TRACKING SHEET Explanatory note - WHO · TRACKING SHEET Explanatory note The purpose of the tracking sheet is to monitor the work of the WHO Secretariat on the implementation of SAGE

TRACKING SHEET

Explanatory note

The purpose of the tracking sheet is to monitor the work of the WHO Secretariat on the implementation of SAGE recommendations. The sheet consists of a consolidated set of recommendations from previous SAGE meetings that

require further action by the Secretariat. The monitoring of progress is conducted by the WHO Department of Immunization, Vaccines and Biologicals. The Department uses the tracking sheet, located online, as a working tool and

updates it regularly. Items completed some time ago have been archived and do not show in this document but are available on request.

Recommendations intended for countries are not included in the tracking sheet but are reflected in WHO vaccine position papers. The implementation of such recommendations is monitored through the UNICEF/WHO Joint Reporting Form.

SAGE TRACKING RECORD OF RECOMMENDATIONS AND ACTION POINTSTopic Recommendations/Action item Category Meeting Date Status Comments and Follow up

General SAGE noted that there have been regional efforts toimprove routine immunization coverage andsuggested that the success observed inAfghanistan and northern Sudan should beanalysed more systematically to inform efforts toimprove vaccination coverage in other countries andregions.

Action Apr 2009 Ongoing In collaboration with CDC Atlanta, EMR has implemented in Sudan in 2007 an evaluationexercise (a peer review) to document Sudan's experience implementing the fivecomponents of the Reaching Every District (RED) strategy, notably in terms ofsuccesses, challenges, and lessons learned. A specific tool designed to this purposewas used. 70 localities of Northern Sudan, excluding the Darfur localities, due to ongoingconflict, were evaluated. The evaluation showed that overall, RED is well established inSudan and has certainly contributed to the increased vaccination coverage observedsince the 2003 implementation, helping the country maintain its course to meet theGlobal immunization Vision and Strategy (GIVS) goals for DPT3. However, additionaleffort will be needed to increase measles coverage to the same level. The exercise inSudan was presented at the 2007 national EPI managers inter-country meeting in Tunis.EPI Sudan has successfully used the evaluation exercise (peer review)recommendations, with technical and financial support from WHO EMRO, which hasallowed the country to reach for the first time in their history routine immunizationcoverage higher than 90% (in 2008, the reported DPT3 coverage was 93% and theMCV1 coverage was 80%). This achievement was sustained in 2009. During the 2010 annual meeting of EMR national EPI managers (Cairo, 4-7 July 2010), afull session was reserved to improving access to routine immunization: following countryexperiences were shared and discussed: 1) Immunization month in Pakistan (held end2009); 2) Community (Ministry of Interior) involvement in Lebanon; 3) Integrated childhealth intervention in Yemen; 4) Child Health days in Somalia. All these initiativesresulted in substantial improvement in terms of reported immunization coverage figures.

General SAGE recommended that new approaches, such asperiodic intensification of routine immunization, becarefully evaluated prospectively to determine theireffectiveness and cost-effectiveness.

Action Apr 2009 Ongoing Ongoing work with Immunization Basics to document country experiences hascontinued. Mission to observe Zimbabwe Child Health Days which included routinecatch up doses was undertaken in June 2009. Final report available (17 June 2010).Mission to Macedonia was undertaken in April/May 2010 to document the EuropeanImmunization Week (EIW) (draft report being prepared). Identification of a third countryfor case-study is underway.

General SAGE requested that WHO assesses how theintroduction of new vaccines has helped strengthenimmunization and health systems.

Action Nov 2008 Ongoing See comment on other recommendation re: New vaccine introduction.

General New vaccine introduction - SAGE stressedimportance for WHO to look at achievements incoverage, also decision-making processes andprogrammatic issues with vaccine introduction.

Action Nov 2007 Ongoing Pneumococcal vaccine and rotavirus vaccine coverage is being included in the JointReporting Form (JRF). A tracking sheet is being maintained on countries with interest,decisions, firm dates for introduction or have introduced the vaccine in their nationalimmunization programmes. Analytic work on the vaccine management issues is currentlybeing undertaken and tools being developed to assist countries with vaccinemanagement and logistics associated with introduction of these new vaccines. Detailedplanning has been conducted with 3 regions in order to ensure proper management ofinjection safety and waste disposal when pre-filled syringes will eventually be used forearly introducing countries with pneumococcal vaccine. Support is also being providedto national technical advisory committees on evidence based decision-making throughprovision of data, guidance materials to evaluate and interpret data and on generalcapacity strengthening for decision-making. All of these form part of the new vaccineintroduction plan of action, a document developed jointly with global and regionalpartners in immunization. WHO also assists countries in conducting post-introductionevaluation 6-12 months after introduction of a new vaccine in the programme, to assessthe programmatic impact of the introduction. These reviews also serve to highlightgeneral deficiencies in programme implementation.

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Topic Recommendations/Action item Category Meeting Date Status Comments and Follow up

General SAGE recommended that ways to improve curriculafor medical personnel should be explored.

Action Nov 2008 Ongoing The African region is working with academia to develop a pre-service curricula fornursing and medical staff. Annual courses for medical and nursing staff take place incollaboration with Network for education and support in immunization (NESI).

General SAGE requested more detailed analysis of childrenwho have not been reached with immunizationservices.

Action Nov 2007 Ongoing The characteristics of children who were not reached by immunization services havebeen identified by country and by determinants. A presentation on the outcomes of thisanalysis was made to the October 2009 SAGE meeting. The analyses of thedeterminants, country level fact sheets and the reviews of literature have been sharedwith WHO regional offices, countries and UNICEF. Further work is continuing on (i) morein-depth analysis of the Demographic & Health Service (DHS) and Multi-indicator clustersurvey (MICS) data using multi-variate analysis, (ii) drafting publications for peerreviewed journals on the literature reviews and analyses of DHS and MICS data and (iii)further work on refining criteria to identify weak areas in triangulation with other availabledata and operational guidelines on improving coverage. In addition, work at the field level is ongoing in Armenia and a proposal to undertake ademonstration in Nigeria is awaiting country clearance so that issues inoperationalization can be detected first-hand and their solutions determined. This willhelp in drafting practical approaches to reduce the numbers of unimmunized children.

General - EMRO SAGE will welcome a report on the outcomes of theEMRO vaccination week.

Action Apr 2010 Completed The evaluation report on the outcomes of the EMRO vaccination week (24-30 April 2010)was shared with SAGE on 11 October.

General - IVBStrategic Plan

SAGE recommended that the IVB strategic planhighlight the importance of completing polioeradication.

Action Apr 2010 Completed

Categorization ofvaccine-preventablediseases

WHO & GAVI work together so that WHOCategorization process and GAVI vaccineinvestment strategy complement each other.

Action Apr 2008 Completed Joint work has been completed, both organizations have derived adaptations for theirown purposes.


A 2nd stage of the vaccine-preventablecategorization exercise should be taken to look atlonger-term priorities for development of vaccines,taking a 10 to 20-year time horizon.

Action Nov 2007 Ongoing This second stage of the categorization exercise has been put on hold during 2009 dueto shortage of resources. In mid-2010 collaboration has been initiated with the UK-HPAand methodology is currently (Oct 2010) being developed. First results should beavailable for information by SAGE at its spring meeting in 2011.


SAGE requested exercise to be completed in atimely manner. Final disease prioritization results tobe submitted for peer-review and provided to SAGEmembers for their review.

Action Apr 2008 Ongoing Status pending completion of global and regional level exercises. A paper summarizingthe global categorization results has been drafted and has been submitted to apeer-review journal. It is currently being peer reviewed and a copy will be made availablefor SAGE.

Cholera Prepare a business case for oral cholera vaccinesto provide critical information for donors regardingthe potential demand for cholera vaccines, the costsand cost-effectiveness of cholera vaccination tomeet this demand, possible funding sources, andthe funding gap.

Action Oct 2009 Completed WHO was not in a position to undertake this task but encouraged other institutions tomove forward. IVI has prepared a draft investment case and they may make it availableupon request for SAGE or other groups interested in investing efforts on cholera controland prevention.

Cholera Update the 2001 WHO vaccine position paper oncholera to reflect the new SAGE recommendations.

Action Oct 2009 Completed Updated cholera vaccine position paper published on 26 March 2010.

