Report on the second meeting of the regional commission for certification of poliomyelitis eradication, Alexandria, Egypt, 2-3 December 1997

LVHO-E.M/POL/-I I E / L Distribution: Limited

Report on the SFCOND XIEETING OF THE REGIONAL COXI>IISSION FOR

CERTIFICATION OF POLIO3IYELITIS ERADICATION A I ~ x : ~ n r l r i Egypt, :~, 7-1 Dc-rcmhpr 1997

World Hcal(h Organization Rcgionul OtSt?ccf o r t h c Eastern Mcdllcrruncun

Alexandria. Egypt 1098

0 World Hcalth Organization 1998 This docu~nentis not issued to the general public and a 1 1 rights arc rcscrved by the World Health 0rg;lnization (WHO). The docurncnt may not be reviewed. ab\tr;lctcd. quotcd. reproduced or translated, in part or in wholc, without the prior written permission o f W H O . No part o f this document !nay he stored in a rctrieval system or transmitted i n any form or by any means--electronic. mechanical or other-without the prior written permission o f WHO. The views erprcsscd in docunicnts by named author5 ;Ire solely the rcsponsibility o f how authors.

2 . GLOBAL OVERVIEW O F POLIOIMYELITIS ERADICATION ............................. 1 3 . REGIONAL OVERVIEW OF EPI PROGRAMME ................................................. 2 3.1 Immunization coverage achievements .......................................................... 2 3.2 EPI discasc suweillonce ................................................................................. 3 4. REGIONAL POLIOblYELITIS ERADICATION PROGRAIMME .........................4 4.1 Regional overview .......................................................................................... 4

4.2 Laboratory support to poliomyelitis eradicationfcertification ........................ 6 4.3 Cross-border transmission of wild poliovirus ................................................ 8

5. RECOMMENDATIONS OF THE RECENT TECHNICAL MEETINGS ON ........................... 9 POLIOMYELITIS ERADICATION: ................................ . . 5.1 Second Meeting of the Global Certification Commission ............................. 9 5.2 Global Technical Consultative Group on Poliomyelitis Eradication ............ II 6 . POLIOMYELITIS ERADICATION M OTHER WHO REGIONS ....................... 13 6.1 Poliomyelitis eradicationlcertitication in the WHO South-east Asian Rcgiuri ....................................................................................................... 13 6.2 Poliomyelitis eradicationfcertitication in the African Region ................ 15

7. POLIOMYELITIS ERADICATION CERTIFICATION IN THE EASTERN MEDITERRANEAN REGION ....................................................................... 16 7.1 Update on the national certification committees .......................................... 16 .. ... 7.2 Drafi rcgional certification plan of action .................................. . I6

Annexes I . Agcndn .......................... . . . .......................................................................... 20 2 . Programme ..................................................................................................... 21 . . 3 . List of part~c~pants .......................................................................................... 23 4 . Guidelines for Certification of thc Eradication of I'ol~omyel~t~s In the Eastern Meditcrrancan Rcgion .. 25

1.

INTRODUCTION

Ihe Second Meetlng of the WHO kastem ~MediterraneanRegional Comlnission for Certification of ~ o l i o m ~ e l i t Eradication is was held in the Regional O f i c e for the Eastern Mediterranean, in Alexandria, E-mt, from 2 to 3 December 1997, under the chairmanship of Dr Ali Ben Jaffer, Director-General of Health Affairs, Ministry of Health, Oman. Dr Abdullahi Deria, former Regional Adviser, Communicable Diseases, was elected as rapporteur. The meeting was a t t ~ n d e dh y members of the Regional Commission, representatives from the Regional Commission for the WHO South-east Asian Region and WI-I0 staff from headquarters and the Regional Offices for Africa and South-east Asia and the Eastern Mediterranean. A list of participants is attached (Annex 3). Dr M.H. Khayat, Deputy Regional Director for the Eastern Mediterranean, opened the meeting on behalf of the Regional Director, Dr Hussein A. Gezairy, and delivered a message from Dr Gezairy, Remarkable efforts were made to accelerate pollomyelitis eradication activ~tiesin all countries of the Region in 1996 and 1997, said Dr Gezairy, and increasing attention given to the critical issues o f certification. Most Member States of the Eastern Mediterranean Region had already convened a national committee or were in the process nf establishing a committee and working on establishing and maintaining appropriate documentation o f key eradication activities. These would be required for the eventual certification of wild poliovirus eradication, said Dr Gezairy. There was an increasingly significant threat of cross-border transmission of wild polioviruses and the Regional Committee for the Eastern Mediterranean had discussed this issue in its mectrng in October 1997 and made a number of recommendations related to special activities at high-risk border areas between countries and rcgions. I<cl'crring lo thc drali Plan of Action for IIegional Ccrtilication, Dr Ciczairy said that the document prepared by EMRO for consideration by thc Regional Commission was expected to guide all concerned in the preparatinn for the certification during the few years remaining before the target date. Thc agenda and tho progrnmmc (Anncxcs I and 2 rcspactivvly) wurc undorsed 2.

GLOBAL OVERVIEW OF POLlOlClYELITIS ERADICATION

Since the establishment in 1988 of the Global fnitiative to Eradicate Poliomyelitis by thc Year 2000 thcrc has been a 90'X reduction in the reported number of cases worldwide. This has been due to the successful introduction, in virtually all poliomyelitis-endemic countries of the world, of the four WIIO-recommended strntegies for poliomyelitis cmdication: high routinc imll~urll~;lriun coverage with oral poliomyelitis vaccine (OPV): national immunization days (NIDs) targeting all

cllild~cr~ ~12i.d lob5 ~11,111 5 jCdI5, S I I L T C I I I ~ I I C C dnci ! J ~ U I ~ ~ II ~I U \ cI~~L ~ ~ ufilll , ? ! ~ u ~ICULL. I I flaccid paralysis (AFP) cases in children aged less than I 5 years; and ]louse-to-house "mopping-up" immunization in areas of persistent focal transmissior? of \ v ~ l d poliov~rus. As of December 1997, over 108 cou~itries i i i l l have b c p n NIDs. Onl.: nine poliomyelitis-endemic countries have yet to begin nationivide polioriipelitis immunization days. but the ma.jority of these have already implemented subnational immunization days (SNIDij and should cornpleti. S I D s by mid-199X 4 F P surveillance 113s improved markedly since 1996. Four IVIIO Rcgions, i n c l u d i n ~the Eastern Mediterranean Region, are achieving non-poliomyelitis AFP rates of nearly 1 case per 100 000 cl~ildrennacd less than 15 years. In tile remaining two Rcfions. .African Region anJ South-cast Asian Region, tllc establrslinicnt and.'or strcngthcning of AFP surveillance is tlie single highest priority. The collection of diagnostic specimens is also improving, wit11 70% of A F P cases worldwide having adequate stool samples collected. Since mid-1997, all laboratories in the Global Poliomyelitis Laboratory Network have been going through an accreditation process which should be completed by the first quartcr of 1998. Intensive "mopping-up" rictivities have noiv begun in a number of countries of the Western Pacific Region, European Region and Eastern Mediterranean Region.

As a result of the nctivities noted above, only 3995 polionlyclitis cases were contirmcd in 1996, compared with over 35 000 cases in 1938. Wild poliovirus transmission is now largely confined to the Indian subcontinent and sub-Saharan Africa. The process of certifying poliomyelitis eradication has also bcen progressing. The Global Certification Commission was convened twice, in 1995 and 1997, and rcgion;il ccrtificrltion cornmissions havc bcen cstnblishctf In all o f the WIIO Rcgions cvccpt tlie ,\l'ric;~n Ilcgion, whcrc a commissio~lwill be cst:~blislietl in 1008. To tl;~tc,only tllc l<c;ior~ oI't11c ;\~iicric:~ I I X S I > C ~ I I ccr!~liccl free o l ' i r ~ ~ l ~ ~ c~ r l i il lx~lioi ~i~~ I I~ ~ I .~ < .' I 11c I ; I ~ I case of poliornyclitis in that Region had onset in August 1991; certification occurred three years later in September 1994. ~

3.

REGION>\L OVERVIEW O F EPI PROGRl\&I&IE

This ovcwicw presents liiglllights on tlie rcgic~n;lland country\vidc general progress of tlic Expanded Programme on Imlnunization based on the reports received from Llcnibcr States.

3.1

Irnn~unization coverage a c h i e v e n ~ e r ~ t s

\lembcr S t a k s rliat r~cliic\cd higli Ievcls of inlniilnizrttion covcragi. \vcrc ablc to sustain these cover:Ige r:ltc*; durin: 1906 : ~ n d1007.

WHO-EM'POLI4IIEIL Page 3 The estimated regional immunization coverage with different antigens for 1996, as reported by Member States, was 89% for BCG, 82% for OPV3, DPT3 and measles, and 7774 for HBV3 amons children under 1 . A significant irnprovcmcnt in the ovcrall regional average routine immunization coverage rates occurred in 1996. Estimates for 1997 are even higher. This was mainly due to the sustained high coverage rates in mosr Member Srares rogerher wirh a significanr improvement in the average coverage rates in the lagging countries, especially Pakistan. The 1997 countrywide immunization covcrage estimated rates indicate that 16 countries reported immunization coverage with DPT3lOPV3 of 90% or more (Bahrain, Cyprus, Epypt, Islamic Republic o f Iran, Iraq, Jordan, Kuwait. Lebanon, Libyan Arab Jamahiriya, Morocco, Oman, Qatar, Saudi Arabia, Syrian Arab Republic, Tunisia and United Arab Emirates as well the self-ruled areas in Palestine and the population served by UNRWA). However, only 13 countries reported a measles coverage rate of 90% or more (Bahrain, Cyprus, Egypt, Islamic Republic of Iran, Iraq, Jordan, Kuwait, Libyan Arab Jamahiriya, Morocco, Oman, Saudi Arabia, Syrian Arab Republic and United Arab Emirates as well as the self-ruled areas in Palestine and the population served by UNRWA). Hepatitis fl immunization is currently fully integrated in the national EPI for children under 1 year of age in 14 Member States, namely Bahrain, Cyprus, Egypt, Islamic Republic of Iran, Iraq, Jordan, Kuwait, Libyan Arab Jamahiriya, Oman, Qatar, Saudi Arabia, Syrian Arab Republic, Tunisia and Untied Arab Emirates as well the self-ruled areas in Palestine and the population served by UNRWA. These countries have just over 40% of the total regional infant population. Very high routine coverage rates (90% or more) were reported from nine out of these 15 countries for 1996, with an over all average of 77%. The average regional TT2+ coverage among pregnant women during 1996 was 49% and is slightly higher for 1997. However, with several years of administration of niultiplc doses of TT vaccino tho proportion o f irnmunc wolncn 1s h~ghcrthan tl1;lt calculated based on immunization carried out during 1996.

Haemophilus inyuenzae b (Hib) vaccine is currently integrated into EPI schedules in two Member States; others are reviewing whether to include the vaccine.

3.2

EPI disease surveillance

The surveillance systems in the majority of Member Statcs has bccn givcn much attention during the past four years. Great improvement was observed in most countries, and this will be an cffcctivc tool to monitor EPI effectiveness in prevention of disease as well as disease eradicarion, eliminarion and reduction goals. The occurrence of poliomyelitis. measles, and tuberculosis showed further significant dccline during 1996.

