sage tracking record of recommendations ......coverage higher than 90% (in 2008, the reported dpt3...

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

27 Nov 2009 General New vaccine introduction - SAGEstressed importance for WHO tolook at achievements in coverage,also decision-making processesand programmatic issues withvaccine introduction.

Action Nov 2007 Ongoing Pneumococcal vaccine and rotavirus vaccine coverage is being included in the JRF. Atracking sheet is being maintained on countries with interest, decisions, firm dates forintroduction or have introduced the vaccine in their national immunization programmes.Analytic work on the vaccine management issues is currently being undertaken and toolsbeing developed to assist countries with vaccine management and logistics associatedwith introduction of these new vaccine. Detailed planning has been conducted with 3regions in order to ensure proper management of injection safety and waste disposalwhen pre-filled syringes will eventually be used for early introducing countries withpneumococcal vaccine. Support is also being provided to national technical advisorycommittees on evidence based decision-making through provision of data, guidancematerials to evaluate and interpret data and on general capacity strengthening fordecision-making. All of these form part of the new vaccine introduction plan of action, adocument developed jointly with global and regional partners in immunization. WHO alsoassists countries in conducting post-introduction evaluation 6-12 months afterintroduction of a new vaccine in the programme, to assess the programmatic impact ofthe introduction. These reviews also serve to highlight general deficiencies inprogramme implementation.

05 Feb 2010 General SAGE noted that there have beenregional efforts to improve routineimmunization coverage andsuggested that the successobserved in Afghanistan andnorthern Sudan should beanalysed more systematically toinform efforts to improvevaccination coverage in othercountries and regions.

Action Apr 2009 Ongoing In collaboration with CDC Atlanta, EMR has implemented in Sudan in 2007 an evaluationexercise (a peer review) to document Sudans 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%).

01 Mar 2010 General SAGE recommended that ways toimprove curricula for medicalpersonnel 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).

19 Mar 2010 General SAGE recommended that newapproaches, such as periodicintensification of routineimmunization, be carefullyevaluated prospectively todetermine their effectiveness andcost-effectiveness.

Action Apr 2009 Ongoing Ongoing work with Immunization Basics to document country experiences. Mission toobserve Zimbabwe Child Health Days which included routine catch up doses wasundertaken in June 2009. Draft report available. Identification of other country activitiesfor case-study is ongoing.

of 1912 April 2010

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

26 Mar 2010 General SAGE requested that WHOassesses how the introduction ofnew vaccines has helpedstrengthen immunization andhealth systems.

Action Nov 2008 Ongoing So far, 14 post-introduction evaluations (PIEs)for the pentavalent vaccine wereconducted as well as one such evaluation for rotavirus vaccine. Further post-introductionevaluations will be conducted in 2010 and will include two countries that have introducedthe PCV7 pneumococcal vaccine, and potentially two countries that have introduced theHPV vaccine. The generic tool for conducting these evaluations will be published in2010, and a publication on the consolidated results from the evaluations conducted inthe Africa Region is nearing completion. A review of available evidence (including that from the PIEs) on the impact of newvaccines on the immunization and health system is being conducted and will bepresented to SAGE for discussion in April 2010.

09 Apr 2010 General SAGE requested more detailedanalysis of children who have notbeen reached with immunizationservices.

Action Nov 2007 Ongoing The work was on three fronts - looking at the DHS and MICS data, reviewing publishedpeer-reviewed literature and reviewing gray literature has been completed and presentedto SAGE in October 2009. The IDRC, Canada brought out a special issue of the Journalof International Health and Human Rights, published by BioMed Central titled TheFallacy of coverage: uncovering disparities and improving immunization coverage - TheCanadian International Immunization Initiative Phase 2 (CIII2). This work has now beenshared with the WHO regions and countries and with UNICEF. It is also envisaged topublish article(s) in peer reviewed journals during 2010. In turn the countries andregions will look at local data, prioritize weak areas and apply appropriate solutions forlocal problems.

01 Mar 2010 Categorization ofvaccine-preventablediseases

WHO & GAVI work together sothat WHO Categorization processand GAVI vaccine investmentstrategy complement each other.

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

19 Mar 2010 Categorization ofvaccine-preventablediseases

SAGE requested exercise to becompleted in a timely manner.Final disease prioritization resultsto be submitted for peer-reviewand provided to SAGE membersfor their review.

Action Apr 2008 Ongoing Status pending completion of global and regional level exercises. A paper summarizingthe global, as well as regional disease categorization exercises (examples AFRO andEURO only) is being drafted for submission to a peer-review journal. The paper could notbe completed yet due to the drop-out of essential co-authors, i.e. the people who hadinitiated the study and who hold exclusive information re the project. Will try to completein Q1 2010, but may not contain the regional exercise, since some of the initial data arenot on file.

09 Apr 2010 Categorization ofvaccine-preventablediseases

A 2nd stage of thevaccine-preventable categorizationexercise should be taken to look atlonger-term priorities fordevelopment of vaccines, taking a10 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 2010, discussions with potential collaborators have beeninitiated and a strategy will be developed during Q2 2010. This second stage will focuson applying the global disease categorization strategy - or adaptations thereof - inregional and country disease/vaccine categorization exercises.