Cholera Cholera vaccines need to be placed on the prioritylist for WHO prequalification so that the newlylicensed low-cost Shanchol vaccine could beaccepted for review and if successful join Dukoral.

ActionFollow-upwith PQ

Oct 2009 Completed Cholera vaccines were placed on the priority list for WHO prequalification.



Financing SAGE requests that WHO conduct further situationanalysis of financial challenges for low ormiddle-income countries and consultation withcountries concerned & partners to distil issues tomore actionable activities.

Action Apr 2008 Ongoing A Request for Proposal (RFP) has been drafted and submitted to the BMGF for funding.This was accepted, the RFP was issued in March 2009 and selection was made in June2009. R4D was selected to conduct the study on LMIC to be launched early November2009. Preliminary results were presented at the GIM and NUVI meeting in 2008 and2010, findings and initial conclusions and recommendations will be presented to theSAGE in November 2010. Actionable activities will be then adopted and discuss withpartners for implementation. Work is now underway to consider ways of addressing thepotential obstacles and issues faced by the 16 graduating countries from GAVI support.A Sharepoint on Middle-Income Countries and new vaccine introduction was created byIVB-WHO to facilitate data collection and exchange between the Middle-Income Countryworking group members. A Middle-Income Country presentation by EMRO during the2009 WHA took place and was well received - the May 2008 WHA resolution onimmunization referred explicitly to Middle-Income Countries. Sessions on Middle-IncomeCountry was held during the NUVI meeting in June 2008 and 2010, an updatedbackground document was discussed and an action plan for 2009-12 was approved withall concerned parties (vaccine industry, country and region representatives, WHO andUNICEF, Gates Foundation, ...).

Financing SAGE identified the need to support countries thatbecome ineligible and lower middle incomecountries through pooled procurement.

Action Oct 2009 Ongoing Various activities are conducted at global and regional level to support non GAVI andLower Middle Income Countries (LMICs) - At global level: a study to enhance globalknowledge and understanding of the challenges that Lower Middle Income Countriesface as they explore potential adoption of new vaccines. Some key areas of the study:What are the barriers/challenges that limit the rate of new vaccine adoption by LMICs?What are the potential options to address these rate limiting constraints? And what arethe likely costs, benefits and implications of various options for supporting countries toaddress identified rate limiting constraints? Based upon these analyses the study willdevelop prioritized strategies and suggest practical measures at the global, regional, andnational level to support non GAVI and LMICs in their decisions to adopt new vaccines.An Advisory Group for the study team was set up with representatives from WHO,BMGF, GAVI, UNICEF, NVI and vaccine manufacturers. The study began in November2009 and is expected to be completed in November 2010. Finding and preliminaryconclusions and recommendations will be presented to the SAGE in November 2010 - Atregional level: EMRO is working with LMICs in the region to set up a pooled procurementsystem with the support of UNICEF and other partners. AFRO is conducting a feasibilitystudy on regional pooled procurement. Identification of graduating countries and theirpotential constraints and issues is on going with GAVI and UNICEF to define measuresand activities to overcome the obstacles et develop transition plans.

GRADing and reviewof evidence

SAGE encouraged the grading discussion group todevelop a communication strategy to mitigate anypotentially deleterious effects of a narrowly appliedGRADE approach used to evaluate immunizationstrategies. SAGE also encouraged the group tosuggest appropriate adjustments to the process –for example, by applying criteria to increase ordecrease the quality-of-evidence score when takinginto account broader population effects – with apossible longer term goal of recommendingfundamental improvements to the approach.

Action Apr 2010 Ongoing A draft document on proposed adjustments to GRADE scoring of quality of scientificevidence for vaccines and clarifications on how to apply scoring for vaccines has beendeveloped by the discussion group. This document is undergoing discussions includingwith partners and should be finalized by end of 2010.



GRADing and reviewof evidence

SAGE also supported the development of a paperdescribing SAGE’s approach to reviewing evidencewhen issuing recommendations. The proposedpartnership among SAGE and other immunizationadvisory committees to enhance the GRADEapproach was encouraged.

Action Apr 2010 Ongoing Active collaboration has been started with CDC and the US ACIP and the GlobalAdvisory Committee on Vaccine Safety and discussions are ongoing with EDCD andother advisory committees for further collaboration and consensus building. The overallmethodological paper will be looked at after the November 2010 SAGE meeting.

HIV - Horizonscanning for R&D ofvaccines againstHIV, Tuberculosisand Malaria

SAGE requested regular updates on the progress ofHIV-vaccine research.

Action Apr 2010 Pending Next annual update will be provided for the April 2011 meeting.

HIV - Horizonscanning for R&D ofvaccines againstHIV, Tuberculosisand Malaria

Additional training of members of nationalregulatory authorities in scientific aspects shouldalso be included in the training programmes that arebeing implemented by WHO and other internationalsponsors.

Action Nov 2006 Ongoing Three policy papers targeting national regulatory authorities and ethics committees havebeen developed and published: "PhaseIIB-TOC trials" (AIDS 2007), "Involvement ofadolescents in HIV vaccine trials" (AIDS 2007) and "Access to care and treatment invaccine trials" (Vaccines 2007). In collaboration with QSS, a session on HIV vaccinescientific and regulatory issues was organized at the African Vaccine Regulators Forum(AVRF) meeting in September 2007 and it has also been discussed at the last AVRFmeeting in September 2009 that was held in Abuja. In addition, a technical report on"HIV vaccine efficacy endpoints in HIV vaccine trials" has been published in Vaccines2009, v 27 pp 1989-1990). In view of the new data on HIV vaccine efficacy fromThailand, a meeting on scientific, efficacy and safety considerations has beenrecommended by the Global HIV Vaccine Enterprise to be convened as soon aspracticable. Two activities have been implemented by HVI with regard to this recommendation: (1) On 16-18 March 2010, HVI in collaboration with the Global HIV Vaccine Enterpriseand Thai MOH organized a technical consultation on "Utility of RV144 trial results", whichdeveloped detailed recommendations for the decision makers and national regulatoryauthorities with regard to ethical and regulatory issues related to the Thai RV144 trial. (2) On 21-22 April 2010, HVI organized a Scientific Briefing session on regulatory issuesand clinical trial design. A meeting report and a working paper on adaptive trial designhave been prepared and circulated for comments. Upon completion of this workingpaper this item could be considered as completed.

HPV SAGE urged the completion of ongoing research inHIV-infected individuals, on prolonged (includingyearly) intervals between doses, demonstrationprojects on delivery methods, andcost-effectiveness studies of vaccinating youngadolescents and older catch-up populations in low-and medium-income countries. The committee alsourged new research on the feasibility andeffectiveness of simplified schedules such as2-dose schedules or infant/young child dosing toassess initial and sustained immunogenicity.

ActionResearch

Apr 2007 Ongoing A study on cost and financing issues for HPV vaccine adoption in developing countrieswas carried out by PATH and the report is available. HVAC, the AC for HPV vaccines metin April 2010 to review and discuss new clinical data available. Of potential importance toSAGE were the updates related to a) cross-protection against oncogenic HPV genotypesnot included in the vaccine, b) comparison of 2 vs 3 doses schedule, c) duration ofprotection induced, d) performance when co-administered with other vaccines, e) use inHIV-infected persons and d) performance an implications of possible use of thesevaccines in males. Lessons learnt with the four demonstration projects conducted by PATH in India, Peru,Viet-Nam and Uganda, as well as other accomplishments from WHO partners were alsopresented and discussed. In respect to the PATH projects, the focus was comparingcommunity-based delivery vs school-based strategies and using the opportunity toanswer a number of distinct operational questions, using the opportunities offered by thedifferent country programmatic preferences. A comprehensive HVAC report has been prepared and a shorter version is available.Nonetheless, it would appear important for SAGE to be updated at a later date on theoutcomes of the above-mentioned studies.



Hepatitis B SAGE recommended that the timely delivery of abirth dose of hepatitis B vaccine (that is, within 24hours of birth) should be used as a performancemeasure for all immunization programmes.Reporting and monitoring systems should bestrengthened to improve the quality of data on thebirth dose.

Action Apr 2009 Ongoing Work in progress to revise JRF and associated materials to improve reporting of birthdose. Analysis of timely birth dose data for 2008 shows no significant changes from2006 analysis and major issue is lack of data quality. A consultation on implementation ofnew universal birth dose recommendation is planned for December 2010 with specialfocus on countries with a high percentage of home births.