The neonatal tetanus climinatiun godl leas achieked i i i 13 o r the 23 Member States. Nevertheless, the elimination goal has not yet been achieved in nine countries, namely, Afghanistan, Djibouti, Egypt, Iraq, Pakistan. Somalia, Sudan, Syrian Arab Republic, Egypt, Iraq and Syrian Arab Republic) and Yemen. Some of these countries (L)j~bouti, currently have only a few districts with a higher rate of neonatal tetanus occurrence than the target and are expected to reach the elimination state soon, provided that the planned high-risk area activities are properly conducted. most of the remaining Member States have started the high-risk approach to reach the elimination goal by the year 2000. The total repnrted number nf car?< nf nronatal tetanus from the E M R Member States is still large (3006). In this respect, it should be noted that there is evidence that surveillance of neonatal tetanus is incomplcte and that reported cases, with the exception of the few countrie!i with scnsitivc survcillancc systcili, rariEes bet\i,een as I o n as 0% of total cases as for Afghanistan and Somalia, where no rcports are received, to about 70% for Esypt. There is considerable underreporting of the disease, with very large numbers o f cases not detected o r rcported. Measles surveillance is still weak in most Member States. This is mainly because in most countries, almost all mild cases do not present at health facilities as the dlsease is considered and accepted as a natural event. Also, in some Member States the reported cases are only those admitted to hospitals, and cascs seen in basic health thcilities (health units and centres) are not reported. In addition, in most Member States, no reports are obtained from the private sector, which is usually very active. Ncvcrthclcss, thc number o f measlcs cascs rcportcd i n 1996 and 1997 is significantly less than those rcported in the previous years. T h c Rcgional Colrlrriillcc nduplcd a resolution ( E I M I R C ~ J I R . ~ to ) achieve measles elimination by the year 2010. Measles elimination strategies have been implemented in two Member States. In addition, scvcn Mernber States are planning to start such strategies during 1998. These countries are the ones which have already reached the poliomyelitis eradication targets, and rncaslcs elimination will hc cxtcndcd to the otlicr c o ~ ~ n l r i :IS c s so011;IS h i s tiirgcl hiis hccll rc;1~11ccI. The number o f reported diphtheria cases during 1996 was more than that reported in the previous yc:Ir. A limited outbreak of diphtheria occurred in northern Iraq. T h c outbreak started during September 1996 with a total o f 196 cases, including 17 deaths, reported by the end of ~ h c year. The outbreak started among a population which is rcfu~ing immunization ilnd 11 1 ' s luw i l r r ~ r ~ u n i ~ . icuvcragc, tiu~~ wirh the grcat majority o f cascs in the age group 5-20 years.

1

Regional overview

The most not;lblc nccomplishrncnts in 1996 &crc the conduct o f ;I highly successful ;;ID i l l ' ~ ' C I I I C alrd I I I ~ I CS I ~ O I I ; commlrrnenr o f [he government to cst:~hl~sh AFP

WHO-EM/POL/4 I/E/L Page 5 surveillance; resumption of NIDs in Sudan; a joint decision of health authorities and partner agencies in Afghanistan to conduct NlDs with OPV in early 1997; and further consolidation of support from partner ngencie:;, including funds in support of purchase of vaccine for N D s and for;4FP surveillance in several Member States. The number of confirmed cases of poliomyelitis reported in the Keg~ondecreased 33%, from 789 in 1995 to 532 in 1996. This decline in reported cascs has been observed although AFP surveillance has improved significantly. Despite a marked decrease in the number of cases reported from Pakistan between 1993 and 1996 (1803 and 341 cases. respectively). Pakistan continues to report the most cases of any country in the Region. As a matter of fact, poliomyelitis control in Pakistan is critical to the success of both the regional and global poliomyelitis eradication initiative, since several poliomyelitis outbreaks in EMR and other WHO Regions have been linked to importation of wild poliovirus from the Indo-Pakistan subcontinent. The number of cases of poliomyelitis from Pakistan in 1997 is not expccled LU be luwcr ~ h a n in 1996 duc L u lllc occurrence of some localized outbreaks. On the other hand, there is evidence of a decrease in the number of cases in 1997, particularly in Egypt. In 1996, the regional average of routine immunization coverage with at least three doses of OPV by 1 year o f age was 82%, showing an increase compared with 1994 and 1995 coverage (78% and 80% respectively). In 1996, 17 Member States (73%) reported OPV3 coverage more than or equal to 90%. During 1996, all Member States except Afghanistan, Djibouti and Somalia conducted NIDs, compared with only five countries in 1994. During these NIDs, most Member Stntcs achicvcd high (above 95%) covcragc of the target age group uf cllildrer~under 5 years of age.

T o maximize the 1mp:lct of Nllls ne~ghhour~ng countrlcs coordinated ;~ctivities so that NlDs were implemented simultaneously. The most impressive results were achicvcd under Operation MECACAR, involving countries o f the Eastern Mediterranean and European Regions. Immunization coverage achieved by the EMR countries was over

95%. All Member States with the exception of Afghanistan, Somalia and Yemen have established AFP surveillance. However, the quality of these systems in the Region remains highly vnrinblc. Eight mcmbcr statcs (Bahrain, Islamic Rcpublic uC Irar~, Jordan. Kuwait, Oman, Saudi Arabia, Syrian Arab Republic, Tunisia) have achicved or cvcccdcd the minimum rcquircd scnsit~v~ty for detecting and reporting cascs of non-pol~omyelitisAFP (1 case per 100 000 children aged less than 15 years). The overall regional average rate for non-poliomyelitis AFP in 1996 was 0.77 cases/ I00 000 with a wide range (0-1.51100 000).

WIIO-E.CI'POLI4 I E/L

Page 6 I.nbo~ato~~-basr sd u ~ \ c i l l u i ~ ifui e wild puliuviius i l l tlte Eastern ivleditrrranean Region, the core component o f AFP surveillance, also made substantial progress in 1996. AFP cases from 16 Member States were investigated in the Regional I'ol~omyei~tis Laboratory Network. Of the 1774 AFP cases reported in the Region during 1996, 1642 (93%) were investigated in the network laboratories. The laboratory performance indicators continued to improve during 1996. No wild poliovirus type 2 has been confirmed in EMR since 1996. 4.2

L a b o r a t o r y s u p p o r t t o poliomyelitis eradicatinnicertificntion

Certification of poliomyelitis eradication will depend on documentation of the absence of the wild poliovirus in the presence o f thc capacity to detcct cil-culatiuri u f these viruses through sensitive disensc surveillance and high quality laboratory performance. Laboratory records will provide critical evidence to document the absence of wild poliovirus. A laboratory network has been set up in the Eastern Mediterranean Region to provide support for the regional poliomyelitis eradication programme. The network is made up o f 12 laboratories: three (in Egypt, Pakistan, and Tunisia) serve as regional reference laboratories (RRL); one (in Kuwait) serves as a subregional reference lahnratnry (sRRL) for the countries o f the Gulf Cooperation Council; and eight are designated poliomyelitis national laboratories (PNLs) (in Islamic Republic of Iran, Iraq, Jordan, Morocco, Oman, Saudi Arabia, Sudan, Syrian Arab Republic). The RRLs and s R R L have responsibilities for training of laboratory staff, differentiation of polioviruses as wild or vaccine-like, provision of cell lines and certain reagents, and conducting special sludies. The activities o f the PNLs are usually restricted to poliovirus rsolation and typing with referral o f isolates to RRLs for characterization as wild or vaccine like. The PNLs in the Islamic Republic o f Iran and Traq are able to perform intratypic diffcrcntiation. A laboratory coordinator at W l f O Eastern Mediterranean Regional Office is responsible for: identifying mechanisms for s;~mplcrcfcrrol to ncttvork l:~l~or:iforics:~notiitoring :t~i<I p~-o\.icli~ig l'ccill~:~ck on viro1ogic:iI s ~ ~ r \ ~ c i l l ; ~ ~ ~ c c ; coordinating annual proficicncy tests; trainindreagent/equipment needs; providing incountry technical assistance as required; and annual accreditation of nctwork 1:lhorntories. Thcrc arc scvcral constraints facing the EMR laboratory nctwork operation. The I~boraturics alc ~ I U ~ U I iInI 12 C U U I I I I ~ but U ~ [)ruvidc S C W ~ C L ' Sfor all 23 countries served by WIIO EMRO. Because o f cost, distance and inconvenient transport, linkages some countries d o not routinely have access to the I a b o r ~ t o r y network. Additioncllly, poor o r slow cornmumcation linkages sometimes exist between laboratorics, EPI programmes and EbIRO. A third problem is that in scvcrul Irtbo~ttoricstl~crcis a I'lst turnovcr o f trained stal'l: which can lcad to poor and unreliable purtbrmancc. All poliovirus laboratories ~vorldtvidcwhich proyidc support to the WIIO global poliornyeliris craclic:~tion pro;r:~mnic are recluirc~f to bc ev:iIu:ited a1111u;iIIy fur

WHO-EMtTOLI4 IIEIL Page 7 accreditation of their performance. Only the results obtained from accredited laboratories are used within the poliomyelitis eradication programme. Accreditation involves in-country review of laboratory records, operating procedures and facilities to evaluate the reliability of t h e lab's performance. Six criteria are evaluated and an accredited laboratory must meet or exceed certain targets for each criterion. To be accredited, PNLs must: test uvrr 150 bar~lplrb pcr ycar; ubtain NPEV (nonpoliomyelitis enterovirus) isolates from at least 10% of all investigated samples; score over 80% on the annual proficiency test; score over 80% for in-ccuntry evaluation of operating procedures; provide results within 28 days for over 8094 of investigated samples; demonstrate over 80% accuracy in virus isolation and typing (e.g. when a PNL's results are compared with those of a RRL for the same samples). RRLs are also subjected to annual evaluation and accreditation using six similar criteria but with higher standards. A number of standard indicators are routinely monitored by poliomyelitis eradication

programmes worldwide, in order to determine the reliability of surveillance and laboratory performance. Thesc indicators wcrc choscn in rccognition of the fact that successful isolation of poliovirus depends on multiple factors: the collection of two stool samples within 14 days of onset of paralysis because of intermittent shedding of decline in the amount of excreted virus as infection progresses; and the poss~bil~ty the need to transport stool samples rapidly (within 72 hours) and in cool conditions to avoid inactivation of viruses; and technical competence of laboratory staff (monitored through an annual proficiency test, and the NPEV isolation rate for investigated samples). In an eradication programme it is also important that laboratory results are provided in a timely manner so that immunization activities can be rapidly carried out, as appropriate, to halt poliovirus transmission chains. The following summarizes the indicators for the EMR Poliomyelitis Laboratory Network for 1997 (up to 30 September ): 1706 AFP cases from 16 countries investigated in the EMR LabNet, of which 89 % had two stool samples collected 68 % had at least one stool sample collected within 14 days of paralysis onset 61 % of cases had two stool samples collected 1-2 days apart and within 14 days of onset of paralysis 42 % of stools were received in network laboratories within three days of their

collection 92 YOof stools were reccivcd i n guud cunditiun

69 % o f stools were reported within 28 days o f thcir receipt in the laboratory

\{'I 10-EM'POL141 E/L Page 8 8

S "/a of stools yielded NPEV

85 % was the averagc score for the lzboratories in the most recent proficiency test. Up to 30 September 1997, wild poliovirus isolates were obtained from AFP cases in four countries in the EMR: Pakistan (wild poliovirus types 1, 2 and 3); Egypt (wild poliovirus type 1); Iraq (wild poliovirus types 1 and 3, although these results are pending confirmation): and T~lamicR e p ~ ~ h l i nf c Trnn (wild poliovirus type 1 and 3). The results do not necessarily provide evidence of lack of wild poliovirus transmission in other countries because: not all countries refer samples for laboratory investigations; for 40% of AFP cascs invcstigatcd in netwo~klaboratories negative virology will be unreliable because of inadequate sample collection; and poliomyelitis isolates from some countries are pending differentiation as wild or vaccine like. An increasingly important laboratory activity in the EMR is the monitoring of genotypes of wild poliovirus isolates. Genetic characteristics can often be used to show temporal, geographic and/or transmission linkages betwecn viral isolates from different origins. Such analyses may be important in situations of importation of wild viruses into previously poliomyelitis-free countries. The technology can also be applied to investigate problems of laboratory contamination. In at least two EMR countries some reported wild poliovirus isolates were actually laboratory contaminants which arose through inappropriate handling of wild vimscs as controls in laboratory tests, or unnecessary handling of wild isolates for research purposes. The programmatic impact of laboratory contaminants can be quite serious since laboratory data arc often usrd to plan costly immunizarion activities. In the coming year the EMR Poliomyelitis Laboratory Network will be placing priority on developing strategies for containment o f wild poliovirus to minimize the potential for contamination of routine work or the cnvironmcnt with I;~bor;~tory stocks of I ; L ~ U T : L I < I I . ~ COTCIS CIS; of \vilcl viruses. Addition;~lpriorirics will hc: cc~~tlputcriz;itio~~ strengthening communication linkages for rapid dissemination of information; and laboratory accreditation.