09 Apr 2010 Cholera Update the 2001 WHO vaccineposition paper on cholera to reflectthe new SAGE recommendations.

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

19 Mar 2010 Cholera SAGE agreed that choleravaccines need to be placed on thepriority list for WHOpre-qualification.

Action Oct 2009 Ongoing The need to prioritize the cholera vaccine has been noted by the prequalification teamand applications from manufacturers will be accepted.

of 1912 April 2010


26 Mar 2010 Cholera Prepare a business case for oralcholera vaccines to provide criticalinformation for donors regardingthe potential demand for choleravaccines, the costs andcost-effectiveness of choleravaccination to meet this demand,possible funding sources, and thefunding gap.

Action Oct 2009 Pending WHO is not in a position to undertake this task but encourages other institutions to moveforward. IVI is preparing a draft investment case.

25 Nov 2009 Financing SAGE requests that WHO conductfurther situation analysis offinancial challenges for low ormiddle-income countries andconsultation with countriesconcerned & partners to distilissues to more actionableactivities.

Action Apr 2008 Ongoing A Middle-Income Country presentation by EMRO during the WHA took place and waswell received - the May 2008 WHA resolution on immunization referred explicitly toMiddle-Income Countries. A session on Middle-Income Country was held during theNUVI meeting in June 2008, an updated background document was discussed and anaction plan for 2008-09 was approved with all concerned parties (vaccine industry,country and region representatives, WHO and UNICEF, Accelerated Development &Introduction Plan (ADIPS) and Hib initiative, Gates Foundation, ..). A Request forProposal (RFP) has been drafted and submitted to the BMGF for funding. This wasaccepted, the RFP was issued in March 2009 and selection was made in June 2009.R4D was selected to conduct the study on LMIC to be launched early November 2009.Preliminary results will be presented at the GIM and NUVI meeting as well as to theSAGE in 2010. A Sharepoint on Middle-Income Countries and new vaccine introductionwas created by IVB-WHO to facilitate data collection and exchange between theMiddle-Income Country working group members.

19 Mar 2010 Financing SAGE identified the need tosupport countries that becomeineligible and lower middle incomecountries through pooledprocurement.

Action Oct 2009 Ongoing Various activities are conducted at global and regional level to support non GAVI andLMICs - At global level : a study to enhance global knowledge and understanding of thechallenges that Lower Middle Income Countries (LMICs) face as they explore potentialadoption of new vaccines. Some key areas of the study: What are thebarriers/challenges that limit the rate of new vaccine adoption by LMICs? What are thepotential options to address these rate limiting constraints? And what are the likely costs,benefits and implications of various options for supporting countries to address identifiedrate limiting constraints? Based upon these analyses the study will develop prioritizedstrategies and suggest practical measures at the global, regional, and national level tosupport non GAVI and LMICs in their decisions to adopt new vaccines. An AdvisoryGroup for the study team was set up with representatives from WHO, BMGF, GAVI,UNICEF, NVI and vaccine manufacturers. The study began in November 2009 and isexpected to be completed in July 2010. - At regional level: EMRO is working with LMICs in the region to set up a pooledprocurement system with the support of UNICEF and other partners. AFRO isconducting a feasibility study on regional pooled procurement. identification of graduating countries and their potential constraints and issues will beconducted in 2010.

of 1912 April 2010


24 Mar 2010 HIV - Horizonscanning for R&D ofvaccines againstHIV, Tuberculosisand Malaria

Additional training of members ofnational regulatory authorities inscientific aspects should also beincluded in the trainingprogrammes that are beingimplemented by WHO and otherinternational sponsors.

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 will organize a Scientific Briefing session on regulatoryissues and clinical trial design with assistance of Dr Helen Rees (SAGE member). Themeeting report and recommendations will be published. Upon completion of this task,this item could be considered as completed.

19 Mar 2010 HPV SAGE urged the completion ofongoing research in HIV-infectedindividuals, on prolonged(including yearly) intervalsbetween doses, demonstrationprojects on delivery methods, andcost-effectiveness studies ofvaccinating young adolescents andolder catch-up populations in low-and medium-income countries.The committee also urged newresearch on the feasibility andeffectiveness of simplifiedschedules such as 2-doseschedules or infant/young childdosing to assess initial andsustained immunogenicity.

ActionResearch

Apr 2007 Ongoing Since the last discussion on HPV vaccine at SAGE meeting, preliminary data on animmunogenicity and safety study with the bivalent vaccine on HIV positive 7-12-year oldboys and girls on optimal antiretroviral treatment were presented at the MalmoInternational Conference on HPV in May 2009 and the study showed that at 7 monthsfollow up no evidence of a lower antibody response in these children and no safetyconcerns. And the vaccine also had no negative impact on the HIV viral load or T-cellcount. Preliminary data was also presented on alternate dosing schedule whichcompared a 2-dose regimen with a 3-dose regimen for the quadrivalent vaccine and theresults showed no difference in the antibody levels at 7 months follow up. However, muchlonger follow up will be needed to assess the long term results of these studies. In orderto demonstrate the feasibility and to assess HPV vaccine introduction strategy in low andmiddle income countries, PATH conducted studies in India, Peru, Uganda and Viet Nam and their reports are available from PATH website(http://www.path.org/publications/). Also a study on cost and financing issues for HPVvaccine adoption in developing countries was carried out by PATH and the report isavailable. HVAC, the AC for HPV vaccines will meet at the end of April to review anddiscuss new clinical data related to cross-protection, duration of protection, performancewhen co-administered with other vaccines, etc. 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 willbe also presented. SAGE will be provided an update at a later date.

of 1912 April 2010


20 Jan 2010 Hepatitis B SAGE recommended the followingrevisions to WHO's position paperon hepatitis B vaccines: in allregions of the world, perinataltransmission is responsible for asizable proportion of chronic HBVinfections. Accordingly, all infantsshould receive the first dose ofhepatitis B vaccine as soon aspossible (<24 hours) after birth.This should be followed by 2 or 3doses to complete the series;immunization programmes shouldwork with maternal and childhealth programmes to promoteadministration of the birth dose ofhepatitis B vaccine.

