AcknowledgementIt gives me immense pleasure to thank Mr Ejazur Rehman National Training CoordinatorIslamabad Merlin, Dr Wisal PMC Merlin Pehsawar and Mr Haji Mohammad BCC MerlinPeshawar for their cooperation in scheduling this training and concluding this activity of capacitybuilding in a thriving way. I am also thankful to DHO, Dr Arshad Ahmed Khan for allowing meto conduct these trainings for Merlin.AbstractThis is a training report in which the author facilitated the training on Routine EPISchedule in Pakistan with a special focus on the introduction of a new vaccine “ThePneumococcal Conjugate Vaccine PCV-10”. There were two batches in which the EPI Staff,Doctors, LHVs and Health promoters of Merlin were trained; besides this, some of the districthealth staff was also given the above mentioned training.Abbreviations Used in the ReportACI: --------------Accelerated Vaccine IntroductionAMC------------Advance Market CommitmentAEFI -----Adverse Event Following ImmunizationAFP------ Acute Flaccid ParalysisBCG -----Bacillus Calmette-GuerinCNS------ Central Nervous System
DHO------District Health OfficerDT-------- Diphtheria-TetanusDPT -------Diphtheria- Pertussis -TetanusDSC------- District Surveillance CoordinatorDSV -------District Superintendent VaccinationEDO (H) --- Executive District Officer (Health)EPI--------- Expanded Programme on ImmunizationGAVI-------Global Alliance for Vaccine & ImmunizationHIV --------Human Immune- Deficiency VirusILR--------- Ice-Lined RefrigeratorLHS ---------Lady Health SupervisorLHW -------Lady Health WorkerMO ---------Medical OfficerNGO------- Non Government OrganizationNRA------- National Regularity AuthorityOPV------- Oral Polio VaccinePCV---------Pneumococcal Conjugate VaccineSO---------- Surveillance OfficerTT ---------Tetanus ToxoidUC--------- Union CouncilVAPP----- Vaccine Associated Paralytic PoliomyelitisVPD -------Vaccine-preventable diseaseVVM -------Vaccine Vial MonitorWHO ------World Health Organization
Background• September 2009: Pakistan submitted application to GAVI for NVS supportfor Pneumococcal vaccine (PCV10)• October 2009: Independent Review Committee (IRC) of GAVI approvedPakistan’s application requesting clarification on certain issues andconforming with its conditions on co-financing• August 2010: MoH expressed its concurrence with GAVI conditions on co-financing for the PCV10• September 2010: GAVI communicated its board decision to the MoH ofapproval of Pakistans application for introduction of Pneumococcal vaccinefrom January 2011• May 2011: As per advisory shared by WHO HQ, Pakistan EPI intended tointroduce the new vaccine from 2012 after completion of the safety studies• April 2012: GAVI mission reviewed country preparation for introduction ofthe new vaccine• June 2012:• High level EMRO mission reviewed country preparation for PCV10introduction and extended technical assistance• National Immunization Technical Advisory Group (NITAG) recommendedintroduction of the new vaccine in the country in a phased manner starting• from 15 September 2012 in Punjab province
Pneumococcal conjugate vaccine, 10-valentGlaxoSmithKline launched a 10-valent PCV (PCV10) in Europe in 2009. PCV10 is aliquid vaccine in a novel presentation, as it is supplied in a 2 dose vial without preservative.Therefore, both doses are intended to be used within 6 hours of the vial being opened. Thispresentation requires that staff is trained to ensure that the vaccines are used safely - i.e.technique to be used to withdraw multiple doses from one container, how to handle vials, and todiscard unused doses after 6 hour maximum from extraction of the first dose. The 2 dosepresentation obtained WHO prequalification on 12 March 2010. However, due to the novelty ofits presentation, the pre-qualification was first limited to Kenya until successful completion of a12 months assessment of programmatic issues in two demographic surveillance sites. On 16April 2010, the AMC Independent Assessment Committee (IAC) reviewed GSK’s applicationfor AMC eligibility and deemed that the candidate vaccine was eligible for purchase pursuant tothe terms and conditions of the AMC. Notification of the decision was sent to the supplier with acopy to UNICEF Supply Division on 6 May 2010. UNICEF Supply Division was thus able tostart the procurement of PCV10 to Kenya in September 2010 . Based on information onavailability of additional supply early 2011, the WHO Quality Safety and Standards (QSS) team– responsible for the prequalification process – set up a committee to assess the possibility toextend PCV10 use to countries other than Kenya, prior to data from the use of the novelpresentation becomes available. The Committee approved the use of PCV10 to other countriesprovided that the following criteria are met by the supplier and recipient countries:• Specific labeling indicating in red text "Discard open vial after 6 hours";• Cooperation with and support for WHO EPI group on development and implementation of atraining program for and supply of materials to immunization staff;• Cooperation with and support for WHO EPI group to monitor the introduction of the vaccinethrough repeated cluster sampling surveys followed by a complete Post-IntroductionEvaluation;• Implementation of a Phase IV study to monitor Adverse Events following Immunization(AEFIs) associated with potential mishandling of the product. Ethiopia has expressed interest inestablishing such structure to allow introduction of PCV10 in 2011. WHO is working closelywith the country to support them to realize their plans.Vaccine uptake in country is subject to both increases and decreases. A close monitoring of thesupply and demand situation is required in order to ensure the sustainable supply to all countriesupon introduction. This is especially important considering the uncertainties with regards tocountry requirements in the early years due to timing of actual introduction and uptake rates aswell as long manufacturing lead-times of pneumococcal vaccines. Since the time of signature ofSupply Agreements in March 2010, GlaxoSmithKline and Pfizer have offered to increase the
