH and Family Planning ini is try of Health Aden Mr Waheeb Mohamed Jaffer Di~rcLur Expanded Programme of Immunization Ministry of Health Aden Dr Saleh Abdel Halim Saleh Director Communicable Disease Department Ministry of Public Health Cairo Dr Loutfi El Sayad Director General MCH Services Central Department Ministry of Public Health Cairo Dr Felix J. ~urji* Director General of Preventive Medicine Alwiyah Baghdad Dr Mahdi Abdul Amir El Samak* Director, Sera Vaccines and Pasteur Institute Baghdad *did not participate

29 EM/IMZ/4 EM/SEM.EYI. 118 Annex I page ii WHO EMRO Dr Abdullahi Deria Director, Control of Communicable Diseases Ministry of Health Mogadishu SUDAN SYKLA YEMEN ~r Guled Hussein Yusuf Medical Officcr School Health Services Ministry of Health Mogadishu Dr Abdel Hamid El Sayed Osman Director of Smallpox Eradication and ~munization Prnp,ramP SEJBCG and Expanded Programne of Immunization Ministry of Health Khartoum Dr ~ohamed Abbas Idris Cllief Operation Officer Immunization Programne Ministry of Health Khartoum Dr Haidar Drk El Bab Nanager of National Imunization Programe Ministry of Health Damascus * Dr Akram El Shaal Chief, Epidemiology IJepartment ni~rcturate of Communicable Diseases Ministry of Health Damascus Mr M. Nasmi Mohiddin Chief Operations Officer Ministry of Health Damascus Mr Yehia Hasson ElDhari Director Expanded Programre of Imunization Ministry of Health Sana'a Dr M.M. Hager Epidemiologist Director of Preventive Medicine Ministry ot Health Sana'a * did not participate

30 E?I/IPIZ/L E~l/SL~l.I~t'I. 118 Annex I pngr iii REPR1:SENTATIVI:S FROM OTIIEK UN ORGAI\IIZATIONS!Ir Vngens 11. Munck Transl>ort Equipment Maintenance Orcanization Consultant ~ahul Afghanistan UNRWA Ur R. Stoelzel neputv Area Representative UNICEF Cairo Area Office Cairo Egypt Dr 3.K. bhlzayyin Chief, Curative tl~dicine Division Department of tlealth!inr!:a Headriuarters Dr I..\[. trikssnn Cl~ief, Preventive \ledicine Division Department of Health II::RWA Headquarters WHO FIE1.D STAFF.?FGIIANISTAN UEMOCWATIC YEMEN Dr A. Rangaraj k;pldemiolo:,ist Kabul l)r Ali Aimed Idris In10 Epiderniolo&ist Aden or ilmt~r Sll! ieman WIiO l:pidcmiolol:ist Is 1 amabad >lr Ismatulla Chaudhry Administrative Assistant i.xpanded Prnyrnmme of Immunization Is1 a>~lai,a~l Dr :.l.i). A1 "inhhari WllO Epiderniolo$:ist Mogadishu 1)r K.I.. Weithaler ifilo ~~idemiolojist Khartoum

31 "tu)r EEIIIMZI4 LPIISCH.C~I.I~O Annex I I ; iv WllO EMRO Mr Abdel Gader El Sid ~dministrative Assistant Exrnnded Programme of Immunization Khartoum Dr M.A. Pnrvez WHO Epidemiologist Sana'a 1~*11) SECRETARIAT IUr M.O. Shoib Ur P. Chasles Director, Health Services Public Health Administrator Communicable Diseases Regional Office for the Eastern Mediterranean, Alexandria, Egypt Regional Office for the Eastern Mediterranean, Alexandria, Egypt Dr R. Cook Adviser on Maternal Regional Office for the Eastern and Child Health and Mediterranean, Alexandria, Egypt Expaudrd F~ogranu~e of Immunization Secretary to the Seminar Dr R.H. Henderson Dr H.R. Husseini Chief, Expanded Programme of Immunization Adviser on Laboratory Services WHO Headquarters, Geneva, ~wi tzerland Regional Office for the Eastern Mediterranean, Alexandria, Egypt l)r N. Racoveanu Adviser on Radiation Health and Cancer Regional Office for the Eastern Mediterranean, Alexandria, Egypt Ur F. Assaad Dr A.B. Christie Medical Officer Expanded Programme of Immunization consultant to the Seminar WHO Headquarters, Geneva, Switzerland Ilon. physician, Faeekerley Hospital, Liverpool England Elr.I. Lloyd Consul rant Expanded Programme of Imuni za tion WHO Headquarters, Geneva Switzerland or R. Tomic ConaulLant WHO Directur, Institute fur Health Headquarters. Geneva Education SRS. Belgrade, Yugoslavia. Mrs C. ~artoudis~6mltrio Conference Officer Regional Office for the Eastern Mediterranean. Alexandria, Egypt Miss S. Bermawi Secretary Regional Office for the Eastern ~edicerranean. Alexandria, Egypt