Action Apr 2009 Completed A revised WHO position paper on the use of hepatitis B vaccine and including SAGErecommendations was published in the WER on 2 October 2009.

27 Jan 2010 Hepatitis B SAGE recommended that thetimely delivery of a birth dose ofhepatitis B vaccine (that is, within24 hours of birth) should be usedas a performance measure for allimmunization programmes.Reporting and monitoring systemsshould be strengthened to improvethe quality of data on the birthdose.

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 mid-2010 with special focus oncountries with high percentage of home births.

24 Mar 2010 Hepatitis B All regions and associatedcountries should develop goals forhepatitis B control appropriate totheir epidemiologic situations.Serologic surveys of hepatitis Bsurface antigen (HBsAg)prevalence, representative of thetarget population, will serve as theprimary tool to measure the impactof immunization and achievementof the control goals.

Action Nov 2008 Ongoing EMRO has received HQ support to brief Regional TAG and countries. Regional TAGendorsed the development of a regional HBV goal and EMRO developed a resolutionwhich has now been approved by the Regional Committee and calls for broad preventionand control of hepatitis B and C. WPRO continues to monitor progress towards achieving2012 goal, 2009 TAG recommended actions to ensure achievement of this goal. Newstaff position developed in WPRO to focus on this issue with donor support. SEAROconducted a regional review of Hepatitis B implementation in 2007. AFRO is developinga background paper and will form, under the umbrella of TFI, a hepatitis TAG onformation of a hepatitis B control goal. EURO has delayed consideration of a regionalhepatitis B control goal originally planned for the fall 2009 ETAGE meeting. No activitiesplanned in PAHO.

of 1912 April 2010


26 Mar 2010 Hib Expand new framework for Hibintroduction to the fullest extentpossible to increase demand forthe vaccine and accelerate thelowering of its price.

Action Nov 2005 Ongoing The Hib Initiative conducted regional fora in Africa, Asia, Europe and the Middle East.The strategic plan to assist the poorest countries with decision-making on Hib vaccineintroduction was approved by the GAVI ADIP Management Committee in June 2006 andalso includes research activities. GAVI has developed a procurement strategy to whichWHO provides advice through the work on vaccine pre-qualification and demandforecast. A WHO-maintained web site provides up-to-date information aboutprogrammatic elements. The Hib Initiative conducted regional fora in Africa, Asia, Europe and the Middle East.The strategic plan to assist the poorest countries with decision-making on Hib vaccineintroduction was approved by the GAVI ADIP Management Committee in June 2006 andalso includes research activities. GAVI has developed a procurement strategy to whichWHO provides advice through the work on vaccine pre-qualification and demandforecast. A WHO-maintained web site provides up-to-date information aboutprogrammatic elements. There has been a clear acceleration of the uptake of Hib-containing vaccines as a resultof the SAGE recommendation, availability of GAVI funding and improving supply base.As of the end of 2009, 157 countries have introduced Hib vaccine while a further four areGAVI-approved for introduction. WHO continues to support UNICEF Supply Division bychairing the PRG for Hib, HepB, and YF vaccines which provides the information uponwhich tenders are issued for vaccine procurement. In addition, as part of theAccelerated Vaccine Introduction Technical Assistance Consortium (AVI TAC), WHOsupports work on long-term forecasting to estimate demand for Hib vaccine to ensurevaccine availability.

05 Feb 2010 IPTi SAGE to review operational datafrom the pilot implementation ofIPTi with SP that UNICEF isplanning in six African countries.

Action Apr 2006 Completed With the agreement of WHO's GMP, a UNICEF pilot implementation project wasundertaken in 20 districts in 6 African countries - Benin, Ghana, Senegal, Mali, Malawi,and Madagascar -- for two years (2007-2009). With additional GATES funding (for a totalproject budget of $7 million), activities were expanded to include safety monitoring(pharmacovigilance, drug resistance and drug quality control) to all countries involved.More than 200,000 infants per year received IPTi-SP. The results of the UNICEF PilotImplementation project were presented at the October 2009 SAGE.

of 1912 April 2010


26 Mar 2010 IPTi SAGE encouraged WHO to furtheraddress the public health value ofimmunization strategies optimizingthe cost-effectiveness ofinterventions for populationscompared with individuals.

ActionAgenda item

Apr 2006 Ongoing 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 serologicaland implementation evidence and supported IPTi delievery through EPI.

27 Nov 2009 Immunization safety SAGE urged for clarification foractivities that could be fundedunder health system strengtheningto incl. injection safety and wastemanagement incl. training andsupervision 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 is due to takeplace in Rwanda and Gambia in 2009 to assess the country strategy but also tospecifically assess the introduction of the PVC7 vaccine in pre-filled glass syringes.Good progress is seen in most GAVI countries and a good number can be seen asmodel countries. There is still a long way to go. Health-care waste management has acost and WHO has developed core principles to advocate for the mobilization ofresources for health-care waste. Health-care waste is now seen by all as a priorityintervention to prevent the transmission of diseases and for safety.