quantities originally made available for 2011-12 during the AMC Capacity Development Period9. Basedon actual country requirements, such additional quantities may be accepted and Agreements amendedaccordingly. As of GAVI-eligible countries approved for the introduction of PCV to date, 19 countrieshave been approved for the introduction of pneumococcal vaccines with GAVI support. 13 countries wereapproved by the GAVI Board as of June 2009-10. In addition, the EC approved the following countriesduring its meeting in August 2010: Benin, Burundi, Ethiopia, Madagascar, Malawi, and Pakistan. Fivecountries received a recommendation for conditional approval from the IRC and will be required to replyaddressing the conditions during the May application round order to receive a final recommendation forapproval.Coordination of introductionsIn September 2010, GAVI set up the Pneumo Ad-hoc introduction group to ensureoptimal coordination around the roll-out of PCV. The group is constituted by UNICEF, WHO,PATH and the GAVI Secretariat to ensure day-to-day operational coordination and informationsharing during the initial years of PCV introduction in GAVI-eligible countries. Under theSecretariat’s leadership, the Pneumo Ad-hoc introduction group has proactively worked withcountries to facilitateIntroduction of PCVConsidering the immediate anticipated high demand for PCV and taking into account ananticipated constrained supply situation in the early years, an analysis was conducted to developan interim procedure to allocate PCV vaccines between countries in case of limited supply anddifferences between available products and country product preferences. The goal of thisprocedure is to ensure a transparent, efficient allocation of PCV vaccines and products in case ofinsufficient supplies. The output of the procedure is a ranking of GAVI approved countries toinform the sequence in which countries will receive scarce PCV products. This procedure isavailable upon request.Status of deliveriesThe first shipment of AMC pneumococcal vaccines was delivered in Kenya in September2010. As of 31 March 2011, UNICEF SD performed a total of 31 deliveries of PCV to ninecountries. The overall number of doses delivered totaled 6.9 million. Six of the 19 approvedcountries introduced PCV in this reporting period. Nicaragua was the first country to roll-outpneumococcal vaccines (in December 2010) followed by Guyana, Kenya, Sierra Leone, Yemenand Mali. An additional nine of the currently approved countries are expected to introduce PCVwithin the next four months and four late this year or early 2012
The AVI DashboardIn order to better monitor country readiness and required partner activities in support ofnew vaccines introductions, the Pneumo Ad-hoc introduction group developed and piloted adashboard. The dashboard intends to provide a clear and concise view of the status of countryreadiness for vaccine introduction in each country and to help identify critical areas requiringpartner attention or action to support introduction in country.The dashboard is divided into three main sections to determine:• The availability of financial resources – information provided by GAVI• Supply considerations – information provided by UNICEF• Countries ‘readiness – information provided by WHO, GAVI and UNICEFIn October 2009, the Governments of five countries (the United Kingdom, Norway, theNetherlands,Canada, and Liberia) and the Millennium Foundation addressed a formal request to GAVI andthe World Bank to jointly engage in exploratory work on a second AMC for vaccines. Inresponse to this request, GAVI and the World Bank jointly developed a concept paper describinghow to move forward.However, while the potential value of an AMC was recognized by GAVI, the Executive Teamdecided in June 2010 to postpone initiation of work due to the funding challenge and uncertaintyabout GAVIs ability to fully fund demand for vaccine roll-out beyond existing commitments. Inaddition, the impact of the pneumococcal AMC and its cost effectiveness compared to othermechanisms had not yet been evaluated. Following GAVI’s pledging conference in June 2011,the concept paper will be revisited by GAVI senior management.The AMC Independent Assessment CommitteeThe IAC serves a number of key functions. Most importantly, it has the mandate toreview and approve the minimum technical requirements (TPP) that candidate products mustmeet to be eligible for AMC funding. In addition, the IAC establishes when and if an adjustmentof the pre-set long-term price of vaccines is necessary.AMC Eligibility Determination MeetingsOn 15 January 2010, Pfizer applied for AMC eligibility for PCV13 while GlaxoSmithKline submitted anapplication for PCV10 on 9 March 2010. Following WHO’s confirmation of prequalification of eachproduct, the AMC Secretariat organized two AMC Eligibility Determination meetings to review thoseapplications.
