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Vaccination in acute humanitarian emergencies: implementation guide

14 août 2017 Organisation mondiale de la santé

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WHO/IVB/17.13

Vaccination in Humanitarian Emergencies I M P L E M E N TAT I O N G U I D E

WHO/IVB/17.13

Vaccination in Acute Vaccination in Humanitarian Emergencies M EIW KUF I M P L EA MF ER NA TAT OO NRG IO DR E DECISION MAKING

This document was developed and published by the Department of Immunization, Vaccines and Biologicals (IVB) with the input by the departments of Essential Medicines and Health Products (EMP) Emergency Risk Management and Humanitarian Response (ERM); and Pandemic and Epidemic Diseases (PED) and by partners received during 2 multi-stakeholder meetings and from peer-review. Ordering code: WHO/IVB/17.13 Published: July 2017 This publication is available on the Internet at: www.who.int/vaccines-documents/ Copies of this document as well as additional materials on immunization, vaccines and biologicals may be requested from: World Health Organization Department of Immunization, Vaccines and Biologicals CH-1211 Geneva 27, Switzerland • Email: vaccines@who.int • © World Health Organization 2017 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 licence (CC BY SA-4.0; https://creativecommons.org/licenses/by-nc-sa/4.0/ ). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. Vaccination in acute humanitarian emergencies: Implementation Guide. Geneva, Switzerland: World Health Organization; 2017. Licence: CC BY SA-4. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use.

TABLE OF CONTENTS Preface��VI Abbreviations and acronyms��VII I. Introduction�� VIII 1. Background information�� VIII 1.1 Definition of an acute humanitarian emergency situation��VIII 1.2 Purpose, operational objectives and scope of this guide ��IX II. Architecture of the operational response structure��1 2. Establishment of the Immunization Task Force ��1 2.1 ITF structure: leadership and membership�� 2 2.2 ITF functionality�� 2 2.3 ITF interactions and coordination�� 4 III. Planning and implementing vaccination services in a humanitarian emergency�� 7 3. Decision on use of vaccines in humanitarian emergencies�� 7 3.1 Situation analysis – National Immunization Programme assessment�� 8 3.2 Integration of vaccination service delivery with other services�� 9 4. Planning for vaccination services in a humanitarian emergency�� 10 4.1 Macroplanning��10 4.2 Microplanning��11 4.3 Vaccine supply �� 13 4.4 Cold Chain�� 14 4.5 Logistics�� 15 4.6 Demand-related and community-based interventions�� 17 5. Implementing vaccination services in a humanitarian emergency�� 18 5.1 Securing access�� 18 5.2 Strategies for vaccination service delivery�� 20 5.3 Vaccination schedule��23 5.4 Monitoring, evaluation and supportive supervision��23 6. Exit strategy and early recovery of routine vaccination services�� 27 Annex 1: Template of a micro plan (preliminary version to be tested in the field)�� 28 Annex 2: Mapping of international entities active in supply of vaccines in humanitarian emergencies�� 39

PREFACE Vaccine-preventable disease (VPD) outbreaks occurring in recent humanitarian emergencies highlighted the need for a comprehensive and evidence-based decision-making framework for vaccination in humanitarian emergencies. In 2013, “Vaccination in acute humanitarian emergencies: a framework for decision making” was developed and disseminated by the World Health Organization (WHO).1.2 Through a series of consultations with partners in 2016 the following has been accomplished: (i) “Vaccination in acute humanitarian emergencies: a framework for decision making” (hereafter referred to as Framework) has been revised and updated, and (ii) “Vaccination in humanitarian emergencies implementation guide” (hereafter referred to as Implementation Guide) has been developed. These two guidance documents provide a complementary package. In addition, a set of interactive tools is being developed to facilitate the use of this package and to keep its content up to date. Lack of access to vaccination services in acute or protracted conflicts and humanitarian emergencies represents an important and growing reason for stagnating vaccination coverage. Delivery of immunization services in such settings presents many challenges. In order to benefit from the vast experience of countries and partners, WHO convened three meetings in 2016. • January 2016, Cairo: WHO representatives from country offices of Afghanistan, Iraq, Lebanon, Pakistan, Somalia, Sudan, Syria and Yemen, the WHO Eastern Mediterranean Regional Office (EMRO) and WHO Headquarters compiled strategies and best practices for delivering vaccination during humanitarian emergencies. • June 2016, Geneva: WHO and Médecins Sans Frontières (MSF) organized a partners consultation to identify challenges and potential solutions to resolve barriers to the timely supply of affordable vaccines in humanitarian crisis. • October 2016, Geneva: experts from United Nations agencies, international non-governmental organizations, partner agencies including Gavi and the vaccine industry agreed on a package of documents and solutions to guide vaccination in humanitarian emergencies which would include an updated version of the Framework on decision making, the Implementation Guide, and a communication plan to ensure availability and use of this package. This Implementation Guide does not supersede existing general guidance and principles related to humanitarian emergencies, but complements them, while focusing on vaccination in the context of humanitarian crisis. For more information, please see The Sphere Handbook3 on minimum standards in humanitarian response. For further information on the WHO’s role in responding to emergencies, please refer to the Emergency Response Framework (ERF).4

Please send comments on the usefulness and/or suggestions for improvement, indicating “Feedback on the Implementation Guide” in the subject line, at: vaccines@who.int.

Vaccination in Acute Humanitarian Emergencies. A framework for decision making. http://apps.who.int/iris/bitstream/10665/255575/1/WHO-IVB17.03-eng.pdf, accessed July 2017 2 A Strategic Advisory Group of Experts (SAGE) on Immunization Working Group on Vaccination in Humanitarian Emergencies was formed in June 2011 to determine key scientific, ethical, economic, public health, operational and political criteria that should be part of such a decision making framework. In November 2012, SAGE endorsed the final version of the “Vaccination in acute humanitarian emergencies: a framework for decision making”. 3 Sphere Project. http://www.sphereproject.org/, accessed July 2017. 4 Emergency Response Framework. http://apps.who.int/iris/bitstream/10665/89529/1/9789241504973_eng.pdf?ua=1, accessed July 2017. 1

ABBREVIATIONS AND ACRONYMS CSO DEWS EMRO EPI ERF EWARN HC IDP ITF MoH MSF NGO OCR SAGE VPD UNDSS WHO Civil society organization Disease and Early Warning System WHO Eastern Mediterranean Regional Office Expanded Programme on Immunization Emergency Response Framework Earl Warning and Response Network Health Cluster Internally-displaced people Immunization Task Force Ministry of Health Médecins Sans Frontières Nongovernmental Organization Operational Control Room Strategic Advisory Group of Experts on Immunization Vaccine-preventable disease United Nations Department of Safety and Security World Health Organization

VII

I. INTRODUCTION 1. Background information Globally, many countries are facing a broad range of humanitarian emergencies resulting from various hazards which differ in scale, complexity and international consequences. These emergencies have extensive political, economic, social, and public health impacts through disruption of the health systems and basic infrastructure. Humanitarian emergencies encompass crisis of short duration, long-standing crisis, and conflicts resulting in protracted humanitarian emergencies. The concept of “acute” emergency does not imply that the emergency in itself is short-lived, as even in a protracted crisis, situations can emerge and be considered as “acute”, in particular when the conditions deteriorate, risk factors accrue or the conditions evolve for a particular disease. Emergencies may lead to major and possibly continuous disruption of vaccination services provided through primary health care with resulting drop in vaccination coverage. This may lead to a decrease in population immunity, increased morbidity and mortality from VPDs with potential risks for outbreaks, which may be of large scale. In addition there may be lower population immunity due to mass population movements. In emergency situations, people, especially children and women, are vulnerable to communicable disease outbreaks including VPD outbreaks. This is aggravated by co-existing malnutrition, crowded living conditions, and inadequate sewage and sanitation. Vaccination should be among the high-priority health interventions implemented in order to limit the avoidable morbidity and mortality of the VPDs. Maintaining or re-establishing routine vaccination services should be the primary objective of every national immunization programme. Well-established programmes are likely to be more resilient during an emergency situation.

1.1

Definition of an acute humanitarian emergency situation

An acute emergency is defined as the occurrence of one or more of the following conditions, due to any reason (natural and/or man-made). 1. Sudden unplanned displacement of a large proportion of the population away from the community of habitual residence and into any settlement (e.g. refugee or internally displaced persons’ camps, host community, urban areas, or uninhabited areas within the same country or across international borders). 2. Direct exposure of the civilian, non-combatant population to new or exacerbated and sustained episodes of armed conflict resulting in risk factors including disrupted access to health care, disrupted water and sanitation, food insecurity, etc. 3. Impending or already occurred sudden deterioration of nutritional status, as evidenced by reliable food security and/or nutritional indicators, beyond and above known seasonal fluctuations or situations of chronic poor nutritional status and/or food insecurity.

VIII

4. Natural or industrial disaster resulting in temporary homelessness, disruption to critical public services (e.g. health care, water and sanitation, food deliveries, etc.), increased risk of injury and/or exposure to adverse weather conditions, famine, drought, environmental degradation for a large proportion of the population. 5. Sudden breakdown of critical administrative and management functions within the public and/ or private sector, due to any reason, resulting in large-scale disruption of public health and related services (e.g. water and sanitation, housing). The definition of acute emergency encompasses a large majority of potential scenarios, but there may be cases in which data and available information are imprecise, incomplete or controversial. In such instances, application of the definition should err on the side of caution, i.e. it is preferable to assume that an emergency is taking place. Additional information on the health impact of emergencies as well as the priority actions and critical steps for health operations across a range of delivery mechanisms and according to specific causes can be found in the Health Cluster (HC) Guide.5

1.2

Purpose, operational objectives and scope of this guide

This guide is applicable for acute and protracted emergency situations, including at the onset of the emergency situation, in the midst of an emergency, as well as in the pre-emptive or post-emergency/stabilization phases. This document does not provide modular guidelines or standard operating procedures. It is intended to: • determine the considerations that need to be taken into account when implementing vaccination in the context of a humanitarian emergency; • support effective management and delivery of vaccination services, including timely reporting/data sharing in emergency situations; • identify the suitable vaccination delivery strategies in different types of emergencies to increase access to the most vulnerable populations and maintain equitable access to vaccinations; • facilitate early recovery of vaccination service delivery to restore equitable access to vaccinations; and • facilitate sustaining and improving routine vaccination coverage during a protracted/chronic emergency situation. TARGET AUDIENCE This guide is designed to provide guidance for the Immunization Task Force in charge of planning and managing routine and/or additional vaccination service delivery in a humanitarian emergency context (see Chapter 2). This Immunization Task Force, ideally a joint group of stakeholders, may include staff from the national immunization programme, Ministries of Health (MoH) and possibly other ministries, district and local level, local, national and international non-governmental organizations (NGOs) as well as international organizations.

Health Cluster Guide. http://www.who.int/hac/network/global_health_cluster/health_cluster_guide_6apr2010_en_web.pdf, accessed July 2017.