01 Mar 2010 Immunization safety SAGE encourages development ofsimple technological solutions withimproved environmentalcharacteristics, and encouragesdonors to support such work as apriority.

Action Nov 2007 Ongoing Project "Optimize" is considering such solutions. Discussed by TLAC in March 2009.

25 Nov 2009 Immunizationschedules

Development of additionaldocuments. 1. Guidance tocountries on consideration forimproving a national schedule, 2.document on implementingvaccination programmes in olderage groups; 3. Tool to help healthworkers avoid missedopportunities.

Action Apr 2008 Ongoing A draft "Companion Document" to go with the Summary Tables of WHORecommendations for Immunization, has been prepared by ImmBasics. A revisedversion is currently being reviewed and finalized.

of 1912 April 2010


05 Feb 2010 Immunizationschedules

SAGE encouraged WHO to furtheraddress the public health value ofimmunization strategies optimizingthe cost-effectiveness ofinterventions for populationscompared with individuals.

Action Apr 2007 Ongoing See above.

05 Feb 2010 Immunizationschedules

SAGE endorsed continuing work inthe related research areas, withrefinement of the research agendaundertaken by the researchcomponent of IVB, under theoversight of the research advisorybodies of WHO. SAGE asked to bekept informed of progress andresults.

Information Apr 2007 Ongoing Work in progress. Staff recruited to work on these issues. Presentation of the project atSAGE October 2009 meeting.

19 Mar 2010 Immunizationschedules

WHO is encouraged to continue itswork to support countries inestablishing & strengtheningnational advisory committees andin efforts to and optimize theirimmunization schedules.

Action Apr 2008 Ongoing Global survey of national technical advisory committees on immunization completed.Three articles have been prepared and pare in press in Health Policy and Vaccine.Results presented at several regional technical advisory group and immunizationmanagers meetings. Data for the Americas summarized by AMR in the immunizationnewsletter. Ongoing regional initiatives to strengthen establishment and strengthening ofnational technical advisory groups with regular video-conferenec and coordination withinWHO. Well established priority of work within the organization. Collaboration with SIVACinitiative, CDC, Provac and other partners. Summary Tables of WHO Recommendationsfor Immunization finalized and published on the WHO web site on 16 January 2009.These will be updated on an ongoing basis whenever there is a new policyrecommendation.

24 Nov 2009 Influenza SAGE reviewed currently availableevidence on H5N1 vaccines withregard to safety andimmunogenicity. SAGErecommends WHO continueurgent development of H5N1stockpile.

Action Nov 2007 Ongoing Negotiations with prospective vaccine manufacturers concerning donation of H5N1vaccines are on hold. The current focus is on H1N1 vaccine donations.

of 1912 April 2010


25 Nov 2009 Influenza SAGE noted that WHO needs,concurrently with the acquisition ofa stockpile, to develop theoperational guidelines that wouldgovern the management andrelease of the stockpiled H5N1influenza vaccine, and to defineappropriate methods for monitoringits use and evaluating outcomes.SAGE further recommended afeasibility study on themanagement and use of thestockpile.

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,http://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 2007http://who.int/vaccine_research/diseases/influenza/meeting_stockpile.WHO in collaboration with Gates Foundation and Oliver Wyman evaluated differentoptions for logistical design of the WHO international H5N1 vaccine stockpile andassociated trade-offs, strategies and mechanisms for funding the stockpile(http://www.who.int/csr/disease/influenza/H5N1_Stockpile_Design_Feb2009.pdf). SAGEworking group on H5N1 vaccine, after evaluating the available evidences, 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. (http://www.who.int/wer/2009/wer8424.pdf).

25 Nov 2009 Influenza WHO should support R&D forpandemic and seasonal vaccines,including alternative and moreeffective methods of vaccinedelivery.

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. It includes R&D aspects as well.Update for 2008/2009: 1). Funding received to support influenza vaccine development indeveloping countries: based on individual progress reports, six such manufacturersreceived installments of these seed grants which support in country influenza vaccineproduction capacity building. 2). Meeting was held in December 2007 on seasonal andpandemic candidate vaccines in preclinical and clinical stage which potentially elicitbroad spectrum and long lasting immune responses. A peer-reviewed meeting summarywas published in the journal Vaccine, in March and May 2008. 3). A meeting was held inFebruary 2008 to evaluate the progress on clinical trials with pandemic prototypevaccines. A summary was published in Vaccine. The next (5th) clinical trial meeting onprototype pandemic meeting was held in February 2009. 4). A workshop was held inSeptember 2008 addressing the role of neuraminidase in vaccination. Report wassubmitted to peer reviewed journal. 5).The GAP advisory group evaluated the two-yearprogress in November 2008. 6). A second grant package was secured during the fall of2008 for continuation of the earlier vaccine production capacity building grants. Inaddition new developing country manufacturers were invited. Announcements of list ofgrantees followed in February 2009: besides the six old grantees five additionalapplicants receive WHO funding. Contracts were finalized during the Spring of 2009.