4.3

Cross-border transmission of wild poliovirus

Onc of thc irnpulta~~t challer~gesfacing thc counrries of the Region IS d ~ r e c tcrossborder transmission and importation of wild poliovirus. This stems mainly from geographic location and thc many endemic areas bordering the Region and also because of the significant travel bctwccn endemic countries and poliomyelitis-frce arcns, especially to countries of the Gulf Cooperntion Council (GCC). Spccial attention has bccn givcn by EMRO to this subject. The Regional Directors of EMRO and EURO have discusscd this issue and agrccd on coordination to halting possiblc cross-border transmission between bordering countries o f the two Regions, particul:lrly in thc :lrc:i of thc. northcrn I r ~ qand southcrn TurLcy. ,Xu well. t\%u

WHO-EM/POL/4 1/E/L Page 9 coordination meetings have been held to discuss the same issue, one for hlaghrebian countries and another for countries of the GCC. These meetlngs yielded plans of d~liurl tu U V C I L U L ~ I C tile puhsibility of ilnpoitatio~ld i d ur usb-bur dcr transrnission, The subject was also discussed during the 1997 Session of the Regional Committee for the Eastern Mediterranean, which endorsed the plan of action praposed during the subregional coordination meetings. The main elements of the plan are: 1. Ensuring that the basic strategies of polinmyeliti< eradication a r p heing implemented at national level (high routine coverage, NIDs and other supplemental immunization and sensitive AFP surveillance including laboratory support).

2. Coordination of poliomyeIitis eradication efforts in border areas. This means rapid exchange of AFP surveillance data. Cases linked to cross-border trarismission should be thoroughly investigated in both countries including their contacts.

Collaborating agencies, and in particular WHO, should facilitate exchange of 3. surveillance data, rapid transfer of isolates to collaborating centres and coordination of supplemental immunization efforts for border areas, especially when NIDs are done at different dates. Countries of the Eastern Mediterranean Region are closely following these rccornmcndations supported by WHOJEMRO and other neighbouring regions.

5.

RECOMMENDATIONS O F THE RECENT TECHNICAL MEETINGS

ON POLlOMYELlTIS ERADICATION: 5.1

Second Meeting of the Global Certification Commission

The Second Meeting of the Global commission for Certification of Poliomyelitis Eradication was held immediately after thc Technical Consultative Group (TCG)and

provided a good update to members of Global Commission and facilitated discussions. In reviewing the reports of thc TCG and the WHO Regional Ofices, thc Global Commission was very much cncouragcd with the progress made so f3r in poliomyelitis eradication, and in particular the increasing number of countries attainin2 the status of poliamyelitis-frcc. f!owcvcr, the Global Commission was also mindful o f the challcngcs poscd by cvents bcyond tllc control of thc poliotnyclitis cradication programrncs-countries plagucd by instability bccause of civil strife, military conflict or other problems. Thc implications that thcsc countries with ditlicultics will hnvc for the cnrly nchicvcment o f global p~liomyclitis eradication on thc appointed datc \vas obvious to the Global Commission.

WI lO-EM!POL/4I\t3'L

Page 10 Since the Global Commission Il;id [lie bcilclil uT dihcuisir~gLIie TCC; and lhi. LVHO Regional reports with those who prepared them, it was opportune for the Commission to make recommendations on a number of issues that nceded either reaffirmation, reemphasis or further clarification. The relevant recommendations of the Global Commission included:

I. Regional certlfication comnri.~.siotr.s Regional commissions should include, as full members, individuals from other adjacent regions. Regional commission members should not be required to have direct responsibility for the activities o f national certification committees nor should they be obl~gatorily required to participate in their meetings.

2. Nutionul certlfication committees These committees should be independent bodies appointed by the national governments, in consultation with the appropriate W I I O Regional O f i c e . The committees should work closcly with the appropriate health fr!:ilitics for immunization and surveillance (including laboratories) within the country. Ilowcvcr, committee members should not have direct responsibility for the poliomyelitis cradication programme. Subregional committees could be established for groups o f countries with small populations as an alternative to several separate certification committees.

Membcr States should ensure sufficient national resources earmarked for sustaining high quality AFP surveillance after rcgional ccrtificntion and until such timc as global certification has been confirmed.

A distinction need to be made between "intermption o f transmission of wild poliovirus" and "eradication o f wild poliovirus". Eradication is defined as the crudication o f all polioviruses. At the rcgional level, this objective should bc untierstood as "the er:~dic:~tion o f re:ior~;~IIy indigenous wilt! poli~virus".111panicul:~r. regional commissions should exprcss the concept as dcmonstruted "abscncc" mtticr than "interruption" o f wild poliovirus transmission.

LVFIO-EblII'OL'3 1 ' E L Page 1 1

Routine colli.ction o f stool samples from contacts of AFP cascs should not be required for certification. However, contact stool samples should be collected in special circumstances, e.g. where there is a failure to collect adequate samples from the case itself or in high-risk areas \vith poor surveillance. Solnc countries may need to collect contact specimens to ensure adequate specimens for maintaining laboratory.

6.Collectioit of one l..s hvo .sfool cpeci1i1ei7.rfior~1 AFP ca.se.r bc required. However, the samples might be reduced to one in regions certified poliomyelitis-free, where regional virological data demonstrate that infected areas would not have been missed ~f only one stool had been collected. 10

Two adequate stool specimens fiom all AFP cases should continue

7. Case confirnrutio~~ rrileriu

Regional com~nissions, in reviewing AFP surveillance data, should pay particular attention to the scrutiny o f AFP cases which have been classified as "poliomyelitis-compatible".

T h e Global Commission was concerned about documented cases of poliomyeliris [raced ro poliovirus escape from laboratory and therefore recommended that a plan of action for the inventory, control and containment of laboratory stocks should be developed soon. Also, prior to global certification, regional commissions should dcmonstrate to the Global Commission that regional laboratory stocks of wild poliovirus have been properly contained. Other issucs in the Global Commission, r;~iscdin its first mcetirlg ill I;cbruary 1005, referred some issues to the T C G for rcvicw. Thesc will appear under item 5.2. 5.2

Global Technical Consultative G r o u p o n Poliomyelitis Eradication

T l ~ cGlul~al T c ~ l ~ l ~ iC ~vi rl~ l ~ u l t i l ~ iGruup ve (TCG) on poliomyelitis eradication IS convcned on an intcrmittcnt basis to rcvicw progrcss towards global poliomyelitis eradication, evaluate new scientific data which is relevant to the eradication initiative and revise, if necessary, the poliomyelitis eradication strategies. The TCG, while being impressed with the progress in NIDs, expressed concern about lagging AFP surveillance and, most important, the situation in countries affected by wars and internal strife. It has made the following recommendations on surveillance and lnhorntnry ~ ~ r v i c r ~ .

Wf IO-EMIPOLl4 1/E/L

Page 12

WHO headquarters to develop guidelines to be used by countries in determining their surveillance and laboratory requirements. 1.

Countries to report AFP weekly to Regional Offices Immediate reporting of any wild poliovims isolates to the Regional Office. Any isolate from a previously poliomyelitis-free area is to be reported to headquarters. Weekly reporting from reaional offices to headquarters providing aggregate data of AFP cases, confirmed poliomyelitis cases, wild poliovirus isolatcs and AFP cases with two adequate stool samples. On a quarterly basis each Regional O f i i c ~~ l i n ~ ~rr7pnrt lrl data to hrari~q~~nrri~rc classified by province. Headquarters to maintain a wild poliovirus database. Rrgiunal Rrfelellcc Labul~atories to providc updatcd information to ~ c ~ i o n a l Office on monthly basis.

2.

-

3.

Maintain the principle o f exarn~nlng two stool sarnples from all suspected cases

4. Case classification: AFP cases with two adequatc samples testing negative in an accredited laboratory should be discarded. Cnllntrir..: with inadrql~ate national AFP surveillance should continue to classify cases of residual weakness, died or lost to follow-up as poliomyelitis unless two adequatc stool samples were tested in an accredited laboratory and were negative. In countrics with good surveillance, an expert committee should determine whether such cases without adequate stool samples should be discarded as nonpoliomyelitis AFP or classified as poliomyelitis compatiblc. Active case search during mopping-up immunization, particularly for cascs with 5. onsct of pnrl~lysiswithin two months. A working group should be established to develop a case definition for vaccineassociated paralytic poliomyelitis.

6.

Significance of ditTerent rates of AFP/100 000 childrcn as an indicator of effective surveillance. 7.

The basic critcria and standards for AFP surveillance to be rcachcd in preparation for certification arc rcafflrmcd. T h e Commission also reaffirmed that the absence of wild poliovims for three years in the prcscnce of high-quality routinc AFP surveillance among childrcn agcd less than 15 years should be rcgardcd by all countrics. regardless of their endemic status, as the gold standard for certification of poliomyelitis eradication.

WHO-Ekf'POLI4 I:C:L Page 13

WHO to convene a meetins of experts to develop a strategy for the containment 1. of laboratory stocks. All network laboratories should be through the accreditation process by April 2. 1998. Supplementary surveillance for wild poliovirus: In countries which have been poliomyelitis free for many years and routin:. AFP surveillance rnay not be p~actical,supplcll~el~tary surveillance methods may be useful. These may include: Environmental surveillance, to be considered after the baseline study is evaluated Aseptic surveillance-a useful supplement but not a substitute for AFP surveillance. 3. Supplementary immunization To ensure high quality NIDs Mopping-up to be considered when high-quality surveillance demonstrates focal transmission of the wild poliovirus. 4.

Modality of certifying non-endemic industrialized countries which have been 5. poliomyelitis-free for a prolonged period and in which it 1s not practical to establish routine AFP surveillance. For these countries, it is essent~al to ensure that the documentation submitted for certification demonstrates that: 5.1 Prompt reporting and proper clinical, virological and epidemiological invcstigation are carried out for "suspected poliomyelitis" cases, that cases of acute onsct o f flaccid paralysis (AFP) receive accurate final diagnosis and th:it :i di:ignr>ui< of poliomyelitis is not missed. 5.2 Laboratory competence to isolate and identify wild poliovirus. This mcans that a minimum, all poliovirus results are confirmed by a WHO-accredited laboratory which also conducts intratypic differentiation o f the virus.

6. 6.1

P O L l O h l Y E L I T I S ER,\DICJ\TION IN O T I I E K W I I O R E G I O N S Poliomyelitis eradication/certilication in the W I I O South-east Asian Region

The first meeting of the Regional Certification Commission for Polio~nyclitis Eradication in the South-east Asian Region was held in June 1997. The Commission is composed of eight members. o f which two are also members of the Global Commission and one is from outside the Region. At this meetlng a dralt plan of action was adopted, which outlines issues relevant to poliomyelitis eradication and

WIIO-EM/POI./4 1 ;F/I Page 14 ccitification: immunization strotcgics. cur*.cillnncc (including lal,o~aiu~y accreditation) strategies, formation of national committees, required documentation for certification, terms of reference for the Regional Commission and national committees, and cross-border transmission. AFP surveillance in the South-east Asian Region made rapid progress in 1997. All countries are taking active steps to move away from poliomyelitis surveillance towards AFP surveillance. For some countries this involves the establishment of an AFP surveillance system, including the recruitment of AFP surveillance officers~ WI-IO/SEARO publishes a weekly bulletin, which is based on weekly reporting of line-list data from the Member States. The non-poliomyelitis AFP rate for 1997 so far is 0.28 (up from 0.06 in 1996), and the percentaye of cases with t\vo adequate stool specimens is 35% (up from 11% in 1996). Significant process has been made in Indonesia and Myanmar (AFP rates of 1.14 and 0.68 respectively), and also in Nepal and Biir~gladcsh.Countries arc making cffurts lo compurerize data management, and to link AFP data with laboratory data.

