Revised plan of action for neonatal tetanus elimination: 16th meeting, 11-15 October 1993, Washington D.C., USA

[I] EPI/GA G//93/WP. 12 Restricted distribution, English only EXPANDED PROGRAMME ON IMMUNIZATION GLOBAL ADVISORY GROUP REVISED PLAN OF ACTION FOR NEONATAL TETANUS EL/MINA TION • -,9"'(1~..,;;;:- WORLD HEAL TH ORGANIZATION ORGAN/SAT/ON MONO/ALE DE LA SANTE 16th Meeting 11-15 October 1993 Washington D. C., USA The contents of this restricted document may not be divulged to persons other than those to whom it has been originally addressed. It may not be funher distirbuted nor reproduced in any manner and should not be referenced in bibliographical matter or cited. Le contenu du present document a distribution restremte ne doit pas etre divulge a des personnes autres que celles a qui ii etait initialement destine. II ne saurait faire l'objet d'une redistribution ou d'une reproduction quelconques et ne doit pas figurer dans une bibliographie ni etre cite. WHO/EPI/GAG/WP.12 Page i FOCUS FOR THE GLOBAL ADVISORY GROUP (GAG) The Global Advisory Group is requested to endorse this revised Neonatal Tetanus Plan of Action and asked to pay special attention to the following new or significantly revised issues since the global plan of action was first presented in 1989: 1. The definition of neonatal tetanus elimination (section Ill, page 7) 2. The distinction between confirmed, suspected and discarded cases of neonatal tetanus {Section IV, pages 13-14) 3. The staging of countries towards neonatal tetanus elimination (section V, pages 16-17) 4. The assessment of neonatal tetanus elimination at district level (section VI, page 18) 0 0 0 0 0 EPI/GAG/93/WP.12 Page 1 THE ELIMINATION OF NEONATAL TETANUS BY 1995 GLOBAL PLAN OF ACTION UPDATE 1993 I. INTRODUCTION In many developing countries, neonatal tetanus (NT) is still responsible for 25% of infant mortality and 50% of neonatal deaths. Neonatal tetanus is particularly devastating in the least developed countries and the poorest populations of these countries. In 1992, it is estimated that more than 500 000 newborns died from neonatal tetanus, and more than 50 000 mothers died from tetanus in the post partum period. These deaths could have been prevented by immunizations or clean delivery practices. In May 1989, the Forty Second World Health Assembly noted the challenge to eliminate neonatal tetanus by the year 1995. This resolution reenforced previous policy statements calling for the reduction of tetanus and other diseases in newborns and their mothers through primary health care services. In 1990, the World Summit for Children endorsed the joint WHO/UNICEF health goals that included the specific goals of neonatal tetanus elimination, poliomyelitis eradication, measles reduction, and maintaining a high level of immunization coverage. With only months remaining to reach NT elimination, the challenges remain formidable. Many women are still not immunized with tetanus toxoid (TT) because immunization services are not available; the groups to which they belong are excluded from services due to political or cultural reasons; or they drop out before they receive the doses they need. Most important , however, is that health workers miss opportunities to immunize the women when they bring their children for immunization. It is recognized that the NT elimination initiative is different from other disease eradication or elimination initiatives, such as those for smallpox and polio, in that, as the causative organism for tetanus is ubiquitous in the environment, the potential for the disease is always present, even after the target of less than one case per 1000 live births by district is reached. EPI/GAG/93/WP.12 Page 2 Therefore, surveillance must be pursued indefinitely and infrastructure development and sustainability of services assume paramount importance. This Plan of Action outlines the WHO strategy for neonatal tetanus elimination, revising the previous plan developed in 1989. It draws on experience gained in various countries in implementing strategies for NT elimination through TT immunization and provision of clean deliveries. The revised Plan of Action also incorporates recommendations of Consultation on NT elimination held in 1990 and the Technical Consultative Group Meeting held in 1993. II. PROGRESS TOWARDS NT ELIMINATION Significant progress towards NT elimination has been made. In developing countries, coverage of pregnant women with at least two doses of tetanus toxoid (TT2 +) increased from 27% to 43% from 1989 to 1992, respectively. An outstanding achievement has been made in the African Region where TT2 + coverage in pregnant women rose from 25 % to 42 % in the period 1989 to 1992. Out of 46 countries in the Region, 9 have reached a coverage of more than 80% (Map 1) . Data on coverage for clean deliveries (defined as deliveries attended by a trained person) indicates that, in 1992, the majority of newborns in developing countries are delivered at home without the assistance of a trained attendant (Map 2). The estimated NT death rate by country is shown in Map 3. This represents a global reduction of 25% compared to the estimates in 1989 and the prevention of 687 204 deaths due to NT every year. In 1993, 80% of the globally estimated number of cases are occurring in 14 countries (Table 1). Neonatal tetanus remains a seriously under-reported disease, even in areas with well developed disease surveillance systems. Globally, it is estimated that less than 5 % of cases are reported. Most of the cases that are never reported occur in poor, rural areas where babies are delivered at home by untrained or poorly trained attendants, the conditions in which the risk of the disease is highest. Most of these babies die without any registration of birth or death. .. Source:WHO/EPI/HQ, Information system, September 1993. ~ ~,-.'