II. ARCHITECTURE OF THE OPERATIONAL RESPONSE STRUCTURE 2. Establishment of the Immunization Task Force In humanitarian emergencies, it is important to clearly identify and appoint the team to lead and coordinate immunization activities. This team, referred to as Immunization Task Force (ITF) in this document, although the name may vary in different settings, should be established by the highest level of the health authority or by the humanitarian country team if a functional government does not exist. An ITF may be established in the country based on existing bodies to avoid creating parallel systems, or can be established de novo, according to needs. An ITF consists of government and/or local authorities and partners such as national and international NGOs, international organizations and civil society organizations (CSOs), and can be a part of the overall Health Task Force or Health Cluster6, if a cluster approach is adopted within the country. The host country government and/ or local authorities have the primary responsibility for directing and coordinating the operational response of the ITF, with the strong support of other stakeholders whenever possible. One of the main strengths of the ITF should be the mechanism for evidence-based decision making that all members adopt, advocate and apply. Ideally, emergency scenarios have been anticipated and prepared for, which would allow for the rapid convening of the ITF when a crisis strikes. In an emergency situation, it is important to take the right action, but even more important to take it at the right time. TAKE THE RIGHT ACTION AT THE RIGHT TIME.

The health cluster serves as a mechanism for coordinated assessments, joint analyses, the development of agreed overall priorities, objectives and a health crisis response strategy, and the monitoring and evaluation of the implementation and impact of that strategy.

2.1

ITF structure: leadership and membership

The first guiding principle stated in the Global Vaccine Action Plan (GVAP)7 is that “countries have primary ownership and responsibility for establishing good governance and for providing effective and quality immunization services for all”. In accordance with this, government or local authorities should chair the ITF to secure its legitimacy and authority. If a functional government does not exist and/or systems and staff are not fully operational, WHO, the United Nations Children’s Fund (UNICEF), NGOs or others may chair. The ITF should ensure representation of all administrative levels (central, sub-national, local) affected by the crisis to be able to directly support planning and implementation activities at the appropriate levels as necessary. To secure credibility, participation of the strong technical national entity (i.e. NITAG) or international technical agency (e.g. WHO, UNICEF) is crucial. To ensure rapid and efficient resource mobilization, it is helpful to have communication and decision-making pathways with the Ministry of Finance. REPRESENTATION OF ALL ADMINISTRATIVE LEVELS AND PARTICIPATION OF A STRONG NATIONAL TECHNICAL ENTITY OR INTERNATIONAL TECHNICAL AGENCY IN THE IMMUNIZATION TASK FORCE IS CRUCIAL.

There is no pre-set optimal number of members serving on the ITF. In some settings, the ITF may be limited to a small number of partners (e.g. the MoH, WHO, UNICEF) envisaging a rapid process of decision making. In other circumstances, including a larger number of available operational partners may be of greater benefit in order to ensure implementation of the planned activities. Due consideration should be given to the required technical expertise. NGOs can be members when appropriate. Civil society organizations and professional society’s membership can be of added value. A smaller group of individuals should serve as secretariat for the ITF. This secretariat should be selected from the organizations participating in the ITF. Major partners could volunteer persons to work as part of the secretariat.

2.2

ITF functionality

All involved partners should agree to the terms of reference (ToR) required for the ITF. In turn, these ToR should help refine the structure and membership of the ITF. Table 1 provides an example of what these terms of reference can include, but are not limited to. Strong collaboration and coordination with the HC, Health Task Force and any other bodies that may be responsible for disease surveillance is necessary. The frequency of the meetings may vary and needs to be determined based on the circumstances. In acute crises, the meetings will likely be on a daily basis to manage the evolving situation. For protracted crises, weekly or biweekly meetings may be appropriate.

Global Vaccine Action Plan. http://www.who.int/immunization/global_vaccine_action_plan/GVAP_doc_2011_2020/en/, accessed July 2017.

Table 1 Example of ToR for the ITF: ∙∙ Plan and oversee the implementation and delivery for one or more vaccines required in the humanitarian emergency context as determined by using the Framework on decision making, with due attention to ethical obligations, community participation and other relevant issues as outlined in the Framework. ∙∙ Use the Framework to assess and identify priority/necessary vaccinations (if the assessment has not been conducted before the establishment of the ITF). ∙∙ In protracted crisis, reassess the need for necessary vaccination using the Framework. ∙∙ Make technical decisions collectively on the appropriate strategies for delivery of selected vaccines. ∙∙ Advocate for the vaccination intervention and mobilize resources (financial and human) utilizing the HC platform. ∙∙ Lead and ensure coordination of work of related partners, ensuring clarity on the respective responsibilities. ∙∙ Establish or ensure that there is an Operational Control Room (OCR) at national and/or sub-national levels. ∙∙ Coordinate with neighbouring countries, if the situation requires. ∙∙ Oversee and/or assist with the maintenance or re-establishment of routine vaccination, including joint interventions to address comprehensive health needs. ∙∙ Oversee the status and functioning of the supply and cold-chain. ∙∙ Ensure vaccine supply and availability of related equipment and devices. ∙∙ Provide information, guidance, and capacity building to the subnational level when appropriate. ∙∙ Monitor and promote community demand for vaccination. ∙∙ Develop core monitoring indicators, monitor and evaluate implementation of the plan and revise as necessary. ∙∙ Document activities and related data.

2.2.1 ESTABLISHMENT OF THE OPERATIONAL CONTROL ROOM At the beginning of the acute emergency, the ITF should establish or ensure that there is an Operation Control Room (OCR) at national and/or sub-national levels. The OCR should be part of or integrated with the Public Health Emergency Operations Centre, if one exists. The OCR needs to be permanently staffed and equipped with the required, suitable and effective means of communications. It is preferred that a senior person from the ITF is in charge of the OCR, or at least a senior member of the OCR team. One cannot be prescriptive about the number of staff and specific skill sets, but staff of the national programme, if still available, and staff from the partners can be used. Technical capacities should include mainly staff experienced in the Expanded Programme on Immunization (EPI), in information technologies, as well as in data compilation and analysis. More information can be found within the WHO Framework for a Public Health Emergency Operations Centre.8 The main function of the OCR is to ensure coordination of activities, and sustain communications with and ongoing response to needs in the periphery. It can also be used to receive and deal with public inquiries if the ITF assigns this task and the technical capacity exists. THE OPERATION CONTROL ROOM SHOULD ENSURE COORDINATION OF ACTIVITIES, COMMUNICATIONS, AND ONGOING RESPONSE TO THE NEEDS IN THE PERIPHERY.

Framework for a Public Health Emergency Operations Centre. http://apps.who.int/iris/bitstream/10665/196135/1/9789241565134_eng.pdf?ua=1, accessed July 2017.

The main responsibilities of the OCR are the following: • In coordination with the Disease and Early Warning System (DEWS) and/or other relevant structure: a. Collect, collate and analyse regular reports on vaccination activities including the number of doses administered, coverage, adverse events following immunization, unreached groups, and refusal. b. Assess human resources needs, training and monitoring of quality. c. Stay up to date on community and facility-based disease surveillance to help plan ahead for communication campaigns and community engagement, and to manage potential rumours. • For information sharing and actively responding to needs, ensure regular two-way communication with the peripheral sites and follow up on: a. Vaccine supply and safety. b. Status of cold chain. c. Functionality of health facilities and immunization services. d. Security threats and maintenance of security profile for different affected areas. • Issue a daily report, shared with the ITF, periphery, and partners. • Issue summary reports, provided at least on a weekly basis. • Receive complaints or queries from the public and respond as necessary (if this function is tasked to the OCR, the contact details need to be disseminated).

2.3

ITF interactions and coordination

2.3.1 INTERACTION AND COORDINATION OF THE ITF WITH THE HEALTH CLUSTER A large number of various organizations may be present in a humanitarian emergency and coordination is a frequent and ongoing challenge. Where a cluster approach is used, the Health Cluster at the country level9 should serve as a mechanism for participating organizations to work together in partnership to harmonize efforts and use available resources efficiently, avoiding gaps and/or duplication of efforts. The ITF should interact with the HC at the national level to ensure that international responses are appropriately aligned with national structures, and that linkages among national authorities, international organizations, national civil society and other stakeholders are coordinated. If subnational ITF and subnational or “zonal” clusters are established, the subnational level will focus on local planning and implementation issues, while the national-level interaction and coordination will focus on policy issues and strategic planning.5 IMMUNIZATION TASK FORCE AND HEALTH CLUSTER INTERACTION ENSURES ALIGNMENT OF INTERNATIONAL RESPONSES WITH NATIONAL STRUCTURES.

By identifying different roles and responsibilities early on, ITF and HC interaction can strengthen the coordination mechanisms between country authorities, partners and organizations delivering different health services. This coordination can ensure rapid identification of risks and challenges through the sharing of experience 9

The Health Cluster at the national level should normally include organizations providing or supporting health services in affected areas: UN agencies (WHO, UNICEF, UNFPA), other international organizations (e.g. IOM, IFRC), the national Red Cross/Red Crescent society, international and national NGOs, representatives of key private-sector health service providers, and the main health-sector donors and other important stakeholders.

and information, and can allow for collective decision making. This results in better management of resources such as human, financial, logistical, and/or material, facilitates adoption, advocacy and implementation of service delivery strategies. The following tasks are important to ensure ef fective coordination of the ITF with the HC: • Ensure that the HC is fully engaged and regularly briefed on the planned vaccination activities and results of implementation.

IMMUNIZATION TASK FORCE NATIONAL-LEVEL FOCUS: POLICY ISSUES AND STRATEGIC PLANNING IMMUNIZATION TASK FORCE SUBNATIONAL-LEVEL FOCUS: LOCAL PLANNING AND IMPLEMENTATION

• Convey mapped areas of service delivery and the organization of partners’ work to the HC. • Ensure vaccination services are a part of the HC activities such as joint assessment, monitoring, preparedness and response plans, pre-positioning, humanitarian convoys, service-delivery during pause of conflict, fund-raising, etc. • Engage the HC at the central and local levels to help with resource mobilization, and as a major coordination mechanism for vaccination service delivery. • Engage with stakeholders within the HC to avoid redundancies and/or gaps in service. • Engage the HC to identify possible new partners to assist in vaccination service delivery. Interaction and coordination of the ITF at the national level with the sub-national level 2.3.2 INTERACTION AND COORDINATION OF THE ITF AT THE NATIONAL LEVEL WITH THE SUBNATIONAL LEVEL In emergency situations, interaction between national and subnational levels may be disrupted. This is why it is important to ensure and/or strengthen technical competence and management capacity at the local level so that vaccination service delivery is sustained. The following activities may be used to help empower management at the sub-national levels: • Formulate and activate the ITF at the sub-national level as much as possible. • Coordinate with the sub-national/zonal HC, if they are established. • Establish and maintain regular, frequent contact between the central and the peripheral ITF to the extent possible, considering the situation. • Decentralize and delegate authority to peripheral levels as necessary, keeping the planning, administrative and financial arrangements flexible to accommodate the local situation. • Through interaction with the community leaders, engage the community in accepting the intervention and sustaining its implementation where possible. Early community engagement may help with identifying possible service delivery staff from that community, and ensure safety and security of staff, beneficiaries and equipment. IN EMERGENCY SITUATIONS, IT IS IMPORTANT TO INVOLVE THE COMMUNITY IN ALL ELEMENTS OF THE WORK OF THE IMMUNIZATION PROGRAMME. THE EARLIER THE COMMUNITY IS INVOLVED, THE MORE IT WILL ADOPT THE PROGRAMME AND SUSTAIN ITS IMPLEMENTATION.