Hepatitis B All regions and associated countries should developgoals for hepatitis B control appropriate to theirepidemiologic situations. Serologic surveys ofhepatitis B surface antigen (HBsAg) prevalence,representative of the target population, will serve asthe primary tool to measure the impact ofimmunization and achievement of the control goals.

Action Nov 2008 Ongoing EMRO is working with Member States to ensure achievement of the Regional Committeegoal for HBsAg reduction in vaccinated children. WPRO continues to monitor progresstowards achieving 2012 goal, 2010 TAG recommended actions to ensure achievement ofthis goal. New staff position developed in WPRO to focus on this issue with donorsupport. SEARO conducted a regional review of Viral Hepatitis prevention and control in2010. AFRO is developing a background paper and will form, under the umbrella of TFI,a hepatitis TAG on formation of a hepatitis B control goal that will meet in November2010. EURO will consider a regional hepatitis B control goal. No activities planned inPAHO.

Hib Expand new framework for Hib introduction to thefullest extent possible to increase demand for thevaccine and accelerate the lowering of its price.

Action Nov 2005 Ongoing The Hib Initiative had conducted regional fora in Africa, Asia, Europe and the MiddleEast and had devised a strategic plan to assist the poorest countries withdecision-making on Hib vaccine introduction including research activities. GAVI has aprocurement strategy to which WHO and PATH provide advice through the work onvaccine pre-qualification and demand forecast. A WHO-maintained spreadsheetprovides up-to-date information about programmatic elements. There has been an acceleration of the uptake of Hib-containing vaccines as a result ofthe SAGE recommendation, availability of GAVI funding and improving supply base. Bymid 2010, 165 countries had introduced Hib vaccine. WHO continues to support UNICEFSupply Division by participating in the Procurement Reference Group for Hib, Hep B, andYF vaccines which provides information upon which tenders are issued. In addition, aspart of the Accelerated Vaccine Introduction Initiative, WHO supports work on long-termforecasting to estimate demand for Hib vaccine to ensure vaccine availability.



IPTi Review recommendations of Technical ExpertGroup in November 2006.

ActionAgenda item

Apr 2006 Completed WHO's Global Malaria Programme (GMP) has held three IPTi Technical Expert Group(TEG) meetings (Oct 25-27, 2006, Oct 8-10, 2007 and April 24-25 2009). Based on newinformation the most recent TEG concluded that Intermittent Preventive Treatment ininfants sulfadoxine-pyrimethamine (IPTi-SP) delivered through EPI be considered forimplementation as an additional malaria control intervention in countries in SouthernAfrica under the following specific conditions: a. In areas with moderate to hightransmission (Annual Entomological Inoculation Rates beyond 10). b. When parasiteresistance to SP in the area is not high. Precise cut-offs cannot be defined on the basisof available data. More information is needed on the relationship between the prevalenceof molecular markers (mutations in Pfdhfr and Pfdhps) and the duration of malariaprotection provided by SP-IPTi. c. If its implementation does not detract from efforts toscale-up access to Artemisinin-based combination therapies for early treatment, and toInsecticide-treated bednets and Indoor residual spraying as preventive measures, all ofwhich have significantly greater efficacy in malaria control. This recommendation is nowaligned with the June 2008 review by the Institute of Medicine (IOM) (USA) that wascommissioned by the Bill & Melinda Gates Foundation. The findings of the IOMCommittee were that IPTi-SP is safe, efficacious, and that there is little concern for arebound of malaria after IPTi is ceased; rebound was small compared to the overallbenefit. The IOM Committee also found that IPTi-SP delivered alongside the WHOsExpanded Programme on Immunization would be one of the most cost effective malariacontrol tools in Africa. The April 2009 TEG meeting was co-chaired by Drs Fred Binkaand Nick White, with the participation of Barry Bloom (co-Chair of GMP TRAC -Technical Review Advisory Committee). In October 2009 SAGE reviewed serological andimplementation evidence and supported IPTi delievery through EPI. As of March 2010the WHO Policy Recommendation on IPTi has been distributed to African Countries byAFRO and posted on the WHO Web Site:http://www.who.int/malaria/news/policy_recommendation_IPTi_032010/en/. IPTi wasalso included in the Technical Briefing note to the Global Fund as a WHO recommendedstrategy.

Immunization safety SAGE urged for clarification for activities that couldbe funded under health system strengthening toincl. injection safety and waste management incl.training and supervision activities.

Action Nov 2007 Ongoing WHO through GAVI support is providing technical support to countries to develop andfinalize national plans. Some countries have now moved into implementation and theallocation of equipment and trainings such as in Mali are taking place in districts. WHOhas also developed a tool to monitor progress in countries. This tool will help to seeprogress and define country status in health-care waste and prioritize interventions. Anassessment on injection safety and waste from immunization activities took place inRwanda and Gambia in 2009-2010 to assess the country strategy but also to specificallyassess the introduction of the PVC7 vaccine in pre-filled glass syringes. Good progressis seen in most GAVI eligible countries and a good number can be seen as modelcountries. There is still a long way to go. Health-care waste management has a cost andWHO has developed core principles to advocate for the mobilization of resources forhealth-care waste. Health-care waste is now seen by all as a priority intervention toprevent the transmission of diseases and for safety.



Immunization safety SAGE encourages development of simpletechnological solutions with improved environmentalcharacteristics, and encourages donors to supportsuch work as a priority.

Action Nov 2007 Ongoing - Work is on-going through Project Optimize in collaboration with the Vaccine Packagingand Presentation Advisory Group to explore vaccine packaging that minimizes the impact on environment. - A document on Environmental due diligence procedures has been developed andshared with GAVI. It expresses steps to be taken to minimize and manage waste from immunization activities in an environmentallyfriendly manner. - The WHO reference document is: WHO policy paper on Health Care WasteManagement (seehttp://www.who.int/water_sanitation_health/medicalwaste/hcwmpolicy/en/index.html) - In the context of the Libreville declaration on Health and Environment in Africa, aworkshop in Cameroon in July 2010 has produced a framework for health care wastemanagement. - The health care waste component of Global Environment Facility (GEF) project isdeveloping a small autoclave in Tanzania to treat waste produced in low incomecountries. - A study on the safety to use needle remover has been completed in Bangladesh. Thiscould influence the WHO position on the use of such device and would have an impacton safety but also on the management of waste from injection activities.

Immunizationschedules

Development of additional documents. 1. Guidanceto countries on consideration for improving anational schedule, 2. Document on implementingvaccination programmes in older age groups; 3.Tool to help health workers avoid missedopportunities.

Action Apr 2008 Ongoing 1. A "Users' Guide" to accompany the Summary Tables of WHO Recommendations forImmunization, has been finalized and is available on the WHO web site(http://www.who.int/immunization/policy/immunization_tables/en/index.html). Thisdocument outlines how countries can use the WHO recommendations to review theirnational immunization schedules. 2.Not addressed yet. 3. Not addressed yet.


SAGE endorsed continuing work in the relatedresearch areas, with refinement of the researchagenda undertaken by the research component ofIVB, under the oversight of the research advisorybodies of WHO. SAGE asked to be kept informed ofprogress and results.

Information Apr 2007 Ongoing Work in progress. Staff recruited to work on these issues. Presentation of the project atSAGE October 2009 meeting. Further update and discussion scheduled for theNovember 2010 SAGE meeting.


WHO is encouraged to continue its work to supportcountries in establishing & strengthening nationaladvisory committees and in efforts to and optimizetheir immunization schedules.

Action Apr 2008 Ongoing Global survey of national technical advisory committees on immunization completed.Several related articles have been published in Health Policy and Vaccine. Resultspresented at several regional technical advisory group and immunization managersmeetings. Data for the Americas summarized by AMR in the immunization newsletter.Ongoing regional initiatives to strengthen establishment and strengthening of nationaltechnical advisory groups with regular video-conferences and coordination within WHO.Well established priority of work within the Organization. Collaboration with SIVACinitiative, CDC, Provac and other partners. Supplement of Vaccine with focus on NITAGspublished in April. SIVAC implementing a resource platform. Summary Tables of WHORecommendations for Immunization finalized and published on the WHO web site on 16January 2009. These are updated on an ongoing basis whenever there is a new policyrecommendation.




SAGE encouraged WHO to further address thepublic health value of immunization strategiesoptimizing the cost-effectiveness of interventions forpopulations compared with individuals.