~ .. ·=:=}f ~ P' D • . []] • lo Legend < 50% 50% - 80% > 80% No data <fJb ~ Wortd Heallh Organization Public■Oon1 of lhe Wo,td Health Otg■nl1■tlon en1oy copyriuh1 p,otecleon In accordance wuh the provisions of Protocol 2 of thu Un111,en.al Copyuyhl Convention. All t1gh11 reserved. The d"4gnaliona en11•loyed ■nd the prnent■llon of the meten■I In 1hi1 pubhcat,on do not in11,ly the eapre111on of any opmion wh111o■v•r on the r.•r1 ol the Sacre1 ■n1t ol the World H■■llh Org•m1■t1on concern,ng the f:g■f status of any country. 1eu11ory. city or ■re■ or ol ih ■uthor,ue), or conct!rn1ng the del,mn■tion of ill honuers o, bound■ncs . The m•nt1on ot spe-c1f1c comp•nies or of certain manuf11ctyren · producu does not imply that tht'y ■r■ endoned or recommende-d \,y the World Heilhh Org■nu: ■uon in preference to others of • s.md■r nature th.at i1re nol rnirnlioned Errors i1nd omn11011, e■cepled. the ni1m•1 of paopue-tary produc11 ire d1111ng,1t1hed by inntal Ci1p1t1l te11ers . 3: )> "'C _. ::t N + 3: 3: C z -E 0 z C') 0 < m :JJ )> C) m "T1 0 :JJ "'C :JJ m C) z )> z -i :E 0 3: m z _. U) U) N m J2 ...._ G) )> G) ...._ (0 c..> ci1~ <O "'O (I) • .... WN & fJ .. Source:WHO/EPI/HO, Information system, September 1993. ~end , .<50% ~ ,,,,:,::::q 50% - 80% 11 -:-:-:-:-:-: ; .>80% ONo dolo . . t. I~ ~~ ~'- .. .. • (/Jt, • World Health Organizalion Publicat ions of the Wottd Health Organilation en1oy copyrt9hl protecllon In accordance wnh lh• pro•ision~ of P,otocol 2 of lhtt Umvenal Copy11yhl Convention. All righ11 reserved Tf1e dnignat,ons employed and the pre1en1a1ton of the n,ateual In th11 publu. at1on do nol imply the uprl!ssion nf any opuuon wha110•""'"' on lht p11n I th• Secre11n11 of th• World H••llh Org.amr.ahon concern,ng lhe legal s1atu1 ol •••Y country. ,.,,,.,o,y-. clly or ar•• or of its au1ho11he:.. or concermng Iha dehnntation ol its honh•rl o, boundaine-s. The mrnt,on at s.pecihc camp:mies or of ceru,n mainufl,ctyra,s· protlucc~ dues not ,mplv th•t lhey •r• endoned "' r•co,nmended by th• WorlJ He~lrh 01gaoi1ahon '" preference lo othen of • tunilar nacu,e lh•I •r• not m~nciont>d Errors and Offlf'lllon• e ■capled . the names of p,opn~tary produce, ■re d111tnguilhed br inrti.al c•pital lenus "'Om Q) "'tJ (0 - CD G) ~ )> G> ---c.o <,J ~ ~ ..... ~ t,J l, "tJ ~ (") r m l, 2 C m r < m :x:, -< (") 0 < m :x:, l, G) !" ... (0 (0 N .. Source:WHO/EPI/HQ, Information system, September 1993. Q t ~, .. '~ .. -:-::::=ffej" ··. ~ ~ P' • . . Legend < 1 imt-5 Ir=========)> s :::::::::::: fONodala .. ~> t World HHllh Otganlulion Publications of the Wortd H••llh Org■nit■tlon enloy copyrlghl p,otection In accordance w,th the provittOn1 ol Protocol 2 ot th• Unn,erwl Copyuyhl Convention . All r19ht1 reten,ed. Th■ dnign•hon1 ■mpjoyad and the pretentauon of the meter ial In th is publication do not in,ply the ••Pre,,ion of any op.mon wh■uo•""' on lhe part of the Se-c.retan•t of th• Wo, td H••flh 0,9.,nu.a11on conce,n,119 lhe legal 1tatus of ■uy country. •••• ita,,. city or ■re■ or ot tis authout1e1, or concerning Iha deltn111etion ot its tronl1ers or boundHtH, The ntf'nllon of 1,pec1f1c cnmp,1mt't 01 ol ceruun manufactyr ■n · products does not ,n,ply that they ••• endorsed or r•co,nm•nc1td by th• Wo,IJ He-aflh Organ11a1,on In preference lo others of • sunilar netur• lh.111 ••• nol mentioned Errors and om,n,on, ••cepled. lhe n~mes of p1op11elMry producls ••• d1111nguished by in1Ui1I ci1piti1l l11ners 3: l> "'D (.J .. m en ::! 3: l> -t m C z -t C m l> -t J: :::D l> -t m en ' ~ U) U) N m ~ --G) )> G) -- (0 (.J -0 ~ ~ -0 CD :_. U1 t,J Countries contributing 80% of the global estimated neonatal tetanus deaths, 1992 r Countries NT mortality Estimated number rate per 1 ooo LB* of NT deaths Somalia 20 9383 Nepal 11.9 9229 Ethiopia 9.1 24022 Nigeria 9 47411 Bangladesh 8.9 41054 Pakistan 8.7 44675 Sudan 8 8991 Kenya 7 7808 Zaire 6.5 12465 Indonesia 6.2 31724 India 4.2 108002 China 3.9 98322 Viet Nam 3.3 6709 Uganda 3.2 3047 \._ Source:WHO/EPI/HQ, Information system, September 1993. * LB: Live births, ** PAB: protected at birth. Reported NT TT2+ or cases PAB** 5 7 22 94 9 799 42 588 80 1737 44 31 12 38 47 29 582 62 5775 76 2 338 36 71 83 ' "'Om 0) "'ti (0 ' CD G) m )> G) --(0 <,J ~ "'O .... N EPI/GAG/93/WP.12 Page 7 Other reporting problems occur. It is only recently that most countries have begun reporting neonatal tetanus separately from other tetanus cases. Timeliness and completeness of reporting are still unsatisfactory. Case reporting at the health facility level is usually not routine, and reports from all levels are often delayed. Global progress towards NT elimination has been made through an increased awareness of the "forgotten" EPI immunization: TT immunization of women. However, one of the best gauges of progress in tetanus toxoid coverage is to compare it to coverage with children's vaccines. The disparity remains great and unacceptable. Globally, coverage for DPT3 rose from 72% in 1989 to 79% in 1992, while TT2 + coverage (two or more doses of tetanus toxoid in pregnant women) in 1992 was still only 42%. However, the strategies which will achieve the goal are well defined and need to be applied thoroughly in all countries. To do this, a high commitment at all levels of the community and allocation of personnel and financial resources essential to achieve the goal and sustain the achievement is required in each country. Ill. OBJECTIVES AND TARGETS The target for NT elimination by 1995 is: A rate of neonatal tetanus cases below 1/1000 live births in every district of every country. By July 1994: 1. All countries will have carried out district assessments of their NT elimination status, identified high risk districts/areas for priority activities to achieve NT elimination, and started implementation. By the end of the year 1995: 1. All countries will have achieved a rate of NT cases of less than 1/1000 LB in all districts. EPI/GAG/93/WP.12 Page 8 2. All countries will have achieved in each district at least 80% protection of newborn against neonatal tetanus, through immunization or clean delivery or both. 3. All countries will have established a system for at least monthly routine reporting of NT, including reports of zero cases, from all districts. The system should include a capacity to investigate cases and take appropriate action in response to a case. By the end of the year 2000: 1. All countries will have demonstrated a capacity to maintain an annual neonatal tetanus incidence rate of less than 1 per 1000 live births in every district. 