20 Jan 2010 Influenza SAGE recommended to theDirector-General that WHO shouldestablish mechanisms for ensuringaccess to pandemic vaccine,should a pandemic be declared bythe Director-General, fordistribution to developing countrieswithout influenza vaccineproduction capacity or resources topurchase such vaccines.

Action Apr 2007 Ongoing The WHO guidelines for the deployment of a pandemic vaccine has been field tested inEgypt in early 2009. The Guidelines stipulate that EPI logistic system should be thetemplate for the rapid delivery of a pandemic influenza vaccine. In the first phase of theGlobal Action Plan to increase the access of influenza vaccines, WHO has supported sixdeveloping country vaccine manufacturers for development of their capacity forinfluenza/pandemic influenza vaccine production, which ultimately increases the accessto vaccines in developing countries. WHO IVB/IVR has started supporting another 5vaccine manufacturers in developing countries for the second phase. Support for the firstphase grantees will be continued for the second phase also.

of 1912 April 2010


25 Feb 2010 Influenza WHO should ensure that there isunrestricted sharing of samplesand 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.

26 Mar 2010 Influenza WHO should collaborate withexpert groups to model the impactof different vaccination strategiesin pandemic control.

ActionResearch

Nov 2005 Ongoing 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 reportwas published in WER (No. 34, 2009, 84, 341352, http://www.who.int/wer) whichsummarizes discussions held at the meeting and presents some preliminary results ofongoing modeling of the pandemic H1N1 2009. Members of the WHO mathematical modelling network have been active in researchingthe transmission dynamics of the pandemic in their respective countries, evaluating theimpact of interventions (e.g., school closure, antiviral use) and optimal vaccinestrategies. Results of ongoing and finished work have been shared with WHO. Inaddition, the network has generated several publications. Recent publications include: anupdate on transmission characteristics published in the 13 November issue of the WER(Vol 84(46) 2009, pp 477-484, www.who.int/wer); and a paper—describing six publichealth challenges (measuring age-specific immunity to infection; accurately quantifyingseverity; improving treatment outcomes for severe cases; quantifying the effectiveness ofinterventions; capturing the full impact of the pandemic on mortality; and rapidlyidentifying and responding to antigenic variants) and highlighting the need for serologicstudies for public health decision making—has been published on PLoS CurrentsInfluenza (available at: http://knol.google.com/k/maria-van-kerkhove/studies- needed-to-address-public-health/agr0htar1u6r/ 18?collectionId=28qm4w0q65e4w.1&position=11). This is currently under review atPLoS Medicine. An analysis of the "Global Mitigation of Pandemic Influenza A (H1N1)with Vaccines" is currently being conducted in collaboration with IVR/IVB and is expectedbefore the next SAGE meeting.

of 1912 April 2010


26 Mar 2010 Influenza WHO should pursue its efforts instrengthening the capability indeveloping countries of healthministries and national regulatoryauthorities to facilitate themovement of samples and toensure prompt registration ofpandemic 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.

26 Mar 2010 Influenza WHO should ensure that theexpertise in rapid mobilization formass 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(NDP)including the compliance of other criteria as requested by the D-G. 27/95 countries have submitted their NDP at the time of this update. The bulk the countries are in the Region for Africa. Of the 45/46 countries thatparticipated in the AFRO workshops which were conducted in late November 2009 onlytwo countries have submitted their plans with one country indicating that they weregrateful of D-G's offer but stated that they were not interested in the donation. The delaysin the submission of the NDP maybe attributed to: 1) the time required by each MoH tofinalize the draft of their NDP and 2) the time required by each government to endorsethe NDP prepared by their MoH. It is expected that by the time the SAGE meets in April 2010 that the remaining countrieswill have submitted their NDP. At the time of the submission of this update, it is doubtfulthe Organization will deploy all of the originally estimated donation of H1N1 influenzavaccine (200 million doses) because of the donors waning interest to provide funds tocover in country deployment operations.

of 1912 April 2010


09 Apr 2010 Influenza SAGE agreed to review availableinformation for it to provide anopinion on: 1) use of H5N1influenza vaccine in theinter-pandemic period; 2) use ofH5N1 influenza vaccine in high riskgroups - incl. vaccine reaching endof 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.

25 Nov 2009 Japaneseencephalitis

SAGE looked forward to betterassessment of the disease burdenand identification of targetpopulations for immunization andto reviewing the regional JE controlgoal currently under developmentand the activities to achieve thisgoal.

Action Nov 2008 Ongoing Efforts are underway to develop a bi-regional JE control strategy to be initially reviewedby regional TAG's, and having a strong surveillance component. A meeting in February2009 between technical partners (WHO, UNICEF, CDC, PATH) did recommend thecreation of a time-limited "JE-control coalition" for technical coordination and fundraisingin support of a JE control strategy. Planning and fundraising efforts ongoing.

25 Nov 2009 Japaneseencephalitis

Interference with the immuneresponse to other vaccinations,number of doses required and theduration of protection need to beassessed.

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. Other issues pending. With on-going discussionson a JE control strategy, pending issue in relation to the JE vaccine needs to addressed.Potential need for discussion at SAGE when new information becomes available. No newdata for discussion at this stage.

of 1912 April 2010


22 Mar 2010 Japaneseencephalitis

Commercial kits for detection of JEspecific IgM assessed andvalidated.