In India, the only South-east Asian Region country bordering the Eastern Mediterranean Region, poliomyelitis surveillance has been stepped up through the establishment of a coordinating poliomyelitis-surveillance unit, which has recruited and trained approximately 6 0 surveillance officers. These officers are posted around the country and are responsible for detecting, investigating, documenting, and following 11p AFP cases The poliornyclitis srlrvcillnnce unit, funded through WHO, works in close collaboration with the Ministry of Health. Recently, an outbreak of poliomyelitis was reported in Uttar Pradcsh, with several 100 children affected, and possibly cross-border transmission into Ncpal (to bc confirmed). Two wild polioviruses type 2 viruses were documented recently in the western part of India, which were the only P2 viruses detected in the Region as of Decembcr 1997. Four laboratories, out of a total of 15, havc so fir bccn accrcditcd, with plans to accrcdit a11 laboratories by April 1998. Lahorutorics arc receiving all rccluirctl support. such as training, human resources, and equipment. The percentage of spccimcns whose results are currently reported within 28 days after receipt is 48%. Computerization of data management in the laboratories is envisaged for the ncar future. National immunization d a y s arc baing organizcd in I997 in all I0 cuu~~tricb of the Region, with six of them performing two rounds on thc same day in December 1997 and January 1998. Covcragc for all countries was 97% or higher in the 199611997 NIDs, and over 190 million children were immunized. Only four countrics havc so far formcd national committees for poliomyelitis eradication. and efforts are being made to obtain nominations from the remaining countries before the end of 1997.

\Vl IO-EhI~POL/4 l:E,'I Page I 5 Cross-border transmissio~i between China and Xlyan~~lar has bee11 discussed at several biregional and intercountry meetings, both at the policy level and at the implementation level. Poliomyelitis remains the t o p priority for E P I in SEAR. The target is to eradicate poliomyelitis by the year 2000 and to obtain certification by 2003. The Technical Consultative Group (TCG) has recommended that resources should not be divcrtsd to other EPI programmes until pnlinmyelitic ha., h r p n ~ r a r l i r a t c d

6.2

Poliomyelitis eradicationicertification in t h e African Region

A poliomyelitis-free zone is emerfing in the Southern Africa Epidemiological Bloc. Countries of the Eastern Africa Epidemiological Bloc have achieved significant progress in poliomyelitis eradicarion. However, poliomyelrtis remalns e n d e m ~ c in the African Region, especially in countries of central and west Africa. Four countries, namely Angola, Ethiopia, Nigeria and Zaire represent major reservoirs o f polioviruses. The first series of national immunization days (NIDs), the biggest ever conducted in Africa, was implemented in 30 countries of the African Region between 1996 and early 1997. Over 74 million children below 5 years o f age were targeted. More than 53 million (72%) children were immunized in the first round and about 60 million (80%) i n the second round of NIDs. blost countries achieved remarkable results in immunizing their children: 25 countries reached coveragc of 80% or higher. Thc sccond s c ~ i c s of natiurral ilrr~rrur~iratior~ days with OPV have been planned to be implemented in at least 36 countries between late 1997 and early 1998 ( including subnational immunization davs in three countries). Out o f these, seven countries ( B u r u n d ~ , Guinea, Guinea Bissau, Madagascar, Mali. Niger and Senegal) arc implerncnting their first NIDs. About 100 million children below 5 ycars of age arc cupected to be immunized with two supplemental doscs of oral OPV in this scrics o f Nllls. By mid-November 1997, rcsl~ltsof nnt: n r both rounds had been reported by 15 countries. Out of these, 13 countrics achieved coveragc rates o f 80% o r higher in at least one o f the two rounds. Six countries reported a significant increase of O P V covcragc comparcd to rcsults o f thc prcvious NIDs. Results o f virological tests in a number o f countries have provided the first evidence o f the impact of these NIDs on the circulation o f pol~ovirus. The currcnt levels of AFP reporting remain inadequate in most countries of the Region. The regional AFP rate is 0.1 l per 100 000 children below 15 ycars of age. flowever, positive trends are obscrvcd in a numbcr of countries, especially in the Southcrn Africa Epidemiological Bloc. Efforts are hcing m;irlt. ti, t.stnhlinh efTectivc national systems for prompt dctcct~on. reporting and investigation of AFP cases and to

WFIO-EILi;POL/4 I 'EIL Page 16 increase the qunlity of viral sur.ei!lilnce in the Region. Strengthening cnpacitics o f district-level health staff, establishing effective data management and analysis at the the national level, and provision o f necessary technical support to countries are ~ m o n g first priorities of the Regional Office for Africa. A regional plan of action for the certification of the eradication of poliomyelitis has been drafted and the regional certification cornmission will be formed in early 1998. 7.

P O L I O J I Y E L I T I S ER.\DIC.\TION CERTIFICI\TION IN T H E EASTERN ICIEDITERRASEAN REGION Update on the national certification committees

7.1

In response to a request from the Regional Director, EMRO, a number of Member States have formed national certification committees. S o far 14 of the 23 member countries have established nat~onal committees. Afghanistan, Cyprus, Djibouti, Pakistan, Qatar, Somalia, Tunisia, United Arab Emirates and Yemen have not yet formed national certification committees. The composition of most national committees has to be reviewed since the members of the committees often include national staff who are directly involved or responsible for poliomyelitis eradication activities within the country. To avoid any conflict of intc~cst, tllc Glvbitl C V I I I I ~ I ~ SlS ~~ nV s i r~c I v ~ ~ ~ ~ ~hat ~ r national l ~ d r d staff may only serve as a secretariat to assist the work of the national committees but not be voting members of thcse committees. Because of the problem of finding committee members that are appropriately qualified and yet not involved in poliomyelitis eradication in several EMR countries small populations have been proposed by some countries subregional committees. Among countrics with ongoing armcd conflict and civil unrest, prohibiting thc formation of ii;~tion:~I ~otii~iiittccs ~ 0 1 i i p o ~ iot' 1 ~n 1: ~ t i o n : l l C V ~ L % R S C, O I I S ~ ~ C ' T : I ~ 11;~s ~ O I 10 ~ bc given 11) identifying ways and means o f fulfilling thc functions of a national committee in such settings. 7.2

D r a f t regional certification plan of action

I h e draft regional ccrtitication plan of action was reviewed by the Regional Certification Commission and several amendments were made. The agreed plan is attached (Annex 4). 8.

CONCLUSIONS AND RECORI>IENDtTIONS

The Regional Commission is impressed by the progress made so far In the implementation of the stratcgies aimed at pc>liomyclitis eradication from the Eastern i\.lcdlterranean Region and particularly with the special efforts being made and

WHO-EMlPOL14 I /E/L Page 17

planned for thc lagging countries and those stricken by wars and civil strife. It has adopted the following conclusions and recommendations I . Interregional coordinatio'n The Commission welcomes the Regional O f i c e initiative to invite to its meeting representatives from the regional commissions of neighbouring regions (African, European and South-east Aqian) and recommends full rncmhership for experts from these regions, particularly members of their regional commissions. It also recommends closer links in eradication efforts between epidsmiologically linked countries (e.g. countries of the Horn of Africa) and calls on the Regional O f i c e to initiate innovative approaches in this regard. Similar links between neighbouring countnes of the South-east AsIan and turopean Keg~onsare strongly recommended for both eradication and certification activities.

2. importation of wild polioviruses The Regional Commission recognizes the importance of cross-border and distant transmission of wild poliovirus from areas in which it is still endemic. It appreciates the efforts made in developing the necessary strategies to address the situation particularly coordination of efforts i n border areas through rapid exchange of information, full epidemiological and virological investigation of these incidents and coordinated immunization actions. The Regional Commission acknowledges the importance of ensuring that populations moving across borders, particularly refugees, are given full attention and are included in all poliomyelitis eradication activities, including vaccination and surveillance, wherever they are located. EMRO should ensure that the responsibilities for eradication activities among all large rcfuree and war-affected populations in the Region are clearly assigned to thc appropriate Mcmhcr Statc, intcrn;~ti~ni~l organizations, or other agency as necessary.

3. Regional cer!ificufion guidelines and docunrenfafion The Rcgiunal Curnrnissiun rcvicwcd tltc draft rrgiunal ccnification guidelines. It acknowledges the efforts made in its preparation and recommended specific modifications. The Commission did not feel the need for subregional certification committees. It recommends that the modified version of the regional certification guidelines be printed and widely distributed.

To facilitate the certification process in Mcmbcr States, the WIlO Secretariat should prcparc a detailed manual of operations for preparing the documentation that will be A draft of this m : ~ n ~ ~ sho~llri nl h r rrvipwcd by thc Regional Commission rrrl~~irpd members and subscqucntly field tested prior to finalization.

WHO-EM/POL/4 I/E/L

Page 18 Although Membur S t a t ~ may nor bi' s u b ~ ~ i r r i n final g documentation foi some years, they should ensure that all materials related to poliomyelitis eradication activities (i.e. routine and supplementary O P V immunization, AFP surveillance and poliomyelitis laboratory activities) are properly recorded arid archived for future use as part of the documentation that will be needed for certification. 4. National contt?littees

The Commission calls for more effnrts tn be made by Member States, taking into consideration recommendations by EMRO, to review and finalize both the composition and functions of national committees. It recommends to EMRO to quickly dcvrlup a ~ l d widcly distlibutc the ~ c g i u ~ lcc~lificaliu~l al guidelirlrs and manual of operations for national committees. It also recommends that EMRO subsequently organize a meeting for chairpersons of national committees to discuss issues related to functions of national committees. This meeting may be attended by one or two members of the Regional Commission and possibly a member of the Global Commission in order to achieve unity of thinking in the work of these bodies.

The Regional Commission calls on the Global Certification Commission to provide guidance on the mechanism and responsibilities for documenting the eradication of poliomyelitis in countrics or areas with ongoing conflict or civil unrest and whcre the functions of a national committee cannot be fulfilled. EMRO should provide full updates on the status of these countries and areas during each meeting of the Regional Commission.

5. Regional certification process While the Regional Commission reaffirms that it will certify the E M R as poliotnyclitis-froc only :llicr ~ v i l dpoliovirus tr:lnsmission has hccti intcrruptetl t i ~ r:it least three years in all Member States, it may consider certifying certain regional epidemiological blocs which have met the criteria for certification before that time. fIowever, all countries would be required to provide an annual update demonstrating that poliomyelitis-free status has been maintained through appropriate immunization activities and surveillance that meets certification criteria. The Regional Commission calls on the Global Commission to review the unique gcogmphical features of the Eastern Mcditcrrancan Rcgion and consider an EMR Commission proposal for certification by epidemiological blocs within the Region, the risk of importation and the poliomyelitis-endemic status taking into considcr~lion of adjacent countries.

W110-!3l/POL/4 I/E/L Page 19

The Regional Commission reaffirms that high-quality AFP surveillance will be the basis for certification a s defined in the regional certification guidelines. The Commission recommended that the regional certification guidelines be modified to reflect the importance of closely scrutinizing poliomyelitis-compatible cases and the work of the national expert committees for the classification of AFP cases in the certification process. Specific recommendations were made in the regional certification guidelines for those countries with small populations where annual nonpoliomyelitis AFP rates may not be a reliable indicator of the sensitivity of surveillance. 7. Laboratories

The Regional Commission welcomes the establishment of specific criteria for the accreditation of laboratories of the Global Poliomyelitis Laboratory Network and reaffirms the Global Commission recommendation that all results pertinent to documenting poliomyelitis eradication in a country must come from fully accredited WHO poliovirus laboratories. Thc Regional Commission recognizes the possibility of spread of wild polioviruses through inappropriate use or handling of laboratory wild poliovirus stocks and strcsscs that all EMR countries should take the appropriate steps to minimize this risk as outlined in the regional certification guidelines.

Wf10-Ebi,'POL/4 1!E.'L

Page 20 A I I I I1 ~.~

Agenda

2.