2. All countries will have achieved and be able to maintain at least 90% coverage with a protective dose of TT for all women of childbearing age in every district. IV. STRATEGIES There are three primary strategies to achieve NT elimination: 1 . Delivery of TT vaccine in the manner most effective for protecting all newborns against NT; 2. Provision of clean delivery services to all pregnant women; 3. Effective surveillance aimed at detecting and reacting to every case of neonatal tetanus. To sustain the status of elimination, countries will have to implement activities to ensure that a high level of immunity in pregnant women is maintained indefinitely and that the surveillance system is capable of detecting any case. 1 . Delivery of TT vaccine Every birth should be protected through tetanus toxoid immunization administered to the mother. In high risk districts for NT, TT immunization should be considered as the primary strategy for controlling NT and coverage close to 100% is required. a. Immunization schedule EPI/GAG/93/WP.12 Page 9 The WHO recommended TT immunization schedule is five doses with a minimum interval between each dose. Five doses of TT, respecting the minimum interval between doses, will provide immunity through a woman's childbearing years. TT1: At first contact, or as early as possible during pregnancy TT2: at least 4 weeks after TT1 TT3: at least 6 months after TT2 or during next pregnancy TT4: at least 1 year after TT3 or during next pregnancy TT5: at least 1 year after TT4 or during next pregnancy Protection of the woman and her newborn starts two weeks after the administration of the second dose. Any subsequent dose administered after the first dose counts as a dose towards the five dose schedule even if administered at a longer interval than the recommended minimum interval. If young women have documentation of having received three doses of DTP in infancy, those doses counts as two doses of TT towards the five dose TT schedule 1 • There is no evidence for contraindications of TT immunization of pregnant women at any time during the pregnancy. Currently available adsorbed TT vaccines are extremely safe and effective, causing only minor local reactions which are usually self limiting and require no treatment. This applies also to situations where the women, due to lack of documentation, has received more than 5 doses of TT vaccine 1 Further information is provided in the EPI document "Immunological Basis for Immunization: Tetanus WHO/EPI/GEN/93.13 EPI/GAG/93/WP.12 Page 10 b. Target population The target population is women of child-bearing age, with a special emphasis on pregnant women. However, any group, including school-age children, all females, or all children and women, can be included in the target group, according to the local situation. The choice of target group will depend on availability of services and resources and can change from area to area within a country. At a minimum, eligible pregnant women should be immunized with tetanus toxoid whenever they are in contact with health services for antenatal care, treatment, or other reasons. For long term sustainability, all girls reaching child bearing age should be fully immunized with tetanus toxoid through infant and childhood DPT, Td, or TT immunizations. c. Immunization strategies To reach a high level of tetanus immunity among pregnant women, TT immunizations should be offered to all pregnant women routinely at antenatal care visits. Non pregnant women should be screened and immunized as necessary at least during immunization sessions for children. Using the DPT1 contacts for systematic screening will facilitate detection of unprotected individual women and/or unprotected groups of women, even in areas with high average TT2 + immunization coverage. To reach women who do not routinely use the health services (the so called "never reached populations") immunizations should be offered at places such as markets, churches, schools, and during home visits. Local immunization days are recommended in areas which can not be served through fixed and outreach services (dispersed and nomadic populations). When national immunization days are conducted for other EPI vaccines, TT should be included and given to women 15-44 years of age, at least in high risk districts. In special circumstances, depending on age at first and last pregnancy, women in the age group 12-35 should be considered for immunizations. Investigations of suspected cases of NT should lead to immunization of the mother of a case. Furthermore, screening and immunization of all child bearing age women in the community where the case occurred should be done. d. Tetanus toxoid immunization cards EPI/GAG/93/WP.12 Page 11 All women and school girls should be provided with a durable lifetime record, or an integrated health care card, which records all TT doses received, including any OPT or Td received during childhood. e. Tetanus toxoid quality All immunizations must be given with potent vaccines that meet WHO standards. Recent country reviews and surveys have revealed subpotent vaccines produced by local manufacturers. Freezing of tetanus toxoid during storage have been frequently documented in the field. The vaccine should never be frozen, since freezing irreparably damages it. The vaccine should be stored continuously between O and + 8 degrees C. f. Sterile injections Blood-borne and sexually transmitted diseases, e.g., AIDS and hepatitis, are becoming increasingly serious problems especially when injections are given to sexually active individuals. The EPI requirement that every injection be made with a sterile needle and a sterile syringe is of critical importance and this