Action Apr 2007 Ongoing See related information on public health value of immunization strategies.

Impact of theintroduction of newvaccines onimmunization andhealth systems

SAGE recommended that the group work towardsproducing guidelines and tools for WHO to assistdecision-makers and EPI managers contemplatingthe introduction of new vaccines, in order to takeaccount of collateral effects inherent in introduction.The guidelines should provide a set of indicatorsthat would enhance the potential positive effects,and reduce any potential negative effects, both onthe immunization system and the health system.The guidelines should accommodate vaccines withdifferent characteristics.

Action Apr 2010 Ongoing See comment on other recommendation re: New vaccine introduction.


SAGE noted the importance of the ad hoc workinggroup continuing to include a broad range of partneragencies, and encouraged to seek endorsement ofthis work at senior levels of partner agencies.

Action Apr 2010 Ongoing See related recommendation re: New vaccine introduction.


In relation with the impact of the introduction of newvaccines of immunization and health systems,SAGE encouraged completion of the literaturereview.

Action Apr 2010 Ongoing See related recommendation re: New vaccine introduction.


SAGE requested that WHO assesses how theintroduction of new vaccines has helped strengthenimmunization and health systems.

Action Apr 2010 Ongoing An ad-hoc working group has produced a framework on new vaccines introductionimpact on the health and immunization systems, which contains hypotheses on majoreffects, partly backed by published literature, which was reviewed by SAGE in April 2010.Further information is being collected through a search of the published, unpublishedand grey literature (such as post-introduction evaluation reports) as well as through keyinformant interviews. Ongoing research conducted on this topic is to be reviewed withregards to specific vaccines (injectable, oral, targeted at infants and older age groups).The ad-hoc group will update the framework based on the data obtained and will draftand pilot-test a guideline to assist country decision makers and EPI managerscontemplating the introduction of new vaccines to take account of the effects/impacts onthe health system. The ad hoc working group continues to include a broad range ofpartner agencies (WHO, UNICEF, WB, CDC, PATH, JSI, LSHTM, JHU) and will seekendorsement of this work at senior levels of partner agencies. A presentation to SAGE isforeseen for November 2011.



Influenza SAGE agreed to review available information for it toprovide an opinion on: 1) use of H5N1 influenzavaccine in the inter-pandemic period; 2) use ofH5N1 influenza vaccine in high risk groups - incl.vaccine reaching end of shelf life at future meetings.

Agenda item Nov 2008 Ongoing A SAGE WG was established to review the evidence available for developing an opinionfor the SAGE to review. The working group (WG) held several consultations between 3November 2008 and 19 March 2009, and presented a comprehensive review of availableevidence to SAGE in April 2009, for consideration in a potential recommendation. SAGE endorsed most of the recommendations proposed by the WG, and left a numberof issues open for further discussion. Among those: - WHO will develop guidance to assist countries to carry out a risk assessment inpersons known to be in contact with poultry in confirmed active H5N1 outbreak areas,before vaccine may be made available; - Holders of licensed H5N1 vaccine stockpile are encouraged to gain experience withH5N1 vaccine use, and to build knowledge further on safety, immunogenicity,cross-reactivity, priming potential and duration of immunity in order to inform publichealth policies. Moreover, SAGE welcomed a future discussion on the cost-effectiveness of vaccinationwith H5N1 vaccines in the inter-pandemic period. Shortly after the SAGE April 2009 meeting, the H1N1 pandemic started, which put onhold most of the activities on H5N1 preparedness. The SAGE H5N1 WG resumed its work on 15 February 2010 with the intention to updateSAGE during its April 2010 meeting on new developments which might impactrecommendations formulated in April 2009. The H5N1 WG will meet on 27 Septemberand report to SAGE in November 2010.

Influenza WHO should ensure that the expertise in rapidmobilization for mass immunization is included ininfluenza preparedness planning.

Action Nov 2005 Ongoing By 1 December 2009, all planned workshops were completed as scheduled. Countrieswhich intend to accept WHO donated H1N1 influenza vaccine have been requested tosubmit their National H1N1 Influenza Vaccine Deployment and Vaccination Plan (NDVP)including the compliance of other criteria as requested by the D-G. 82 countries from allWHO Regions have submitted their NDVP, vaccine have been delivered to 76 countriesand over 76 million doses have been donated with syringes and safety boxes at the timeof this update. A series of workshops at WHO regional level is being planned by the firstsemester of 2011, for reviewing deployment and vaccinations activities, one of theobjectives of the workshops is to ensure that the experiences in deployment andvaccination is integrated in the immunization area of preparedness and response plans.

Influenza SAGE recommends WHO continue urgentdevelopment of H5N1 stockpile.

Action Nov 2007 Ongoing Negotiations with prospective vaccine manufacturers concerning donation of H5N1vaccines are on hold. The focus had been on H1N1 vaccine donations for the last year(2009-2010).



Influenza WHO should ensure that there is unrestrictedsharing of samples and vaccines strainsinternationally.

Action Nov 2006 Ongoing Under the overarching goal of pandemic influenza preparedness, Member States workedthrough an intergovernmental process (IGM) to develop a Framework to increase thetransparency of the WHO virus sharing system and establish fairer and more equitablemechanisms for the sharing of resulting benefits. The IGM process formally concludedin May 2009. Through WHA resolution 62.10 Member States requested that theDirector-General facilitate a transparent process to finalize the remaining elements of theFramework, including the SMTA, and report thereon to the 126th Executive Board. In thisconnection, the Director-General has invited Member States and regional economicintegration organizations to a consultation on 19-20 October 2009. Following discussionsat the Executive Board, it was agreed that negotiations between Member States shouldbe conducted by an open-ended working group that would be convened from 10-12 May2010. The aim of said working group would be to reach agreement on remainingelements under the draft Framework. The Executive Board requested that theDirector-General facilitate the process and specified that the outcome of the work of theopen-ended working group would be reported to WHA 63.



Influenza WHO should collaborate with expert groups tomodel the impact of different vaccination strategiesin pandemic control.

ActionResearch

Nov 2005 Completed As a follow up to the SAGE recommendation a Influenza vaccine scenario modellingmeeting was planned mid of June. Because of the escalating outbreaks of a novelinfluenza A (H1N1) strain in several countries WHO convened another informal networkof mathematical modelers with the following goals: (a) to describe and predict thebehaviour and impact of the pandemic H1N1 2009 and demonstrate the potentialoutcome of proposed pharmaceutical and non-pharmaceutical interventions in differentsettings; (b) to present these analyses in formats suitable for various audiences,including technical experts, policy-makers and the general public; and (c) to adaptmodels and interpret experiences from developed countries so they can be applied inlow-resource countries. The mathematical modelling network met in Geneva in early July2009. The network consists of representatives from infectious disease modelling groups(academic and public health institutions), professionals from national public healthagencies, and WHO staff responding to the pandemic H1N1 2009. A meeting report waspublished in WER (No. 34, 2009, 84, 341352, http://www.who.int/wer) which summarizesdiscussions held at the meeting and presents some preliminary results of ongoingmodeling of the pandemic H1N1 2009. Members of the WHO mathematical modellingnetwork have been active in researching the transmission dynamics of the pandemic intheir respective countries, evaluating the impact of interventions (e.g., school closure,antiviral use) and optimal vaccine strategies. Results of ongoing and finished work havebeen shared with WHO. In addition, the network has generated several publications.Recent publications include: an update on transmission characteristics published in the13 November issue of the WER (Vol 84(46) 2009, pp 477-484, www.who.int/wer); and apaper—describing six public health challenges (measuring age-specific immunity toinfection; accurately quantifying severity; improving treatment outcomes for severecases; quantifying the effectiveness of interventions; capturing the full impact of thepandemic on mortality; and rapidly identifying and responding to antigenic variants) andhighlighting the need for serologic studies for public health decision making—has beenpublished on PLoS Currents Influenza (available at:http://knol.google.com/k/maria-van-kerkhove/studies-needed-to-address-public-health/agr0htar1u6r/18?collectionId=28qm4w0q65e4w.1&position=11). This manuscript was published inPLoS Medicine in June 2009 and is freely available at:http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000275 An analysis of the "Global Mitigation of Pandemic Influenza A (H1N1) with Vaccines" iscurrently being conducted in collaboration with IVR/IVB and is expected before the nextSAGE meeting. Members of the H1N1pdm mathematical modelling network have metwith members of IVR/IVB to discuss and present results of this work. At the request of the SAGE Working Group on H5N1 Influenza Vaccines, mathematicalmodelers at Imperial College London and CDC, conducted a risk-benefit analysis ofpre-epidemic vaccination against H5N1 avian influenza. These results were presentedto the H5N1 working group at their 27 September 2010 meeting in Geneva. Thiscollaborative effort will become ongoing for influenza modelling more generally.