Opening of the meeting Message of the Regional Director, WHOIEMRO Global poliomyelitis eradication Regional ovewiew of EPI programme Regional poliomyelitis eradication programme Regional overview Laborarory suppon to poliomyeliris eradicationicertificat~on Cross-border transmission of wild poliovirus Recommendations of the recent technical meetings on poliomyelitis eradication: Second Meeting of the Global Certification Commission, Geneva,April 1997 Technical Consultation on the Global Eradication of Poliomyelitis Poliomyelitis eradication in other WIIO Regions: Poliomyelitis eradicationlcertification in the South-cast Asian Region Poliomyelitis eradicationlcertification in the African Region Regional poliomyelitis eradication certification Update on the national ccrtification committees Draft regional certification plan of action

3. 4.

5

6.

7.

8.

10.

Conclusions and recommendations

Annex 2 Programme Tuesday, 2 December 1997 08:OO-08: 15 08: 1 5 4 8 : 3 0 Registration Opening session Message of Regional Director, WHOIEMRO

erudicution 08:30-08:45 Global poliomyelitis eradication Dr B. Aylward, WHO/FIQ Dr T. Gaafar, WHOIEMRO Dr R. Aslanian. WHOIEMRO Dr E. de Gourville, WflOIEMRO

08:45:-09:00

Situation of the Regional EPI Programme

09:00-10:OO

Regional poliomyelitis eradication Regional laboratory support to poliomyelitis eradication1 certification Cross-border transmission of wild poliovirus

Dr M.IH. Wahdan, WI IOIEMRO

Session 11: Update on the recon~nzendations o/ the recent technical meetings reports 10:30-11:OO Second meeting of the Global Certification Commission, Geneva, April 1997 Prcscnt;~tionand tliscussion Technical consultation on the global eradication of poliomyelitis Poliomyelitis eradicatiodcertification in the South-cast Asinn P . L.\on ~'

Dr A.Deria

11:OO-12:lS

Poliomyelitis cradicationlccrtification in the African Region

Dr R Aylward, W r-IOlHQ Dr J. Vandelaer, W I IOISCARO Dr A. Lobanov, WI IOIAFRO

Wf IO-EMlPOLl4 l/E/L Page 22 Sessio~~s 111 and J l / . Regional polion~~elitis eradication cerflficution

12: 15-12:45-

Update on the nalior~alctrtificarion committees Discussion Presentation and discussion of the draft regional certification plan of action

Dr H. Jafari, WHOIEMRO

14:15-16:OO

Dr H. Jafari, WHOIEMRO

Wednesday, 3 December 1997 Session F Regionalpoliomyeliti.~ eradica!ion certificution(contit~ue~

09:OO-1O:OO

Discussion of the draft regional certification plan of action Revision of planned activities for the regional commission for certification of poliomyelitis eradication Conclusions and recommendations

10:3&11:30

11:30-12:30

WHO-EMIPOLI4 IIEIL Page 23

Annex 3 List of participants EGYPT Dr Imam Zaghloul Adviser to the Egyptian Organization for Biological Products and Vaccines

(VACSERA) Cairo

ISLAhlIC REPUBLIC OF IRAN Dr H. Malek Afzali Advise1 to the Mir~ibtcrof Hrallll and blccli~al Education Teheran

IRAQ Dr Abdullahi Deria Former Regional Adviser, Communicable Diseases Baghdad

OMAN Dr Ali Ben Jaffer Director-General of I-lealth Affairs Directorate-General of Health Affairs Ministry of Health kluscat

SAUDl ARABIA Dr A. Al Mazrou Assistant Deputy Minister for Preventive Medicine Ministry of IHealth Riyadh

SUDAN Dr S. Mahgoub El Taycb Epidemiologist Ministry of EIealth Khartoum

LVl10-LLI, POL.14 I/E/L Page 24

Dr ,M.H. Khayat, Deputy Regional Director, WHO,'EMRO Dr .CI.II. Wahdan. Assistant Rcpiunal Di~cctul, WHOiElLIRO Dr B. Sadrizadeh, Director, Integrated Control o f Diseases, WHO/EMRO Dr T. Gaafar, Regional .4dviser, \'accine Preventable Diseases and Imm~~nization. WtlOItMKO

Dr R. Aslanian, hledical Officer. Eradication and Elimination of Specific Diseases, WHOIEMRO Dr H. Jafari, ,Medical Officer, Poliomyelitis Eradication, WF-lOiE,LlRO Mr t.Brlgharbi, Technical Officer, Vaccine Preventable Diseases and Immunization, WHOIEMRO Dr Faten Karnel. Medical Officer under SSAIEPI, WHOiEMRO Dr E. de Gourville, Short-term Consultant, Laboratory/PoliomyelitisEradication, WHOIEMRO Ms N. Abou Zeina, Secrctary, WEiOIRegional Office for the Eastcm Mediterranean

WHOIHQ AND OTHER REGIONAL OFFICES Dr Bruce Aylward, Medical OfficerNPI, WHOIHQ Dr A. Lobunov, Medical Officer for Poliomyelitis Eradication, WIIOIAFRO Prof Natth Bharnarapravati, Chairman, fnternational Certification Comnlission for Eradication o f Poliomyelitis in S E A R 0 (ICCPE) Dr Jos Vandclacr, Short-term Consultant, EPI, WfIO/SEARO

WIIO-tXt 'P01./4 IT!L Page 25 Anner 4 Guidelines for Certification of the Eradication of Poliomyelitis in the Eastern hlcdit~rrnn~a R n~ g i n n

CONTENTS I. 2. 3.

Introduction Detin~tion of poliomyelitis erndicntion Background - the Poliornyel~tisEradication Iniriativc 3 . I Paralyric poliomyeliris, polioviruses and poliomyeliris vaccines

3.2 Strategies for poliomyelitis eradication in enclemic countrics

4. 5.

Criteria for certificat~ono f poliomyelitis eradication Overview: the strategy for the certitication of poliomyelitis eradication in the Eastern Mediterranean Region of the World Health Organization The Regionnl Commission fnr Certification o f Erndication nf poliornyclitis in the Eastern Mediterranean Region of WHO 6.1 Composition 6.2 T c r ~ r of ~ ~rcfcrcr~cc s National conimittccs for the certification o f polioniyclitis eradication 7.1 Compos~tlon 7.2 Terms o f reference Documentation required from each country for certification i) Ilistory of clinical poliornyclitis and wild polioviruses in the country ;~ntl inventory of I:~horatorics with wild polioviruses i i ) I'crfbrrnancc of national AI'I' survcill;~nce and poliomyelitis laboratory iii) Immunization activitics for the eradication o f wild polioviruses iv)Background information: demography, geography and health infrastructurc of the country Uorder areas will1 urlicr W I l O llcgiorls Role oftlie WIIO Secretariat in the ccrtilicalion oSpoliolnyelitis eradication

6.

7.

8.

9.

10.

Annex I. Timetable l i ~ ccrtificatior~ r activities in the [lastern blcditerranc.an Rcgion Annex 2. 1. Standard of AFP surveillance for thc certific:~tion of poliomyelitis eradication I .I Pcrforinancc of AFP survcill;incc 2nd case invcstigut~on I.:! i\ccrcd~t:~tion of national and regional poliomyelitis Iaborntories

WF{O-T:MiP01./4 I/E!L

Page 26 7.

Additional survcillancc strategies and acti\itirs ~ L iIi i c i i b i ~ i i 1 1puur AFP suneillancc anctor at high risk o f ongoing wild poliovirus transmission 1) EstablishmenVstrengtheningof actlve sume~llance for AFP cases ii) Collection o f stool specimens from contacts o f AFP cases iii) Stool surveys iv) Other surveillance activities Additional surveillance activities for countries with limited populations i) extending the target age groups for routine AFP surveillance ii) high quality "zero reporting" iii) retrospective hospital record reviews for AFP cases

3.

WI 10-EMIl'OLI4 I/E/L Page 27

1.

Introduction

In 1988, the World Health Assembly, the govemlng body o t the World Health Organization (WHO), adopted the goal of global poliomyelitis eradication by the year 2000. In the same year, the Regional Committee o f the Eastern Mediterranean Region (E,MR) adopted a resolution to eliminate poliomyelitis from the Region by the year

2000. In February 1995, W H O convened the first meeting of the Global Commission for the Certification of the Eradication of Poliomyelitis. The Global Commission established the basis, principles, and essential criteria for elobal certification of poliomyelitis, basing its work in part upon that of the International Commission for the Certification of Poliomyelitis Eradication (ICCPE) which had declared the eradication of' poliomyeliris from the Americas in 1994. The Global Commission has decided that certification should proceed on a regional basis, with the establishment of regional commissions which would review the documentation provided by national committees and, if appropriate, eventually certify the respective region as po. The ongoing and successful implementation of poliomyelitis eradication strategies in the Eastern Mediterranean Region should result in the interruption of wild poliovirus throughout the Region by 2000 and confirmation o f that achievement soon after. As thc necessary supplementary immunizatinn and surveillance strategies for achieving polio~nyclitiscradication have now been defined for the Eastern Mediterranean, it is increasingly important to establish the mechanism for certifying that countries which report zero cases are in fact free of wild poliovirus. The following Guidelines for Certification o f the Eradication of Poliomyelitis from the Eastern Med~terraneanK e g ~ o n are deslgned to serve as a rctcrence for use mainly by the members o f the Regional Certification Commission and National Certification Committees, WIIOIEMRO Secretariat, and health authorities involved in poliomyelitis eradication in Mcn1bi.r States. The guideline :Ire basrd o n the procccd~ngs of the Meetings o f the Eastern Mediterranean Regional Commission for Certification of Poliomyelitis Eradication and recommendations o f the first and second meetings o f the Global Commission for the Certification of the Eradication o f Poliomyelitis. The Regional Guidelines include a proposed timetable for regional certification octivitic:i and a summary o f the docurncntiition that will bc rcquircd froni each member country. 2.

Definition of poliomyelitis eradication in t h e Eastern k l e d i t e r r i n e a n Region

The definition of global and Regional poliomyelitis eradication was contirmed during the Second Meeting o f the Global Commission for the Certification o f the Eradication of Poliomyelitis in April 1997 as follows:

LVI 10-kbl POL14 1 ,'FA

Page 28 Global crudicatiot~must be dcfincd as the "eradication of all \vild polio\.iruscs". At the Regional level this objective can be understood as "the eradication o f regionally indigenous wild poliovims". Because of the risk of accidentally reintroducing wild poliovimses after indigenous transmiss~onhas been i n t e m p t e d the Global Commi5sion also stated that: The control of laboratory stocks of wild poliovims is essential to the global eradication of poliomyelitis....Prior to global certification. regional commissions should demonstrate.. .that Regional laboratory stocks of wild poliovirus have been properly contained. Thus, the existence of laboratory stocks of poliovirus without appropriate containment could potentially delay certification o f eradication. 3.

Background-the

poliomyelitis eradication initiative

Paralytic poliomyelitis can follow infection with any one of three wild polioviruses all o f which are mainly transmitted faecal-orally. The disease is seasonal with peak tr:~~~stnission U S L I ~ I I occurring ~ in thc hot, humid months. Poliovirus types 1. 2 , arid 3 cli f i r in their cpicfcminloyic:tl protilt!.;, with typc 1 hciny thc most common cause o f epidemics and having the highest ratio o f paralysis to infection. There is no nonhuman host for poliovimses and they survivc in the environment in a tropical ctivironmcnt for at most onc to thrcc months. Infcctcd pcoplc d o not cxct~ctc thc virus for more than a few weeks, but excretion by irnrnuno-compromised people can be much longer. Irnmunity to poliovirus fi)llowing natu~.;~linkction is lifelong. Immunity alicr vaccin;rtio~lis dspcndcnt on nl;iny tictors, including tlic typc of vaccine used ; I ~ L I the nurnbcr of doscs administcrcd. Oral poliovirus vacciric (OI'V) mimics natural infection, it induces humoral immunity and secretory immunity in the gut and spreads to contacts o f the recipient.

LVI I 0 recommends the I'olloeing strutegics for eradicating polio~nyclitisin endemic countrics.