requirement should apply to all injections. Sterility cannot be ensured when the supply of syringes and needles is inadequate, there is not enough sterilization equipment, or health workers are not trained or not properly applying skills learned in their training. g. Monitoring protection against NT through immunization Monitoring of protection at birth against NT should be done at the time infants are brought for the DPT1 immunization 2• Data should be compiled monthly at health facility and district level. In addition, tallies of doses given to pregnant and non-pregnant women should be recorded and compiled and coverage should be calculated for pregnant women only using the following formula: TT2 + TT3 + TT4 + TT5 (administered to pregnant women) ---------------------------------------------------------------------------------- X 100 PREGNANT WOMEN (Number of newborn) 2This method is described in the EPI training module WHO/EPI/MLM/91.6 Monitor Immunization Coverage EPI/GAG/93/WP.12 Page 12 2. Provision of clean delivery services a. Definition For the purposes of NT elimination, a clean delivery (CD) is defined as a delivery attended by health staff in a medical institution or by a trained birth attendant at home using hygienic practices (i.e assuring the cleanliness of hands, cord, and perineum, as well as any substances applied to the cord). Hygienic practices can reduce other causes of perinatal mortality and morbidity as well as preventing tetanus and septicemia and other perinatal infections in the mother. b. Clean delivery strategies Activities to improve the quantity and quality of clean deliveries in the following four situations are well described in other documents of FHE/WHO references: ► institutional deliveries; ► non institutional deliveries; 1> deliveries attended by a medical person; 1> deliveries attended by a trained TBA; 1> deliveries attended by an untrained person, including the woman herself. c. Monitoring clean delivery coverage The FHE division of WHO is presently developing indicators for clean deliveries. However, at a minimum, countries should monitor by district the following: ► antenatal care coverage with: - one visit - two or more visits ► institutional deliveries ► home deliveries by: - a medical person - a trained TBA - an untrained person 3. Effective surveillance for NT EPI/GAG/93/WP.12 Page 13 Surveillance is an essential component of an effective disease control programme. Improvements in surveillance and the use of surveillance data for planning and evaluation of NT elimination will be a core activity for significant advancements in primary health care. Accordingly, improving surveillance of EPI diseases, with an emphasis on NT, is a high priority for NT elimination3 • a. Developing routine surveillance Surveillance for NT elimination should aim to improve routine surveillance systems in all countries and all districts. The most important use of NT surveillance data is to identify districts and populations in which newborns are at risk of neonatal tetanus, to measure the quality of immunization and clean delivery services, and to monitor disease elimination. All districts and all health facilities should submit monthly reports on neonatal tetanus cases, separate from other tetanus cases. managers at all levels should monitor the completeness and timeliness of reporting and take actions on deficiencies. b. Case definition For reporting purposes, the following standard case definitions should be adopted: A confirmed case of NT: A confirmed case of neonatal tetanus is defined as a child with a history of all three of the following: 1. Normal suck and cry for the first two days of life. 2. Onset of illness between 3 and 28 days of life. 3Detailed guidelines on how to improve routine diseases surveillance systems and make use of surveillance data is given in the EPI document "Improving Routine Systems For Surveillance of Infectious Diseases Including EPI Target Diseases "WHO/EPI/TRAM/93.1, and in the document "An integrated approach to high coverage, control of measles, elimination of neonatal tetanus and eradication of poliomyelitis; introducing the high risk approach" WHO/EPI//GEN/93.21 EPI/GAG/93/WP.12 Page 14 3. Inability to suck followed by stiffness and/or convulsions4 • A suspected case of NT: A suspected case of NT is defined as: OR Any child reported as suffering/having suffered from neonatal tetanus (and not investigated) Any neonatal death occurring between 3 and 28 days of life where the cause of death is not known. A discarded case of NT: A discarded case of NT is defined as a suspected case which has been investigated and does not fit the definition of a confirmed case. c. Case reporting The number of NT cases reported at each level of the surveillance system should be the total number of suspected cases minus the number of suspected cases discarded through investigation. Zero cases must be reported (submitting a report marked with a O [zero] if no cases are seen). d. Feed-back Managers at all levels should give regular feed-back to the level reporting to them. This should include the completeness and timeliness of reporting as well as aggregated data on cases. 