• Identify NGOs and non-traditional EPI partners who may play an important role in service delivery, should the government system be non-operational. • Assist local management with identifying and interacting with the local authorities/armed groups (see section 3.1). • Document and share information and coordinate with neighbouring districts or governorates/provinces to maintain transparency, ensure proper use of available resources and avoid duplication of efforts. • The sub-national level should follow the central ITF guidance, allowing some flexibility to accommodate for local circumstances. 2.3.3 INTERACTION AND COORDINATION OF THE IMMUNIZATION TASK FORCE WITH THE NATIONAL IMMUNIZATION TECHNICAL ADVISORY GROUP (NITAG) NITAGs are multidisciplinary groups of experts responsible for providing independent, evidence- based advice to health authorities on policy issues related to vaccination and vaccines for all population groups. In countries where a functional NITAG existed before the onset of the humanitarian emergency, the ITF should work closely on technical issues with this advisory body. The ITF can benefit from the expertise represented in the NITAG and the knowledge of the local context. Interaction and coordination with the NITAG will reinforce the use of national structures and promote the visibility of NITAG. In countries where the functioning of the NITAG is disrupted, the ITF may draw on expertise of available previous members. Although it is not a priority in the initial response, the ITF may facilitate re-establishing the NITAG in the recovery phase. THE IMMUNIZATION TASK FORCE AND NATIONAL IMMUNIZATION TECHNICAL ADVISORY GROUP SHOULD WORK TOGETHER ON TECHNICAL ISSUES.

III. PLANNING AND IMPLEMENTING VACCINATION SERVICES IN A HUMANITARIAN EMERGENCY 3. Decision on use of vaccines in humanitarian emergencies Senior level government and partner agency officials, within the ITF if established, should use an evidence‑based, transparent and rigorous methodology to decide on the vaccine(s) to be used in a given situation. Where the decision on the vaccine(s) to be used has not been taken, the Framework1 provides such a methodology. The outcome of this decision-making process is a determination on implementation of the vaccination intervention(s) for each selected vaccine-preventable disease, and represents a vital point of the vaccination contingency 10 and/or response planning. Interaction of the ITF with the HC, if one has been established, is important to obtain the best synergies for these plans between national and international stakeholders. This can be achieved through advocacy meetings and prepared communications, which provide situation analysis, highlight the magnitude of the problem, provide good estimate of risks, and identify areas for coordination and collaboration.

Vaccination contingency plan involves anticipating various scenarios and should be a part of the overall national contingency plan for humanitarian emergencies, if one exists. It should include routine and campaign services as necessary, and address requests for vaccination services outside the crisis affected areas in situations when vaccination intervention is planned to be implemented in crisis affected areas only. Most plans are made for individual countries, but can also be made jointly for a number of countries or for regions where there are cross-border issues to consider.

3.1 Situation analysis – National Immunization Programme assessment As soon as it becomes clear that there is an imminent emergency or crisis, the ITF should undertake an assessment of the national immunization programme as a part of the overall situation analysis. The main purpose of the immunization programme assessment is to document the current structural and functional status of the programme in the affected areas. It helps identify the feasibility of vaccine implementation and the resources needed to enable the development of a realistic plan in the context of social, cultural and access barriers present in the emergency situation. AS SOON AS POSSIBLE, THE IMMUNIZATION TASK FORCE SHOULD ASSESS THE NATIONAL IMMUNIZATION PROGRAMME TO HELP DETERMINE WHAT EMERGENCY VACCINES TO DEPLOY, THE SPECIFIC TARGET POPULATIONS AND THE RELEVANT GEOGRAPHIC LOCATIONS.

The immunization programme can be assessed as a part of an overall health assessment linked to the HC, or it can be a stand-alone assessment. A field assessment is preferred, but if this is impossible, a desk review 11 of available documents and data may be undertaken until conditions allow for a field assessment, if need occurs. The most recent data available should be obtained from official WHEN COMPREHENSIVE government sources and other reliable partners. Assessment of ASSESSMENT IS NOT FEASIBLE, gender and equity, vaccine acceptance, social issues and other PRIORITIZE ASSESSMENT OF THE challenges that may affect vaccination should be included in OPERATIONAL REQUIREMENTS. the situation analysis. Analysis of the information should be organized in an easy to read format and comprehensive to the extent possible. However, comprehensive assessment of all aspects of the immunization programme may not be feasible during an emergency situation. In that case, an assessment of the operational requirements for vaccination delivery should be given priority. In protracted emergencies, this assessment should be systematically repeated every two months. Alternatively, the assessment can be used as a baseline, and specific data, collected by any partner/sector within the HC, can be used to regularly update the assessment. The OCR, if already established, is responsible for collecting, monitoring and analysing data. As a part of the situation analysis, due attention should be given to operational requirements, including logistics. This should serve as a starting point for resource mobilization. If available, recent microplans can be useful sources of data. The assessment of operational requirements should include the following: • Disease characteristics: recent and ongoing outbreaks of VPDs, seasonality of epidemic prone diseases (e.g. measles, cholera, meningitis, etc.). • Target/beneficiary population and service delivery characteristics (for routine or supplementary vaccinations): age groups, gender, geographic location, population movements, appropriate and equitable delivery strategies (i.e. fixed sites or outreach), baseline immunization coverage in the affected areas considering available data from different sources such as recent microplans. • Material resources: health facility infrastructure and functionality, vaccine and supplies availability, cold-chain inventory and current cold-chain capacity (to include information on possibility to resource equipment from other sources such as military, food industry, etc.), information on power supply 11

The data that can be used for the desk review of the status of the national immunization programme are vaccination coverage data (national and sub-national), national health documents, data on disease incidence, and other (findings of reviews and assessments, improvement plans, etc.)

(electricity, gas, solar, etc.), information on waste management practices (including availability of incinerators from health and non-health sector). • Logistics capabilities: estimate of resources needed for efficient and cost-effective flow of vaccines, materials and personnel to the target/beneficiary population (including transportation and shipping, storage, inventory management, cold-chain logistics, physical security, lodging, personnel security, etc…). • Human resources: mapping and availability of trained health care personnel and volunteers including information on private providers, community based organizations, and international partners. • Financial resources: estimate of funds needed and funds available for the intervention with regard to annual forecast and availability of donor funding. • Social context: information on demand and acceptance of vaccination, identification of possible communication channels that could facilitate access and acceptance (local religious and opinion leaders, traditional healers, others). • Local challenges: local government processes (e.g. customs procedures), partner collaboration processes, physical and personnel security.

3.2

Integration of vaccination service delivery with other services MAXIMIZE INTEGRATION OF VACCINATION SERVICE DELIVERY WITH OTHER SERVICES.

Integration of vaccination service delivery with other health and non-health services or interventions should be maximized during crisis and emergency situations.3

Although water, food, and safe shelter are of utmost priority, vaccination against epidemic prone VPDs must be considered among the highest priority interventions. As resources are always in short supply during an emergency, integration of vaccination delivery with other humanitarian interventions is essential to success. In protracted crises, such integration can contribute to sustainability of vaccination service delivery. Examples of integration can include: • Adding vaccination to services provided by mobile clinics and all primary health facilities established in refugee camps • Using UN transportation to distribute vaccine and injection equipment • Using nutrition clinics to administer vaccinations • Setting up vaccination posts during food/cash distributions If vaccines are delivered through campaigns, adding non-vaccine related interventions, such as vitamin A supplementation and deworming medicines, should be carefully planned on a case-by-case basis, as integration of multiple interventions may raise additional logistical challenges for already resource intensive interventions. Campaigns, however, provide an excellent platform for delivery of other interventions, and if there is a demand for them, the integrated approach can in turn positively impact the campaign outcome. INTEGRATION CAN INCLUDE USING ESTABLISHED CLINICS AND FOOD/ CASH DISTRIBUTION POINTS FOR VACCINATION OR USING UN TRANSPORT FOR DISTRIBUTION

4. Planning for vaccination services in a humanitarian emergency 4.1 Macroplanning

Vaccination service delivery plan as an operational plan can be THE NATIONAL-LEVEL MACROPLAN developed as part of an overall contingency plan, or as a part OUTLINES THE OPERATIONS AND of a response plan which occurs after the completed decisionBUDGET FOR VACCINATION DELIVERY making process on which vaccines to use and following the immunization programme assessment. The ITF is responsible for the development of the operational plan. The plan should be monitored and updated regularly according to the changing situation and available information. Initially, the ITF develops a macroplan which outlines the operations and budget for vaccination delivery. This high-level plan at the national level consists of: • Targets/beneficiaries, scope, objectives, timing and strategies based on the Framework decisions and situation analysis • Description of opportunities for integration of vaccination delivery with other interventions, and/or integration of other interventions with vaccination delivery service • Outline of potential barriers to vaccination service delivery and methods and resources needed to overcome them • Plan of action with estimated timeline of activities • Realistic budget estimate to outline available funds and funding gaps, as a basis for resource mobilization The budget estimate represents initial calculations of necessary financial requirements needed for the delivery of planned vaccinations. These would consist of a mixture of known actual amounts and estimates and approximations. Where available, data from peripheral levels should be used to develop better estimates. National tax and customs procedures should be considered for possible impact on the budget. As the field condition in an emergency situation can be unpredictable, it is important to include a budget line for contingencies. In case a funding gap exists, measures to reduce it should be identified. These may include possibilities for co-funding by partners, donations, re-allocating funding from non-emergency activities, etc. The macroplan should also identify the gaps in necessary resources other than funding, which would then enable the ITF to initiate resource mobilization to fill these gaps. Accountability and use of all resources including funds for operations at each level should be tracked and the staff should be aware of these processes and requirements. RESOURCE MOBILIZATION Mobilization of resources during a humanitarian emergency is crucial and requires efficient communication and coordination among partners and donors. Ideally, the HC team should integrate resource mobilization for vaccination as a part its overall fundraising effort. This should include holding advocacy meetings and preparing communications which highlight the magnitude of the problem and provide a good estimation of the risk. Proper calculation of the required resources should include, among others, assessment of the

required human resources, logistics, quantity of needed vaccine and injection equipment and operational costs including transportation, training, monitoring and supervision.

4.2

Microplanning

Microplanning is a detailed planning process carried out at OBJECTIVES OF MICROPLANNING: the lowest implementation level possible, with the objective COMPREHENSIVE OPERATIONAL PLAN to develop a comprehensive operational plan, including a DETAILED BUDGET WITH COMPLETE final budget with completed resource mobilization activities. REQUIRED RESOURCES In an emergency situation, time constraints may limit the direct participation of all levels usually involved in microplan development. In such situations, microplans from routine programme or recent SIAs (e.g. measles, polio) may serve as guidance. The microplan should address and budget for the following components: • Vaccine (may be accounted for at the national level), human resources and logistics requirements (including maps) • Vaccine logistics movement plan (distribution and human resources) • Cold chain status and plan • Training plan • Social mobilization and communications plan • Adverse events following immunization management plan • Waste management plan • Supervision plan • Monitoring and evaluation plan (including rapid convenience monitoring and/or coverage surveys, if at all possible) • Reporting plan Microplans should be prepared even if the catchment areas are inaccessible, and should envision different scenarios of population accessibility (full, limited or no accessibility). It is important to involve the community in the microplanning process at the community or facility level whenever possible. The community can make important contributions regarding feasibility of the plan or of fer resources, e.g. providing a community room or other adequate space for vaccination sessions. PREPARE THE MICROPLAN EVEN IF THE CATCHMENT AREA IS INACCESSIBLE, AND ENVISION VARIOUS SCENARIOS OF ACCESSIBILITY. WHENEVER POSSIBLE, INVOLVE THE COMMUNITY IN THE MICROPLANNING PROCESS.