Influenza WHO should pursue its efforts in strengthening thecapability in developing countries of healthministries and national regulatory authorities tofacilitate the movement of samples and to ensureprompt registration of pandemic vaccines.

ActionResearch

Nov 2005 Ongoing WHO, through its GISN (Global Influenza Surveillance Network), has made great effortsin building influenza laboratory diagnositic, surveillance and response capacity indeveloping countries and strengthening the global shipping capacity of clinicalspecimens/virus isolates from developing countries to WHO Collaborating Centers orother reference labortories of GISN. The process of influenza virus and benefit sharing is ongoing. During the ExecutiveBoard Jan 2010 there were many discussions - both in session and informally amongmany Member States - about options for continuing the IGM process. It was finallyagreed that from 10-12 May 2010, Member States will hold negotiations to finalize theoutstanding elements of the Framework. The basis of negotiations will be the Frameworktext as set forth in A 62/5Add.1(http://apps.who.int/gb/ebwha/pdf_files/A62/A62_5Add1-en.pdf). Developing country NRAs are included in WHO activities to strengthen regulatorypreparedness. WHO has facilitated the development of a comprehensive guidancedocument on regulatory preparedness for pandemic flu vaccines. This covers regulatorypathways; technical specifications for the evaluation of quality, safety and efficacy; qualitycontrol preparedness; and adverse event monitoring. The regulatory preparednessdocument was approved at the October 2007 ECBS. WHO has developed tools toassess regulatory capacity of NRAs for influenza vaccine registration and coordinatedsite visits in countries newly developing influenza vaccine production capacity. Capacitybuilding needs identified as a result of the in-country visits are being addressed e.g. by(i) a course on QC of influenza vaccines and (ii) a workshop on clinical trial evaluation ofinfluenza vaccines. Influenza vaccine registration was included as a topic for theDeveloping Country Vaccine Regulatory Meeting, October 2008.

Influenza SAGE noted that WHO needs, concurrently with theacquisition of a stockpile, to develop the operationalguidelines that would govern the management andrelease of the stockpiled H5N1 influenza vaccine,and to define appropriate methods for monitoring itsuse and evaluating outcomes. SAGE furtherrecommended a feasibility study on themanagement and use of the stockpile.

ActionResearch

Apr 2007 Ongoing The WHO Guidelines stipulate that EPI logistic system should be the template for therapid delivery of a pandemic influenza vaccine. In 2007 two meetings were convened - 1.Informal consultation on regulatory preparedness for human pandemic influenzavaccines, held in Geneva on 14-15 June 2007 (seehttp://webitpreview.who.int/entity/vaccine_research/diseases/influenza/meeting) and 2.Informal consultation on technical specifications for a (WHO) international H5N1 vaccinestockpile, held in Geneva on 17-18 October 2007 (seehttp://who.int/vaccine_research/diseases/influenza/meeting_stockpile). WHO incollaboration with Gates Foundation and Oliver Wyman evaluated different options forlogistical design of the WHO international H5N1 vaccine stockpile and associatedtrade-offs, strategies and mechanisms for funding the stockpile (seehttp://www.who.int/csr/disease/influenza/H5N1_Stockpile_Design_Feb2009.pdf). SAGEworking group on H5N1 vaccine, after evaluating the available evidence, recommendedthat the size of the stockpile should remain at 50 million doses for rapid containment and100 million doses for equitable distribution to low and middle income countries to helpmaintain the services considered most essential. SAGE working group recommendedthe use of the of licensed H5N1 vaccine in different groups during interpandemic period.In addition, the use of stockpiled vaccines before they reach their expiry date may beconsidered for use (see http://www.who.int/wer/2009/wer8424.pdf). Due to the outbreak of the Pandemic (H1N1) 2009 in April 2009 and the declaration ofthe pandemic phase VI in June 2009, activities related to the WHO international H5N1vaccine stockpile were interrupted. The SAGE H5N1 Working Group convened in 27 September 2010 and reviewed thestockpile related SAGE recommendations. This will be discussed during the influenzasession in November 2010 SAGE meeting.



Influenza SAGE approved the proposal from the Secretariatto update the WHO position paper on seasonalinfluenza vaccination as well as the establishmentof a new working group on influenza vaccines andimmunization.

Action Apr 2010 Ongoing The new working group on influenza vaccines and immunization was constituted, underthe chairmanship of Professor Liz Miller. Its first meeting took place on 11-12 October2010. An update of the meeting and workplan of the working group will be presented toSAGE in November 2010.

Influenza WHO should support R&D for pandemic andseasonal vaccines, including alternative and moreeffective methods of vaccine delivery.

Action Nov 2005 Ongoing May 2-3, 2006 consultation intended to produce a global action plan to increase supplyof pandemic influenza vaccines. The Global Action Plan (GAP) was developed andpresented at the November 2006 SAGE meeting. Update for 2009/2010: 1) Since 2007eleven developing country vaccine manufacturers, which never produced any licensedinfluenza vaccine in the past, and two technology transfer "hubs" have received ~40million USD "seed" grant in total in support of influenza vaccine production capacitybuilding. 2) At the time of this report, as a result of these "seed" grants one seasonal(Indonesia), four pandemic H1N1 vaccines (Rumania, Korea, India) were licensed byNational Regulatory Authorities (NRAs), including a live attenuated influenza vaccine(LAIV). More than 25 million of the licensed pandemic vaccines were used during the2009/10 H1N1 pandemic in Europe, Asia and the Americas. Three additional pandemicH1N1 vaccines reached clinical trial stage (Thailand, Brazil, Indonesia), including anadditional LAIV vaccine. 3) The GAP Advisory Group evaluated the three-year progressin May 2010. 4) The 4th meeting on seasonal and pandemic candidate vaccines whichpotentially elicit broad spectrum and long lasting immune responses was held inNovember 2009 in collaboration with the Wellcome Trust in London, England. A peerreviewed meeting summary was published in Vaccine. 5) The 6th meeting to evaluate theprogress on clinical trials with pandemic prototype vaccines, including pandemic H1N1,was held in Geneva, Switzerland in February 2010. A peer reviewed summary waspublished in Vaccine. The next clinical trial meeting is planned to be held in early 2011.6) In 2009 a report was published in the journal Vaccine from a WHO organizedworkshop, September 2008, Vilamura, Portugal, which addressed the potential role ofneuraminidase in influenza vaccination. 7) A novel grant package was secured duringthe fall of 2010 for continuation of these influenza vaccine production capacity buildingprogrammes. In September 2010 a Technical Advisory Group (TAG) reviewed nineapplications. Approved contracts expected to be finalized in November 2010. 8)Additional funds were secured for 2011 with possibilities to invite additional vaccinemanufacturers from regions still without local influenza vaccine production, such asCentral Asia or Sub-saharan Africa.

Influenza SAGE’s recommendations on H5N1 vaccinewarranted modification following experiences duringthe H1N1 pandemic. A detailed presentation toSAGE should be made in November 2010.

Action Apr 2010 Ongoing This is scheduled as an agenda item for the November 2010 SAGE meeting following ofmeeting of the H5N1 working group.



Influenza SAGE recommended to the Director-General thatWHO should establish mechanisms for ensuringaccess to pandemic vaccine, should a pandemic bedeclared by the Director-General, for distribution todeveloping countries without influenza vaccineproduction capacity or resources to purchase suchvaccines.

Action Apr 2007 Ongoing WHO supports developing country manufacturers since 2007 to acquire the capacity toproduce influenza vaccines. After the declaration of the 2009 pandemic, 6 of these 11developing countries have produced clinical lots of A(H1N1) vaccine, 4 have completedor are conducting clinical trials of pandemic vaccine, 3 have registered this vaccine foruse in humans. A royalty-free license was negotiated by WHO with Nobilon-Schering-Plough-Merck onthe LAIV technology. A Center of Excellence and Training for transfer of technology (technology hub) wasestablished at the Netherland Vaccine Institute, to overcome the lack of a willingtechnology provider. To help countries protect people from developing severe disease from pandemicinfluenza H1N1 infection, WHO is coordinating the distribution of donated pandemicinfluenza vaccine to eligible countries. As of 27 August 2010, 72,260,990 doses pandemic vaccine were distributed to 69countries, and the distribution of 6,866,800 more doses to 8 countries was pending.