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 will be evaluated by the Lab working group shortly after all testing iscompleted. A meeting of the JE Laboratory working group was held in Geneva, 9October 2009 to discuss the JE assay assessments and future development of the JELabNet. A paper summarizing the development of the JE LabNet is in the final editingstage and will be submitted 2nd quarter 2010.

19 Mar 2010 Malaria SAGE indicated that furtherdiscussion on the optimal schedulefor a malaria vaccine will need tooccur during the evaluation.

Action Oct 2009 Pending

01 Dec 2009 Measles mortalityreduction

SAGE encouraged a carefulanalysis of the challenges facingthe end stages of polio eradicationas part of the work to assess thefeasibility of measles eradication.

Action Oct 2009 Ongoing

10 Feb 2010 Measles mortalityreduction

The secretariat will report back toSAGE on the outcome of theJanuary 2010 Executive Board aswell as the results of the ongoingstudies relating to the impact onhealth systems and estimatedcosts of measles eradication.

Action Oct 2009 Ongoing The January 2010 Executive Board noted the measles report which laid out 2015 globaltargets as milestones to the eventual eradication of measles. The EB requested additionof preliminary cost information related to achievement of the 2015 targets andsubmission of the updated report to the World Health Assembly in May 2010.

12 Feb 2010 Measles mortalityreduction

Undertake work to prepare fordiscussions on the feasibility of aglobal 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 (written report stillpending); 3) each of the 6 WHO regions has conducted an assessment of theprogrammatic feasibility; 4) data collection is ongoing for the studies of the cost andcost-effectiveness, and impact on health systems; 5) a contractor has been identified toconduct a post-eradication risk assessment; and 6) terms of reference for a consultant toassess the global context have been developed (contract still to be awarded). Tentativedates have been identified for a global consultation (29-30 July 2010) to review allaspects of the feasibility of measles eradication. The report from this consultation will besubmitted to SAGE.

of 1912 April 2010


19 Mar 2010 Meningitis SAGE recommended that theimpact of inter-African migration onthe occurrence of meningitisshould be monitored.

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.

26 Mar 2010 Meningitis Vaccine supply of meningococcalpolysaccharide vaccines, 2010epidemic season.

Action Apr 2007 Ongoing Meninigitis 2010 epidemic season is just starting. Global availability of MeningitisMeningococcal Polysaccharide vaccines for the epidemic season 2010 will be between20 to 23 million doses. International Coordinating Group (ICG) stockpile under contractis: 3 million doses Bio-Manguinhos and 3 million from Sanofi-Pasteur of men AC and 2.7million doses from GSK of Men ACW. The total ICG stockpile for 2010 season is 9,7million doses. It may not be necessary to use a fractionated dose of Ps AC vaccine,however it is always a valid alternative if a large epidemic occurs and vaccine supply isnot enough to meet the demand.

12 Feb 2010 Mumps WHO secretariat to collaboratewith industry to increase globalavailability of MMR vaccines thatcontain strains of mumps vaccineswith best safety profile.

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.

19 Mar 2010 Pertussis control SAGE requested information onefforts being taken to achievepertussis control.

Action Nov 2008 Ongoing SAGE pertussis working group established. This will impact on Discussions on pertussiscontrol at the AMR TAG meeting which took place in August 2009. Discussion and initialconclusions and rcommendations at the October 2009 SAGE meeting. The workinggroup met again face-to-face on 15-16 February 2010 to prepare for final review ofrecommendations at the April 2010 SAGE meeting. Publication of the updated pertussisvaccine position paper is scheduled for 1 October 2010.

19 Mar 2010 Pertussis control SAGE supports expanding thecurrent efforts of the Child HealthEpidemiology Reference Groupand the Pneumonia EtiologyResearch for Child Health tofurther demonstrate the burden ofinfant disease and mortality due topertussis in developing countries.

Action Oct 2009 Ongoing 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 case, which will provide additional inputs on the contribution of B. pertussisto atypical presentations such as pneumonia (where classical manifestations of pertussisare absent).

26 Mar 2010 Pertussis control Pertussis surveillance and controlneeds to be raised and placed theresponsibility on the Regions tomake 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.

of 1912 April 2010


04 Feb 2010 Polio The major process and outcomeindicators of the Programme ofWork should be internationallymonitored as a basis for tailoringstrategies but also, if needed,facilitating 'go/no-go' decisions bythe end of 2011.

Action Oct 2009 Ongoing Senior management of GPEI reviewing options for decision May 2010 WHA.

04 Feb 2010 Polio SAGE reiterated the need forenhanced routine andsupplementary polio immunizationactivities with high qualitysurveillance for acute flaccidparalysis.

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

04 Feb 2010 Polio SAGE strongly supported theproposal for an enhanced researchagenda. SAGE agreed that bOPVwas likely to be an important newtool for polio eradication andsupported its rapid scale-up.

Action Oct 2009 Completed Afghanistan became the first country to use bOPV in December 2009. bOPV will havebeen used in SIAs globally by mid-2010.

04 Feb 2010 Polio SAGE agrees with the proposal forrecommendations on the use ofIPV in low-income settings in thepost-eradication era to be issued inApril 2011.

Action Apr 2009 Ongoing During the April 2010 meeting, the Working Group Chairperson will give a short updateon current work towards preparing the suggested post-eradication IPV policyrecommendations

19 Mar 2010 Polio SAGE stated it would review thespecific wording of the draft WHOPosition Paper on Routine PolioImmunization in advance of itsfinalization.

