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WHO/CDS/CSR/GAR/2002.2 International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control. Report of the Seventh Meeting Geneva, Switzerland 18 – 19 September 2001 World Health Organization Department of Communicable Disease, Surveillance and Response This document has been downloaded from the WHO/CSR Web site. The original cover pages and lists of participants are not included. See http://www.who.int/emc for more information.

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WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on VaccineProvision for Epidemic Meningitis Control. Report ofthe Seventh Meeting

Geneva, Switzerland18 – 19 September 2001

World Health OrganizationDepartment of Communicable Disease,Surveillance and Response

This document has been downloaded from the WHO/CSR Web site. The original coverpages and lists of participants are not included. See http://www.who.int/emc for moreinformation.

© World Health OrganizationThis document is not a formal publication of the World Health Organization (WHO), andall rights are reserved by the Organization. The document may, however, be freelyreviewed, abstracted, reproduced and translated, in part or in whole, but not for sale norfor use in conjunction with commercial purposes.

The views expressed in documents by named authors are solely the responsibility ofthose authors. The mention of specific companies or specific manufacturers' productsdoes no imply that they are endorsed or recommended by the World Health Organizationin preference to others of a similar nature that are not mentioned.

International Coordinating Group (ICG) onVaccine Provision for Epidemic MeningitisControl

Report of the Seventh Meeting

Geneva, Switzerland18 – 19 September 2001

1 International Federation of the Red Cross and Red Crescent Societies2 Médecins sans Frontières3 United Nations Children's Fund4 World Health Organization

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Contents

Summary Report of the Seventh Meeting of the International CoordinatingGroup (ICG) on Vaccine Provision for Epidemic Meningitis Control ……… 1

Annex 1 : Agenda ……………………………………………………………… 13

Annex 2 : List of Participants ………………………………………………… 17

Annex 3 : Report from the Secretariat on ICG activities 2000/2001 ………. 23

Annex 4 : Preparedness and response to the meningitis epidemic in West Africa ………………………………………………………….. 27

Annex 5 : The 2001 epidemic meningitis season and the ICG ……………… 31

Annex 6 : Presentation of country experience from 2001 epidemics:Meningococcal meningitis in Sudan ………………………………….. 35

Annex 7 : Guidance to countries on the management of contingency stocks of vaccine ………………………………………………………. 41

Annex 8 : ICG mechanism for yellow fever vaccine release …..……………. 49

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International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 1

Summary Report of the Seventh Meeting of the International Coordinating Group

(ICG) on Vaccine Provision for Epidemic Meningitis Control

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1. Opening address and introduction to the objectives of the meetingand adoption of the agenda

The seventh meeting of the International Coordinating Group on Vaccine Provision forEpidemic Meningitis Control (ICG) was held on 18 and 19 September 2001 at the Palais desNations, Geneva at the invitation of the WHO. This ICG meeting follows a scientificconsultation meeting on the emergence of Neisseria meningitidis serogroup W135 as a publichealth problem.

Dr Guenael Rodier, Director of the WHO Department of Communicable Disease Surveillanceand Response, welcomed the participants. In his opening address Dr Rodier outlined thestructure and the successes of the ICG partnership. He underlined some of the challenges thathad arisen in recent times: the global vaccine shortage and the misunderstanding of countriesabout the goal of the ICG, which is to facilitate the timely supplies from a global buffer stockupon urgent request from countries affected by epidemic meningococcal disease.

Although epidemic meningococcal disease is not one of the three priority communicablediseases for WHO, namely tuberculosis, HIV/AIDS and malaria, it remains a major publichealth problem in the African meningitis belt area.

Disappointment was expressed that major vaccine manufacturers were absent from themeeting, however the report of the meeting will be shared with them and communications withthese manufacturers will continue.

The preliminary agenda was adopted by the meeting. Dr. Max Hardiman was elected chairman,with Steve Edgerton as rapporteur.

2. Report on epidemic season, ICG activities and vaccine supply 2001(Annex 3)

(Dr Max Hardiman)

Points raised

Dr Mishkas, Saudi Arabia, asked what the importance of W135 was in the 11 countries of theAfrican meningitis belt affected by outbreaks; and if the ICG would play a greater role in theprovision of W135 vaccine for travellers, e.g. pilgrims to Hajj/Umra.

Dr Max Hardiman replied that all of these outbreaks were laboratory confirmed as N.m.serogroup A on a limited number of samples at the beginning of the outbreak. It was stressedthat the role of the ICG relates to epidemic response, and not to ensure vaccine availability fortravellers. However, the ICG will closely monitor the W135 situation.

It was remarked that the price of vaccine through the ICG had been 0.14 euros per dose sincethe establishment of the ICG. Presently, no final agreed price of ICG vaccine has been

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established, but the price is expected to double. The price of injection material had decreased.There were availability constraints for the vaccine this year, although the outbreaks were notas bad as in previous years. This is because one manufacturer has decreased the productioncapacity for AC vaccine and another manufacturer committed a large share of its productioncapacity to a single country before the epidemic season. The Pasteur Aventis representativestated that they expect to produce around 50 million doses for the next epidemic season.

3. Preparedness and response to the meningitis epidemic in West Africa(Annex 4)

(Dr. Yada)

Points raised

In Niger samples were sent to the Centre Recherches Médicales et Sanitaires (CERMES) andwere confirmed as W135. In Central African Republic, the Institut Pasteur laboratoryconfirmed W135 cases and in Burkina Faso samples were laboratory confirmed as W135 bythe Centers for Disease Control and Prevention (CDC). There is still a considerable gap between the detection of outbreaks at district level and theresponse at national level. This is partly due to the fact that data are not analysed at districtlevel, only at central level. In addition, that countries face difficulties elaborating vaccinationand epidemic response plans during outbreaks. Questions were raised on the rigidity of the criteria for releasing supplies from the ICG stocks.While recognizing that strict criteria are necessary because of global vaccine stock constraintsand the need to ensure rational and optimum use of the available vaccine, it was argued thatthere is a need for flexibility and consideration of each situation.

AFRO suggested establishing a pre-paid vaccine stock of 100 000 to 200 000 doses in Abidjanfor immediate response. However, it was noted that such a sub-regional stock could lead toan increase in dispersion of stocks and to a decrease in availability of vaccine. EMROremarked that stockpiling of vaccine at sub-regional level will not compromise the ICG, butwill allow quick delivery of supplies to where they are needed. It was noted with appreciation that information on outbreaks is exchanged during the epidemicseason between countries in AFRO through meetings and through the WHO outbreakverification system.