Japaneseencephalitis

Interference with the immune response to othervaccinations, number of doses required and theduration of protection need to be assessed.

Action Apr 2006 Ongoing Some studies are being initiated by PATH, and planned by Governments consideringintroduction of the vaccine. Issue of interference with measles vaccination discussed atthe December 2007 GACVS meeting. Measles co-administration had to be redone dueto assay incosistencies - results still pending. Number of dosese required (one or twodoses for primary immunization with live JE vaccine) has been assessed through casecontrol studies in Nepal and India (publication pending). WHO review might be neededonce results are available.


SAGE looked forward to better assessment of thedisease burden and identification of targetpopulations for immunization and to reviewing theregional JE control goal currently underdevelopment and the activities to achieve this goal.

Action Nov 2008 Ongoing Planning and fundraising efforts are ongoing in the Regions. Control goals have currentlynot been formulated. A literature review on the JE burden of disease has beenconducted, which is submitted for publication. Identification of target populations arebeing discussed in the context of country control strategies.


Commercial kits for detection of JE-specific IgMshould be compared and validated. Valuableexperience had been gained from linkingsurveillance of encephalitis to detection of acuteflaccid paralysis.

Action Apr 2006 Ongoing Assessment using serum carried out by PATH, published Am J Trop Med Hyg July 07.Field validation of serum and CSF in India and Bangladesh assessed in a jointWHO/CDC meeting, SEARO, February 2008. Assessment using serum carried out by PATH, published Am J Trop Med Hyg July 07.Field validation of serum and CSF in India and Bangladesh assessed in a jointWHO/CDC meeting, SEARO, February 2008. Nepal and Cambodia field evaluation of JEassays is complete and paper submitted to JID. Assessment of kits using CSFs acceptedfor publication in Am J Trop Med Hyg. CDC Fort Collins contracted to assemble a serumand CSF assessment panel to evaluate in-house and commercial JE ELISA assays. Thepreliminary assessment panel has been distributed to key JE reference Labs, firstquarter 2010 and has been evaluated by the Lab working group. A JE proficiency testingpanel (serum and CSF) will be distributed to key labs 3rd quarter 2010. A meeting of theJE Laboratory working group was held in Geneva, 9 October 2009 to discuss the JEassay assessments and future development of the JE LabNet. A paper summarizing thedevelopment of the JE LabNet is in the final editing stage and will be submitted 4thquarter 2010.



Malaria SAGE indicated that further discussion on theoptimal schedule for a malaria vaccine will need tooccur during the evaluation.

Action Oct 2009 Pending In March 2010, SAGE was provided with a summary of the unpublished results of aPhase 2 comparison of 0,1,2 month vs 0,1,7 month schedule for RTS,S, conducted inGabon, Ghana and Tanzania. The safety and immunogenicity results from this trial arenow published in Journal of Infectious Disease (seewww.ncbi.nlm.nih.gov/pubmed/20735271). 511 infants were randomized to receiveRTS,S/AS01(E) at 0, 1, and 2 months (in 3 doses with diphtheria, tetanus, and whole-cellpertussis conjugate [DTPw]; hepatitis B [HepB]; Haemophilus influenzae type b [Hib];and oral polio vaccine [OPV]), RTS,S/AS01(E) at 0, 1, and 7 months (2 doses withDTPwHepB/Hib+OPV and 1 dose with measles and yellow fever), or EPI vaccines only.

Measles mortalityreduction

Undertake work to prepare for discussions on thefeasibility of a global elimination goal.

ActionAgenda item

Apr 2009 Ongoing By end of January 2010, the following have been completed: 1) the biological feasibility;2) a vaccine supply analysis has been done by Oliver Wyman; 3) each of the 6 WHOregions has conducted an assessment of the programmatic feasibility; 4) studies on theeconomic analysis and, and impact on health systems have been completed; 5) Thepost-eradication risk assessment has been completed; and 6) two contracts have beenissued and the work has been completed to address the global context of eradication(stake holders analysis and a technical, economical, political and a societal analysis ofmeasles eradication in comparison to previous eradication programmes. A globaltechnical consultation to assess the feasibility of measles eradication was held inWashington DC on 29-30 July 2010. The meeting summary report will be available inthe yellow book and all other documents of the different work areas will be available toSAGE members. A presentation and discussions of the findings and recommendationsof the meeting is at the agenda of the November 2010 SAGE meeting.


Report back to SAGE on the outcome of theJanuary 2010 Executive Board as well as theresults of the ongoing studies relating to the impacton health systems and estimated costs of measleseradication.

Action Oct 2009 Ongoing The January 2010 EB accepted the report with the proposed 2015 milestones and thereport was discussed and the milestones endorsed at the 2010 May WHA. The ongoingstudies on the impact of measles eradication on health and immunization systems andthe cost and cost effectiveness of measles eradication have been completed. The resultswill be presented at the November 2010 SAGE and the reports of these studies areposted on the SAGE Sharepoint website.


SAGE encouraged a careful analysis of thechallenges facing the end stages of polioeradication as part of the work to assess thefeasibility of measles eradication.

Action Oct 2009 Ongoing A discussion of the challenges facing the polio eradication efforts and how these mayapply to measles eradication efforts were held with Director of Global Polio EradicationBruce Aylward at the Technical Global Consultation meeting to assess the feasibility ofmeasles eradication (July 2010). It was highlighted that a proof of concept in the mostchallenging areas (weakest links) should be considered prior to embarking on a measleseradication efforts.

Meningitis SAGE recommended that the impact of inter-Africanmigration on the occurrence of meningitis should bemonitored.

Action Apr 2009 Ongoing Following the 3rd international Meningitis Environmental Risk Information Technologies(MERIT) technical meeting held in Niger in November 2009, current efforts of the publichealth, meteorological and research communities are focused on advancing thedevelopment of a decision-support tool for testing prospectively in Niger during thecurrent meningitis epidemic season. The decision-support tool will integrateepidemiological information and knowledge of the environmental and social influencesimpacting meningitis epidemics across the Meningitis Belt. Close monitoring of thecurrent 2010 epidemic season by several MERIT partners is providing near real-timeanalyses of the forecasts and changes in environmental conditions associated withmeningitis incidence in affected areas. This information will be analysed alongside thedynamics of the disease in the context of the decision-making process for the distributionof vaccines, the results of which will be reviewed at the end of the epidemic season inMay 2010, with a view to further informing decision-making processes in followingepidemic season.



Mumps WHO secretariat to collaborate with industry toincrease global availability of MMR vaccines thatcontain strains of mumps vaccines with best safetyprofile.

Action Apr 2006 Completed WHO secretariat has met with industry representatives to explain the timeline andprocess for updating WHO recommendations for use of mumps vaccines with the bestsafety profile. The Mumps Position Paper was published in February 2007recommending a 2 dose schedule in countries using mumps vaccine and included thelatest recommendations from the November 2006 GACVS meeting regarding safety ofdifferent mumps vaccine strains. MMR vaccines containing strains of mumps vaccinewith the best safety profile have been prequalified by WHO.

National regulatoryauthorities

SAGE agreed on the need to strengthen thecapacity of national regulatory authorities and AEFIcommittees, since they have the primaryresponsibility for dealing with these events. SAGEencouraged further discussion of these issues withthe Global Advisory Committee on Vaccine Safety(GACVS) and encouraged countries in the region toengage with organizations of health-careprofessionals at the country level.

Action Apr 2010 Ongoing The Global Vaccine Safety Blueprint project has been launched to develop the basis of aglobal consortium aiming at strengthening countries capacity for vaccine safety work.This project is expected to be completed by the summer of 2011. GACVS participates inthe project through a consultatitive committee and also receives regular progress reportsat its bi-yearly meetings.

Pertussis SAGE endorsed the establishment of apertussis-vaccine strain repository and a databaseon the genealogy and characteristics of differentvaccine strains. A proposal should be presented tothe Expert Committee on BiologicalStandardization.