32 EM/IMZ/O EMfSEM.EPI.Il8 Annex I1 page i ANNEX I1 TABLES OF IMMUNIZATIONS PERFORMED 1975, 1976 AND FIRST HALF OF INFORMATION SUPPLIED BY PARTICIPATINC COUNTRIES EXPLANATORY NOTES ON TABLES 1 TO years 0 14 years mainly to newborns all susceptible groups in population DPT and Polio: from Khartoum Province Health Centres only For 1975 and 1976 and first half of 1977, combined For entimoted births January 1975 to June 1377 Khartoum Province Health Centres plus EPI (Development phase) For Democratic Yemen see 1976 table For the month of July 1977 only Special Polio Vaccination Campaign November 1976 April 1977

33 WHO EMRO Annex I1 page ii TABLE I IMMUNIZATIONS PERFORMED 1975 I! AWHANISTAN. DPlOCRATIC! EOYPT IRAQ I SVDAN I rnen Polio 3 Polio Booster R~tio 1 tn , ' 1.s ~~0, ' ? I see 1976, l.u?0.053, : ~, 0,01!7' I began sheet I I I idpt I 993.5m. AO.3rO, 5.F.oz, ; DPT B1 / ' W.896 I b.789 I 1 Soocter DPT Ratio 1 to % Q( c,1,., d (4:) Polio % 11.7?0 11 Polio B ? ) d T.5 % '15 5'!.3 d., 1. UU7.flR7 '),,603(3) 8 ' 110.9'41 11?5.7''1 Primary Smallpnr Secondary ' (I' see 1q76 sheet % bIl MEASLES I Tet Tox 1. / Tet Tox 2. Tet Tox BooPter Ratio 3rd DPT to estimated live births as per cent >.ti0 3rrl Poll0 to estimated live births ~ o in t schedule i ~ o in t schedule ~72"" ' 01) PP. 117' (4) 77.2 % 1 $ in ~ o t rchaiyuli * S 1 Not in FF~C~U~T. ~ Not applicable Not pplicable

34 IJklO EllKO EPIIIMZII, EMlSEM.EPI.118 TNlLE 2 Annex I1, IMMENI%ATIONS I'!:Ri 3RYEli page iii EGYPT Est.No. of , live births st. ~opula ' tlon under i 5 v. I DPT 1 DPT 7 DPT 3 IDPT Boater Ratio 1 to 3 Progrme began in July 1177 I, Wl 4. A67 l.oip 149 $ , o q , 0? % 5.351"' f5j J1.7~5 p IY Polio 1 Polio 2 Polio 3 polio Booster Ratio 1 to 3 KC Smalloox Rimary Smallpox Secondary ( fl) 761.Y+8"' X U f $ I '~' 471, '; Measles ~ o in t Schedule Not in Schedule Not in Schedule Tet Tox Booster Not in Schedule ~ Not in Schedule '~) 376.9n") m2.101 (4) Not in Schedule I Natin Schedule ~ Ratio p d DPT Not applicable / Rstio 3rd Polio to est. live births % % Not applicable!& =

35 EM/IMZ/4 EM/SEM.EPI./lR Annex I1 page iv WHO ENRO Jan. 1 to June Yl only (9) IRAQ SODAN I I etio 1 to 3 Polio 1 1. Polio 7 Poltn 3 Polio Lboster Ratio 1 to 3 KO 1.q7.560 %allpox Primary rp3.708 See 1976 Sheet Smallpox Secondary 1 I, t, Measles Not in ~ o in t schedule schedule yet Tet Tox 1 N O in ~ Not in schedule schedule Tet Tox 2 Tet Tox Booater Rstio 3rd DPT 'to estimated births % Ratio 3rd Polio to estimated births $ Not in schedule ~ o in t I ~ o in t schedule 1 schedule 6 I Not appli I cable I Not appli 16.9 $ cable