Information obtained from the local/facility-level microplanning should be collated sequentially upward to the ITF. The ITF should incorporate these microplans into an overall working microplan. However, it is important to note that revisions may take place at the ITF to address any unforeseen factors and take into account available funding and resources. This final microplan should be validated by the ITF, but could still be fluid, as the situation in the field, funding and resources change.

Steps in microplanning are the following: 1. List and map: a. List all populated areas (e.g. villages, town, settlements) with estimated number of target population. b. List all major transit points including information on population movement. c. Obtain maps of the area and chart distances, population density, population movements, landmarks, borders, seasonal characteristics (e.g. floods). d. Identify and chart high-risk and hard-to-reach areas with population groups. e. Identify and chart border areas with population groups. 2. Calculate: a. Calculate the number of teams (vaccinators and volunteers) required based on location (i.e. urban, rural, nomadic, hard-to-reach) and vaccination strategy applied (i.e. permanent, temporary, mobile posts). b. Calculate the number of supervisors required based on location of staff being supervised (i.e. urban, rural). c. Calculate requirements for vaccines and supplies, taking into account wastage rate. d. Calculate requirements for cold chain and logistics (cold boxes, vaccine carriers, coolant-packs, tally sheets, reporting forms, social mobilization materials, transportation). 3. Plan for vaccination teams and supervisors: a. Develop day maps for vaccination teams and supervisors with clear geographical demarcation. b. Develop plan for deployment of vaccination teams at major transit points. c. Develop plan for mobile vaccination teams assigned for hard-to-reach areas and special population groups. d. Develop plan for training of volunteers, vaccinators and supervisors, as necessary. 4. Assign vaccinators and supervisors to teams and allocate the teams according to the plan developed in Chapter 3. 5. Develop logistics plan for distribution of vaccines, supplies and staff, and management of waste. 6. Develop social mobilization and communications plan, and plan for demand-related interventions (materials, staff, schedule and assigned area of responsibility, community engagement). 7. Develop reporting plan (timeline and person responsible). Annex 1 provides an example of a microplanning template. For more information on microplanning, refer to the resources from the polio programme12, the Reaching Every District (RED) strategy 13, and the SIA Field Guide.14

GPEI Tools, Protocols and Guidelines. http://polioeradication.org/tools-and-library/resources-for-polio-eradicators/gpei-tools-protocols-andguidelines/, accessed July 2017 13 RED Strategy. http://www.who.int/immunization/programmes_systems/service_delivery/red/en/, accessed July 2017 14 Planning and Implementing High-Quality Supplementary Immunization Activities for Injectable Vaccines. http://www.who.int/immunization/ diseases/measles/SIA-Field-Guide.pdf?ua=1, accessed July 2017 12

4.3

Vaccine supply

Timely supply of affordable vaccines of assured quality and safety is fundamental for immunization service delivery. In humanitarian emergencies, close collaboration among partners is essential to ensure uninterrupted availability of vaccines needed to sustain routine immunization or implement campaigns. The factors to consider regarding access to vaccine supplies in emergencies are the following. Information on how to timely access a supply of affordable vaccines of assured quality and safety, in particular information about international groups that are able to fund and/or procure vaccines. Annex 2 provides a list of international entities active in supply of vaccines in humanitarian emergencies and their roles, target vaccines, vaccine manufacturers and useful contacts. • Funding and price of vaccines. All countries are able to THE “HUMANITARIAN MECHANISM” access vaccines through pooled procurement agents ENABLES TIMELY ACCESS TO AN such as UNICEF Supply Division. Most countries AFFORDABLE SUPPLY OF VACCINES. eligible for support from Gavi procure vaccines through UNICEF at Gavi-negotiated prices, and during humanitarian emergencies, countries have access to special flexibilities for Gavi support.15 Countries and territories in the WHO Region of the Americas can use the Revolving Fund of the Pan American Health Organization (PAHO) as a procurement mechanism for vaccines and related supplies. Vaccines can also be accessed through civil society organizations or directly from manufacturers. In times of emergencies, it is sometimes possible to access supply at more favourable prices. For instance, the “Humanitarian Mechanism” was recently launched by WHO, UNICEF, Médecins Sans Frontières, and Save the Children, which enables timely access to affordable supply of vaccines for entities such as CSOs, governments, or UN agencies who are procuring on behalf of populations facing humanitarian emergencies and who otherwise do not have access to affordable vaccines.16 However, the mechanism currently covers only a few vaccines. Manufacturers are constantly encouraged to provide price offers under the mechanisms and other means for humanitarian emergencies. The international community should support countries in coping with the added demand for vaccination in case of substantial influx of refugees which might add significant cost to the national programme. • Choice of vaccine product and procurement method. In case of multiple partners delivering vaccination services, it is important to standardize the type/presentation and source of the vaccine in order to avoid programme-related errors in the field, as front-line personnel in emergencies may be new and lacking experience. Ideally, priority should be given to the vaccine types/presentations that the country health workers are familiar with, for ease of training and reduction of errors. Pooling procurement will help standardize the vaccine and larger quantities will likely lead to lower prices. • Forecasting vaccine needs (quantities and timelines) and lead times required by manufacturers. Calculation of bundled vaccine and related supply requirements may be challenging due to population movement and difficulty in obtaining accurate target population data. During emergencies, vaccine wastage may increase and needs to be accounted for in forecasts. In the absence 15

IN THE ABSENCE OF DATA FROM OFFICIAL SOURCES, USE THE HIGHEST POPULATION ESTIMATE TO AVOID POSSIBLE STOCK-OUTS.

Gavi policy on fragility and immunisation. http://www.gavi.org/about/governance/programme-policies/gavi-policy-on-fragility-andimmunisation/, accessed July 2017. 16 Accessing Affordable and Timely Supply of Vaccines for use in Humanitarian Emergencies: the Humanitarian Mechanism. http://www.who.int/ immunization/programmes_systems/sustainability/The_Humanitarian_Mechanism_ToRs.pdf?ua=1, accessed July 2017

of data from official sources, data from other health or non-health programmes can be used (e.g. from the Ministry of National Planning). Data from previous vaccination activities (e.g. polio campaigns), geospatial imaging and other data sources can help establish realistic population figures. In countries where different population figures are available, the highest should be used to avoid possible stockouts. It may also be important to take note of the geographic location where the vaccine will need to be delivered and include this information when communicating the demand. • Introduction of new or different vaccines in accordance with the country regulations. The requirements for vaccine registration or other forms of regulatory approval must be considered in ensuring timely availability of quality-assured vaccines. As the timelines usually required by standard regulatory pathways may not be suitable in emergencies, specific alternative procedures may be considered. These options may include the following. –– Implementing fast track authorization pathways for timely access to the vaccines in emergency situations: ʝʝ Reliance on WHO prequalification decision and/or assessment reports through implementation of the collaborative procedure and/or the WHO Emergency Use Assessment and Listing (EUAL) assessment report. ʝʝ Reliance on decisions and/or assessment reports of other regulatory authorities for national authorization based on pre-established procedures and conditions on the use of the particular vaccine. –– The options for fast track pathways within the regulatory framework in emergency situations are part of regulatory planning within a contingency/emergency response plan. Regulatory planning should include the following. ʝʝ Establishment of the regulatory decision options, regulatory requirements, and vaccine dossier required for decision making. ʝʝ List of the key units and/or qualified persons responsible for establishing emergency regulatory pathways. ʝʝ List of the roles, responsibilities and authorities of these persons during contingency/emergency planning and during the emergency. ʝʝ Establishment of a communication path for the regulatory disposition decisions, entity responsible for communication and the recipient(s). These should include all parties involved in vaccine introduction. • Customs procedures for import of vaccines and related materials. Procedures for customs clearance should be documented and a focal point assigned to facilitate the customs procedures and clearance.

4.4

Cold Chain

Adequate vaccine storage space at peripheral levels is often a challenge when mass supplies of vaccines and syringes arrive at storage centres. The current capacity and functionality of cold chain should be known from regular inventory and maintenance plans. This information, along with information on possibilities to resource equipment from other sources (e.g. military, private sector, industry, etc.) and information on power supply (electricity, gas, solar, etc.) should make a part of the situation analysis and vaccination contingency/ emergency plans.

Once the volume of vaccines expected to be received at each THE SITUATION ANALYSIS AND subnational level has been determined, the programme VACCINATION CONTINGENCY/ managers or cold-chain logisticians will need to calculate the EMERGENCY PLANS SHOULD INCLUDE storage volume needed, keeping in mind the space used for THE CURRENT STATUS OF COLD CHAIN, the routine programme and that one third of the space in the AND INFORMATION ON RESOURCE refrigerator should remain empty to allow for air circulation. EQUIPMENT FROM OTHER SOURCES The storage volume needed will depend on the manufacturer’s AND POWER SUPPLY. specifications and the vial size. It can be calculated using the vaccine volume calculator. This and other WHO tools on cold chain and logistics such as cold-chain inventory and the gap analysis tool are available online at: http://www. who.int/immunization/programmes_systems/supply_chain/resources/tools/en/index4.html. Programme managers or cold-chain logisticians should also prepare for different scenarios of vaccine delivery strategies (e.g. fixed/outreach, mobile, campaigns) and ensure adequate number of vaccine carriers, portable cold boxes, and coolant packs. Real-time tracking of temperature is essential. In case of equipment breakdown and/or electricity failure or fuel shortage, plans for alternative storage arrangements should be in place as a part of an emergency plan for the district and/or health facility. The emergency plan for the district and/or health facility level should ensure the following: • Readily available contact information of persons responsible for cold chain and logistics. • Readily available information on location and functionality status of the nearby cold storage and/or alternative storage spaces. • Adequate quantity of cold boxes and other passive containers (e.g. vaccine carriers) that can serve as temporary cold storage. • Readily available information on transportation means for transfer of vaccines. • Adequately trained staff for safe handling and transfer of vaccines to alternative locations. • Regular check of availability of identified alternatives and awareness of the responsible persons. In some contexts, it may be useful to keep a low-profile of the immunization cold-chain and vaccine carriers to ensure their integrity and safety.

4.5

Logistics

Logistics planning should ensure the availability of EFFICIENT LOGISTICS ENSURES adequate quantities of vaccines and related ancillary items AVAILABILITY OF VACCINES at all storage and service points in a timely and efficient AND EQUIPMENT WHERE AND manner. This represents a part of the microplanning process. WHEN NEEDED. In the context of humanitarian emergencies and cluster response, logistics activities can include shared leadership, communication, procurement, transportation and shipping, storage and warehousing, supply chain, inventory management, cold-chain logistics, reverse logistics, physical security and lodging, and personnel security. Most of these activities will likely be carried out as a part of the overall logistics cluster. The ITF should have the logistician as a member to coordinate logistical needs of vaccination interventions. Logistics management

can be complex because of political and time constraints, dealing with national and international partners, gaps in human resources, lack of or poor-quality infrastructure, and security conditions. Along with the distribution of vaccines and related items, DISTRIBUTION OF FUNDS IS distribution of funds is an integral part of the response. AN INTEGRAL PART OF THE Disbursements of funds from the central level should be as RESPONSE AND SHOULD BE QUICK quick and efficient as possible. When normal channels such AND EFFICIENT. as banks and institutions are not available or not functioning, solutions with partners and donors must be found while ensuring accountability for use of all resources at each level. Processes and requirements to ensure this accountability must be established and all staff made should be made aware of them. Real-time tracking of stock and active distribution plans are critical. To account for variability of demand and movement of people, it is important to optimize the stock kept in the central store/warehouse and at subnational levels. Pre-positioning supplies can serve to enable local actors to implement vaccinations at short notice once the situation allows. PRE-POSITION SUPPLIES TO HELP IMPLEMENT VACCINATION AT SHORT NOTICE.