PCV10 - 2 dose presentationPCV10 in 2 dose presentation obtained WHO prequalification on 12 March 2010. TheIAC met by teleconference on 16 April 2010 and unanimously determined that PCV10 meets allof the TPP criteria and that the candidate vaccine is therefore eligible for purchase pursuant tothe terms and conditions of the AMC for pneumococcal disease16. The decision wascommunicated to the supplier on 6 May 2010.AMC Baseline StudyFollowing the publication of the AMC Monitoring and Evaluability Study 20 inNovember 2008, the Secretariat commissioned the Swiss Centre for International Health (SCIH)in 2008 to conduct an AMC Baseline Study This study represented the first step in themonitoring and evaluation of the pneumococcal AMC. The goal of the study was to establish theenvironment prior to the AMC as a basis for future evaluations. The study identifies indicatorsrelated to the objectives of the AMC and populates them with baseline estimates which willdetermine the point of comparison for future Monitoring and Evaluation (M&E) activities. Thestudy also models counterfactual scenarios to serve as a basis for ascertaining the potentialimpact of the AMC vis-à-vis traditional financial and procurement strategies.The AMC SecretariatThe AMC Secretariat is hosted by the GAVI Alliance and is responsible for providingoperational, administrative and financial support to the pneumococcal AMC. This includescoordinating with the World Bank, UNICEF Supply Division and WHO, and liaising with AMCdonors. The AMC Secretariat also manages the overall payment mechanism, in accordance withthe terms of the AMC Supply Agreements, and implements GAVI’s co-financing and defaultpolicy according to standard GAVI practice. As the AMC is now in the implementation phase,the AMC Secretariat has been integrated with the Accelerated Vaccine Introduction (AVI)initiative which is responsible for coordinating the roll-out of all new vaccines. The GAVISecretariat leads the AVI through a cross function management model, with team members fromWHO, UNICEF, PATH and the Bill & Melinda Gates Foundation. The AMC Secretariat istherefore involved in all activities linked to the introduction of pneumococcal vaccines and leadsthe Pneumo Ad-Hoc introduction Group. Progress on AMC related activities is reported to theAVI management team on a weekly basis.In addition, the AMC Secretariat organized the first AMC Stakeholders Meeting on 17 June2010. As per the AMC legal agreements, the second AMC Stakeholders meeting will beorganized in July 2011 –at the same time as the GAVI first Board Meeting of the year.
Monitoring and Evaluation ProcessesThe AMC Baseline Study developed a methodology to be used in future AMC M&Eactivities, including a list of defined indicators, a methodology for data collection at the countrylevel and at the industry level. The study also defines the counterfactuals which will be used toevaluate the impact of the pilot. The report includes insights to help future M&E efforts ingeneral and is linked to the availability and reliability of data collected. In particular, it notes theavailability and difficulty of access for industry data. The AMC Baseline Study was published onthe AMC website on 10 December 2010.Media and Communications2010 represented a pivotal year in the AMC’s development and implementation with thecelebration of the first introduction of AMC pneumococcal vaccines in GAVI countries.Communications activities were undertaken in partnership with the AMC donors, the WorldBank, UNICEF and WHO. GAVI’s communication objectives for the pneumococcal AMC wereto:• inform and educate target audiences about the AMC;• increase the promotion of the AMC as an innovative market-based approach;• mitigate criticism of the AMC in the press;• celebrate the first introductions of pneumococcal vaccines in GAVI-eligible countries.The following activities were employed to achieve the communication objectives:Materials developmentExisting communication materials were updated and re-designed in 2010 in order toprovide a suite of materials tailored to the needs of various target audiences and also provide anongoing means of managing communication with key AMC stakeholders. These materials areavailable both on the GAVI22 and AMC websites23 and in hard copy. They include:• “All in one” AMC Fact Sheet provides: general information about the AMC fundingmechanism; answers to the most commonly asked questions about AMCs; detailed informationabout the AMC process and the key stakeholders involved in the pilot; advice and guidance todeveloping countries seeking to accelerate access to new and affordable vaccines.• Global Pneumo Fact Sheet provides: information about pneumococcal disease; the latestgeneration pneumococcal vaccines tailored to the needs of children in developing countries;explains the potential impact of pneumococcal vaccines if rolled out in more than 40 countries.