4. The 2001 epidemic meningitis season and the ICG (Annex 5)

(Dr. Francis Varaine)

Points raised

Some countries vaccinate children of less than 2 years of age with polysaccharidemeningococcal vaccine. Although the use of monovalent A vaccine in children under 2 poses

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no concern, questions were raised on the effectiveness of vaccinating children less than 2 yearsold with the bivalent A/C polysaccharide. WHO was asked to provide guidance on whetheror not to vaccinate children under 2 years of age with this vaccine. Médecins sans Frontières (MSF) compared the quality of syringes and needles and theirpackaging. This report was distributed to the ICG and its partners and it was felt that there isa need for unified recommendations by the ICG. It was noted that these evaluations could beorganized more frequently, carried out for other products and this should be the role of WHO.

It was also mentioned that in some cases there are false latex kit results caused by crossreactions because of the use of polycloning antibodies or by misinterpretation of theagglutinations, or by transport.

5. Presentation of country experience from 2001 epidemics. Meningococcal meningitis in Sudan (Annex 6)

Sudan has five regional laboratories, which are able to confirm N.m. and perform serogrouping.The country currently has a total of 570 000 doses of vaccine available and it is estimated thatit needs 7.5 million doses for routine immunization.

6. Report on WHO consultation on the emergence of serogroup W135meningococcal disease

(Dr. Maria Santamaria)

Points raised

The available scientific evidence indicates that serogroup W135 can be associated withoutbreaks of considerable size and that this strain is present in a number of African areas.However, the present laboratory-based surveillance information is inadequate and there is anurgent need to fully identify and document the prevalence of different meningococcal strainsin as many areas of the African meningitis belt as possible. This should be done both duringinter-epidemics, by confirmation of all clinical cases, and during epidemic periods throughlongitudinal and cross-sectional monitoring.

With regard to the protection of travellers to Saudi Arabia during pilgrimages, the participantsencouraged efforts to enhance the global laboratory-based surveillance in returning pilgrims,discussed the usefulness of mass chemoprophylaxis in this context and endorsed the currentrequirement of Saudi Arabia for the use of a tetravalent meningococcal vaccine for all pilgrims.To that effect WHO has been requested to investigate options with the manufacturers toaddress the supply situation.

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7. Guidance to countries on the management of contingency stocks ofvaccine (Annex 7)

(S. Edgerton)

The WHO strategy on epidemic meningococcal disease requires a timely delivery of a costeffective and quality supply. Following the epidemics in the African meningitis belt in 1996,a WHO meeting in 1997 in Ouagadougou recommended the establishment of nationalcontingency stocks in the countries at high risk of epidemic of meningococcal disease. It alsoenvisaged the exchange between national stocks and circulation of vaccine and drugs duringepidemics. Since 1996 many countries have established national contingency stocks and arevision of these stocks was felt necessary.

A review of the formula mentioned in the Ouagadougou report should be based on the delaysexperienced by countries in obtaining supplies from abroad, and the amount of supplies neededto cover the needs during these delays. Furthermore, an analysis of and guidance on the mostappropriate stocking level for contingency stocks will also be included, apart from otherguidance on the procurement, management and use of epidemic meningitis contingency stocksupplies.

Points raised

S. Edgerton was questioned whether there was a need for national stocks in view of the limitedvaccine supply and limited resources of the concerned countries. Therefore, it was suggestedthat there might be more need for budget lines at national level as transport delays of suppliesis not the major problem; rather the problem is lack of funds to urgently buy the vaccine. However, it was noted that national stocks should still be in place to cover the needs for thefirst weeks, as some delays in procuring and delivering cannot be avoided. The formula forestimating the needs should be reviewed, as it is already five years old. It was felt thatcontingency stocks should not necessarily be positioned in country, but rather stocked at sub-regional level in order to counteract eventual pressure to vaccinate, which may not be fullyjustified in public health terms. However, many countries coherently and consistently usecontingency stocks. This year in Burkina Faso, many districts had already used the vaccinewhen they did not experience an outbreak; therefore there was no more vaccine available whenoutbreaks occurred.

The Sudan representative remarked that there was a need for contingency stocks at nationallevel and that these stocks should be kept at a central level to ensure good management. Theuse of treatment kits implies a slightly higher price for the sum of all the products, but kits havethe advantage that all the needed materials are available in the right amounts and the freightand insurance costs are lower. It was suggested that a checklist is compiled, containingcatalogue numbers with all products and their references needed for epidemic response and thatinjection material should be bundled for shipping.

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8. Preparations for the inter-country workshop on epidemicpreparedness and response

In May 2001, the Executive Sub-Group advised strengthening preparedness in countries andagreed to convene a meeting on this issue before the next epidemic season. Donors should beinvited to establish funding mechanisms. In addition to the meeting, there would be need forsupervision and follow-up of the preparedness plans at country level. The preparedness planshould include a financial component. The proposed preparedness plan would be of a technicalnature; therefore political decision-makers should also participate in the preparedness meeting.

There would be a possibility of combining preparedness for epidemic meningococcal disease(EMD) with yellow fever; however, it was felt that EMD preparedness was critical at themoment and could serve as a model for expansion to other diseases at a later stage.

The objectives, expected outcomes and methods of the workshop needed careful consideration. It was remarked that instead of having a preparedness workshop for nine countries, thepreparedness plan could initially be piloted in one or two countries.

9. Financing international response to epidemics

Dr Max Hardiman outlined the following two issues:

1. Financing the international stockpiles.2. Financing the epidemic response.

Points raised

Max Hardiman underlined the need for fundraising to establish a sufficient stockpile. Whatcould be the mechanism for quick access and release of funds? What could be the process forestablishing such mechanism? Possibly ICG could act as facilitator.

A revolving fund instead of event-driven fundraising, which delays response, has beensuggested. WHO could facilitate donor relations instead of the current practice of individualcountries going to national representatives of donors when there is a crisis. It is necessary togo back to the donors to establish a mechanism for quicker release of money.

M. Santamaria answered that funds could be held at manufacturers level for ensuringavailability of vaccine. As for the modalities of financing, some donors might be reluctant tofund a global fund and would prefer to target their support on specific events or countries.Some donors might prefer working through nongovernmental organization, others throughUnited Nations agencies. All these factors need to be considered when appealing for support.The donors want to receive very specific information on contacts and events and areenthusiastic in supporting a number of countries; they might be reluctant for a global fund,which is not country specific.

A. Paganini said that donor awareness should be increased for meningitis, e.g. use W135 asa potential global problem. ICG should not manage finances, but should look for a mechanismfor release of funds from donors in order to decrease time delay.

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It has been noted that funding is a major problem at two levels: international and national. Atthe international level, it is necessary to investigate what global envelope exists for theepidemic response. This is a task for the ICG. At national level, there is a need for anepidemic response committee, including donors and the need for the establishment of a fundduring an epidemic period. In case of an epidemic, donors can be involved in the response.

The donors were initially invited by ICG when an appeal was made to establish stockpiles in1997. Now, the ICG meeting is more technical and donors are less interested. It is necessaryto re-establish links with the donors.