Action Apr 2010 Ongoing A proposal will be presented to the ECBS at its annual meeting in October 2010. SAGEwill receive feedback in November 2010. The following issues will be examined: 1) ownership of the data; 2) use of the strains; 3)use of the information generated on these strains.

Pertussis control Pertussis surveillance and control needs to beraised and placed the responsibility on the Regionsto make this a priority.

Action Oct 2009 Ongoing The SAGE recommendation has been flagged at the December 2009 AFR TFI meetingand at the Global Immunization Meeting. Further communication and visibility given to itwith the publication of the uptade pertussis postion paper in October 2010.

Pertussis control SAGE requested information on efforts being takento achieve pertussis control.

Action Nov 2008 Ongoing SAGE pertussis working group established. This impacted on discussions on pertussiscontrol at the AMR TAG meeting which took place in August 2009. SAGE reviewed initialconclusions and recommendations at its October 2009 meeting and completed review ofrecommendations at its April 2010 meeting. Publication of the updated pertussis vaccineposition paper on 1 October 2010.

Pertussis control SAGE supports expanding the current efforts of theChild Health Epidemiology Reference Group andthe Pneumonia Etiology Research for Child Healthto further demonstrate the burden of infant diseaseand mortality due to pertussis in developingcountries.

Action Oct 2009 Completed Based on ongoing discussions with the SAGE Pertussis WG, a Delphi panel will beorganized to get updated estimates of the age-specific force of morbidity for pertussisand CFRs that will be used by NIH to develop new burden numbers. The CHERG groupworking on the pertussis burden estimates have been contacted with an invitation toparticipate in the Delphi panel. The PERCH team has been contacted and haveconfirmed that they will include pertussis in their etiological investigations of hospitalizedpneumonia cases, which will provide additional inputs on the contribution of B. pertussisto atypical presentations such as pneumonia (where classical manifestations of pertussisare absent).

Polio SAGE reiterated the need for enhanced routine andsupplementary polio immunization activities withhigh quality surveillance for acute flaccid paralysis.

Action Oct 2009 Completed Both were incorporated into the Programme of Work 2010-12 as two of the four majorobjectives.

Polio SAGE recommends that the mathematical model(s)of post-eradication risks be evaluated byQuantitative Immunization and Vaccine RelatedResearch Advisory Committee (QUIVER).

Action Nov 2008 Ongoing The existing models of post-eradication risks were subjected to detailed andcomprehensive expert review during the 13-15 October 2009 meeting of the QUIVERcommittee, followed by specific guidance and recommendations of QUIVER, which wereshared with SAGE at its October 2009 meeting.



Polio SAGE recommended, given the need for intensive,quarterly oversight of the new plan, that a specific,high-level independent advisory body be constitutedby the spearheading partners of the initiative for thispurpose.

Action Apr 2010 Ongoing The GPEI will establish a new, high-level advisory body. This global advisory body willmeet face-to-face or by telephone/video conference on a quarterly basis to evaluatewhether each of the major milestones of the GPEI Strategic Plan 2010-2012 is ‘on track’,‘progressing but with issues of concern’ or ‘at risk for completion’. The nomination and appointment of members to the global advisory body will follow aprocess similar to that instituted for SAGE, with similar criteria for eligibility. Appropriateexpertise will be sought across the major disciplines relevant to optimizing policy andstrategy for interrupting WPV transmission and managing the attendant risks. Thefndings and recommendations of the global advisory body, including the evaluation ofeach milestone and key corrective action plans from infected countries, will form thebasis for the reports of the WHO Secretariat on polio eradication to the Executive Boardand the WHA. The global advisory body will work closely with SAGE, consulting on itsfndings at each of the six-monthly SAGE meetings.

Polio SAGE noted that high priority must be given totranslating the recommendations of theIndependent Evaluation and recent clinical trialresults into a new, three-year Programme of Workfor Interrupting Wild Poliovirus Transmission andagreed to participate in its review, finalization andmonitoring, particularly by focusing future SAGEpolio sessions on areas or countries whereprogress is faltering.

ActionAgenda item

Oct 2009 Ongoing The new 3-year Strategic Plan 2010-2012 was prepared and shared with SAGE at theApril 2010 meeting; the new plan was informed, amongst others, by input from SAGE,the recommendations of the Independent Evaluation and recent clinical trial results, andwas endorsed by the May 2010 World Health Assembly.

Polio SAGE requested that it be informed of theoutcomes of the deliberations between WHO and itsGPEI spearheading partners.

Information Oct 2009 Completed For the last two years, each SAGE meeting included a detailed session focusing on thecurrent status of the GPEI, including a summary reports on relevant recent meetings ofcritical GPEI advisory groups, as well as on other key aspects of the programme. TheGPEI will continue to provide the same detailed updates to SAGE during SAGEmeetings, and will, if an when appropriate, also directly inform the SAGE chair aboutimportant developments between SAGE meetings.

Polio SAGE urged a differentiation between the newGPEI strategic plan for 2010–2012's milestones andkey process indicators, with the major milestonesbeing internationally evaluated quarterly (ratherthan every 6 months).

Action Apr 2010 Ongoing The successful implementation of the GPEI Strategic Plan 2010-2012 will be facilitatedby an independent process for evaluating the major milestones, monitoring thedevelopment and implementation of mid-course corrections, and guiding the programmeon major issues of policy, strategy and priorities. To oversee this process at the global level, the GPEI will establish a new, high-leveladvisory body. This global advisory body will meet face-to-face or by telephone/videoconference on a quarterly basis to evaluate whether each of the major milestones of theGPEI Strategic Plan 2010-2012 is ‘on track’, ‘progressing but with issues of concern’ or‘at risk for completion’. CDC will assist the global advisory body in its quarterly evaluation of the majormilestones by preparing a preliminary report on the status of each major milestone and,where appropriate, key process indicators and corrective action plans. In addition, CDC will prepare comprehensive annual reports on all of the major milestonesand process indicators of the GPEI Strategic Plan 2010-2012. All CDC reports will besimultaneously shared with the polio-infected countries, relevant national and regionalTAGs, SAGE, the GPEI spearheading partners, donor partners, and other stakeholders.

Polio SAGE agrees with the proposal forrecommendations on the use of IPV in low-incomesettings in the post-eradication era to be issued inApril 2011.

Action Apr 2009 Ongoing Following the publication of the WHO position paper on routine pre-eradication poliovaccination, the SAGE Working Group on IPV is focusing now on preparing thesuggested post-eradication IPV policy recommendations; an update on progress towardsthis objective will be given at the November 2010 SAGE meeting.



Prequalification ofvaccines

SAGE urged WHO to develop appropriate capacitybuilding tools to provide tech. support to dev.country NRAs that have limited skills to evaluate thequality component of license applications.

Action Apr 2008 Ongoing Capacity building for NRAs to evaluate quality components of license applicationsongoing via mentoring arrangements, facilitated by WHO, between NRAs.

Prequalification ofvaccines and NRAstrengthening

SAGE strongly endorsed work on prequalification ofvaccines and NRA strengthening and stressed needto ensure work continues at high professionalstandards.

Action Apr 2008 Ongoing Performance review of vaccines prequalification shows WHO work is on track. NRAstrengthening work focusing on strategically important countries. Performance ofprequalification group reported to a "Prequalification Stakeholders' meeting in February2010. WHO D-G confirms that prequalification is a high priority for the Organization.Meeting to review prequalification took place in April 2010 after discussion at the April2010 SAGE meeting. Working document posted for review prior to finalization at October2010 ECBS.

Reports from otheradvisory committeeson immunization

Efforts needed to ensure GACVS conclusions &recommendations are disseminated to regionaltechnical advisory groups and national healthauthorities.

Action Nov 2006 Completed GACVS recommendations are published in the WER soon after each meeting of thegroup and posted on the GACVS website. Efforts have been made to disseminatemeeting reports widely, through the Global Immunization News newsletters, eClusterbriefings (internal high level WHO dissemination mechanism), WHO Pharmaceuticalsnewsletter, and the European Centers for Disease Control Newsletter with extensiveemail distribution. Further dissemination through regional newsletters and VaccineWeekly have been attempted. In 2009, dissemination was not undertaken to the sameextent as in previous years due to reassignment of responsible staff to other projects butsteps have been taken in 2010 to address these gaps. In 2010, several news storieshighlighting GACVS conclusions have also been posted on the IVB website


SAGE to provide continuous oversight of work onimmunization safety (in view of termination ofsteering committee of immunization safety priorityproject.