Transportation of vaccines, related supplies and human resources should be well planned and should include in-country distribution timelines. The transport requirements may vary widely depending on the situation, therefore, flexibility in transport options and routes should be considered. The plan should be budgeted, and although there is no simple formula for calculating the transport requirements, the following are suggested steps: 1. Identify transportation needs (vaccines and related supplies/materials, vaccination teams and other personnel such as supervisors) and consider various means of transportation (vehicles, boats, aircrafts, rafts, animals). 2. Conduct an inventory of available transportation resources at all levels. 3. Identify additional sources of transportation. Whenever possible and/or necessary, transportation of vaccines and staff should be integrated with that of other supplies, e.g. transporting vaccines via convoys and integrated with delivery of other medical or lifesaving supplies. 4. Estimate fuel needs based on average consumption per vehicle and estimated mileage per day. 5. Estimate costs of fuel and/or car rental if applicable. Calculations of the fuel should take into account possible variations in fuel prices within a country or field conditions. Analysing the historical meteorological records of the country or region helps determine the impact that severe weather might have on the cost and capacity of the transport system at different times of the year. Additionally, the ITF should review safe waste disposal options17 during the planning phase. This should include an assessment of existing local practices (e.g. incineration, burying) and decision on a safe, locallyadapted, and feasible solution. Operational plans are further developed at sub-national levels and included in the overall logistics plan.

Management of wastes from immunisation campaign activities. http://apps.who.int/iris/bitstream/10665/204415/1/WHO_SDE_WSH_04.11_eng. pdf?ua=1, accessed July 2017.

4.6

Demand-related and community-based interventions

Interventions intended to generate demand and optimize INVOLVING COMMUNITY LEADERS uptake of vaccination among the affected population require INCREASES THE SUCCESS OF THE a community and emergency-context specific approach and SOCIAL MOBILIZATION STRATEGY. coordination among the various partners. Historical data on population acceptance and demand for vaccines is important for identifying potential barriers and facilitating factors, and for designing (and where possible, monitoring) the appropriate interventions. This assessment should be a part of the situation analysis within the vaccination contingency and/or response plan. Any additional rapid assessments may also be considered, to take into account any changing information channels, as well as any new or evolving social and cultural factors that may influence uptake of vaccination services. Community participation is crucial and involvement of influential leaders, such as religious and community leaders, will add to the success of the planning and implementation of the social mobilization strategy. The ITF may consider establishing a Community Reference ENGAGE COMMUNITY AND Group to assist specifically conceptualizing and implementing COORDINATE WITH PARTNERS TO the demand creation activities, and to help build trust within CREATE DEMAND AND OPTIMIZE the beneficiary population. Assessing risk, insecurity level VACCINE UPTAKE. or emergency situation, along with identifying barriers to immunization and other priorities for the communities provides the basis for planning. Different advocacy strategies should also be considered at different levels to pave the way for successful implementation of the needed community engagement strategy.18,19 Existing global frameworks to ascertain demand-related needs and design appropriate interventions developed by UNICEF or other agencies should be used to guide the response.20 In many countries routine vaccination programmes have traditionally focused on women of child-bearing age and children under five or even only on infants. In emergencies, vaccines may be given to older children and adult men and women. Depending on the target population, communication strategies may need to be altered as well as implementation strategies.

Communication for development. https://www.unicef.org/cbsc/, accessed July 2017. WHO dealing with vaccine hesitancy. http://www.who.int/immunization/programmes_systems/vaccine_hesitancy/en/, accessed July 2017. 20 Partnering with communities. http://apps.who.int/iris/bitstream/10665/70184/2/WHO_IVB_08.02_eng.pdf, accessed July 2017. 18 19

5. Implementing vaccination services in a humanitarian emergency 5.1 Securing access

In most emergency situations, access to vaccination service delivery can be hindered by lack of physical access to communities due to natural disasters or due to insecurity or ongoing conflict. Therefore, all strategies which facilitate service delivery and increase the uptake of vaccine (see section 5.2) should be considered according to the prevailing local situation. Three key issues that significantly influence the type of strategies to be adopted are: 1. Prevailing security situation in the proposed areas of delivery. 2. Local community profile (acceptance and trust). 3. Level of support from national or local governments. The following elements should be considered to help successful delivery of vaccination services. • Detailed and thorough security analysis of the proposed areas of operation from a wide range of sources such as UN, WHO field security officers, local law enforcement officials, local or international NGOs, community-based organisations and local authorities with influence. • Levels of insecurity or threat will determine the scope of activities to be conducted and the periods of access to communities. COMMUNITY ACCEPTANCE IS THE FOUNDATION FOR ALL ACCESS APPROACHES.

• Thorough analysis of the local communities, their leadership, influential people, and political analysis is essential to engage with affected communities, and secure their trust and acceptance of the proposed health services. • Securing community acceptance is the foundation for access. • Local Access Negotiations (LAN) can be initiated after securing a better understanding of the local community, their influencers, and their critical needs. • Integration of transport of vaccines and related supplies with that of other necessary products delivered in humanitarian emergencies. • Combining different service delivery strategies according to the security situation, accessibility and stage of the emergency. Opportunistic vaccination in insecure areas with sporadic access with possible delivery strategies such as quick in-and-out operations, reaching target population through transit points, health camps, self or community-based vaccination, mobile clinics, and community protected campaigns in high-threat areas (see section 5.2). • Community protection strategies or use of military escort in high-threat areas. • Considering a range of activities over a period of time, rather than a one-off activity.

• “Remote management” of training or implementation of vaccination activities using local healthworkers and community members in high-risk areas that are inaccessible to the UN and/or national staff, or where their movement is reduced or restricted. • Mapping of settlements, communities, and internally-displaced people (IDPs) using all available means, such as technology, local information, and government and UN sources. • Regular reviews and revisions of the microplans based on the evolving situation. • Access to residents in informal settlements or irregular residents. • Training of community health workers and non-traditional vaccinators (depending on agreement with national health authorities). • Conducting and sustaining advocacy efforts with national and local government leadership to ensure that access for delivery of health interventions, including vaccinations, is highly prioritized, and any windows of opportunity are quickly used for delivery of health services. 5.1.1 NEGOTIATED ACCESS Local negotiations can be effective only after community ENGAGE INFLUENTIAL LOCAL trust and acceptance is secured. In order to obtain community AUTHORITIES AND LEADERS TO trust and acceptance, it is critical to engage local religious and OBTAIN COMMUNITY TRUST. traditional leaders, tribal or clan elders, and local authorities with influence. Where the humanitarian situation dictates, negotiation conducted in independent, neutral and impartial manner is essential. This may provide the opportunity to access more areas while sustaining credibility of the immunization programme. Only staff familiar with local culture and community should be engaged in these negotiations. In some instances, a neutral third party may lead negotiations for access and safe passage. This can help to maintain an arm’s length approach and avoid the engagement of UN or government officials with nonstate armed groups. However, the local situation should be well understood and third party action carefully considered as some communities may not trust the third-party agents. 5.1.2 LOCAL COMMUNITY APPROACHES In areas of active conflict, local community-based approaches can provide solutions for challenges due to political barriers or acute fighting. In long-standing conflicts, there is more clarity on leadership, as conflicting parties become generally better defined and more open to negotiations for the delivery of health services (including vaccinations) to areas under their control. In refugee camps and informal settlements, it may be easier to identify key stakeholders for negotiation. Dialogues with community elders and leaders are essential prior to the delivery of services to ensure full support from the community in IDP camps and settlements. 5.1.3 INTERACTION WITH PARTNERS ITF should actively cooperate with HC partners, as they often have more information on access to security-compromised areas. All available health care providers should be engaged in order to implement the planned activities in the shortest possible time and achieve the highest possible coverage, especially when implementing campaigns. Local NGOs, local CLOSE COORDINATION WITH UNITED NATIONS DEPARTMENT OF SAFETY AND SECURITY IS CRITICAL TO IDENTIFY THE TIME FOR OPPORTUNISTIC VACCINATION EFFORTS.

community groups, and faith-based groups are often very helpful in providing access to security-compromised areas and can help engage local health-care workers. Their contacts with local religious, tribal, and/or influential leaders can be helpful in religious/tribal advocacy for programme operations. For insecure areas with sporadic access, close coordination with the United Nations Department of Safety and Security (UNDSS) or other security officials, and community contacts are critical to identify periods of access for opportunistic vaccination efforts. These may include pre-positioning vaccines and operational funds to quickly implement vaccination activities once a window of opportunity opens for quick in-and-out operations (in some locations referred to as “hit and run”). 5.1.4 REMOTE MANAGEMENT AND HUMAN RESOURCES MOBILIZATION In case of disruption of the health system when the health-care facilities are destroyed, local health workers, staff and partners may still be available. When possible, planning, training of local staff, and management of operations can be conducted outside the high-risk zone using remote management approaches. This can be achieved through local organisations, or through communication technology solutions (like Skype, cell phone, WhatsApp). Further, in some contexts it may be an option to involve the local private sector, use militaryprovided health services or other (e.g. NGO) health facilities as well as mobile health clinics. In case of disruption of the central and/or subnational authorities, the aim should be to provide services directly with approval of community.

5.2

Strategies for vaccination service delivery

The decision on strategies for vaccination service delivery depends on the situation and the context of humanitarian emergency. Whenever possible, vaccination service delivery should occur through the routine immunization programme channels, following the established methods of service delivery. When routine vaccination services are disrupted, the choice of vaccination strategy should consider accessibility, security situation, vaccination programme criticality, and the local community context. The selected strategy should be convenient and acceptable to local community. This may include third party negotiation or local access negotiation. Such negotiated access may determine or limit the options for service delivery as some parties may only agree on a specific type of delivery. CHOOSE THE VACCINATION STRATEGY CONSIDERING ACCESSIBILITY, SECURITY SITUATION, VACCINATION PROGRAMME CRITICALITY AND LOCAL COMMUNITY CONTEXT.