10. Report from manufacturers on the availability and price of vaccine in 2001-2002

P. Laturnus, AVENTIS representative, said there is currently a large demand for 20 millionvaccines. One African country has asked for a huge quantity. For 2002, the production chainwill be adapted to 50 000 000 doses. Currently 17 000 000 doses are available for Africaoutside ICG.

The price of the vaccine remained the same for 8 years. The indirect costs increased in recentyears for biologicals, due to tightening of quality requirements. The ICG Price is still 30-40%below the price for the countries.

The production capacity of the tetravalent vaccine is limited. A-C vaccine production inFrance is the same as for other vaccines for which production has been decreased. Thetetravalent vaccine is produced only in the United States (US); therefore there is no potentialfor an increase and almost 100% of the 2 000 000 doses are for the US market. There is nopossibility to provide a substantial number of doses outside the US.

F. Senatore, CHIRON representative, said his company is interested in meningococcal C andconjugate vaccines, but not in A-C vaccine production now. Therefore AVENTIS has amonopoly on A-C vaccine.

F. Garin, presented her company: Becton Dickinson is the largest supplier of AD syringes anddevices. Last year UNICEF bought 100 000 000 and 800 000 000 for the current year. Emergency buffer stocks can be established if required. The price depends on the volume.

A. Itani, from LAFRAN, said his company produced oily chloramphenicol (OC) since 1990in Germany but it stopped production in the beginning of 2001 in Switzerland. No othermanufacturers have been found in Europe because it is difficult to produce. PharmaMed inMalta, which produces for the International Dispensary Association (IDA) is willing toproduce for LAFRAN, but there is competition with IDA. Presently, there is no solution forproduction. The current stock equals 20 000 vials, already allocated to ICG.

The ICG Executive Sub Group representatives should meet with vaccine and other supplymanufacturers (as needed) to assess possibility and constraints in meeting supply and demandand cost.

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11. ICG mechanism for release of yellow fever vaccine (Annex 8)

(R.Arthur and A. Dabbagh)

When the ICG was established for EMD, other vaccines such as yellow fever (YF) were alsoincluded. The problem with yellow fever is the detection of cases. Now there is a shortageof yellow fever vaccine.

There is quite a lot of debate on the volume of the contingency stocks needed. It should bebased on endemicity. This stock is estimated as 2.9 million doses as per UNICEF availabilityof vaccine until September.

Points raised

ICG could call a yellow fever vaccine subgroup and work with similar mechanisms. Thefollowing questions were discussed: Should yellow fever ICG be joined or separate frommeningitis? How can technical meningitis people decide on yellow fever since the number ofcountries, the manufacturers, and the experts concerned by YF are different to those ofmeningitis?

The participants concluded that ICG could be mandated for yellow fever vaccine release. Theyhave no objection to a current ad hoc Executive Sub-Group on yellow fever/meningitis. Butthere is a need for yellow fever experts to meet and endorse the Executive Sub-Group foryellow fever, which could be held back-to-back with meningitis. As with meningitis,monitoring of the market for yellow fever vaccine must be done. Other countries and regionsshould be involved.

12. Update on WHO/PATH conjugate vaccine project

(L. Jodar)

The conjugate vaccine project started some years ago and has evolved into a partnership withWHO/PATH and received 80 million US$. The major flaw of current polysacharide vaccineis a time-limited immunity induction, not indicated for children of less than 2 years andtherefore not appropriate for inclusion in the Extended Programme of Immunization. A newtool is therefore required with a family of conjugate vaccines capable of inducing long-termprotection and capable of being administered to children under 2 years.

Tasks to be undertaken:- Vaccine manufacturers to produce conjugate vaccine A and/or C. It needs

development, licensing and commercialization.- Field testing for efficacy.- Distribution through routine and age group targeting strategies.

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To achieve these tasks, funding through links with GAVI and donors, and collaborators (CDC,MSF, Institut Pasteur) are needed.

Points raised

The conjugate vaccine project needs to be capable of dealing with W135 if required. ThePATH representative underlined that more information on this emerging serogroup is neededfirst. If it is confirmed that W135 became epidemic, the project will be adjusted.

13. Review of ICG Terms of Reference

The discussion concerned mainly the stocks: necessity to maintain them, level, nature andusage.

A retrospective analysis should be led by WHO secretariat with support of Headquarters,Regional Office and the Executive Sub-Group partners.

14. Conclusions and recommendations of the meeting and closing remarks

• The group participants endorsed the careful application of criteria to release ofmeningococcal vaccine, particularly when there is shortage of this material.

• The group participants endorsed the proposals of the WHO consultation on the emergenceof W135 Meningococcal Disease (Geneva, 17-18 September 2001) concerning the provisionof vaccine as needed, and the support and follow-up of laboratory-based surveillance actionplan (see attached). The Executive Sub-Group to the ICG is requested to actively support theabove.

• Inter-country epidemic preparedness workshop for epidemic meningococcal disease:WHO/AFRO to investigate pilot testing a) 3-4 countries b) single country at higher epidemicrisk. This workshop should not conflict with other related activities. WHO/AFRO to lead.

• Financing:The Executive Sub-Group to the ICG works towards re-establishing 10 million doses ofvaccine prepaid for epidemic response at the corresponding amount of injection material andoily chloramphenicol.It should contact potential partners to explore innovative ways to finance country operationsas needed.The group stresses the importance of establishing national epidemic response budgetary lines.

• Conjugate vaccine:ICG continues to work with partners WHO/PATH (Dr Laforce) bearing in mind involvementof other serogroups (e.g.W135) epidemiology and products development.

• Evaluation of materials used by ICG partners:Information on methodology and the results of the quality of the ICG materials used inepidemic response interventions to be shared among partners and appropriate action taken.

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• Yellow fever: Terms of Reference of the Executive Group to the ICGThe group endorses the temporary arrangement for the Executive Group to provide technicalreview of requests to provide yellow fever vaccine.WHO should convene an expert meeting on epidemic response to YF at which the role of theExecutive Group should be reviewed.

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ANNEX 1

Agenda

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SEVENTH MEETING OF THE INTERNATIONAL COORDINATING GROUPON VACCINE PROVISION FOR EPIDEMIC MENINGITIS CONTROL (ICG)

GENEVA, 19-20 SEPTEMBER 2001

AGENDA

08:30 - 09:00 Registration

09:00 - 09:10 Opening Address

09:10 - 09:30 Welcome, Introduction and Adoption of Agenda

09:30 - 10:30 Report on Epidemic season, ICG activities and vaccine supply 2001

10:30 - 11:00 COFFEE BREAK

11:00 - 12:30 Presentations of country experiences from 2001 epidemics (3 - 4 countries)

12:30 - 14.00 LUNCH

14:00 - 14:30 Report on WHO Consultation on emergence of Serogroup W135meningococcal disease

14:30 - 15:00 Guidance to countries on the management of contingency stocks of vaccine

15:00 - 15:30

15:30 - 16:00

Preparations for the inter-country workshop on epidemic preparedness andresponse

COFFEE BREAK

16:00 - 17:00 Preparations for the inter-country workshop on epidemic preparedness andresponse (cont.)