36 WHO EMRO EM/IMZ/4 EM/SEM.EPI./I~ Annex I1 page v

37 WHO Em0 EM/IMZ/4 EM/SEM.EPI./18 Annex I11 page i ANNEX 111 INCIDENCE OF THE SIX IMMUNIZARLE DISEASES IN THE REGION The six imunizable diseases are notifiable in most of the countries of this Region (Table 2). Ilowever, the data available are insufficient to determine the extent of the problem. The marked difference in the number of cases notified for each of the six diseases by various countries in the Region (Tables 3 to 8) speaks for itself, viz, that the notifications are neither complete nor reliable. It is well known that in the countries of the Region, health facilities are inadequate and the vast majority of the population has little access, if any, to such facilities. Mort of the cases of these diseases, particularly in rural areas and to a considerable extent in urban areas, are brought to the health institt~tions only if they have severe complications. Quite often death occurs before a case is brought to a hospical or a health centre. Furthermore the notification system in the countries of the Region is not adequately developed. Even the cases which reach the health institutions are not all notified by the medical profession. The availnhle data have been pre8ented (Tables 3 to 8); there can be no difference of opinion that these data are grossly underreported. An effort has therefore been mde based on experience in other countries of the world, to define the magnitude of the problem in the countries of this Region. The available data may be seen in Table 3. It is seen that the incidence of the disease varies from (Lebanon) per thousand of population. to 26.4 (Oman) per thousand Of population. The incidence in Llirsr countries per thousand births is betveen 0;008 to 529. In a study of the natural history of measles in a rural and in an urban area ii. India in it was seen that the attack rate in the general population was 72.8 and 31.0 per thousand of population respectively, while for children below 10 years of age it was 345 and per thousand in the two areas respectively. Furthermore in a study in ~ en~a(~) where approximately children are born each year, the reported yearly incidence of measles is or 200 per thousand birth*, mostly in the first 2 years of life. Mayden(2) found that 23 per cent of Kenyan children contract measles before they reach six months of age, 2530 per cent before the age of 12 months and 5560 per cent before the age ue two ycara. By the age of 4 ycors, practically a11 rhildren have experienced measles. The above findings of Mayden are corroborated by David Morley in his paper "Severe measles in the tropicsn; he states that in the developing countrier, more than 30 per cent of children in urban areas may develop measles in the firet year of life. ~orle~(~) has further shown that in West African towns, 1520 per cent of children may get measles before they are 9 months old and over 80 per cent by the time they are three years.

38 EMlIMZl4 EM/SEM.EPI./~R Annex 111 page ii WHO EMRO It has also been estimated that in the United States about 4 million cases(5) of measles were occurring each year before 1963, i.e. before the vaccination against measles started there. This number is almost equal to the number of births in the Unired scaces each year. It is however said that, before the widespread use of the vaccine, as manv as 1530 per cent of children without a clinical history of natural measles infection had serological evidence of a previous measles infection. Taklng into consideration all the above evidence, one may be inclined to agree that the yearly incidence of measles may be equal to cases for the Region as a whole, or about 25 per thousand of the total poplilation. The above number is equal to about 60 per cent of the births each year in the Region. It is also seen that in Kuwait in 1975, about 83 per cent of the cases were less than five years of age, and that about 25 per cent were under one year of age. ~ ~ on ~ these e findings, d one may say that about ceaes of maales do occur onnually in the Region in children under one year of age and that about such cases occur annuslly in children of up to five years of age. *he experience in ~uwait(') Shows that mortality was 1.7 per cenr in 1974 and 3.1 per cent in both 1973 and Since malnutrition along with overpopulation and unhygienic urban conditions, as well as inadequate health resources, are the major Eactnrs r~nfavourably influencing the severity of the disease. there is no doubt that mortality from measles in the countries of the Region is going to be substantial. Even if one may put the case fatality from measles around one per cent, the result would he that deaths from measles may be expected annually in the Region. As the case iatality is the highest in the lower age groups. one may agree ro a case fatality of 1.9 per cent in age group under one year and of 0.9 per cenr from 1 to L years of age. At these rates there will be about deaths from measles in rl~ildren under one year of age and about deaths in children of 1 to 4 years of <I,:@. The deaths from measles (Table 3A) will then form about 1.7 per cant of the general mortality or 0.25 per Ll~uuaa~~d ut pupuln~iul~. Whooping cough Whooping cough is said to almost rival measles in importance and severity. Deaths from whooping cough are frequent among infants aged less than one year. However, recordine of cases is very low because of the difficulty of making the diagnosis in edx ly infancy. ~h~ number of cases recorded in the countries of the Region (Table 4) varies from 1.2 (Cyprus) per population to 1517 (Oman) per population. lhe total number of cases notified (Table 4A) by fourteen countries/populations amounts to about cases from a population of These notifications give an incidence of 124 cases per population. While looking into the data on whooping cough notifications of ~n~land(8) from 1954 to 1966, it is seen that on an average 95 cases of whooping cough were notified per population. It has also been said that in ~alifornia(9) in 1940, just before introduction of potent vaccines, there were reported cases and 102 deaths, and morbidity and mortality rates of 228 and 1.47 per respectively. The case fatality in this case stands at 0.64 per cent.