Provision of vaccination should be impartial, and service delivery to residents, refugees, or population considered as non-state armed groups needs to be planned and ensured, as some of these groups may be unwilling or unable to access the governmental structures. The selected strategies for delivering routine vaccination depend on the condition and functioning of existing facilities. In case of damaged infrastructure, the possibility and overall benefit of establishing new vaccination posts in case of damaged infrastructure can be considered. Vaccination service delivery can occur through: • Fixed sites and/or outreach (i.e. permanent and temporary fixed sites). • Mobile teams from fixed facilities. • Mass campaigns, including “multiple vaccines” campaigns. Fixed permanent sites, if available, and planned outreach on a regular basis are preferred options where there is satisfactory access. In situations of decreased accessibility, mobile teams or special “multiple vaccine”

campaigns may be the only options for vaccination service delivery. In sparsely populated areas with limited infrastructure, a mobile strategy may be the best option, but safe passage for health workers is paramount. If there is a high risk of imminent disease outbreak, conducting STRENGTHEN ROUTINE a mass campaign in order to protect a large target population VACCINATION IN PARALLEL WITH quickly is often the best option. The drawbacks to this strategy THE CAMPAIGN. are its high cost and non-sustainability. Furthermore, ensuring procurement, shipment and reception of vaccines and supplies in a short period of time is a challenge. Therefore, (re)establishing and/or strengthening routine immunization activities in parallel with or after the campaign are important. In general, flexibility in approach to service delivery is often needed (e.g. combination of routine vaccination and campaigns, and possibly considering a staggered approach to the campaign). Should the context require, innovation and variation of strategies may be considered and used. Some examples include: • Periodic intensification of routine immunization (PIRI).21 • Initiatives with community involvement as well as compensation to the community when the community organizes vaccination sessions. This can include strategies which encompass the recruitment (and training) of local and/or female volunteers to deliver vaccinations. This may further include the selection of a generally accepted location, for example the community guest room of village elder as a neutral venue for vaccination. • Quick in-and-out operations, using windows of opportunity, such as temporary cease fires, to access the targeted area and conduct vaccination within a short timeline. • Vaccination at transit points with frontline workers placed at the borders to vaccinate those exiting or entering hard-to-access and security compromised areas. • Staggered approach. • Cross-border team strategies. • Partnering with private for-profit health service providers to increase access to vaccination and basic package of health care services. • Collaboration with CSOs working in the area. With the caveat that each context is different and may warrant a specific vaccination delivery strategy based on the local situation assessment, Table 2 provides some suggested strategies according to different emergency situations.

Periodic Intensification of Routine Immunization. http://www.who.int/immunization/programmes_systems/policies_strategies/ piri_020909.pdf, accessed July 2017.

Table 2: Suggested strategies for service delivery for specific contexts during different emergency situations CONTEXT Area of active conflict ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ ∙∙ OPERATIONAL STRATEGIES Outreach Fixed sites for routine vaccination Quick in-and-out operations Vaccinations at transit points Periodic intensification Community-based involvement Outreach Fixed sites Periodic intensification Mobile teams Quick in-and-out operations Vaccinations at transit points Vaccination campaigns Vaccination before moving populations out of newly accessed places Under certain circumstances, partnership with medical services of the military Fixed sites Outreach Mobile teams Vaccination campaigns Fixed sites Outreach Cross-border teams Entry vaccination Holding areas for observation before entry into camp Vaccination campaigns Periodic intensification Partnerships with private for-profit health service providers Vaccination campaigns Re-establishment of basic health functions, including essential longterm medication programs like ARVs-HIV. DOTS-TB, etc.

Long-standing conflicts

Natural disasters

IDP/Refugees

Disruption of the health system

Disruption of the central authority/subnational authorities

∙∙ Periodic intensification ∙∙ Partnerships with private for-profit health service providers ∙∙ Vaccination campaigns

Vaccination activities have at times been subject to serious attacks results in deaths. Some parties may perceive vaccination delivery as hostile or as a cover for a military purpose. In such a context, vaccinators should use a low profile approach while in the field and may choose small vaccine carriers to avoid attracting too much attention. Obtaining valid consent from individuals prior to offering medical intervention is an obligation guided by ethical principles discussed in the Framework.1 The nature of the consent processes during a humanitarian emergency will often differ from those appropriate in a routine, non-emergency health setting. Given the range of challenging conditions during such emergencies, verbal informed consent, without the use of signed consent documents, may be warranted. Informed consent processes should not preclude or delay the implementation of interventions. In exceptional situations, there may be legitimate reasons to override an individual’s refusal of vaccination. Where there is an imminent threat of infectious disease that poses a significant risk of substantial harm to a large number of persons, individual liberties may be justifiably curtailed, and “compulsory vaccination” may be indicated. RESPECT INTERNATIONAL HUMAN RIGHTS AGREEMENTS AND INTERNATIONAL HUMANITARIAN LAWS.

Any such vaccination programme curtailing personal liberties must balance competing ethical principles. Countries which impose such actions must respect their obligations under international human rights agreements and international humanitarian laws. DOCUMENT EMPLOYED INFORMED In any case, it is critically important to document the employed CONSENT STRATEGIES. informed consent strategies.

5.3

Vaccination schedule

Vaccinations should be administered according to the host country USE THE HOST COUNTRY schedule and efforts should be made to maintain the same schedule VACCINATION SCHEDULE throughout the country, including IDP camps, refugees hosted THROUGHOUT THE COUNTRY. in the community, and areas which are not under government control. If this is not possible, the emphasis should be on preventing diseases outbreaks and providing the antigens as decided within the ITF. The decision-making process on the antigens to be included in the vaccination activities/immunization schedule during humanitarian emergency situation is guided by the Framework. Recent reports from countries hosting refugees highlighted the “VACCINATION IN ACUTE difficulty in deciding on the appropriate immunization schedule HUMANITARIAN EMERGENCIES: for refugee populations/refugee camps. Questions that may be A FRAMEWORK FOR DECISION encountered are whether to continue the immunization schedule MAKING” PROVIDES GUIDANCE of the country of origin of the refugees or use the immunization ON DECIDING WHICH VACCINES schedule of the host country. Continuation of the immunization TO INCLUDE. schedule of the country of origin may, should for example more antigens be covered by this schedule, raise animosities within the host population towards the refugee population and the perceived better health care coverage. All attempts should be made to provide vaccines to refugee populations using the vaccination schedule of the host country given that, while many refugees plan to return home, prolonged durations in host countries is more common than return to their home country.

5.4

Monitoring, evaluation and supportive supervision22

Reporting of vaccination activities should be maintained in humanitarian emergency situations and can follow the regular reporting system of the EPI. If the national programme is interrupted, the ITF should ensure continuation of reporting. The chosen method and flow of data should ideally be the same as before the emergency, or simplified, if keeping the pre-emergency method is not feasible. Additionally, periodicity of reporting may be altered as well. As a general principle, attempting to collect good quality basic data is preferable over attempting to collect complex exhaustive data which may be incomplete and/or of poor quality. If there are ongoing routine vaccination activities, weekly or monthly reporting may suffice. In case of a special campaign, vaccination delivery data should be submitted as THE METHOD USED TO REPORT ON VACCINATION ACTIVITIES AND DATA FLOW SHOULD BE THE SAME AS BEFORE THE EMERGENCY, OR SIMPLIFIED.

Service delivery. http://www.who.int/immunization/programmes_systems/service_delivery/en/, accessed July 2017.

recommended by the ITF. Daily reporting is preferred in order to monitor and provide necessary support and/ or modification in a timely manner. ITF should develop simple but specific core monitoring SIMPLE BUT SPECIFIC CORE indicators so that health workers and concerned partners MONITORING INDICATORS understand goals and the evaluation process. Suitable ARE RECOMMENDED. monitoring indicators that include only a few core input, process and output indicators are recommended, with strong emphasis on avoiding overburdening the fragile system with unnecessary data collection and processing. This should be done with agreement of all involved partners and standardized for use by all involved. Monitoring can be part of the overall health care monitoring and results discussed in the HC meetings to ensure engagement of partners. Health care workers assigned monitoring and supervision should be trained in order to avoid difficulties in completing their appointed tasks. If travel for monitoring and supervision by concerned staff at the central or provincial levels to the periphery is not possible, and in case of disputed areas, training of local staff should be conducted so that they can take over this responsibility. Locally acting NGOs can help with this. Independent monitoring during campaigns14 should not be omitted, even under the difficult or highly challenging situations. Locally active stakeholders, especially local NGOs, can take this responsibility. International technical partners, especially WHO, can take the responsibility of developing the related tools and training of local health workers on doing so. Data sharing should be liberal and open. Collecting the information, production and sharing the indicators is the responsibility of the OCR under overall guidance of the ITF. Field monitoring and supervision should be transparent and participatory and done in a systematic way using specifically designed checklists.23,24 Supervisors should have clear standard operating practices. In recent events, using modern technology for monitoring and supervision, such as WhatsApp and Skype where internet connection is available, proved to be highly effective for sharing data and indicators, and for follow up and discussion.25 Trained volunteers could play an important role. Independent monitoring, remote monitoring approaches, intra-programme monitoring to address barriers and bottlenecks which can guide programme adjustments and increase uptake should be considered. It is important that every team is supervised, particularly early-on to ensure safety and that they are following the campaign as planned. 5.4.1 INFORMATION SHARING AND DISSEMINATION Regardless of situation in the field, a well-defined data flow, established by the ITF, should ensure that data are rapidly and efficiently communicated to the correct persons, from the community and facility level up to district or national level decision makers (Figure 1). The OCR plays an important role as data-collector and data-compiler and designated members of the ITF may analyse the data and oversee its collection. It is useful to report to the HC for support in obtaining needed resources. The HC is also an efficient mechanism to disseminate data on a regular basis and in a standard Supportive supervision. http://www.who.int/immunization/documents/MLM_module4.pdf, accessed July 2017. Supervisory checklist on monitoring during a visit to a health unit. http://www.who.int/immunization/monitoring_surveillance/routine/ indicators/monitoring_supervisory_checklist.pdf?ua=1, accessed July 2017. 25 Real-Time Monitoring of Vaccination Campaign Performance Using Mobile Phones — Nepal, 2016. https://www.cdc.gov/mmwr/ volumes/65/wr/mm6539a5.htm, accessed July 2017. 23 24

format to a large group of partners. The OCR can also be used to disseminate information from the ITF or other decision making body to the sub-national levels. Figure 1 Proposed flow of data in the emergency hierarchy. Vaccination teams ∙∙ Collect ∙∙ Review ∙∙ Submit to the supervisor ∙∙ ∙∙ ∙∙ ∙∙ Cross-check for accuracy Analyze team data Compile and submit to OCR Provide feedback to vaccination teams

Supervisor

OCR

∙∙ Aggregate team data ∙∙ Analyze and submit to ITF ∙∙ Provide feedback to supervisors ∙∙ Aggregate data ∙∙ Submit reports to the HC ∙∙ Provide feedback to OCR ∙∙ Disseminate data to partners

ITF

5.4.2 INDICATORS AT DIFFERENT LEVELS Although the indicators may vary based on the context, an example of suggested indicators based on the different emergency situations is given in Table 3 below. Data required for calculating some of the indicators can be collected as part of the EPI assessment and updated periodically (e.g. some of the input indicators). Data for some other indicators can be collected as part of the regular reporting system (e.g. vaccination coverage by antigen).