17:00 Day 1 close

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DAY 2

09:00 - 09:45 Financing international response to epidemics

09:45 - 10:30 Report from manufacturers on the availability and price of vaccine in2001/2002

10:30 - 11:00

11:00 . 12:00

12:00 - 12:30

COFFEE

ICG Mandate for release of Yellow Fever Vaccine

Update on WHO/PATH Conjugate Vaccine Project

12:30 - 14.00 LUNCH

14:00 - 14:30 Review of ICG ToR

14:30 - 15:30 Conclusions and recommendations of the meeting and closing remarks

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ANNEX 2

List of participants

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WORLD HEALTH ORGANIZATION

SEVENTH MEETING OF THE INTERNATIONAL COORDINATING GROUPON VACCINE PROVISION FOR EPIDEMIC MENINGITIS CONTROL (ICG)

GENEVA, SWITZERLAND, 19-20 SEPTEMBER 2001

LIST OF PARTICIPANTS

Saudi Arabia

Dr Amin Mishkas, Director of Infectious Diseases, Ministry of Health, PO Box 26650,Riyadh 11496, Saudi Arabia. Tel: 966 1 4014 262, Fax: 966 1 405 7494, Email:[email protected]

Sudan

Dr Telal El Fadil Mahadi, Ministry of Health, Sudan.

Partners

Dr I. Parent du Chatelet, Association for Preventive Medicine (AMP) a l'InstitutPasteur, 25-28 rue du Dr Roux F-75724 Paris cedex 15, France. Tel: +33 1 53 86 8921,Fax: +33 1 53 86 8939, Email: [email protected]

Dr A. Da Silva, , Association for Preventive Medicine (AMP), a l'Institut Pasteur, 28rue du Dr Roux, F-75724 Paris cedex 15, France. Tel: +33 140613840, Fax: +33140613618, Email: [email protected]

Dr Dominic LeGros, EPICENTRE, 8 Rue Saint Sabin, 75011 Paris, France.Tel: +33 1 40 21 28 15; 22 140 212 848, Fax: +33 1 40 21 28 03,Email: [email protected]

Dr A. Paganini, UNICEF, Senior Adviser Health Programme Division, Three UnitedNations Plaza New York, New York 10017, USA. Tel: +1 212 824 6338, Fax: +1 212824 6484, Email: [email protected]

Dr Birgitte Stadler-Olsen, IFRC (International Federation of Red Cross and RedCrescent), 17 chemin de Crêts, 1211 Geneva 19, Switzerland. Tel: +41 22 730 4222,Fax: +41 22 733 0395, Email: [email protected]

Dr Bernard Morinière, IFRC (International Federation of Red Cross and Red CrescentSocieties), 17 chemin de Crêts, 1211 Geneva 19, Switzerland. Email:[email protected]

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Dr F. Varaine, MSF, Conseiller Technique, Département Techniques Médicale,Medecins sans Frontiers, 8 rue Saint-Sabin, 77755 - Paris, Cedex 11, France. Tel: +33 14021 2935, Fax: +33 1 4806 6868, Email: [email protected]

Marc LaForce, CVP/PATH, Email: [email protected]

WHO Collaborating Centres

Dr Dominique Caugant, WHO Collaborating Centre for Reference & Research onMeningococci, National Institute of Public Health, PO Box 4404 Nydalen N-0403Oslo, Norway. Tel: +47 22 0423 11, Fax: +47 22 0425 18, Email:[email protected]

Dr Pierre Nicolas, WHO Collaborating Centre, BP46, 13998 Marseille Armees,France. Tel: +33 4 91 15 0115, Fax: +33 4 91 59 4477, Email:[email protected]

Dr N. Rosenstein, Centers for Disease Control and Prevention (CDC), Meningitisand Special Pathogens Branch, Division of Bacterial and Mycotic Diseases, 1600Clifton Road N.E. - MS C-09 Atlanta, GA 30333, USA. Tel: +1 404 639 3158, Fax:+1 404 639 3059, Email: [email protected]

Manufacturers of vaccine

Dr P. Laturnus, Manager, International Tenders/ Responsible AdjudicationsInternationales, Pasteur Mérieux Connaught International, 2 Avenue Pont Pasteur, F-69367 Lyon, France. Tel: +33 4 37 37 70 75, Fax: +33 4 37 37 78 30, Email: [email protected]

Dr Franceso Senatore, Chiron Vaccines, Via Fiorentina 1, 53100 Sienna, Italy. Tel: +39 5 77 24 32 26, Fax: +39 05 77 24 30 07, E-mail: [email protected]

Manufacturers of auto-disable injection material

Mr E. Kateraas, Becton Dickinson, BD Medical Systems – immunization, 1 BectonDrive, Franklin Lakes, N.J. 07417 – 1880, USA. Tel: +1 201 847 5175, Fax: +1201.847. 4845.

Dr Fiona Garin, Becton Dickinson, Complejo los Libertadores, Carretora General SanMartin, KM 16,500 Sitio 33, Colina, Santiago de Chile, Chile. Tel: +56 2 460 0380,Fax: +56 2 460 0306, Email: [email protected]

Mr J. Schoenfeld, Chairman, UNIVEC, 22 Dubon Court, Farmingdale, New York,11735, USA. Tel: +1 631 777 20 00, Fax: +1 631 777 2786, Email: [email protected]

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Dr A. Gold, 22 Dubon Court, Farmingdale, New York, 11735, USA. Tel: +1 631 77720 00, Fax: +1 631 777 2786, Email: [email protected]

Manufacturers of oily chloramphenicol

Dr A.N. Itani, Commercial Director, S.N. Laboratories Lafran, 1 Route de Stains, F-94387 Bonneuil/Marne Cedex, Tel: +33 1 43 39 50 00, Fax: +33 1 43 39 78 00, Email: [email protected]

Mr G. Bakker, IDA Foundation, P.O. Box 37098, NL-1030 AB Amsterdam,Netherlands. Tel: +31 204033 051, Fax: +31 204031 854, Email: [email protected];

WHO SECRETARIAT

WHO/HQ

Mr Paul Acriviadis, Informatics and Infrastructure Services (PRS). Tel: +41 22 7912187, Email: [email protected]

Dr Ray Arthur, Epidemic Disease Control (EDC). Tel: +41 22 791 2658, Email:[email protected]

Dr Teresa Aguado, Health Technology & Pharmaceuticals (HTP). Tel: +41 22 7912644, Email: [email protected]

Mr Alejandro Costa, Health Technology & Pharmaceuticals (HTP). Tel: +41 22791 4965, Email: [email protected]