Action Oct 2009 Ongoing The draft was circulated to SAGE members and will be discussed at the April meeting.

19 Mar 2010 Polio SAGE noted that high priority mustbe given to translating therecommendations of theIndependent Evaluation and recentclinical trial results into a new,three-year Programme of Work forInterrupting Wild PoliovirusTransmission and agreed toparticipate in its review, finalizationand monitoring, particularly byfocusing future SAGE poliosessions on areas or countrieswhere progress is faltering.

ActionAgenda item

Oct 2009 Ongoing The 3-year Programme of Work to be shared with SAGE at the April 2010 meeting.

09 Apr 2010 Polio SAGE requested that it beinformed of the outcomes of thedeliberations between WHO andits GPEI spearheading partners.

Information Oct 2009 Ongoing The minutes of the GPEI will be shared with SAGE.

of 1912 April 2010


26 Mar 2010 Polio SAGE urged the Global PolioEradication Initiative (GPEI) torapidly consider the newrecommendations, including theimportant role fornon-governmental organizations indifficult-access districts and thetargeted use of IPV in areas ofcompromised OPV efficacy.

Action Oct 2009 Completed The Programme of Work 2010-12 highlights district-specific planning with key roles forNGOs in the districts with difficult access; a trial of IPV vs. bOPV impact on mucosalimmunity is planned for India in 2010.

26 Mar 2010 Polio SAGE recommends that themathematical model(s) ofpost-eradication risks be evaluatedby Quantitative Immunization andVaccine Related ResearchAdvisory 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.

09 Apr 2010 Polio WHO position paper on poliovaccine to be published in April2010.

Action Apr 2009 Ongoing The position paper has been drafted and the draft will be submitted to SAGE fordiscussion at the April 2010 SAGE meeting with a view to publish the position paper on 4June 2010.

09 Apr 2010 Polio SAGE requested furtherstrengthening of the position paperto emphasize the importance of afull-OPV schedule both to interruptwild poliovirus transmission andreduce the risk of consequences ofimportations into high riskcountries.

Action Oct 2009 Ongoing Addressed in the draft position paper.

24 Nov 2009 Prequalification ofvaccines

SAGE urged WHO to developappropriate capacity building toolsto provide tech. support to dev.country NRAs that have limitedskills to evaluate the qualitycomponent 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.

05 Feb 2010 Prequalification ofvaccines and NRAstrengthening

SAGE strongly endorsed work onprequalification of vaccines andNRA strengthening and stressedneed to ensure work continues athigh professional standards.

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 process is planned for April 2010. Discussion item atApril 2010 SAGE meeting.

24 Mar 2010 Reports from otheradvisory committeeson immunization

WHO and NIBSC should developwith other stakeholders, abusiness plan to assure long-termsecurity of global public healthresource and additional efforts beundertaken to disseminateoutcomes of the committeesdeliberations and to explain therelevance of its work to thebroader immunization community.

Action Nov 2006 Ongoing Business plan under development; new communication tool widely disseminated afterlast ECBS meeting. Broad communication strategy for the normative work of WHO underdevelopment. A comprehensive review of the work of the ECBS is planned for 2010. Thereview will include (but not be restricted to) consideration of communication of ECBSoutcomes.

of 1912 April 2010



SAGE to provide continuousoversight of work on immunizationsafety (in view of termination ofsteering committee ofimmunization 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.


Efforts needed to ensure GACVSconclusions & recommendationsare disseminated to regionaltechnical advisory groups andnational health authorities.

Action Nov 2006 Ongoing GACVS recommendations are published in the WER soon after each meeting of thegroup and posted on the GACVS website with additional material. Systematic effortshave been made to disseminate meeting reports widely, through the GlobalImmunization News newsletters, eCluster briefings (internal high level WHOdissemination mechanism), WHO Pharmaceuticals newsletter, and the EuropeanCenters for Disease Control Newsletter with extensive email distribution. Furtherdissemination through regional newsletters and Vaccine Weekly have been attempted. In2009, dissemination was not undertaken to the same extent as in previous years due toreassignment of responsible staff to other projects. Steps are being taken in early 2010,however, to address these gaps and improve on previous practice.

26 Mar 2010 Reports from otherimmunization-relatedAdvisoryCommittees

SAGE supported WHO's decisionto change the TLAC mandate.

Action Oct 2009 Ongoing Process to establish new committee is ongoing, will be finalized after the April SAGEmeeting. Meeting of the Immunization Programme Advisory Committee (IPAC)scheduled for 28-30 June 2010.

29 Jan 2010 Rotavirus SAGE recommends that the firstdose of either RotaTeq or Rotarixbe administered during the periodwhen the infant is aged 6 weeks to15weeks. The maximum age foradministering the last dose ofeither vaccine is recommended tobe 32 weeks. Thisrecommendation is made pendingreview and concurrence byGACVS.

Action Apr 2009 Completed GACVS reviewed and supported SAGE recommendations at its June 2009 meeting. Anupdate to the WHO rotavirus position paper was published on 18 December 2009.

19 Mar 2010 Rotavirus In countries where rotavirusvaccines are introduced, clearcommunication strategies beimplemented to preventmisconceptions regarding theefficacy of rotavirus vaccines toprevent all childhood diarrhoea.