39 WHO EMRO EMIIMZI~ EM/SEM.EPI./18 Annex 111 page iii The prevailing conditions in the countries of the Region should be borne in mind, together with the fact that most of the cases of whooping cough do not come to the health institutions, and also that even their diagnosis is quite difficult. One is inclined to agree to an incidence rate of 250 cases per population for the countries of the Region. At this rate, these will be about cases of whooping cough annually. ~t is also seen(') that about 9 per cent of the cases are under one year of age, and that the case fatality for whooping cough in children under one year of age is 8.9 per cases. The overall case fatality in whooping cougit in 1.08 per of cases. With the above number of estimated cases in the Region, the number of deaths from whooping cough is calculated to amount to 662. This assumption appears to be too low, as it is said(8) that the majority of people contract the disease at some time during their life and it is thought that about 70 per cent suffer from a clinical attack. If this be taken as the basis for estimating the morbidity from whooping cough. then there will be almost an equal number of cases ( ) as given for measles in the Region. Based on this figure, the number of cases in children under one year of age will amount to , with about deaths annually. The total of deaths from whooping cough in the Region will then be about annually. Tetanus Tetanus is of relatively high incidence in agricultural and underdeveloped areas, where contact with animal excreta is more coolaon. The disease will continue in agricultural countries and in those with a lov standard of living and poor hygiene, unless the population is protected through vaccination. A considerable number of cases of tetanus occur amongst the newborn, where the mortality is very high. The disease in the newborn is due to the lack of obstetrical care. Babies born in rural areas frequently have a septic umbilical wound. The risk of tetanus neonatorum is particularly high in places where soil, cow dung, ashes and similar substances are used for dressing the umbilical stump. In the countries of the Region, data on tetanus are available for eleven areas (Table No. 5 (A)). A total of cases was notified, which gave an incidence of 0.3 per population or 6.9 per live births. Iiowever, i a paper entitled "Recent trenda of tetanus mortality in the world" by B. ~ytchenkoql~). it is estimated that, for the Asian countries, the mean mortality rate may be as high as 14.7 per population. With the above rate, the mortality in this Region from t tanus would be about annually. As the overall mortality rate from tetanus 11) is estimated at 45 per cent of the cases, one would expect almost cases of tetanus in the Region annually. Since tetanus neonatorum in estimated(ll) to account for about 18 per cent of the total cases, there are likely to be cases of tetanus neonatorum in the 'i

40 EM/IMZ/4 EM/sEM.EPI./~~ Annex I11 page iv WHO EMRO. I.,!; Region annually with a case fatality rate of almost 85 per cent(ll). In tetanus neonatorum hhe number of deaths in the newborn may be expected to be 12 25ly in the Region. However, in another paper entitled "Factors determining mortality due to tetanusg', by B. Bytchenko ~ ( 1 2 the ) estimated mortality due to tetanus neonatorurn for Iran is per birtha, while fnr Pdkiatnn it is per livi b:.rths. At this rate, Iran will have approximately neonatal deaths due to tetanus, while Pakistan will have almost deaths due to tetanus neonatorumlmeaning thereby that over 11 per cent of the total deaths in infants under one year of age are due to tetanus neonatorum. Even if che lower estimaced races for ran are applied to the Region, this would result in deaths due to tetanus neonatorum in the countries of the Region annually. It has been said that in some tropical areas tetanus is responsible for as many as 80 incidences per live births. This would result in about cases of tetanus neonatorum in the Region, but it would almost certainly be incorrect to apply such a high rate Regionwide. ~iphtheria The number of cases of diphtheria notified by fourteen countries of the Region amounts to (Table No. 6 (A)) which gives an attack rate of 4.1 per of population in the countries concerned. It is however stated(l3) that if 50 per cent of the school population and 30 per cent of preschool children are innuune, either by artificial imnunization or previous infection, the population may remain protected against diphtheria. In the United ~tetes(13), the highest incidence rate of diphtheria recorded is about 40 per population and a caae fatality rate of around 10 per cent. With an attack rate of say 15 per population cases of diptheria annually, with about deaths, may be predicted for the Region. However, if the attack rate is assumed at 30 per population, then the annual number of cases would he with deatha in the conntriee of the Regton. olio myelitis In countries such an those of this Region, where che living conditions of che population are still developing. poliomyelitis remains essentially an infantile disease or one affecting young children. Nearly all cases of paralysis occur in children under the age of 5 years and the majority in infants under the age of 3 years. The number of cases reported in the Region (Table No.7 (A)), by 14 of the areas, for one year comes to This gives an average attack rate of 2.5 per of population in the cuuntriea re)mr~irrg the incidence. This appears to be on the very low side as in a study(14) by David D. Nicholas et entitled "Is Poliomyelitis a problem in developing countries? The Danfa Experience", an annual incidence of at least 28 per of population has been estimated. Based on this incidence, the countries of the Region, may expect about cases. of ~aralytic poliomyelitis annually. The age distribution of cases of poliomyelitis in this Region may not be comparable with that in Europe or North America, where relatively a higher percentage of older age Croups are also affected. However in ~lexandria(l5). it is seen that 78.6 per cent