Ms S. Chungong, Integrated Surveillance & Response (ISR). Tel: +41 22 7912377, Email: [email protected]

Dr Alya Dabbagh, Health Technology & Pharmaceuticals (HTP). Tel: +41 22 7914693, Email: [email protected]

Mr Steve Edgerton, Integrated Surveillance & Response (ISR). Tel: +41 22 7912586, Fax: 41 22 791 4198, Email: [email protected]

Dr Abdel El Abassi, External Relations and Governing Bodies (EGB). Tel: +41 22791 3719, Email: [email protected]

Dr Max Hardiman, Integrated Surveillance & Response (ISR). Tel: +41 22 7912572, Fax: 41 22 791 4198, Email: [email protected]

Dr David Heymann, Executive Director, Communicable Diseases. Tel: +41 22 7912212, Email: [email protected]

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:22 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

Dr Luis Jodar, Health Technology & Pharmaceuticals (HTP). Tel: +41 22 7913744, Email: [email protected]

Dr Lianne Kuppens, Sustainable Developments and Health Environments (SDE). Tel: +41 22 791 2516, Email: [email protected]

Dr Xavier Leus, External Relations and Governing Bodies (EGB). Tel: +41 22 7912851, Email: [email protected]

Dr Julie Milstien, Health Technology & Pharmaceuticals (HTP). Tel: +41 22 7913564, Email: [email protected]

Dr Chris Nelson, Health Technology & Pharmaceuticals (HTP). Tel: +41 22 7913615, Email: [email protected]

Dr Jonathan Quick, Health Technology and Pharmaceuticals (HTP). Tel: +41 22791 4443, Email: [email protected]

Dr Guénaël Rodier, Director, Department of Communicable Disease Surveillanceand Response (CSR). Tel: +41 22 791 2109, Fax: +41 22 791 4198, Email:[email protected]

Dr Mike Ryan, Integrated Surveillance & Response (ISR). Tel: +41 22 791 3691, Email: [email protected]

Dr Maria Santamaria, Integrated Surveillance & Response (ISR). Tel: +41 22 7912725, Email: [email protected]

Dr Jay Wenger, Health Technology & Pharmaceuticals (HTP). Tel: +41 22 7914511, Email: [email protected]

WHO/CSR/LYON

Mr Augusto Pinto, 58 avenue Debourg, 69007 Lyon, France. Tel: +33 4 7271 6473, Email: [email protected]

WHO/AFRO

Dr Yada. Email: [email protected]

WHO/EMRO

Dr Nadia Teleb, WHO Post Office, Abdul Razzak Al Sanhouri Street, Nasr City, Cairo11 371 Egypt. Tel: +202 670 2535, Fax: +202 670 2492, Email: [email protected]

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 23

ANNEX 3

Report from the Secretariat on ICG activities2000/2001

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International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:24 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 25

Report from the Secretariat onICG activities 2000/2001

7th Meeting of the International CoordinatingGroup on Vaccine Provision for EpidemicMeningitis control

Levels of Levels of meningococcal meningococcal disease in Africadisease in Africa2000/20012000/2001

bb So far reported: 52,000 cases, 5,000 deathsSo far reported: 52,000 cases, 5,000 deaths(CFR= 9.6)(CFR= 9.6)

bb 11 countries of the meningitis belt11 countries of the meningitis beltexperienced epidemicsexperienced epidemics•• 7 reached cumulative national incidence of7 reached cumulative national incidence of

100/100 000100/100 000

•• 4 more localised epidemics4 more localised epidemics

ICG activitiesICG activities

bb ICG sent out over 8 million doses ofICG sent out over 8 million doses ofvaccine to 5 countriesvaccine to 5 countries

CAM 280000ETH 3665000BUR 2374000CHA 1225000NIG 600000Total 8144000

ICG activitiesICG activities

bb however 5 countries were supplied throughhowever 5 countries were supplied through19 separate releases19 separate releases

bb shortage of vaccine - careful application ofshortage of vaccine - careful application ofthe criteria and policy of initial release withthe criteria and policy of initial release withfollow upfollow up

ICG issues - limited vaccineICG issues - limited vaccine

bb Reasons for vaccine shortage:Reasons for vaccine shortage:•• Reduced global productionReduced global production•• large quantity purchased prior to the epidemiclarge quantity purchased prior to the epidemic

needneed

bb Response - cautious approach to the releaseResponse - cautious approach to the releaseof ICG stocksof ICG stocks

bb Decision to increase the size of ICG stocksDecision to increase the size of ICG stocksfor 2002for 2002

bb How to predict such situations in the future?How to predict such situations in the future?

ICG issues - low emergencyICG issues - low emergencystocksstocks

bb ICG is still in negotiation over ICGICG is still in negotiation over ICGprice/reconstitution of the ICG stock - priceprice/reconstitution of the ICG stock - priceseems certain to increaseseems certain to increase

bb At a time of restricted vaccine availabilityAt a time of restricted vaccine availabilityICG is unable to reconstitute its stocks toICG is unable to reconstitute its stocks tolevel of 7 million but has identified a needlevel of 7 million but has identified a needto increase to 10 million.to increase to 10 million.

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:26 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

ICG Issues - coverageICG Issues - coverage

bb Why did the ICG not release vaccine toWhy did the ICG not release vaccine toBenin, Central African Republic or Togo?Benin, Central African Republic or Togo?•• Requests were never made that fulfilled theRequests were never made that fulfilled the

criteria - lack of criteria - lack of epi epi data, vaccination plan and/data, vaccination plan and/or commitment to recover costsor commitment to recover costs

ICG issuesICG issues

bb Emergence of W135 diseaseEmergence of W135 disease•• ICG is not directly concerned with vaccineICG is not directly concerned with vaccine

provision for travellers to the provision for travellers to the HajHaj•• But if an epidemic occurs that is shown to beBut if an epidemic occurs that is shown to be

largely due to largely due to serogroup serogroup W135, ICG will haveW135, ICG will haveto turn its attention to supplies of to turn its attention to supplies of quadrivalentquadrivalentvaccinevaccine

ConcernsConcerns

bb ICG stocks are low and current resourcesICG stocks are low and current resourceswill not permit replenishment to the agreedwill not permit replenishment to the agreedlevelslevels

bb Implementation of preparedness workshopImplementation of preparedness workshopfor national epidemic response teamsfor national epidemic response teams

bb Delays in response due to resourceDelays in response due to resourcemobilisationmobilisation

SummarySummary

bb There has been some success:There has been some success:•• 8 million doses of vaccine sent out to countries8 million doses of vaccine sent out to countries

with epidemicswith epidemics•• rational distribution of the limited vaccinerational distribution of the limited vaccine

stocksstocks•• rapid communication and consultation processrapid communication and consultation process