• Pneumo Fact Sheet in Kenya provides: information about pneumococcal disease and the burdenof pneumonia in Kenya. It also introduces the potential of the pneumococcal vaccines reachingKenyan children. These publications are currently available in English, and will be available inFrench in 2011.Media relationsThroughout 2010, GAVI’s Media and Communications team has continued to workproactively on strengthening media relations with key reporters to promote AMC stories in keymedia outlets. During the period covered by this report, more than 100 articles featuring or citingthe AMCs and/or the AMC pilot were published in English. Between June 2010 and March2011, three specific events featured the AMC, namely World Pneumonia Day, the pneumococcalvaccine roll-out in Latin America, and the global roll-out of pneumococcal vaccines in Kenya.General objectives of the training• Provide TOT to the officials nominated by the districts & NGOs for training ofvaccinators and other EPI staff at district level on– Pneumococcal vaccine introduction and– Immunization basics• The TOT will be conducted for three days in batches• At the end of the TOT, trainers will be identified through a rigorous selection processwhich includes,– Objective assessment of knowledge on the subject through a formal Post-trainingevaluation– Subjective assessment of personal attributes• Punctuality, timely attendance in the TOT• Attentiveness, interest in the subject and enthusiasm• Active participation in the training• Capacity to express and communication skill of the individual
Specific objectives of the training• At the end of training, the participants will know– The new schedule of EPI childhood immunization– Protocol for pneumococcal vaccine administration– Fundamentals of the vaccines and logistics used in EPI– Safe vaccine handling and injection safety– Adverse Events Following Immunization (AEFI)– Cold chain– Recording and reporting– Basic calculations for EPI– Social mobilization & advocacy for the new vaccine andimmunizationSpecific objectives of the training• At the end of training, the participants will know– The new schedule of EPI childhood immunization– Protocol for pneumococcal vaccine administration– Fundamentals of the vaccines and logistics used in EPI– Safe vaccine handling and injection safety– Adverse Events Following Immunization (AEFI)– Cold chain– Recording and reporting– Basic calculations for EPI– Social mobilization & advocacy for the new vaccine and immunization
Agenda of TrainingAgenda for Day-1Launching of New Vaccine in Routine EPI SchedulePneumococcal Vaccine PCV-10Day: 1===========================================================9:00 – 9:45 am Introduction• Recitation• Introduction• Registration and Pre Test===========================================================VPDs, Vaccines and their schedules in EPI Pakistan9:45 – 11:30 am Topic 01: Immunization Basics• What is Immunity• What is antigen• What is B-Cell & T-Cell Response• What is a Conjugate VaccineTea Break===========================================================11:30 – 1:30 pm VPDs
• What are the Vaccine Preventable Diseases• Routine EPI Vaccine in Pakistan & Their Schedule• What is PCV-10• What Diseases are prevented byPCV-10• What is PVC-10 ScheduleLunch Break & Prayer===========================================================2:00 – 2:30 pm Vaccines, injection equipments and other logistics required forvaccination session• Use of Tally Sheets, EPI Card and Registers• Use of safety boxes• Safe vaccine handling• Safe vaccine handling===========================================================Agenda for Day-2Launching of New Vaccine in Routine EPI SchedulePneumococcal Vaccine PCV-10Day: 2
==========================================================9:00 – 9:30 am Recap of Day 1==========================================================Adverse Effects Following Immunization (AEFI)9:30 – 11:30 am Topic 01: AEFI• Introduction & definition• Correct injection Techniques• Special Care in Some vaccines• Some important anatomical sites regarding injectingvaccinesWorking Tea===========================================================11:30 – 1:30 pm Topic 02: Cold Chain• Differences in ILRs & Domestic Refrigerators• Heat resistant & cold resistant vaccine• Doses of various vaccinesLunch & Prayer Break===========================================================2:15 – 3:00pm Topic 03:• Record Keeping and Reporting• Video on injection Techniques===========================================================
Agenda for Day-3Launching of New Vaccine in Routine EPI SchedulePneumococcal Vaccine PCV-10Day: 3===========================================================9:00 – 9:30 am Recap of Day 2===========================================================EPI Calculations9:30 – 11:30 am Topic 01: Diarrhea• What is data• What is numerator & Denumerators• What is proportion, Ratio and percentage• What is Mean ,mode and Median• How to calculate ratesTea Break===========================================================11:30 – 1:30 pmTopic 02: Social Mobilization & Advocacy• What is IPC
• How IPC can be used in EPI• Group Communication• Post Test• Concluding Remarks and Participants FeedbackLunch and Prayer===========================================================2:00 – 2:45pm Certificate Distribution• Certificates Distribution• End of the Training