ActionResearch

Nov 2005 Ongoing Two rotavirus vaccines are commercially available and WHO pre-qualified.Rotarix™(GSK) and Rotateq™ (Merck) are now recommended for use in all routineinfant immunization programmes. Support from the GAVI Alliance for their introduction inGAVI-eligible countries became available in 2007. Thus far, 19 countries are using thisvaccine in their national immunization programmes and 5 countries from Latin Americaand the Eastern Mediterranean Regions are introducing in 2009. Vaccine safetymonitoring has focused on occurrence of intussusception among children vaccinatedbefore and after six months of age and GACVS has recently reviewed the evidence andconcluded that these vaccines are safe and that an intussusception risk of the order ofthat which had been associated with Rotashield® can be ruled out with confidence.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 have been discussed at the April 2009 SAGE meeting, and data from RotaTeqtrials in Mali, Ghana, Kenya, Bangladesh and Viet Nam at the October 2009 SAGEmeeting.

of 1912 April 2010


19 Feb 2010 Surveillance SAGE supported the EuropeanTechinical Advisory group ofExperts (ETAGE) recommendationthat the European Centre forDisease Control (ECDC) and WHOto set up a common surveillanceplatform for measles.

Action Oct 2009 Ongoing

10 Mar 2010 Surveillance SAGE requested to receive areport on how surveillancenetworks are being reinforced incountries and regions.

Action Apr 2008 Ongoing Transition of selected ADIP/Hib initiative supported surveillance sites to WHOcoordination is now in its final stages. The following were the main activities conducted:Contracts with sites which have been identified for transition into WHO coordination havebeen completed. Surveillance data collection, sharing and reporting has beenstandardized; and the revision of Standard Operating Procedures, case report forms anddatabases is ongoing. Update of case reporting forms of transitioned sites has beeninitiated. Installation, training and implementation of the updated WHO-New VaccineSurveillance database has been initiated in transitioned sites. A layered approach tosurveillance has been established: layer 1 is core surveillance taking place at hospitalsentinel sites (1 per country) for bacterial meningitis and severe diarrhoea, layer 2 isadded surveillance at additional select sites for invasive bacterial disease (bacteraemicpneumonia/sepsis, 1 site for every 3 countries), and layer 3 is enhancedpopulation-based surveillance" to determine incidence of IBD and rotavirus diarrhoea (atleast 1 site per region). Identification of population based surveillance sites and itsincorporation into the network is ongoing in AFRO and SEARO. The planned expansionof the Regional networks to GAVI eligible countries not currently conducting surveillanceactivities in each Region is being conducted. The global inventory of all existingsurveillance sites and laboratories providing support for these networks is beingupdated. Laboratory networks to support new vaccines surveillance are beingstrengthened considering a planned structure for Global Laboratory Network forRotavirus and bacterial diseases. Contracts or agreements with regional laboratorieshave been put into place for most regional offices. The newly contracted globalreference laboratory is currently working with regional offices in planning assessmentvisits to regional laboratories.

04 Feb 2010 Typhoid Need for feedback from WHO'sregional offices and countries todetermine how countries couldimplement SAGErecommendations (feed-backexpected within 12-18 months).

Action Nov 2007 Ongoing Medical officer recruited and joined IVR early July 2009 to work on follow up activties ofthe SAGE recommendation on typhoid. Since the contacts have been made with the keyregional focal points of SEAR, WPR, EMR and EUR. Also individual country contactswere made with India, Bangladesh, Sri Lanka, Bhutan, Myanmar, Nepal, Indonesia,Pakistan and Fiji. Further discussions are on-going to determine the exact countrysituation or intentions. A full and detailed report will be submitted to SAGE meeting inNovember 2010.

05 Feb 2010 Typhoid Need for advocacy andprioritization at international level.To include prioritizing WHO'sprequalification for new-generationtyphoid vaccines and the need forinternational financingmechanisms.

Action Nov 2007 Pending A regional meeting took place in March 2009 in Bangkok, organized by IVI with WHOstaff participation; an inhouse departmental meeting was held to update on progress indifferent areas. A proposal for support for a communications professional to assist theprogramme in the development of communications materials and messages and a highlevel, advocacy meeting were submitted, but so far no funds are available. At least twoproduct summary files submitted for prequalification have been examined and feedbackprovided to the manufacturers. At the global level, a loose coalition of interested partiesis being formed under the leadership of Sabin Insitute and relevant WHO focal is aparticipant. Similarly close working relations are being maintained with the InternationalVaccine Institute, Seoul, the Delivery Team at the BMGF, and advisory groups such asthe Diarrheal and Enteric Diseases Advisory Group (DEVAC). Typhoid vaccine is now recognized as a priority for prequalifcation by the relevant WHOteam.

of 1912 April 2010


09 Feb 2010 Unvaccinated infants SAGE emphasized the need toaddress the persistent challenge ofreaching children not currentlyreached by immunization services.Local level operational researchwas considered important forunderstanding and addressingthese gaps. SAGE requestedWHO to provide a plan on howthese findings can beoperationalised at local level toensure that the 24 million childrenper annum currently not benefitingfrom routine immunization are alsovaccinated.

Action Oct 2009 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 will be shared withcountries, WHO regional offices and UNICEF. The countries will be encouraged toprioritize weak areas and address local problems with appropriate solutions.

of 1912 April 2010

sage tracking record of recommendations ......coverage higher than 90% (in 2008, the reported dpt3...

Documents