SSummaryummary

bb There are some challenges:There are some challenges:•• to increase the size of the emergency stocksto increase the size of the emergency stocks•• how to respond to resource implications of an increasehow to respond to resource implications of an increase

in vaccine pricein vaccine price•• need for more extensive laboratory surveillance of theneed for more extensive laboratory surveillance of the

serogroupsserogroups causing epidemic disease causing epidemic disease•• to build national capacity in epidemic preparedness andto build national capacity in epidemic preparedness and

responseresponse•• to identify rapid financing mechanisms for epidemicto identify rapid financing mechanisms for epidemic

responseresponse•• inclusion of yellow fever vaccine in the mechanisminclusion of yellow fever vaccine in the mechanism

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 27

ANNEX 4

Preparedness and response to the meningitisepidemic

in West Africa

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International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 29

Préparation et Réponse auxPréparation et Réponse auxEpidémies de méningite enEpidémies de méningite en

Afrique de l’OuestAfrique de l’Ouest

Leçons à tirer des récentesépidémies de méningite

WHOAFRO- CSR/EPR

Plan de la présentationPlan de la présentation

lLa méningite en Afrique et dans les pays de laceinture

lComment ces épidémies ont été gérées auNiger et au Bénin

lLeçons tirées

WHOAFRO- CSR/EPR

 

Cas Cas et det déécèscès de M de Mééningite dansningite dansla la Ceinture AfricaineCeinture Africaine

l50 896 casl4 873 décès

(De la 1ère à la 35ème semaine 2001)

BeninNiger

Pays affectés 2000-2001

Comment ces épidémies ontComment ces épidémies ontelles été gérées au Niger et auelles été gérées au Niger et au

Bénin?Bénin?lLa préparation à l’épidémie:

• Comité national de gestion des épidémies s’ilexiste ne tient pas de réunions régulières

• Pas de comité au niveau région et district• Plan national de lutte contre les MPE existe

mais sans aucun financement• Pas de fonds pour la lutte contre les épidémies• EIR existe au niveau national

WHOAFRO- CSR/EPR

La préparation à l’épidémie (suite):La préparation à l’épidémie (suite):

l Existence de stock de vaccin etchloramphénicol huileux au niveau national,et prépositionnement au niveau région

lAssez bonne notification des données auxniveaux supérieurs

lAnalyse des données non faite au niveaudistrict,

l Les nouveaux seuils d’alerte et épidémiquesconnus au niveau central, mais non utilisés;non connus des autres niveaux

WHOAFRO- CSR/EPR

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:30 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

La réponse à l’épidémie (suite)La réponse à l’épidémie (suite)

l Il y a eu des ruptures de stocks de vaccinpendant l’épidémie dans les pays et sur lemarché international (stock ICG).

l La prise en charge des cas a été bonne dansles 2 pays d’où cette létalité <10% mais ellen’était pas gratuite..

WHOAFRO- CSR/EPR

Weekly Attack Rates of SuspectedWeekly Attack Rates of SuspectedMeningitis in Meningitis in TanguiTanguiéétata District DistrictBenin, January 1 – April 6, 2001Benin, January 1 – April 6, 2001

0

20

40

60

80

100

120

05-jan

v12-

janv19

-janv

26-jan

v

02-mars

09-mars

16-mars

23-mars

30-mars

06-av

r

Week of 2001

Cas

es /

100,

000

popu

lati

on

VaccinationCampaign

Tanguiéta population = 52,233

Action Threshold Crossed

La réponse à l’épidémie:La réponse à l’épidémie:

l Retard dans la détection et retard dans laréponse, allant jusqu’à 8 semaines aprèsl’atteinte du seuil.

l Identification de la souche N. meningitidisW135 au Niger

l L’exécution des campagnes de vaccinationde masse est inefficiente car trop lente etelles ne touchent pas tous les villages d’undistrict. Le personnel de santé courait aprèsl’épidémie

WHOAFRO- CSR/EPR

Appui deAppui de l’OMS l’OMS/AFRO aux/AFRO auxpays en épidémiepays en épidémie

l Soutien technique pour la détection rapide par l’envoid’un tableau d’analyse automatique des donnéeshebdomadaires par district ou aire de santé

l Soutien technique pour la riposte et l’évaluation (Bénin,Burkina Faso, Ethiopie, Angola, Niger, Ghana)

l Appui financier pour investigation, achat de vaccin,seringues et chloramphénicol (tous les pays en épidémiespar le bureau pays et bureau régional)

l Appui laboratoire par envoi de Kit latex

Leçons tiréesLeçons tirées• Former le personnel de santé niveau district sur les seuils

• Assurer la supervision du personnel avant, pendant, après les épidémies au niveau national

• Le problème de la disponibilité et de l’approvisionnementen vaccin Antiméningococcique demeurent, le stock ICG amontré ses limites durant la saison 2000-2001

• Encourager les fabricants à produire de plus grandes quantitésde vaccin

• L’OMS/AFRO devra avoir un stock d’urgence en VAM eten VAA basé auprès de l’équipe ICP/Abidjan

•Conduire avec les pays des recherches sur le W135 dans lespays en épidémies (pays, OMS, CDC, MSF …)

• Assouplir les conditions de délivrance du vaccin à partir du stock ICG

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 31

ANNEX 5

The 2001 epidemic meningitis season and theICG

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:32 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 33

7th ICG/MSF 2001

2001 epidemic meningitisseason and the ICG

MSF

7th ICG/MSF 2001

Anti-meningococcal A+Cvaccines/country

• Ethiopia 1,290,000• Chad 1,225,000• Niger 600,000• Burkina Faso 474,000• Cameroon 280,000• Angola 35,000• Total 3,904,000

7th ICG/MSF 2001

Main issues1. Availability of vaccines

• No vaccines available on the market (from20th February)

• Lack of transparence• Cost: 300% increase market price in June

7th ICG/MSF 2001

Main issues2. Technical aspects

• Target populations: no vaccination before 2 years of age

• W135 : identified in Niger, Centrafrican Rep .and Burkina

7th ICG/MSF 2001

Main issues2. Technical aspects

• Aberrant lab. results• New thresholds• Quality of injection material

– Safety boxes– AD syringes

7th ICG/MSF 2001

Main issues3. ICG functionning

• Essential tool to prevent shortages• Rapid answers: 24 hours• Narrow escape!

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:34 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

7th ICG/MSF 2001

Next year

• Increase the ICG stockpile up to 10 million• Negociate with manufacturers (On-going

talks…)

• W135• The conjugate vaccine?

7th ICG/MSF 2001

Yellow fever

• Mechanism?• Scientific group:

– estimation of the needs– contra-indications, adverse effects…– diagnostic, alert,

• Meeting with manufacturers• Appeal?