Rorrtitrc ittr~trut~i;ritio,r co\.c,rtrge: Achieving high routinc immunization coverage with at least three doscs of O P V signitic;intly roduccs the circulation of wild polioviruses. In poliomyelitis-endemic countrics with tropical clirnatcs and developing countrics with low cnvironmcntal sanitation conditions. high levels o f routine coverage with

WIIO-EMlPOLl4 IIEIL Page 29 three O P V doses will not interrupt wild poliovirus circulation and hence supplementary doses of OPV are needed.

h'utioi2ul i i ~ ~ n i i ~ r ~ i z u d tui y o.t~ 6VID): NIDs are critical for interrupting wild poliovirus circulation. During national immunization days, all children within a specified age limit (< j years) receive two doses of O P V one month apart in the low season for transmission, regardless of their prior immunization status. Acute Juccid pu,-u!vsis lilFP) .sirrvri//ai~ce:For the purposes of the poliomyelitis eradication initiative, surveillance is conducted for all cases of AFP. AFP is defined as:

any case of acute flaccid paralysis, i n c l u d i n ~ Guillain-BarrC syndrome, in a child aged lcss than 15 ycars, for wllich no o t l ~ c rcausc can bc found or suspcctcd poliomyelitis in patients of any age. All APP cases should have a full clinical, epidemiological and virological investigation, including the analysis of two adequate stool specimens in a WlHOaccredited laboratory. Even in the absence o f wild poliovirus circulation, surveillance systems should be expected to dctcct at least 1 case o f non-poliomyelitis AFP per 1 0 0 000 population aged less than 15 years, due to conditions such as other cnterovirus infections, Guillain-Bani. syndrome and transverse myelitis.

"Mopping-rip" Activities: When wild poliovirus circulation i s reduced to focal arcas of persistent transmission, special mopping-up activities should be conducted.

Mopping-up should include house-to-house immunization over a wide geographic area with an active case search for unreported AFP cases. 4.

Criteria for certification of poliomyelitis eradication

'fhc (ilohal Commission for the Ccrtificntion o f the IJrudication of Polio~nyclitishas statcd that WI-10 Rcgions can only be certified as poliomyelitis-free after all countries of the region have fulfilled the following criteria: I) no circulating indigenous wild polioviruses have been detected during a three year period in which survcill:~ncehas been maintnincd nt the lcvcl of pcrform:~ncencedcd for certification. 2 ) a national committee for thc ccrtitication o f polioniyclitis eradication in eaclr

country has validated and submitted the certification documentation required by the regional cotnmission. (Thc EbIR Regionill Cornmission intcrprctcd this criterion as "submission of documentat~on by nat~onal cornmlttces that 1s required and is accepted by the Rcgional Commission).

3) stocks of wild poliovirus have bccri propcrly inventoricd and contained

4 ) dppropriatc n-icasi~rcsarc in plat: t o d c t c c t a n d r i s p o n d to iniport,ltinn.s of wild

poliovirus. 5.

Overview: t h e strategy for t h e certification of poliomyelitis eradication in t h e Eastern Xlediterranean

The certification of wild poliovirus eradication from appropriate epidr.miological blocs in the Eastern blediterranean Region \\.ill be the decision of a regionai certification commission. which will base its decision upon the review of documcntation on pol~omj~elitis eradication provided by national ccrtification committees (see beloit.). National committees for certification of poiiomyelitis eradication will bc rcsponsible for reviewing and verifying the documcntation which national immunization and surveillance personnel assernbIe LU pruvt. [hat poliomyeliris has been eliminated from that country. Whcn thc comniiri .c members havc completcd this process, the docurnentatioll wtll be forwarded to the regional commission for consideration. Rcgional certification will only hc considered when all >Ic.mbcr States have becn frco of indigenous wild poliovirus fdr at least three years, in the presence of surveillance that meets the level of performanct: needed for certification. 6.

T h e liegional Commission for Certificrttiot~of Eradication of Poliomyelitis in the Enstern Xlcditerr:~n~r:~n Rcgion of \ % ' I 1 0

The Regional Certification Commission appointed by the Regional Director is cornposcd of experts in fields related to poliomyelitis eradication such as public health ott~ctals, virolog~st, and cp~dcrn~ologtsts. ~Mernbcrs of the Iiegional Certiticati,~n C'onimissiori shoi~ld not havc clircct responsibility for poliomyelitis cradication activities in any b1ctlihcr Sti~tc of tlic Rcgiori, but a rncnlbcr(s) nliiy o n occasion attend rclcvant technical mcctings as obscrvcrs and participate in mcctings of national committcc mcmbcrs. Thc Regional Commission will acgularly communicate with thc Global Commission through two members who serve on hnth certifiratinn bndics

To prepare and cndorsc guidelines and a timetable for certitication of poliomyelitis eradication in the Eastern bleditcrrancan Rcgion. To definc the documcntation that will bc required fratn each cuunrry for ccrtification of poliomyelitis eradication. To encourage countnes to constitute the appropriate national committcts for ccnitication of poliurn~,clitis cr;~dlcation 2nd coordinate their activities.

WHO-EMiPOLI4 IIEIL Page 3 1 To endorse and update as necessary the protocol for the collection of national immunization and surveillance data for certification o f poliomyelitis eradication. To request or endorse innovative or alternative methods for verifying poliomyelitis eradication in "high risk" areas which do not meet the required quality o f surveillance for certification. To conduct site visits during the certification process. if needed. to review a n d o r verify certification data in individual countries. To bring unresolved certification issues to the attention of the Global Certification Commission. To verify the inventory of wild polioviruses and their containment in secure

.

facilities. To advise the Regional Director, EMR, of any actions required on the part o f the WHO Secretariat and national authorities to facilitate the certification process. To certify, if and when appropriate, the eradication o f poliomyelitis from epidemiological blocs in the Eastern Mediterranean Region o f WHO and to provide the Glnbal Commission with the documentation necessary to endorse regional certification as a part of certification of global poliomyelitis eradication. 7.

National committees f o r poliomyelitis eradication

The validation o f the documentation needed for cert~fication ot'mcmbcr countries will be conductcd by national certification committees.

The members of the national certification committees should be appninted by the government o f each Member State, taking into consideration rccommcndations o f WHOfEMRO. The national committee in each country will consist o f not fewer than three person::, dupcnding on the size of thc country. Onc mcmbcr from cilch n ~ t i o ~ r a l committee shall be nominated as chair and take responsibility for liaison with the Regional Commission. The national committee members should not have direct responsibility for poliomyelitis eradication in their country. Ilo\vevcr, i t may be both necessary and desirable to have one o r more persons from either the immunization services o r disease surveillance programme serving as secretariat to the committec. These persons cannot, howcvcr, be voting members of the committcc.

WHO-EIM/POL/~ l/E/L Pagc 32 Sational Committee members should be persons \vho have the necessary expertise and experience to evaluate poliomyelitis eradication activities in their country. The candidates will probably have a background in public health, epidemiology, virology, paediarrics, neurology or orher related discipline and have a starure consisrent with rhe importance of this position. Selection of members of national committees should be based on professional reputation anti merits and be vielved as a distinctive honour.

National committees do not have the authority to certify their country as having eliminated poliomyelitis. Rather, these committees will, if and when appropriate, be responsible for verifying and suhrnitting the documentation for certification to the Regional Commission. Therefore, the tenns of reference of national certification committees are as follows: To guide national surveillance and immunization personnel with the preparation of the documentation required for certification of poliomyelitis eradication. To review the documentation provided for certification and inform the national surveillance and immunization personnel of additional requirements for certification (however, committee members should not have direct responsibility for the poliomyelitis eradication programme in the country). To conduct site visits to hospitals, laboratories, outlying areas and other sites to validate national immunization and surveillance data. To review the role and work of the National Expert Committee for Classification of AFP Cases, giving particular attention to polio-compatible cases. To rccommcnd additional surveillance activities or the collection of additional data as required for ccrtitication in consultation with the Regional Commission. To provide the Regional Certification Commission with a periodic summary o f progress towards certification. unresolved difficulties which may delay the certification process, and potential solutions to such obstacles. Beginning no later than 1999, thc summary report should be submitted at least annually. To review, endorse and submit a final country report for consideration by the Regional Certitication Commission after there has been no evidence of wild poliovirus circulation for a minimum o f three years and all relevant documentation is complete.

WHO-EMiPOLI4 1IEIL Page 33

8.

Documentation required frorn each c o u n t r y for certification

Each national certification committee must provide suficient documentation to support the statement that the country is poliomyelitis-free, that all wild poliovirus stocks are properly controlled and that wild poliovirus importation would be readily detected if it were to occur. In addition, mechanisms should be in place to ensure an appropriate response to any importations of a wild poliovirus. The purpose of the documentation is to provide the Regional Commission with a set of standard, internationally accepted data upon which it can base its decision \vhethcr or not to accept a count~y'sclai111 to bc poliomyelitis-fier. If alld WIICII Lhe Regional Commission certifies the Eastern Mediterranean Region as poliomyelitis-free, the country documentation will be used by the Global Commission as a basis for endorsing the decision of the Regional Commission. I h ~ sectlon s describes in general the minimum documentation that will be necessary for the purpose of certification. The national committces may request and require additional information if necessary to provide adequate evidence to the Regional Commission. A manual endorsed by the Regional Certification Commission that describes in detail the process and format for documentation will be distributed to the National Certification Committees and health authorities responsible for poliomyelitis eradication in each Member State. Thc documentation must cover four general subject areas I) The first scction of the documentation should detail the history o f the epidemiology of both clinical poliornyclitis and wild poliovirus in the country. This section should include the inventory and containment status o f any wild polioviruses remaining in laboratories o f the country o r subregion.

2) The second scction o f the documentation should demonstrate that national AFP surveillance meets the standard necdcd for certification. Documcnt;~tionmust cover two specific areas: w

the performance o f AFP surveillance in the detection, investigation, specimen collection and follow-up o f AFP cases in the country. thc pcrfomiancc of the poliumyclitis l a b u ~ u l u ~i ly l pruucssing speeimcns and reporting results.

.

3) I he t h ~ r d sect~on of the documcntat~onshould provide details o f all immunization activitics conducted ;is part o f the nationallsubrcgional initiative to cradica~ewild polioviruses. This scction should also demonstrate the capacity to respond to a wild poliovirus importation, if one should occur.

4) The fourth section o f the docurncnt:~t~on ~hn111rf hr nn anncv which provides comprehensive background information in t\vo arcas:

\VI 1 0 - E M POL14 1/E/L

Page 34

the health infrastructure of the country, giving particular attention to the health information system, .the nat~onalpol~omyelitis eradication in~tiative and the interaction between the HIS and the eradication initiative. The information required under each of these subject areas is explained in the followings. 8.1 Histoy of cli~~icalpolionzyeIitis and wildpoliovir~rs and inventoty of wild poliovirus it1 all laborator-ies in the colmtty

Purpose: to demonstrate the decline and elimination of clinical poliomyelitis and wild poliovirus in a country or subregion and document the control of any remaining laboratory stocks of wild poliovirus or potentially infected materials. Dutu required: the national epidemiology of poliomyelitis should be summarized in this section, including all relevant information on both clinical poliomyelitis cases and the circulation of wild polioviruses.