4 Reactive convulsions are typical of NT and will help discarding other causes of neonatal convulsions such as: congenital (cerebral anomalies); perinatal (complicated labour, perinatal trauma an anoxia, or intracranial haemorrhage); and postnatal (infections and metabolic disorders). EPI/GAG/93/WP. 12 Page 15 e. Neonatal deaths As the routine disease surveillance system improves and TT and/or clean delivery coverage exceeds 80%, all neonatal deaths should be reported. All suspected cases of neonatal tetanus (as defined above) should be investigated5 • f. Case investigation/Case response When a district reaches a protection against NT of > 80% through either TT immunization or clean deliveries, all suspected NT cases should be immediately investigated and case response implemented for confirmed cases. At a minimum case response should include: ► immunization of the mother of the case; ► screening and immunizing of all women of child bearing age in the community/village/ward when the case occurred; ► active surveillance for additional cases; and ► any other corrective measures relevant to case investigation findings, such as: missed opportunities, vaccine failures, insufficiently trained TBAs, and harmful traditional delivery and cord care practices. g. Identification of high risk districts High risk districts should be identified and given priority. High risk districts are defined as: ► Districts with a reported NT rate of more than 1/1000 live births; ► Districts with less than 80% coverage with clean delivery or TT2 + immunization; ► Districts with unreliable data (such as: incomplete reporting, absence of reporting, or low access to treatment facilities). If resources are not available to intensify elimination activities in all high risk districts, priority should be given to high risk districts with the largest populations and the highest reported NT incidence rate. 5See the EPI document "Guidelines for Investigating Suspected Cases of Neonatal Tetanus WH0/EPlffRAM/93.3 EPI/GAG/93/WP.12 Page 16 h. Community participation in disease control As the majority of NT cases are never brought to the attention of health workers, complete, timely, and accurate reporting by health facilities is not sufficient to ensure elimination of NT. In addition to the health and allied health personnel, the surveillance system should aim at including at least one reporting source identified in each village/community, preferably persons with a good knowledge of life events in the population (key informants). He or she should report to the local health facility at least once a month, whether suspected cases have been seen or not. Reporting of suspected cases must trigger investigations and appropriate response. Liaison with other disease control initiatives, such a the drancunculiasis eradication programme and the onchocerciasis control programme is fundamental to eliminate NT in remote villages or dispersed populations which presently have limited access to health services. i. Monitoring effective surveillance Managers should monitor: ► ► ► completeness and timeliness of reporting at all levels of the surveillance system (by health facility, by district, by region/province); the proportion of suspected cases investigated; the proportion of confirmed cases followed by an appropriate response. V. STAGING To assist countries in determining which activities are most appropriate according to the level of development of their immunization and MCH programmes, the following staging is proposed. The staging is intended as a planning guide for managers, and should be broadly interpreted. Stage 1: Infrastructure development; Stage 2: Acceleration of activities; Stage 3: Maintenance of NT elimination. Coverage Reported NT with TT incidence and/or CD* Stage 1 Infrastructure <80% > 1 /1000 LB development or unreliable Stage 2 Acceleration >80% > 1 /1000 LB of activities or unreliable Stage 3 Maintenance >80% < 1/1000 LB of NT (in every elimination district) reliable data * Clean Delivery EPI/GAG/93/WP.12 Page 17 ACTIVITIES 1> establish or optimize existing infrastructure to provide TT and/or clean deliveries to protect at least 80% of newborns against NT; 1> establish the basis for a complete, timely and accurate routine reporting system in every district 1> assess annually district status towards NT elimination to have a country profile; 1> identify specific causes for the high risk classification and select activities; 1> implement intensified immunization and clean delivery activities in high risk district/populations; 1> improve the quality of surveillance (monitor completeness and timeliness by district, investigate all suspected cases of NT); 1> implement corrective measures in response to confirmed cases; 1> ensure maintenance of elimination status in every district by: •annual assessment •annual district planning •budget allocation •detection of unprotected groups through DPT1 contact assessment •explore feasibility to immunize school age children •pay specific attention to the last districts that achieved elimination status or where occasional cases are still occurring EPI/GAG/93/WP.12 Page 18 VI. ASSESSMENT OF NEONATAL TETANUS ELIMINATION Assessment of elimination must take place yearly, country-wide and in each district. The number and percentage of districts that have eliminated neonatal tetanus should be reported yearly. The district assessment will consist of collection of data on: ► children protected at birth against NT through immunization of their mothers and through clean delivery practices; and ► reported data on NT incidence complemented by active surveillance. Active surveillance is defined as a search for NT cases based on a review of vital event data (when available), health facility record review, and community based searches for NT (e.g. using focus group or key informants). Districts have eliminated NT when the NT rate is below 1/1000 live births AFTER correction for gender bias (number of NT cases in male infants multiplied by two) and AFTER active surveillance. In addition, the percentage of children protected at birth through TT immunization of their mothers or through clean delivery practices should be above 80%. In populations where proper disease surveillance cannot be established due to lifestyles or cultural practices, all women of childbearing age must be fully immunized. District assessment should also include the collection of data on: ► disease incidence for other EPI target diseases; ► immunization coverage of other EPI antigens; ► antenatal care coverage. ► outcome of full term pregnancies The outcome of this assessment in districts that have not eliminated NT should be a list of priority activities that will lead to its elimination. For districts that have reached the stage of elimination the outcome should be a list of priority activities