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 35

ANNEX 6

Presentation of country experience from 2001epidemics

Meningococcal meningitis in Sudan

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:36 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 37

Meningococcal Meningococcal Meningitis inMeningitis inSudanSudan

lIntroductionlCSM Epidemics in SudanlControl Measures:

–Diagnosis and Treatment–Surveillance System–Vaccination–Health Education

lConstrains

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

Introduction:l Sudan is a vast country, about 2.5 million square

km in area

l The population is estimated about 31 million

l Sudan is divided into 26 states, each state is dividedto 4-5 provinces, and each province to 5-6 localities

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

Introduction:

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

CSM epidemics in Sudanl The first worst epidemic was in 1950-1951 when

72.162 cases were reported

l The 1988-89 was the second worst epidemic with atotal number of 38.805 cases of whom 2.770 died

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

l The last epidemic occurred in 1999, a total of33.216 cases and 2.386 deaths

l This year there is no epidemic, a total numberof cases were 5.659 (Jan. To July) with 440deaths (CFR= 7.8%)

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

Weekly Reported Meningitis Cases In Sudan from 1999 to 2001

0200400600800

10001200140016001800200022002400260028003000320034003600380040004200

Weeks

Cases 2001 19 28 34 41 39 16 69 13 23 29 53 112 97 103 131 106 121 92 126 115

Cases2000 44 70 71 76 119 136 285 274 171 328 377 406 315 290 285 275 150 101 99 69

Cases 1999 45 45 62 78 182 346 427 753 1264 1838 1842 2086 2518 3565 3735 3945 3905 2984 1624 831

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:38 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

Weekly Reported Meningitis Cases in the year 2001 Compared with the same periond 2000

0

50

100

150

200

250

300

350

400

450

w e e k s

Cases 2001 19 28 34 41 39 16 69 13 23 29 53 112 97 103 131 106 121 92 126 115 121 132 63 38 44

Cases2000 44 70 71 76 119 136 285 274 171 328 377 406 315 290 285 275 150 101 99 69 46 18 28 19 15

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

Control Measuresl There is an Emergency Committee at Federal and

State Ministries of Health, usually activated inDecember

l There is a National Task force at the Federal level,

– It includes Epidemiology Dep. , The Central MedicalSupplies, Humanitarian Aid Commission, WHO, UNICEF,International and National NGOs

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

Diagnosis and Treatmentl There is a protocol for diagnosis and treatment

of cases

l Cases treated in general words in hospitals, butalso temporally treatment units were erected inremote areas

l The laboratory services are not adequate andconfirmation of cases by lab. is minimum

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

Surveillance Systeml It is part of the integrated disease surveillance

l Meningitis is one of (Group B) diseases for weeklynotification

l The notification of cases changes to be immediate(Daily) from Jan. to July every year

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

l Data analysis and use carries out by State authoritiesand in the Central Epidemiological Department

l There is specific forms for reporting and caseinvestigation

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

lAn In depth review of the integrated diseasesurveillance system was conducted in last April, itcomes with a valuable recommendations

l Accordingly– Revision and Updating of National guidelines for

communicable disease surveillance

– A plan to strengthen the surveillance system wasdeveloped

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 39

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

Vaccinationl Group (A&C) vaccine used to vaccinate areas of

cases

l In 1999 around 10.5 million had been vaccinated,one million in 2000 and 1.6 million in 2001.

l This includes pilgrims, school children (only inKhartoum State), areas of displaced people andareas of cases

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

l There is a plan to vaccinate third of school childrenyearly (around 2.8 million) and displaced people

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

Health Education

l Health education using National and StatesTVs, Radio, Newspapers and health educationsessions in schools and houses is a continuousactivities during meningitis season

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

Constrainsl Poor communication facilities between lower levels

and State level that affect timely notification

l Minimum budget for CDS and EPR

l Minimum budget for regular vaccination

l Weak laboratory services to support epidemiccontainment

MeningococcalMeningococcal Meningitis in Meningitis inSudanSudan

Thank You

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:40 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 41

ANNEX 7

Guidance to countries on the management ofcontingency stocks of vaccine

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:42 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 43

National ContingencyStocks for the Control of

Meningitis Outbreaks

Draft Guidelines for Estimatingthe Needs, the Procurement,

Management and Use

Outline of Presentation

z Background & Statement of the Problemz Document Development Processz Summary of Contentsz Questions for Discussionz Next Steps

WHO Meningitis OutbreakControl Strategy

z Early Detection of Outbreaksz Timely Mass Emergency Immunization

Campaignsz Adequate Case Management

Implications for Supplies

z => Need for Timely Delivery of Supplies isEssential

z Supplies Require following Characteristics:y Most Cost-Effective Suppliesy Right Quantitiesy High-Quality

1996: Large Outbreak inthe African Meningitis Belt

z >> in Mali, Burkina Faso, Niger, Nigeria &Chad

z Result: +- 190’000 Cases

1996: Large Outbreak inthe African Meningitis Belt

z Result: Exhaustion of the GlobalVaccine Stock

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:44 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

Ouagadougou Meeting (Nov.1996)

z 16 African Countries:y Developed National Plans of Action for the

Control of Meningitis Outbreaks

z Satellite Expert Meeting Recommended on:x Establishment of Contingency Stocksx Exchange between National Stocks and Circulation of

Vaccinesx Management of Vaccines and Drugs during

Epidemics

Since 1996

z January 1997: ICG Establishedy Goal: Ensure Rational Use of Available

Vaccine

z Many Countries have Established NationalContingency Stocks

z But Concerns on:y Estimated Needsy Management & Use of these Stocks

Development of DraftGuidance Document

z => by WHO HQ with Input fromStakeholders

z Basis of this Document:y 1996 Ouagadougou Expert Meeting Report

z Questionnaire to Meningitis Belt Countriesz Comments and Feedback received from:

y 12 Countries, ROs & Subregional Epid. Blocks

Draft Guidance Document

z With Input from:y WHO HQ (EDM, V&B)y ROs and Subregional Epid. Blocksy ICG Executive Subgroup Members

z Differences Highlighted between 1996Ouagadougou Report & Country Situation

z => Discussion Document

Summary of Contents

z Stock Definitionsz Formula for Estimating Needsz Procurement:

y Funding,y Pooling,y Order Period,y Quality Assurance

Summary of Contents

z Management:y Standard Procedures,y Stocking Level,y Release of Supplies from Stocks,y Standard Kits,y Stocks Close to Expiry Date

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 45

Meningococcal A-C VaccineStocks and their Use

Global VaccineStock

Global Contingency Stock

Routine Immunization

National Contingency Stocks

Emergency Immunization

National Routine Stock

Composition of NationalContingency Stocks

z Meningococcal A-C Vaccinez Oily Chloramphenicol IMz 0.5 ml Autodisable Syringes with Mounted

Needle for Vaccinationz Disposal/Incineration Boxesz Additional Supplies:

y Syringes & Needles for Vaccine Reconstitutionand Chloramphenicol Administration

Formula for Estimating theNeeds

z Formula =Approximative Tool

z => Risk of Over- orUnderestimation

z However: DifferentFormulas Used byCountries

E ≠ mc2 ??