The history of poliomyelitis incidence in the country should be outlined. A detailed history should be provided for the 10-15 most recent cases of poliomyelitis (or all cascs with onset sincc the beginning of 1995 if fcwcr than 10 cases have occurrcd within the last five years). The documentation should outline the criteria by which these cases were confirmed as poliomyelitis, the laboratory findings, and the probable urigir~ of any virusrs that wcrc isolatcd. Thrrc should bc documentation of the response to each case. The history of wild poliovirus circulation in the country should be provided, particularly for the previous fivc-year period. A detailed summary should be provided for each of the last 10-15 wild polioviruses that were isolated in the country (or all viruses isolated sincc the beginning of 1995 if fewer than I0 viruses were detected in the five-year period). Data on each virus should include the source of the specimen was isolated, the geographic location of the source of specimen, from which the v i n ~ s the probable origin of the wild poliovirus and the subsequent investigations to demonstrate the elimination of the virus. (Note: for the purpose of this information, rh cd dam data on an outbrcak causcd by a singlc strain of wild virus will be c u ~ ~ ~ i d u a on a single virus, regardless o f the number of isolates in the outbreak.) An inventory should be provided of all laboratones in the country which continue to store wild poliovirus or potentially infcctcd materials. Details including inventory of wild viruses and infection material should be provided to demonstrate that such viruses are held under secure, properly controlled conditions. To be certified as poliomyelitis-free, a clear commitment should be demonstrated from a11 levels that all

~ v i l d polioviruses and infected material will be disposcd off according to the recommendations of the global certification commission. ofnational AFP siit~eillance at~dpoliott~);elitis laboratoty 5.2 Perfort~~uilce Piirpose: to demonstrate that (a) AFP sunreillance is of a sufficient standard to detect cases of paralysis due to either indigenous or imported wild polioviruses and (b) that ld ; ~ n didentify wild poliovirus in tlic stool o f a the poliomyelitis laboratory c o ~ ~ isolate paralysed child. This is essential for demonstrating t h a t a country is poliomyelitisfrez. u) Data required

(a) A F P surve~llance system: the results and data on performance lnd~catorsfor Apt-' surveillance should be provided for each year since surveillance for AFP was established as a national policy. Data on the structure of the routine AFP reporting system should be provided, including the number of routine reporting sites in the country, the geographical representativeness of the reporting sites, timeliness of reporting and completeness o f "zero" reporting. Case investigation, follow-up and line-listing forms should be available for all AFP cases identificd since AFP surveillance was established. The national certification comrnittcc should review a sample of the AFP case investigation forms from each year to ensure that the forms have been properly completed and that the data in the line listings is complctc. Particular attention should be given to demonstrating that AFP surveillance performance has reached the standards set by the Global Commission (see Annex 2, section 1.1). A spot map o f AFP cases should be included for each o f at least the previous thrce years. The reasons for any geographical areas with an obvious lack of c;tscs should he explained (i.e. lack of population, poor s~trvcillancc),along with information on special survcillancc activities that were undertaken, if necessary, in thnse areas. The results of all AFP investigations for at least the previous three year period should bc summarized using the AFT' virological classification system ( F i p u ~ c I).

WI 10-EMIPOL!4lIEIL

Page 36 Wild poliovirus Confirm

AFP

/ . / No wild poliovirus Two adequate specimens

Residual paralysis. died. or lost l o follow-up

-

Expert

/

Compatible

re,iew

Discard No residual paralysis Discard

t

Discard

Figure I: Virological classification of AFP cases Special attention should be given to polio-compatible cases. For each poliocompatible case the following information should be provided: clinical feahlres including the probable clinical diagnosis, epidemiological features (whether from a high risk area, clustering of similar cases, etc.), virological fcaturcs (prcscncc or absence of any spccimcns, tillring uC sprcimen collection and transport, condition of specimen upon arrival in laboratory, other viruses found, results of contact specimens, etc.). results of extra clinical and epidemiological evaluations (investigations of the cluster, active search for additional cases, stool survey in the area, etc.). details on "mop-up" campaigns in the area of the polio-compatible case, Thc national comrnittcc should be satisticd that all ncccssary stops havc been takcn to ensure that polio-compatible cascs do not rcprcscnt arc:ls nf ~~nrc.~~ognizcd wild poliovirus transmission. (b) Poliovirus laboratory

This section should idsntify the laboratory responsible for poliovirus isolation and documenr rhc year of irs accreditation in the W l I O Poliomyelitis Laboratory Nctwork. The standard laboratory performance indicators (see Annex 2, section 1.2) should be documented for each year during which it scrved as the national poliovirus laboratory (a minimum of three ycars of performance indicators should be providcd). A copy of each laboratory assessment that was performed should be available if requested by thc Regional Commission.

WI 10-EM/POL/41/E/L

Page 37 For as many years as possible, but a minimum of three years, tlic folloiving documentation will be required from each national laboratory: i) Laboratory process and results: the total number of stool specimens received, the total number o f AFP cases from which stool spccirnens were received and the total numhcr of stool specimens that were processed each year the number and source o f any other specimen? ~ v h i c h were ~ x n m i n e d for polioviruses the timeliness of specimen processing and reporting by the laboratory for AFP caScS or contacts the total number of non-poliomyelitis enternviruses that were isolated and the non-poliomyelitis entcrovirus isolation rate the total number o f polioviruses that were isolated, and the total number of AFP cases that had any polioviruscs isolated the results of all intratypic differentiation studies, by specimen and AFP case a the total number of isolates that were referred for intratypic differentiation the total number differentiated within the laboratory

.

ii) Missing laboratory data the reasons for each instance in which a specimen was received in the laboratory and was not processed the reasons for any failure to send a poliovirus isolate for intratypic differentiation thc reasons for any missing intlmtypic diffcrcntialiurl results The national committee should review and comment on the data management system in the national laboratory and ensure that all specimens can be tracked.

A scparatc section should provide details on how the surveillance and laboratory activities are coordinaterl in the cnllntry Partirlllnr attention should be given to determining whether there are regular (LC. at least monthly) meetings or communications between national surveillance and laboratory personnel to ensure that the linc listings of both the survcill;incc unit and laboratory arc co~nplctc and up-todate and without discrepancies. 8.3 /~,~ti~fmfz(~lforr ~ ~ t ~ v f I ~ e .the sjO erarlrcalrotl r reporting ro ~vildpoliovirtts ittrl~orrcrriotls

o/

i ~ t d ~ ~ e t ~bvilrl o~r. poliovirlt,ses s cctld

Plrrpose: to demonstrate that high routine poliomyelitis immunization coverage has been maintained and that, if necessary, appropriate supplementary immunization i~ctivitlcs have been implcmcntcd to interrupt wild poliovirus circulation. This srction

WI 10-EMIPOLI4 IIEIL Page 38

should also dcmonstratc that thc sprcad of importcd wild polioviruscs \vould bc limited by high levels of population immunity. Data req~rlred:this section.should contain full information on both the routine and supplementary poliomyelitis immunization activities that have been conducted in the country. The history of poliomyelitis immunization should be outlined, including the routine immunization schedule, the poliomyelitis vaccines that have been used and the immunization coverage that has been achieved.

National poliomyelitis vaccine immunization f i g r c s should be provided for as many years as possible (at least since the beginning of 1995). Routine immunization coverage should be provided by first and second administrative level (i.e. highest subnational level of governments: e.g. Province, region, statc, oblast, and second level such as district or province etc.) for the previous three-year period to demonstrate l~urr~ugrr~ruusly high cuvrrdgc. 111 Lllusc gcug~aphir;arras or population subgroups with low routine immunization rates (i.e. high-risk areas or groups), there should be evidence of targeted measures taken to improve coverage. Data on supplementary poliomyelitis immunization should include all national and subnational OPV immunization days and all "Mopping-up" activities. In addition to national level coverage, the results of NIDs should be provided by first and second administrative levels for each year. 8.4

Background information: demography, geography and health injkstructlrre of the country

Purpose: to rapidly familiarize regional and Global Commission members with (a) the basic demographics and geography of the country that are relevant to poliomyelitis eradication and its certification and (b) the organlzatlon of the poliomycliti.; eradication initiative in the country (immunization, s u ~ c i l l a n c c and laboratory). Data required: this section should include information on the population of the country, relevant vital statistics and major population centres. Minority populations should be reviewed along with other groups which may not fully utilize the health services or who are known to have low immunization coverage. Remote areas, areas with difficult access, and areas which border poliomyelitis-endemic countries should also be specified. The country background information should include a national map which indicates the major popularion centres, bordering countriesloceans, and principal geograph~c features (mountain ranges, high plateaus, rivers, etc.). Information should be providcd on the number, type, and distribution of health care facilities and access of the population to those health care services.

WI 10-EM,'POL/41/li/L Page 39 The structure of personnel responsible for poliomyelitis immunization, AFP surveillance, and the enterovirus (poliovirus) laboratory should be outlined. This sectton should expla~n the relatronshtp between these units or departments and outline their interaction. It is particolarly important to: demonstrate how AFP,'poliomyclitis notifications are transmitted to those responsible for undertaking the case investigation, stool sample collection and implementation of appropriate control measures, particularly in the evcnt nf a n imported poliomyelitis case or wild poliovirus detection. demonstrate how both positikrc and negative 1nboratoq-r' rcsults arc transtnittcd to those responsible for initiating a response, whether it be supplementary immunization activities or adjusting (of routine immunization strategies. 9.

Borders with o t h e r WHO Regions

The Eastern Mediterranean Region of WI-10 shares land borders with four other WI-I0 regions. It is recognized that there will be a risk o f reintroduction o f wild poliovirus to or from the Region across a number of borders along EMR countries until such time as all countries are certified as poliomyelitis-free. Therefore, the Regional Commission will require sufficient information on the status of poliomyelitis cr:iilicatinn activitics in horder countries to assess this risk and evaluate thc appropriateness of the measures that are being proposed to detect and respond to importations. The WHO Secretariat will ensure that appropriate background information on the progress towards poliomyelitis eradication and certification in adjacent countries is provided to the Regional Comm~sslon. Lhe Kegional Commission will also monitor activitics in bordering regions through the Global Commission. If necessary, an cxtr;lordinary meeting with the Conirnission from one or rnorc of the othcr rcxions will be considered. 10.

Role of t h e WHO Secretariat in the certifiratinn of poliomyelitis

eradication Under the general guidiincc of RDIEMRO, thc WI1O:EblRO Scc~cta~iilt will bc responsible for supporting the work of the Rcgion;ll Commission and the nationill committees. The Secrctariat will facilitate the finalization of the certification strategy and national committees. The E M R U Secrctartut w ~ l l also assist with the implementation of the certification strategy at the national level and, when appropriate, act as a liaison bctwccn the committees and the Regional Commission. The Secretariat will prepare a manual to enable national poliomyelitis eradication programmes to provide standard documc.nt:~tion nccdcd for the certification process. The Secretariat will bc responsible for identit-ing the unlnct resource rerll~ircrnrntsfor the certification proccss.

WHO-I:M/POI I 4 I/E/L Page 40 Annex 1

Timetable for Certification in the Eastern hlediterranean Region 1995 Appointment of initial members of Regional Certification Commission First meeting of the Eastern Mediterranean Regional Commission for the Certification of Poliomyelitis Eradication Request to Member States to finalize the membership of the national certification committees. Second meeting of the Eastern Mediterranean Rcgional Commission for the Certification of Poliomyelitis Eradication Finalization of the membership of national certification committees

1995 Sept

1997

1997 Dec

1998 (April)

Distribution of Guidelines for Regional Certification 1998 Review and endorse the manual for national documentation for certification of poliomyelitis eradication Distribution of the manual for national documentation for certification of poliomyelitis eradication Third meeting of the Eastern Mediterranean Regional Commission for the Certification of Poliomyelitis Eradication to endorse a format for the subm~sslon of the final country Reports of national certification committees Briefing of the chairs of national certification committees Begin preliminary review of certification briefing papers prepared and submittcd by the national committee of any EMR country which has been poliornyclitis-frcc for a pcriod of at Icast t h ~ ~ ycalb. cc

I999

Fourth mcctinf of 111,. Cxsterii 'Ltediterraiienn Refio~llilC o n i m i s i o n for the Certification of Poiiomyelitis Eradication

Review inventory of all wild poliovirus isolates or potentially infected materials in a11 laboratories in the Region. Implementation of control measures to minimize the risk of reintroduction of virus from the laboratory.

1999 on:vards

Review of certification briefing papers by the national committ'es of all EkIR countries which have been poliomyelitis-free for a period o f nt least three years. Periodic mectings of tlic Eastem Xlcditerruncail Regioncil Commission for the Ccniticitrion oSPoIiornyeliris Erndic;tiion

2000 onwards

WI IO-EIM/I'OL/SI/E/L

Page 42 Annex 2 AFP Suweillance for Certification, EkIR Standard of AFP Surve~llance for the Cert~l~cation of Pol~omyelitis Erad~cation As noted by the Global Commission, the absence of wild poliovirus for three years in the presence of high quality routine AFP surveillance among children aged less than IS years rhni~ldh r regarded by all countries ... as the gold standard for certification of poliomyelitis eradication. The eradication of wild poliovirus in a country can only be cons~deredwhen the performance of the surveillance system has met the specific standards set by the Global Commission. For countries with an established acute flaccid paralysis surveillance system and poliomyelitis laboratory services, there are standard ind~cators that are used to monitor performance. While the indicator targets were orig~nally designed for strengthening AFP surveillance systems, a subset forms the basis of the certification process. The Regional Commission may require data based on alternative surveillance activities to confirm the eradication of wild poliovirus circulation in areas where AFP surveillance does not meet the level of performance established for certification. Additional activities may also be required in countries with populations of less than 12 million people due to the limited utility of standard AFP performance indicators in such scttir~gs.