Table 3 Suggested indicators for different emergency situations. Types of indicators Area of active conflict 1. Number of individuals available (HR) 2. Number of trained local health workers able to provide immunizations 3. Cold chain availability and capacity 4. Number of supplied doses (by antigen). 5. Number and proportion1 of fixed sites functioning 1. Number of sessions/ activities per day/ week 2. Link with the Early Warning and Response Network (EWARN) for fever and rash/acute flaccid paralysis cases 1. Number of target population vaccinated per antigen per age group 2. Number of doses used Long-standing conflicts 1. Number of individuals available (HR) 2. Number of trained local health workers able to provide immunizations 3. Cold chain availability, capacity and functional status 4. Contribution of partners at provincial/ governmental level 5. Number of supplied doses (by antigen) 6. Number and proportion of fixed sites functioning 1. Number of sessions/ activities per day/week 2. Number of vaccine vials utilized per (antigen) 3. Link with the VPD surveillance system or EWARN 4. Vaccine wastage 5. Waste disposal 1. Vaccination coverage estimate2 per antigen dose per age group Natural disasters 1. Number of individuals available (HR) 2. Number of trained local health workers able to provide immunizations 3. Cold chain availability, capacity, and functional status 4. Contribution of partners at provincial/ governmental level 5. Number of supplied doses (by antigen) IDP/refugees 1. Number of individuals available (HR) 2. Number of trained local health workers able to provide immunizations 3. Cold chain availability, capacity and functional status 4. Contribution of partners at provincial/ governmental level 5. Number of supplied doses (by antigen)

Input

Process

1. Number of sessions/ activities per day/week 2. Number of vaccine vials used per antigen 3. Vaccine wastage

1. Number of sessions/ activities 2. Number of vaccine vials used per antigen 3. Link with the VPD surveillance system or EWARN 4. Vaccine wastage

Output

1. Number of target population vaccinated per antigen dose per age group 2. Vaccination coverage per antigen per age group

1. Vaccination coverage per antigen dose per age group

6. Exit strategy and early recovery of routine vaccination services The exit strategy in this context is considered to be a transition from implementation of vaccination under humanitarian emergency to implementation of regular routine immunization. This should be planned early on and be part of the overall contingency/response plans. This approach may facilitate accountability and avoid donor fatigue. It needs to be highlighted that provision of routine vaccination should always be assured, not only at the stage of the exit strategy. Shifting from crisis mode to rehabilitation of vaccination services and infrastructure should be considered only when the situation improves and a return to routine service delivery is possible. The general aim is to optimize the use of the resources which were made available during the emergency. The interventions conducted, experience gained or innovations applied during the emergency should be sustained and strengthened. The partnership and coordination which have been built during the crisis should be sustained and the integrated health service delivery should be expanded and strengthened. Retaining staff who have been trained during the crisis and the additional infrastructure added during the emergency may aid in providing/sustaining high vaccination coverage. Development or updating of a comprehensive multi-year plan may be useful for immunization programme recovery. In protracted emergency situations, and even in active conflicts, all attempts should be made to (re)establish routine vaccination services utilizing available and rehabilitated health facilities and the activities of all health care providing partners who can deliver vaccination on the ground. The proportion of vaccinations provided through each of the fixed, outreach and mobile delivery strategies will depend on available and rehabilitated infrastructures as well as feasibility of implementation.

ANNEX 1: TEMPLATE OF A MICRO PLAN (PRELIMINARY VERSION TO BE TESTED IN THE FIELD) 1. The sample template may be used to generate a detailed budget for the campaign. The sample template may be retrieved from: http://www.who.int/immunization/Microplan_vaccination_humanitarian_ emergencies.xlsx 2. The template may be modified to accommodate local needs. If modified by adding rows or columns, the formulas for calculating amounts/costs may need to be changed to include the modification. 3. Generally, inputs are made in white (non-shaded) cells. Specific instructions on each spreadsheet may indicate variations to this. 4. If using this spreadsheet, cells populated with numbers (NOT formulas) will need to be cleared and amounts/costs replaced with those specific to the current campaign. 5. Each sheet has instructions for the table within that sheet. These instructions are highlighted in purple just below the respective table. 6. The displayed example sheets provided below contain fictive numbers, amounts, costs, etc. indicated in each sheet.

Target and Required Supplies Bundles

No 71,650,00 25,048 34,590 25,280 18,568 19,562 123,048,00 194,698,00 5,840,94 5,548,89 29,204,70 17,522,82 5,840,94 21,324,00 3,691,44 3,506,87 18,457,20 11,074,32 3,691,44 14,321,00 587 558 2,934 1,761 587 2,180 1,973 13,147,00 19,868,00 Total Vials needed per Vaccine: 557 529 2,785 1,671 557 1,993 1,851 758 720 3,792 2,275 758 3,126 2,991 1,038 986 5,189 3,113 1,038 4,370 4,202 751 714 3,757 2,254 751 2,652 2,130 2,149,50 2,042,03 10,747,50 6,448,50 2,149,50 7,003,00 6,721,00

Governorate District

Health Facility <5 Yr (15%)

Total Live births (3%) Population

Surviving infants (2.85%) Target coverage

Children 12-48 Months (9%) Pregnant women (3%) No of students in Class 1 No of Students in Class 6

Vaccine Variables:

Sub Total

iii

Sub Total

TOTAL

Target Populations: Enter the number of target population for each Health Facility in columns. Change the column heading if necessary. In Target coverage C, normally 100%.

VACCINES Target Population 1 Target Population 2 Target Population 2 Target Population 2 Target Population 2

Target Population 1

No of Students in Class 6 Total doses required with wastage 2,257 789 1,090 796 585 616 3,876 6,133 6,133 24,411 6,103 1,839,90 22,192 24,411 4,882,20 5,548 6,103 18,309,00 1,162,80 14,028 15,431 3,086,20 3,507 3,858 11,574,00 10,521 16,647 184,80 2,232 2,455 491,00 558 614 1,842,00 1,673 175,50 2,116 2,328 465,60 529 582 1,746,00 1,588 1,667 1,757 11,047 17,481 238,80 2,880 3,168 633,60 720 792 2,376,00 2,161 2,269 327,00 3,944 4,338 867,60 986 1,085 3,255,00 2,957 3,105 236,70 2,856 3,142 628,40 714 785 2,355,00 2,142 2,249 3,148,60 4,347,00 3,176,60 2,333,80 2,459,80 15,465,80 24,473,40 17,481 714 986 720 529 558 3,507 5,548 Total doses required with wastage 2,245 Total doses required with wastage 6,434

BCG Target Vaccine coverage Variables: Number of Doses required 751 1,038 758 557 587 3,691 5,840

6,721,00

2,149

Total doses required with wastage 4,298

Hep b Total Number vaccine of Doses cost required (Currency) 610,40 2,149

OPV (bi valent) Total Total doses Number vaccine required of Doses cost with required (Currency) wastage 677,10 8,164 8,980

IPV Total Number vaccine of Doses cost required (Currency) 1,796,00 2,041

Penta Total Number vaccine of Doses cost required (Currency) 6,735,00 6,126

MMR Total Number vaccine of Doses cost required (Currency) 9,007,60 2,041

Total doses required with wastage 2,919 1,021 1,410 1,030 756 798 5,015 7,934

Total vaccine cost (Currency) 3,528,00 1,236,00 1,692,00 1,236,00 912,00 960,00 6,036,00 9,564,00 797

2,130

751

1,502

212,80

4,202

1,038

2,076

291,20

2,991

758

1,516

212,80

1,851

557

1,114

156,80

1,973

587

1,174

165,20

13,147,00

3,691

7,382

1,038,80

19,868,00

5,840

11,680

1,649,20

Total Vials needed per Vaccine:

589

In columns for Vaccines:

Enter the appropriate amount/cost for each Variable in the color coded cell.

Please note, 'Cost' is per vial.

The vaccine for that specific target population can be entered. Vaccines given above are the most common and given as example.

In the 'Total vaccine cost' column for each vaccine, please indicate the currency being used. The same currency should be used throughout the spreadsheet.

If you add columns for an additional vaccine/target population, you must adjust the formulas for the appropriate syringe needed and in the 'Total Bundle Cost ' at the far right of the spreadsheet.

VACCINES Target Population 2 Vit A Total vaccine cost (Currency) Number of Doses required 4 10 1,10 1,50 157,50 159,00 252,00 142,50 711,00 249,00 343,50 250,50 184,50 195,00 1,222,50 1,933,50 1,289 53 87,013 22,195 24,414 551,20 6,429 14,027 15,430 343,20 4,062 2,230 2,453 52,00 646 96,90 609,30 964,35 2,117 2,329 52,00 613 91,95 2,882 3,170 72,80 834 125,10 3,943 4,337 93,60 1,142 171,30 18,276 13,193 8,978 9,574 61,688 95,109 2,855 3,141 72,80 827 124,05 11,667 8,168 8,984 208,00 2,367 355,05 33,421 1,642 1,806 41,60 476 71,40 6,570 985,50 5,013,15 1,750,05 2,741,40 1,978,95 1,346,70 1,436,10 9,253,20 14,266,35 2,893 3,182 72,80 838 125,70 11,552 1,732,80 1,832 2,015 52,00 531 79,65 7,683 1,152,45 1,801 1,981 41,60 522 78,30 7,616 1,142,40 76,00 77,00 122,00 69,00 344,00 120,00 166,00 121,00 89,00 94,00 590,00 934,00 10,40 0,15 0,15 1,10 1,10 1,10 0,25 19,00 19,25 30,50 17,25 86,00 30,00 41,50 30,25 22,25 23,50 147,50 233,50 83 83 126 72 364 127 196 142 97 104 666 1,030 1,50 124,50 124,50 189,00 108,00 546,00 190,50 294,00 213,00 145,50 156,00 999,00 1,545,00 7,032 7,140 11,078 6,291 31,541,30 11,023 15,880 11,554 8,267 8,748 55,471,30 87,012,60 500 Total doses required with wastage Total Vit A capsules cost (Currency) No. of AD syringes for BCG No. of other AD syringes No. of Safety Boxes Box size: 100,00 Total cost of AD syringes for BCG Total cost of other AD syringes (Currency) Total cost of 5 ml syringes (Currency) No of 5 ml syringes for reconsitution (10 and 20 dose vials) Injections materials Total cost of safety boxes (Currency)

Target Population 6 and 7

Target Population 5

Td for School students

Td for women

Number of Doses required

Total doses required with wastage

Total vaccine cost (Currency)

Number of Doses required

Total doses required with wastage

Total Bundle Cost of vaccines, injection materials and Vit A (Currency)

1,10

1,50

3,250

3,575

537,00

948

1,043

3,248

3,573

537,00

964

1,060

4,601

5,061

760,50

1,523

1,675

2,625

2,888

433,50

864

950

13,724

15,097

2,268,00

4,299

4,728

4,782

5,260

789,00

1,503

1,653

8,572

9,429

1,414,50

2,075

2,283

6,117

6,729

1,009,50

1,517

1,669

3,844

4,228

634,50

1,114

1,225

4,153

4,568

685,50

1,174

1,291

27,468

30,214

4,533,00

7,383

8,121

41,192

45,311

6,801,00

11,682

12,849

4,534

Injections Materials:

Enter the wastage factor and enter the cost of each item.

For safety boxes, enter the box size in cell AV8, taking into account any 'safety margin' per box (eg. 100 syringe box filled to 80% = box size of 80)

NOTE: If you add additional columns for more vaccines in the vaccine area, you must adjust the formulas for syringes and safety boxes to include the additional amounts.