Formula for Estimating theNeeds

z Ouagadougou 1996 Formula vs FormulasUsed by Countries:y Other Factors & Weights

z Review of Formula => RetrospectiveCountry Analysis of:y Delays in Delivery of Supplies from Abroady Population which should have been

Vaccinated in Due Time in Recent Outbreaks

Procurement of NationalContingency Stock Supplies

z Pooling of the Orders through 1Intermediary Purchaser

IntermediaryPurchaser Manufacturer

+

Procurement of NationalContingency Stock Supplies

z Pooling of the Orders through 1Intermediary Purchaser

z Pro’s:y Less Orders per Product for Manufacturer;y Preferential Prices?

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:46 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

Procurement of NationalContingency Stock Supplies

z Pooling of the Orders through 1Intermediary Purchaser

z Con’s:y Administration for Intermediary Procurery Less Freedom for Countries for Procuring

Suppliesy Financial Arrangements per Country in the

Pool System

Exchange between National Stocksand Circulation of Vaccines

z 1996 Ouagadougou Report:y Constitution of Contingency Stocks at

National Level => Over -& Underestimationy Countries Decided: Exchange & Circulation of

Vaccines and Drugs in Case of Urgent Needby Country

y => Need for Stock InformationCentralisation, Stock Exchange, Financial &Stock Replenishment Procedures

Exchange between National Stocksand Circulation of Vaccines

z However:y How can Quality of Exchanged or Circulated

Supplies be Guaranteed?

z => Not Recommendable by WHO

Stocking Level of ProcuredSupplies

z Options:y Manufacturersy Regional & Subregionaly Nationaly Subnational

Stocking Level of ProcuredSupplies

z Issues to Consider:y Time Delay for Deliveryy Storage Conditions & Facilitiesy Ownershipy How to Avoid Expiry & Ensure Rational Use?

Stocking Level of ProcuredSupplies

z Manufacturers:y Pro’s:

x Avoids Expiry of Unused Stocksx Storage in Ideal Conditions

y Con’s:x No Physical Ownership of Procured Stocks

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 47

Stocking Level of Supplies

z Regional and Subregional:y Con’s:

x No (Sub-)regional Storage Facility Availablex Complex and Timely Intercountry Transport in the

Regionx No Physical Ownership

Stocking Level of Supplies

z National:y Pro’s:

x Storage Facilities in Placex Centralized Stock Managementx Ownership

z Subnational:y Con’s: Potential for Dispersion of Supplies

Urgently Needed Elsewhere

Standard TreatmentSupply Kits

z 1996 Ouaga Report Recommended:z Establishment of Standard Kits of

Adequate Quantities of:y Vaccines,y Drugs,y Needles andy Syringes for a Given Population

Standard TreatmentSupply Kits

z Pro’s:y Rapid & Grouped Availability of Specific

Materials when Demands might Be Excessivey Simpler Logisticsy Increased Security as Kits are Sealedy Kit Products are Usually Offered Free of

Charge

Discussion

z Formula: Adaptation Needed? How?z Pooling of Procurement: Desirable?

z Stocking Level of Supplies: Where?z Standard Kits: Desirable?

Next Steps

z Further Input and Review of Document:y Virtual Working Group?y Meeting?

z With Who?

z Process?z ...

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:48 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 49

ANNEX 8

ICG mechanism for yellow fever vaccinerelease

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:50 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control: Report of the Seventh Meeting. Geneva, Switzerland, 18-19 September 2001 51

ICG Mechanism for YellowFever Vaccine Release

ICG Meeting 19-20 September 2001

Geneva

Global Shortage of Yellow FeverVaccine

Increase in Demand:vFor outbreak control - unpredictablev Re-emergence of YF with the risk of urban outbreaks (e.g.

Guinea- 2.3 m doses)v Improved Surveillance (Liberia)

vFor disease prevention- predictablevGAVI support for routine- 75% of countries at-risk eligible

Decrease in Supply:vLoss of manufacturer interestv Low or unpredictable demandv Competition with higher return vaccinesv Fewer suppliers since 1995

Increase in Demand:vFor outbreak control - unpredictablev Re-emergence of YF with the risk of urban outbreaks (e.g.

Guinea- 2.3 m doses)vImproved Surveillance (Liberia)

vFor disease prevention- predictablevGAVI support for routine- 75% of countries at-risk eligible

Decrease in Supply:vLoss of manufacturer interestv Low or unpredictable demandv Competition with higher return vaccinesvFewer suppliers since 1995

Supplier Current production(Md)

Aventis France 20.0

IP Dakar Senegal 12.0

Total 32.0Md = Million doses

AVI meeting 22 March

Total current production Pre-qualified suppliers

0

10

20

30

40

50

2001 2002 2003

Nunm

ber

of d

oses

in M

illio

ns

Demand-AmericaDemand- AfricaCurrent and Planned Global Production

Estimated Vaccine Demand for Estimated Vaccine Demand for RoutineRoutineImmunization and Pre-qualified SupplyImmunization and Pre-qualified Supply

Reported Cases of Yellow Fever,1976-2000

Reported Cases of Yellow Fever,1976-2000

0

1000

2000

3000

4000

5000

6000

Nu

mb

er o

f cas

es

76 78 80 82 84 86 88 90 92 94 96 98 2000

Americas Africa

COUNTRY

ICG Mechanism

1. Evidence of a confirmed case2. Immunisation strategy/plan3. Evidence of a co-ordinatingbody

UNICEFSupply Division

WHO/CSR, Geneva

ICG Executive Sub-group

Consultation Approval

Aventis

Yellow Fever vaccinereleased

YELLOW FEVEROUTBREAK

WHO/CDS/CSR/GAR/2002.2

International Coordinating Group (ICG) on Vaccine Provision for Epidemic Meningitis Control:52 Report of the Seventh Meeting: Geneva, Switzerland, 18-19 September 2001

Experience so far..Country Date of Request

(2001)AmountRequested

Outcome Vaccineordered

Remarks

CIV May 25 200,000 ApprovedJune 11(2 wk)

August(6 wk)

Funded byECHO

Liberia 13 June 350,000 Notapproved

20 July(112,000doses)

Funded byWHO,from IPDakar

Liberia Aug 30 100,000 Approved Sep 4

September6?

Funded myMSF, IPDakar

CIV Sep 4 3 million ApprovedSep 6

Sep. 11-142 million

Funded byseveralpartners

ISSUES

• Delayed response from members.• Lack of funds.• Fund release difficulties- UNICEF funding

mechanisms.• Entire stock used within 10 weeks of its

formation.

Way Forward...

• Continue with the ICG mandate for YFvaccine release?

• Size of stock pile?• Speed up process -

- Improve operational aspects- Secure funding