1. I Performance of AFP surveillance and case investigation The Global Commission for Poliomyelitis Eradication has stated that indicators listed below should have prcccdcncc in dcnionstrating that a national AFP system rnects the level of performance required for the certification: i) At least 80% of expected routine AFP sirrveillance reports should be received on time.

COIIII~IW Thcrc I ~ ; must bc documcntcd cvidcncc that at l u ~ s t 8036 vT tlle rvgular (weekly or monthly) surveillance reports that health Fccilities are expected to submit are received on time by national surveillance authorities. The distribution of reporting sites should be representative of the geography and demography o f the country. There must be at least one reporting site in each of the "most peripheral administrative arcas" (i.c. districUsubdistrict). ii) The AFP surveillance system should be able to detect a non-poliomyelitis AFP rate of at lcast 1 case per 100 000 population aged Ies%than I S yr:ir.;

Wf IO-EbI/POL/4 I/E/L Page 43

C O ~ J I ~ JIn IU the I Iabsence : of wild poliovirus, countries should still detect at least one case of non-poliomyelitis AFP per 100 000 population aged less than I5 years, due to other condlt~onssuch as Gu~llain-BarreSyndrome and transverse myelitis. Achieving -this level of performance indicates that a surveillance system would probably be sufficiently sensitive to detect paralytic poliomyelitis cases due to ivild poliovirus should they occur. To ensure that the national AFP rate does not obscure local weaknesses in the surveillance system, the AFP rate in each governorate or province or densely populated districts should he examined, with the target again being > I case per I00 000 population aged less than 15 years. i i i ) 100% of reported AFP cases should be investigated.

iv) At least 80% of AFP cases should have two adcquace stool specimens examined in an accredited laboratory and a follow-up exam for residual paralysis at 60 days after the onset of the paralysis.

Conlnrent: Adequate stools are defined as two samples collected at least 24 hours apart 0-14 days after the onset of paralysis, and arriving in the laboratory with ice present (or still-frozen ice packs), sufficient quantity for complete analysis and accompanied by proper documentation. A panel of experts should hc convcncd frcqucntly, nn at lcast a n a n n u a l basis, to makc t h c final classification of AFP cascs as confirmed poliomyelitis, discarded as nonpoliomyelitis, or poliomyelitis-compatible'. All poliomyelitis compatible cases must have complete documentation of the reasons for being considered compatible, the investigations to rule out wild poliovirus circulation in the area of the case and the possible alternative clinical diagnosis. All AFP cases discarded as nonpolioniyclitis should havc a final diagnosis. Comnrenf:

V) All virus isolation tests, including negative rcsults, must be pcrformcd by laboratories which are accredited as part of the Global Laboratory Network. All AFP stool specimens and other diagnostic specimens must be procc:;:;cd by n lohorotory <vhich i:: accrcdit~.d a:; port of tho global nctwork of laboratories for poliomyelitis eradication. Any polioviruscs isolnted by laboratories not accrcditcd within the network must be confirmed by an accrcditcd network laboratory (sce below). Conrment:

I

I'arliom!eli~ir-comp.l~hlec;l\c.; arc indicative o f a sur\eillanue ucokness in lhal insullicicnl lahoral<rrv ssmplcs a c l~ ; ~ \ ~ i l i c ; l l i~ ~~ ~n\ I c InI iI~rcurncnl;~tiun) I~

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WI~iO-EM/POL/4 I/E/I Page 44

To ensure a consistently high level of laboratory performance and competence in the initiative to eradicate poliomyelitis, a network of accredited poliovin~s laboratories has been established under the auspices of WHO. The results of all stool samples from AFP cases, diagnostic specimens from other cascs and alternative surveillance activities that are s ~ ~ b m i t t e as d evidence supporting poliomyelitis eradication must be from, or verified by, a WI-IO-accredited laboratory. elobal " Accreditation provides documentation that the laboratory has the capacity to detect, identify, and promptly report wild polioviruses from clinical specimens. The accreditation status of each network laboratory is rcvicwcd annually by WIIO and is based on proficiency testing and laboratory performance during the immediately preceding 12 months. Accreditation of national laboratories is based on the following six items: I. Laboratory results on t 80% of AFP specimens are reported to appropriate surveillance and immunization personnel within 28 days of receipt. Virology tests are performed on at least 150 specimens per year. The non-poliomyelitis cnterovims (NEPV) isolation rate from all stool specimens from AFP cascs is 2 10%. The accuracy of poliovirus detection and identification among all virus isolates is ; .80% (by comparison with results obtained in regional reference laboratories for referred isolates/specimens). The score on the most recent WHO approved proficiency panel is t 80% The scorc from an on-sitc revicw of laboratory operating procedures and practices is 2 80%.

2.

3.

4.

5.

6.

Laboratories achieving less than 80% score for each of the criteria listed above are placed on a provisional status (with the possible exception of criterion no. 3 for which acceptablc reasons for a low NPEV isolation rate should be provided). During the ~ x ~ ~ whcn i u d a Ialru~aLu~y i b U I I p~uviaiur~al bliilus all stool samplcs are eirher sent directly to an accredited reference laboratory or are tcstcd in parallel in an accredited reference laboratory. Results obtained by the reference laboratory arc considered as thc "gold standard". The criteria for accreditation of regional reference laboratories arc currently being established by the Global Poliomyelitis Laboratory Network.

WI-10-EM'POLI.1 I/E/L Page 45 2.

.\dditional s u r ~ e i l l a n c e strategies a n d activities for areas \\it11 p o o r surveillance a n d / o r at high-risk

The Regional Commission rnay require additional surveillance activities if the standard o f AFP surveillance is not homogeneous throughout a country. For example, in addition to reaching the AFP suneillance standards for certification at the national level, the non-poliomyelitis AFP rate and the percentage of AFP cases ~ v i t htwo adequate stool specimens qhn~lld alco reach certification rtandarclc in t-acli lar:y geographical area within the country (i.e. at the governorate or province level). In addition, ccrtain arcas in a country may rcquirc hcightcncd survcillancc duc to charactcristics which put them at a high risk of ongoing unrecognized wild poliovirus circulation, such as: borders with countries which are known to be poliomyelitis-endemic, minority populations which have frequent contacts with similar populations in poliomyelitis-endemic countries, underdeveloped health care services which result in low immunization coverage (less than 80% OPV3 coverage) and incomplete disease reporting (AFP reporting rate below I per 100 000 children undcr 15 years old and stool specimen collection below 80%). laboratory-conlirmcd poliolnyelitis cases occul-ring withir~the last three years in areas with poor surveillance.

In these high-risk areas, or where the standard o f AFP surveillance is low, additional surveillance activities may be rcquircd to demonstrate the absence of wild poliovirus circulation. Examples of such additional survcillancc activities include: i) Establishment/strengthening o f active surveillance for AFP cascs Weekly active surveillance visits to major hospitals and referral centres to search for unreported AFP cases should always be the first step in areas where surveillance indicators fail to rcach tlic standards rcquircd for ccrtilicntion. Oric:1tLition of p ~ i v a t c physicians and brictiny sessions in m;~jorhcalth facilities, should be considcrcd ;IS instruments to improve the results of active survcillancc. When a new AFP casc is found, the casc should be invcstigntcd and two stool samples should be collected. Documentation on thc completeness and timclincss of the active surveillance visits will be required to support the certification process. In countries where the routine AFP surveillance system cannot meet the requirements for ccrtification. a nationwide active surveillance system may be needed.

WI 10-EMIPOLII 1IEIL

Page 46 ii) Collection of stool specimens from conracrs of AFP cases Although stool specimens from contacts of AFP cases are not required on a routine basis, in special circumstances contact specimens may be needed to help demonstrate that absence of wild poliovirus circulation in an area. In particular, stool samples should be collected from contacts of AFP cases in any of the following cases: if samples cannot be collected from the AFP case itself, if the AFP case is detected more than one month after the onset of the paralysis, if the case occurs in an area where few cases are detected due to either the local

geographyldemography or a poor surveillance infrastructure, In areas w ~ t h pol~omyel~t~s-compat~ble cases Ideally, contact specimens should be collected from at least five contacts aged less than 5 years of age. A separate investigation sheet to document specimens taken from contacts should be introduced. iii) Stool surveys In geographic areas where AFP reporting and investigation is unreliable and thcrc arc possible contacts with poliomyelitis-endemic areas (i.e. due to large minority populations, traditional trade routes, or religious pilgrimages), stool surveys may be required to provide supportive evidence for demonstrating the absence of ongoing wild poliovirus circulation. Stool surveys, however, should only be interpreted in conjunction with other evidence of the absence o f wild poliovirus.

Thc most appropriate target age group for stool sampling will depend upon thc local epidemiology of poliomyelitis and the routine and supplementary OPV immunization activities which have been conducted. Usually, surveys should target non-vaccinated children aged less than 5 years. It should be noted that, depending on the size of the population, a very large number of negative stool specimens could be needed from an area for negative results to have statistical significance. iv) Other surveillance activities

As the eradication initiative progresses, other appropriatc surveillance activities may be dcfincd for ensuring the elimination of ongoing wild poliovirus circulation in high risk areas. Examples are community-based activities such as "key informant reporting" or "active market scarchcs".

WIIO-EM:POL14 liE.'L Page 47

.Another example of additional sun.eillance activities is "active case searches during mop-up operations". During such searches, highest priority should be given to the identification of AFP cases with onset within two months prior to the search.

3.

Additional surveillance activities for countries with limited populations

Countries which do not have a sumciently large population to produce statistically valid numbers of expected AFP cases, may require additional surveillance activities or a modification o f the standard AFP surveillance strategy. In such countries, the standard AFP surveillance stratem may not yield enough information to document the absence of poliovirus. Additional surveillance strategies include: i ) Extending the target age group for routine AFP surveillance Extending the target age group for AFP surveillance from all individuals aged less than IS years to an older age group (i.e. aged less than 30 or 45 years of age) will provide further information that wild p o l ~ o v i m sis not endemic in countries with total populations of less than 2 million people. Such a strategy may also be epidemiologically appropriate if the country has been poliomyelitis-free for more than 10 or 15 years. i i ) Iligh-quality zero reporting

As noted above, to meet the certification standards for routine AFP surveillance, at lcast onc rcporting sitc nccds to be idcntificd in cach district (or comparable small geopolitical unit) and the distribution o f reporting sites should be representative o f the geography and demography o f the country. After checking the records o f the health facility, cach rcporting site should file a weekly report, even if no AFP cascs have occurred in that period. Under such a zero reporting system, all reporting units must submit a weekly report, cvc.11 iJ'zc,ro cu.ves of

AFP were seen. It will be particularly important to demonstrate the completeness and timeliness o f the routine zero reporting o f AFP cases in countries with populations o f fewer than 2 million pcoplc. iii) Periodic retrospectivc hospital record rcvicws for AFP cascs Periodic rctrospcctivc record reviews for childhood paralysis could bc conducted in all of the pacdiatric hospitals, rehabilitation centres. infectious discasc hospitals, referral hospitals and general hospitals with pacdiatric and neurology wards. The record reviews would need to be conducted at a minimum of every six months and cover at Ici~st thc three-year period immediately prior to request for certification. Ideally, attending physicians. such as paediatric neurolugists. ncurologists. and paediatricians

WI IO-Eb11POL/41lEII Page 48 should also be i n t c ~ ~ i c w c A d .n y p ~ xiuusly \ ~ l i r ~ u p u ~ tA ur FlP cascs which arc derecrcd

should be fully investigated with the appropriate virological and follow-up examinations. The collection of contact specimens may be warranted if the case is detected more than one month afier the onset o f paralysis.