to maintain the elimination status. EPI/GAG/93/WP.12 Page 19 VII. WHO RESPONSIBILITIES AT NATIONAL, REGIONAL AND GLOBAL LEVELS WHO will provide technical leadership in the management and coordination of the Initiative for the elimination of NT. Success will depend on NT elimination being perceived as a universal challenge, and WHO will actively solicit the collaboration of as wide a spectrum of institutions and individuals as possible. Commitment from governments and individual political and community leaders will be essential. Financial and technical support will be required from multi- and bilateral development agencies, other international agencies, nongovernmental organizations, technical institutions, universities, private and voluntary groups and concerned individuals. Organizations whose work is focused at community level will be of particular importance. WHO activities associated with the neonatal tetanus elimination initiative will be conducted as part of the Expanded Programme on Immunization in collaboration with the Family Health Division and other programmes as appropriate. The most important activities will be those of national health authorities in improving the performance of their surveillance systems in detecting NT cases and identifying the areas and populations where NT is still occurring. National health authorities will need to improve their immunization and clean delivery programmes to stop NT occurrence in these areas. The main responsibilities for planning, resource mobilization, donor coordination, training, implementation, monitoring, evaluation and research are at the national level. WHO Regional Offices will: ► provide technical support to countries and coordination within the region; ► update regional Plans of Action based on the results of assessments of national programmes; ► support national managers in planning, donor coordination, training, monitoring, evaluation and research; ► place special emphasis on neonatal tetanus surveillance, including neonatal death surveillance; ► provide technical support to national programmes to adapt and develop computer software for disease surveillance; ► engage in regional resource mobilization and coordination to the extent possible; EPI/GAG/93/WP.12 Page 20 ► review regional progress at least annually at regional or sub-regional meetings of national EPI programme managers or at regional Technical Advisory Group meetings; ► ensure coordination of various disease control initiatives in disease surveillance and service delivery activities. At the Global level, WHO through EPI and FHE will provide overall technical direction for the initiative including the following activities: ► provide leadership in resource mobilization and donor coordination, ► develop prototype materials and technical support documents as required, ► promote the development and application of improved disease surveillance and programme monitoring and evaluation techniques, ► support Regional Offices and national programmes by providing expertise, by assigning short- and long-term staff and by providing funds, particularly to strengthen: donor coordination, planning, training, supervision, surveillance, monitoring and evaluation and research, ► provide feedback on a quarterly basis to programme managers with global information on disease incidence and other selected parameters, ► participate in the development of a strategic plan to ensure sufficient quantity of tetanus toxoid vaccine to all countries, ► promote the production and the use of a safe and effective TT vaccine, ► promote operational research addressing surveillance needs for neonatal tetanus elimination at national and district levels in collaboration with national offices, ► ensure annual review of the Initiative for the elimination of neonatal tetanus by a technical consultation and/or the EPI Global Advisory Group, and periodic review by the WHO Executive board and the World Health Assembly. The review will focus on the following items and indicators: 1. Global progress towards NT elimination, by WHO Regions and by countries, 2. number of countries estimated to have reached NT elimination in the previous year, EPI/GAG/93/WP.12 Page 21 3. proportion of districts having achieved NT elimination during the previous year in each country, 4. number of NT cases reported, 5. timeliness and completeness of district reports by country, 6. number of countries in each stage of NT elimination, and 7. obstacles faced by countries to achieve the NT elimination targets. ► confirm the elimination of neonatal tetanus (that coverage and surveillance requirements have been met in each district of the country). VIII. ROLE OF OTHER AGENCIES UNICEF will continue to be a major provider of programme support, especially in the least developed countries. This includes supply of vaccines; provision of cold chain, injection and logistics equipment; participation in planning, implementing and evaluation of immunization activities; implementation of training programmes; promotion of social mobilization; and monitoring of public health communication that create demand for immunization services and promote community participation in surveillance systems. UNICEF will also continue its successful advocacy efforts to keep immunization programmes on the agenda of decision-makers and leaders at the highest political levels. UNICEF and WHO will continue to work closely together to ensure that their activities are complementary, using such mechanisms as WHO/UNICEF inter-secretariat meetings, the UNICEF/WHO Joint Committee on Health Policy and inter-agency coordinating committees at all levels. Other United Nations organizations and agencies, including UNDP and the World Bank, will continue to support immunization programmes in their development assistance programmes. UNFPA will also play a role in helping to increase immunization coverage with tetanus toxoid for women of childbearing age. The Task Force for Child Survival and Development will serve as a forum