ActionAgenda item

Nov 2005 Ongoing Special session on reporting from immunization safety was organized at April 2006meeting. Regular reports from the Global Advisory Committee on Vaccine Safety tocontinue. WHO interdepartmental report on immunization safety discussed at the SAGENovember 2007 meeting. This overlaps with the "Immunization safety" topic.


WHO and NIBSC should develop with otherstakeholders, a business plan to assure long-termsecurity of global public health resource andadditional efforts be undertaken to disseminateoutcomes of the committees deliberations and toexplain the relevance of its work to the broaderimmunization community.

Action Nov 2006 Ongoing A comprehensive review of the work of the ECBS is planned for 2011. The review willinclude (but not be restricted to) consideration of communication of ECBS outcomes.

Reports from otherimmunization-relatedAdvisoryCommittees

SAGE supported WHO's decision to change theTLAC mandate.

Action Oct 2009 Ongoing First meeting of the Immunization Programme Advisory Committee (IPAC) was held on28-30 June 2010. Second meeting scheduled from 4 to 5 November 2010.



Rotavirus In countries where rotavirus vaccines areintroduced, clear communication strategies shouldbe implemented to prevent misconceptionsregarding the efficacy of rotavirus vaccines toprevent all childhood diarrhoea.

ActionFollow-upimplementation

Nov 2005 Completed Two rotavirus vaccines are commercially available and WHO pre-qualified.Rotarix™(GSK) and Rotateq™ (Merck) are recommended for use in all routine infantimmunization programmes. Thus far, 24 countries are using this vaccine in their nationalimmunization programmes. Additional clinical trials were undertaken in Asia and Africa, in order to documentperformance in these areas of the world. Data from Rotarix TM trials in South Africa andMalawi were discussed at the April 2009 SAGE meeting, and data from RotaTeq trials inMali, Ghana, Kenya, Bangladesh and Viet Nam at the October 2009 SAGE meeting. Results from these trials showed that oral rotavirus vaccines have a lower efficacy inhigh mortality countries than in low mortality countries, where the initial licensure clinicaltrials had been undertaken. It is therefore important to specifically address this issue incommunication with decision-makers and in training sessions with health care workers. Itis also critical to integrate rotavirus vaccination in a broader diarrhoeal controlframework. A comprehensive strategy to control diarrheal diseases should include,among other interventions, improvements in hygiene and community-wide sanitation(hand-washing with soap, household water treatment, stopping open defecation), zincand vitamin A supplementation, promoting breastfeeding, community-basedadministration of low-osmolarity oral rehydration solution and overall improvements incase management. WHO is providing guidance materials for policy makers and health workers whichprovide standard communication messages addressing on all of the above. Moreover, effective risk-communication strategies are essential after vaccine introductionin order to be able to react early and comprehensively to AEFI or potentialanti-vaccination messages. Vaccine safety monitoring has focused on occurrence ofintussusception among children vaccinated before and after six months of age. In August2010, GACVS reviewed additional post marketing surveillance data which revealed thepossible increased risk of intussusception shortly after first dose of rotavirus vaccinationin some populations. However, WHO maintains that vaccinating against rotavirus-relateddisease yields benefits that greatly outweighs the risk of vaccine-associatedintussusception.

Rotavirus SAGE requested updates from GACVS asinformation becomes available with respect to thepresence of DNA from porcine circovirus type-1(PCV1)in rotavirus vaccines.

Action Apr 2010 Completed GACVS reviewed the latest information available at its June 2010 meeting. Thecommittee's conclusions were published in the WER on 23 July 2010.



Surveillance SAGE requested to receive a report on howsurveillance networks are being reinforced incountries and regions.

Action Apr 2008 Ongoing Transition of selected ADIP/Hib initiative supported surveillance sites to WHOcoordination is now complete. Technical support from WHO continues to sentinel sitesto ensure adherence to the agreed standardized data collection, sharing and reportingprocedures. Five WHO Regions have deployed an electronic data management systemto sentinel sites, with the 6th planning to do so. Contracts or agreements with regionalreference rotavirus and IBD laboratories (RRLs) have been put into place for all regionaloffices with one IBD contract still in progress. Monthly conference calls are held with theglobal rotavirus and IBD reference laboratories (GRLs) to plan and follow-up onassessment visits and trainings for Regional Reference Laboratories. RRLs are beginingcountry laboratory assessments and trainings. Activities are underway to enhanceprocurement of laboratory supplies. Countries are reporting data through WHORegional Offices to WHO HQ, and the first global surveillance bulletins for rotavirus andinvasive bacterial diseases were distributed in December 2009. Countries are using thedata to develop GAVI applications, and to share with external partners (e.g. in countryWorld Bank office, Ministry of Finance). WHO has initiated discussions regarding thetransition of rotavirus and IBD surveillance from WHO coordination to the Ministries ofHealth. A global rotavirus and IBD surveillance meeting will be held in September 2010,which has invited representatives of all RRLs and GRLs, Ministry of Health, WHORegional office focal points, and other partners. A substantial focus of this meeting willbe on improving the quality of IBD data, which WHO has identified as a priority activity.This surveillance meeting will be used to develop action points to be completed duringthe next 12 months to enhance the quality of IBD surveillance, more fully integrateexisting centers of excellence/population based surveillance sites, to better integraterotavirus and IBD surveillance into other surveillance activities, transition to full Ministryof Health ownership, and to develop lessons learned around the introduction of rotavirusvaccine in countries of the Americas. A pilot project (SURVAC) is ongoing in 3 centralAfrican countries (CAE, CAR, DRC) that seeks to improve surveillance for VPDs,epidemic prone diseases, and other diseases of public health importance in acoordinated fashion. Lessons learned from this pilot will be developed and appliedglobally, as appropriate.

Surveillance SAGE supported the European Technical Advisorygroup of Experts (ETAGE) recommendation that theEuropean Centre for Disease Control (ECDC) andthe WHO European Regional Office work towardsdeveloping a common surveillance platform formeasles and rubella data collection from MemberStates to avoid redundancy.

Action Oct 2009 Ongoing WHO European Regional Office and ECDC have met on two separate occasions tomove this recommendation forward. In October 2010, data collection for the EuropeanUnion resides with EUVAC.NET. There is an ongoing handover to ECDC planned to becompleted by late 2011. WHO EURO and ECDC are discussing methods for datasharing and ensuring all data elements are captured to allow for accurate and reliablemonitoring towards the measles and rubella elimination goal in the Region.

Typhoid Need for feedback from WHO's regional offices andcountries to determine how countries couldimplement SAGE recommendations.

Action Nov 2007 Ongoing A full report will be presented to SAGE in its November 2010 session to provide thefeedback from countries and regions on the progress and challenges with regards tointroduction of typhoid vaccines in typhoid endemic countries.

Typhoid Need for advocacy and prioritization at internationallevel. To include prioritizing WHO's prequalificationfor new-generation typhoid vaccines and the needfor international financing mechanisms.

Action Nov 2007 Ongoing At the global level, a Coalition against Typhoid (CaT) formed by interested parties underthe leadership of Sabin Vaccine Institute and will soon become functional as soon asfunding agreements are signed with the BMGF. Information update on WHOprequalification is awaited from QSS Team and should be available to update at theupcoming SAGE session.



Unvaccinated infants SAGE emphasized the need to address thepersistent challenge of reaching children notcurrently reached by immunization services. Locallevel operational research was consideredimportant for understanding and addressing thesegaps. SAGE requested WHO to provide a plan onhow these findings can be operationalised at locallevel to ensure that the 24 million children perannum currently not benefiting from routineimmunization are also vaccinated.

Action Oct 2009 Ongoing Work at the field level is ongoing in Armenia to field test approaches to reducing thenumber of unimmunized children in one area of the country. In addition, a proposal to undertake a demonstration in one or two LGAs (localgovernment areas, equivalent to district) in Nigeria is awaiting country clearance. In both these instances issues in operationalization can be detected first-hand and theirsolutions determined. This will help in drafting practical approaches to reduce thenumbers of unimmunized children.


Documents

TRACKING SHEET Explanatory note - WHO · TRACKING SHEET Explanatory note The purpose of the tracking sheet is to monitor the work of the WHO Secretariat on the implementation of SAGE