for dialogue among heads of WHO, UNICEF, UNDP, World Bank, UNFPA and the Rockefeller Foundation. In addition, special meetings called by the Task Force serve an important function by raising awareness of the needs and challenges facing immunization programmes as well as the actions necessary to achieve the goals of the Plan of Action for Implementing the World Declaration on the Survival, Protection and Development of Children in the 1990s. EPI/GAG/93/WP.12 Page 22 Bilateral development agencies are expected to continue to support immunization programmes in their development assistance programmes as called for in the Plan of Action. They will be active partners in inter-agency coordinating committees at all appropriate levels. Nongovernmental organizations, including such organizations as the Canadian Public Health Association, the League of Red Cross and Red Crescent Societies, Medecins sans Frontieres, the Rockfeller Foundation, Rotary International, and Save the Children Fund, will continue to support immunization programmes in ways specific to their own mandates. It is anticipated that in the 1990s an increasing number or organizations, both international and local, will join in the global immunization effort. They would also participate actively in interagency coordinating committees at all appropriate levels. Private physicians will have an increasing role in many countries in providing immunization services, and special efforts will be made to involve medical societies in the recording and reporting of immunizations administered and cases of EPI target diseases diagnosed. IX. RESOURCE REQUIREMENTS In all countries, neonatal tetanus elimination is based on the foundation of routine immunization services delivered as a part of Primary Health Care. Unofficial figures from 1992 suggest that, for many countries, 80% of EPI costs are borne by the countries themselves and 20% by external support. This external support is approximately $231 million a year, with 40% from multilateral, 47% from bilateral, and 13% from other donors such as non- governmental organizations. Of the $231 million, $60 million is for vaccines, $15 million for personnel, $106 for operational support and $50 million for capital investment. Most support for EPI services will still originate in the countries themselves as they develop better immunization services in high-risk districts, strengthen surveillance and case response and mobilize health staff and the community to implement corrective measures. However, support from external sources is essential if the neonatal tetanus elimination initiative is to succeed. The requirement for vaccine and logistics will increase considerably, especially in high risk districts, and technical assistance must be available to support national disease control activities. EPI/GAG/93/WP.12 Page 23 The funds needed for NT elimination fall into 6 main categories: Vaccine and cold chain and logistics; supervision; personnel (technical assistance); training; communication; and research. However, many of the activities that need funding in these categories are not for NT elimination only, but are needed to further develop the immunization services in general. Each country will have to elaborate specific plans for NT elimination, including a budget for the activities. This budget will depend on the strategies chosen by the Ministry of Health. Since many activities for NT elimination are common components of immunization programmes, such as measles control and polio eradication, the budget for the immunization programme must be consi.dered in totality. The activities requiring additional funding should be discussed with potential donors during regional and country meetings. VACCINE: Sufficient quantities of TT meeting WHO requirements must be available to meet both needs for pregnant and childbearing age women. A critical factor in ensuring the provision of adequate supplies of vaccine will be to increase the effectiveness of forecasting both demand and production capacity. Increasing TT production from existing manufacturers or developing the capacity to locally produce or package TT vaccine, must be explored. COLD CHAIN AND LOGISTICS: Although there is the potential to take TT outside of the cold chain when a vial indicator becomes available, there is a present need to maintain the cold chain and to extend it to reach more remote and less accessible areas and populations. Sufficient quantities of needles, syringes, sterilization equipment and equipment for clean deliveries will have to be made available in every facility providing immunization or clean delivery services to prevent the risk of unsafe practices. SUPERVISION: To be effective, supervision should be allocated specific resources (logistic support and funds). Supervision requires identification of adequate staff, training and retraining of supervisors in the field focused on identification of problems, selection of appropriate solutions and monitoring of progress. EPI/GAG/93/WP.12 Page 24 Supervision of the specific needs for NT elimination should be included in supervisory activities for any PHC programme. PERSONNEL: Sufficient numbers of skilled and experienced personnel must be available to support national immunization programmes as they commit themselves to NT elimination and other disease control initiatives. This includes short term consultants to provide required skills and back-up to national and long-term staff in meeting the challenges of additional activities or existing epidemiological situations. TRAINING Training in managerial techniques, which has been widely seen as a major EPI success, will need to be continued in NT elimination. Existing training courses and district planning workshops will need to use available specific material on surveillance, conduct of immunization days, case investigation and response, and district assessment. As countries commit to NT elimination, training will be needed for many types of workers. Health workers at all levels will need to understand the demands of the surveillance system. District staff will need to be trained on how to conduct case investigation, perform activities in response to such investigation and analyze information. COMMUNICATION Communication incorporates four main items: ► meetings to ensure exchange of experiences and information, ► technical policy meetings, held annually to review progress and further develop policies within the elimination initiative, ► newsletters for feedback to all health staff, and ► development of the capacity to process and analyze data. RESEARCH EPI/GAG/93/WP.12 Page 25 The main topics for research for NT elimination initiative have been identified as follows: ► a simple and rapid field test to assess the level of tetanus antibody; ► development of an inexpensive vial indicator to take TT outside of the cold chain and to ensure the absence of freezing; ► improved methods of community based routine surveillance; ► development of a slow release TT vaccine which is effective with fewer doses; and ► simple and inexpensive procedures to accurately monitor NT elimination at district level. e 0 0 EPI/GAG/93/WP.12 Page 26 FORTY-SECOND ~QRtJ) HEALTH ASSEMBLY Agenda item 18,2 EXPANDED PROGRAMME ON IMMUNIZATION The Forty-second World Health Assembly, ANNEX A i.HA42.32 19 May 1989 Noting the report of the Director-General on t~e Expanded Programme on ImNnization and the Executive Board's discussion on the report; Appreciating the accomplishments of the programme to date, including the provision of immunization services for over half the children of the developing world and the prevention each year of some 1.9 million deaths of children in developing counc=ies from measles, pertussis and neonatal tetanus, and of over 200 000 cases of poliomyelitis; Recognizing, however, that full immunization coverage has r~t yet been acn..ieved in all countries and that over 3 million deaths from the above diseases and over ZOO 000 cases of poliomyelitis preventable through immunization continue to occur each year; Aware that further challenges need to be addressed during the decade of d::.e 1990s with respect to: • achieving and sustaining in all countries full immunization coverage wi~ all the antigens used by the Expanded Programme; - controlling the target diseases, including the global eradication of poliomyelitis by the year 2000, the reduction of measles by 90% compared with pre-immunization levels, and the elimination of neonatal tetanus by 1995; - improving surveillance to provide accurate assessment of the progress of the programme; - introducing within routine national immunization services new or improv~ vaccines as these become available for public health use; - promoting other primary health care practices which are appropriate for ~~e programme's delivery system and the target populations; • research and development in support of the above; l. RECALLS resolution IJHA41.28 which committed WHO to the global eradication of poliomyelitis by the year 2000 and, inter alia, emphasized that eradication ef=orts should be pursued in ways which strengthen the development of the Expanded Prog:=amme on Immunization as a whole, fostering its contribution, in turn, to the developmec: of the health infrastructure and of primary health care; 1 See document EB83/l989/REC/2, summary records of the Board's eleventh ar..c t,.,elfth meetings. WHA42.32 page 2 2. ENDORSES the plans outlined in the report for the programme for the coming decade, including the plan for the eradication of poliomyelitis; 3. URGES all Member States to continue their vigorous pursuit of the aim of providing immunization services for all children of the world in the hope that coverage levels under the Expanded Programme will surpass 80% in all countries/areas by the end of 1990 and that levels of 90%, in the context of comprehensive maternal and child health services, can be achieved by the year 2000; 4. ASKS the regional committees to promote the establishment of national disease reduction tArgets for all the diseases included within national immunization programmes, including targets for geographically limited areas and targets for locally defined populations at risk, as appropriate; 5. THANKS the international community (including other organizations of the United Nations system, multilateral and bilateral development agencies, private and voluntary groups and individuals) for their continuing support, giving special recognition to UNICEF as WHO's major partner in the Expanded Programme, and congratulating Rotary International on its success, under its "Polio-Plus" initiative, in fund-raising and in obtaining the personal involvement of thousands of its members in support of national immunization programmes; 6. WARNS both developing countries and outside collaborators that they will need to increase their· investments in immunization if full coverage is to be achieved and sustained during the 1990s and if the targets for reduction in the number of cases of measles and neonatal tetanus and for eradication of poliomyelitis are to be achieved; 7. ENCOURAGES those concerned to make these investments, noting the special demands which the poliomyelitis eradication initiative is now making on WHO extrabudgetary resources; 8. REQUESTS the Director-General: (1) to pursue the actions outlined in his report pertaining to the achievement and maintenance of full immunization coverage, control of the target diseases, introduction of new or improved vaccines, and promotion of other primary health care practices and research and development; (2) to pursue the action outlined in resolution WHA41.28 with respect to the eradication of poliomyelitis; (3) to continue to seek from extrabudgetary source'S the contributions required to support these activities; (4) to continue to keep the Health Assembly informed of the progress of the Expanded Programme, including progress in the eradication of poliomyelitis by the year 2000. Thirteenth plenary meeting, 19 May 1989 A42/VR/13