Required Human Resources Supervisors Administrators Other Personnel

Nurses

Gov. Total Salaries No. of months Total Salaries No. of months Type of Staff No. of Staff No. of months Total Salaries

District

H.F

No. of Nurses

No. of months

Salary per month 2,400 4,800 2,400 1 1 400 400 1 12 300 3,600 -

No. of supervisors

Salary per month

No. of Administrators

Salary per month

Total Salaries/ Yr ( US$ 300/m/ admin in charge Salary per month

Total Salaries (Currency)

200

2,400 4,800 2,400 4,000

200

District Office A 1 1 400 400 1 12 300 3,600 -

District Office B 1 9,600 2,400 4,800 2,400 9,600 4,800 1 1 400 400 1 12 300 3,600 3 6,800 2 7,200 12 500 6,000 Assistants

4,000

Main Office

3 3 -

250

9,000 9,000 -

15,000 32,600 2,400 4,800 2,400 9,600 4,800 4,000

Sub Total

32 1 1 400 400 1 12 300 1 24,000 33,600 6 3 12 500 6,000 6,800 13,600 2 4 -

200

iii

200

District Office A

District Office B

3,600

4,000

Main Office

Assistants 7,200 14,400

3 3 6

250

9,000 9,000 18,000 Total Personnel

15,000 47,000 79,600 30

Sub Total

TOTAL

Human Resources:

For each level, Health Facility (HF), District, Governate/State, fill in the Number of Staff, number of months to be paid, and the salary per month.

For 'Other Personnel', there is a column to identify the Type of staff needed such as Assistant, driver, supply clerk, etc.,

Training Facilitators Misc. Costs

Trainees

Gov

District

H.F

No. of Trainees

No of training Days No. of Facilitators

Perdiem of Trainees (Currency) No of Facilitator Days Perdiem of Facilitators (Currency) Total Cost for Facilitatiors

Total Cost of Transportation of Trainees (Currency) Total Cost per H.F.for Trainees No. of sessions (Max 25 trainees) Total Cost of Transportation of Facilitatiors (Currency) 15 15 15 15 3 1, 680 3 2 3 2 30 100 640 640 15 30 30 30 30 430 270 510 470

Misc. Expense per day per person (Stationary/ refreshment/ etc.) Total Misc. Cost 330 360 180 300 270

Total Cost for Training

1 2 2 2 20 20 20

800 870 450 730 910 1, 440 3, 760 3, 760

Sub Total ( at Governorate level) 2 2 2 2 2 3 2, 190 3 3 20 30 350 2 2 30 20 30 670 20 30 510 20 30 230 20 30 430

33 3, 870 6 4

15 15 15 15 15 100 640 640 15

300 150 360 480 240 270 1, 800

730 380 870 1, 150 590 910 4, 630 4, 630

iii

Sub Total ( at Governorate level)

TOTAL

1, 280

3, 240

8, 390 8, 390

Training:

For each location scheduled for training, fill in the total number to be trained, the number of days, the perdiem (if necessary) per each location and the total cost of transportation for the location.

Fill in the information on Facilitators needed to carry out the training in each Governate/State as per the column headings.

Travel of supervisors

No.

Gov

District

No. of supervisors 50 50 50 1,250 2,100 3,350 12 600 15 20 600 1,200 12 450 15 20 900 1,350 12 200 15 20 600 800 12 9,600 16,200 14,400 40,200

No. of overnight stays per month No. of travel days per month Transport cost per day Number of months in campaign Total Travel Cost (Currency)

Perdiem per overnight stay (Currency)

Total perdiem cost for overnight stays (Currency) Total transport cost (Currency) Total Travel Cost per Month (Currency)

Sub Total ( at Governorate level) 50 50 50 1,300 2,100 900 15 20 900 200 15 20 600 800 1,800 3,400 200 15 20 600 800 12 12 12 12

9,600 9,600 21,600 40,800

Sub Total ( at Governorate level) 2,550 4,200

TOTAL

6,750

81,000

For supervisor travel, fill in the appropriate number/amount for each district/Governate/State for each column in the cells as necessary.

Operating Costs

Gov

District

Health Facility 100 100 100 100 150 150 200 900 100 100 100 100 100 150 150 200 1,000 1,900 500 1,150 250 600 2,600 5,050 250 150 950 100 450 12 12 100 450 12 50 150 12 50 150 12 50 150 12 1,800 1,800 1,800 5,400 5,400 11,400 31,200 60,600 50 150 12 1,800 50 150 12 1,800 250 550 2,450 29,400 250 150 950 12 11,400 100 450 12 5,400 100 450 12 5,400 50 150 12 1,800 50 150 12 1,800 50 150 12 1,800 50 150 12 1,800

Cost of fuel for generators per month (Currency) Cost of fuel for heating per month (Currency) Misc. cost per month (Currency) No. of months in campaign Cost of transport per month (Currency) Total Cost for Campaign (Currency)

Total Operating Cost per Month (Currency)

200

350

Sub Total

750

iii

200

350

Sub Total

750

TOTAL

1,500

Operating Costs: fill in the necessary cells in columns for each HF, District, and Governate as necessary.

Cold Chain Equipment Cold Boxes Vaccine Carriers Temperature Recorders Freeze Watch Generators Batteries

Refrigerators

Freezers

Gov.

District H.F

No.

Total Price cost (CurNo. (Currency) rency) 700 700 700 700 2,800 700 700 700 700 700 700 700 9,800 31 2,480 74 3,700 226 16 1,280 32 1,600 146 1,400 1,400 1,400 146 226 700 6 80 480 4 50 200 34 1 34 1 80 80 5 50 250 40 1 40 12 13 88 159 2,800 2 80 160 6 50 300 19 1 19 16 1,400 2 80 160 7 50 350 23 1 23 12 2 2 2 2 700 5 80 400 10 50 500 30 1 30 35 2 15 1,200 42 2,100 80 80 71 142 70 24 32 24 26 176 318 4 1 1 1 1 1 5 9 800 800 800 800 800 700 9 50 450 20 1 20 11 2 22 1 700 4 80 320 11 50 550 12 1 12 10 2 20 1 800 800 700 3 80 240 10 50 500 8 1 8 10 2 20 1 800 700 8 80 640 12 50 600 40 1 40 40 2 80 1 800 800 800 800 800 3,200 800 800 800 800 800 4,000 7,200 2 2 2 2 8 2 2 2 2 2 10 18

Total Price cost (CurNo. (Currency) rency)

Total Price cost (Cur(Currency) rency) 100 100 100 100 200 200 200 200 800 100 100 100 100 100 200 200 200 200 200 1,000 1,800

Total cost of Cold Chain (Currency) 4,060 2,468 5,102 2,692 2,000 2,000 2,000 20,322 3,700 2,957 6,311 2,394 3,940 3,400 3,400 3,400 29,502 49,824

500

1,000

500

2,500

500

2,000

500

2,000

500

2,000

Sub Total

10,000

500

1,000

500

36 12,600

500

2,000

500

1,000

iii

500

1,500

500

2,000

500

2,000

500

2,000

Sub Total

11,500

TOTAL

21,500 18

Cold Chain Equipment: For each administrative level, in the cells fill in the appropriate number and price for each piece of equipment needed.

Summary Cost of Campaign Budget Training 800 870 450 730 9,600 16,200 910 3,760 730 380 870 1,150 590 9,600 9,600 910 4,630 8,390 8,390 81,000 60,600 81,000 60,600 49,824 49,824 40,800 31,200 29,502 21,600 11,400 3,400 5,400 3,400 22,400 52,310 208,603 366,427 366,427 5,400 3,400 22,400 1,800 3,940 19,878 1,800 2,394 23,211 1,800 6,311 22,935 1,800 2,957 25,817 1,800 3,700 19,653 40,200 29,400 20,322 157,823 14,400 11,400 2,000 43,710 5,400 2,000 27,600 5,400 2,000 21,000 1,800 2,692 13,913 1,800 5,102 23,230 1,800 2,468 12,278 1,800 4,060 16,092 Travel Operating Cost Cold chain Grand Total (Currency)

No.

Gov.

District

H.F. Vaccine Cost

Human Resources

7,032

2,400

7,140

11,078

4,800

6,291

2,400

4,000

15,000

Sub Total

31,541

32,600

11,023

2,400

15,880

4,800

11,554

2,400

8,267

9,600

iii

8,748

4,800

4,000

15,000

Sub Total

55,471

47,000

TOTAL

87,013

79,600

87,013

79,600

NOTE: Amounts in this summary table flow from the respective detailed sheet.

PLEASE DO NOT ADJUST AMOUNTS HERE. Make any adjustments in the individual sheets

Sample Calculation surviving infant 2,80% 280 560 840 1,120 6,000 1,200 4,500 900 3,000 600 1,500 300 15% 3% < 5 Yr Preg women

Total Population

Live births

10,000

300

20,000

600

30,000

900

40,000

1,200

ANNEX 2: MAPPING OF INTERNATIONAL ENTITIES ACTIVE IN SUPPLY OF VACCINES IN HUMANITARIAN EMERGENCIES Purpose People affected by emergencies, epidemics and other humanitarian crises face unique challenges to access recommended vaccinations. Among these, countries and humanitarian organizations have highlighted the lack of clarity on how to access vaccine supply with support from international agencies. This document aims to provide information on the main international entities involved in supporting supply of vaccines in humanitarian emergencies and on how to access this support. The document is intended for stakeholders in charge of planning and managing immunization service delivery in a given humanitarian emergency context i.e. staff from the national immunization programme, from ministries of health (MoHs) and possibly other ministries, from the district and local level, from local, national and international non-governmental organizations (NGOs) as well as from international organizations.

Methodology A web search was undertaken to identify entities active in supply of vaccines in humanitarian emergencies for each of the 48 Health Cluster partners.26 Wherever the web search identified an active role in the areas of vaccine funding, supply and/or procurement as defined below, further investigation was conducted through questionnaires and direct contact with relevant entities. 26

http://www.who.int/health-cluster/partners/current-partners/en/ (last accessed 05.12.2016)

Conclusions were drawn on the main actors supporting countries to access urgent vaccine supply. For each of these entities, relevant information on organizational role, type of support provided, vaccine and country eligibility, links to useful information, and information on how to access support were provided. In addition, all manufacturers with WHO prequalified products have been listed with their contact information. Finally, Gavi, the Vaccine Alliance, Cerf, and bilateral donors were also added to the list given their key role in vaccine funding, including in emergencies. The following definitions were applied to investigate organizational roles: • Funding: provision of financial support for vaccine purchase including for use in humanitarian emergencies. • Vaccine supply and management: vaccine production and management of vaccine stockpiles. • Vaccine procurement: purchasing and arranging delivery of vaccines to countries.27 It should be noted that mention of an organization within this document is not an implicit endorsement of the quality of its operations. Also, no mention of entities does not preclude their engagement in supply of vaccines in humanitarian emergencies. This annex will be updated periodically to reflect any major change in landscape.

Key international entities supplying vaccines in humanitarian emergencies Following a review of all health cluster organizations and their current involvement in vaccine supply for humanitarian emergencies, it is concluded that there are currently ten entities active in core supply functions. In addition to providing funding, vaccine supply, and/or vaccine procurement, some of these entities also provide: • International and/or local coordination and communication between different partners and local actors. • In-country vaccine delivery through in country vaccine distribution, vaccination campaigns and outreach, and/or implementation of vaccination services. • Technical support such as education & training on vaccination, vaccination logistic support, monitoring and assessment. An overview of each entity role is provided in Table I below. A more detailed description of support provided and how to access it is provided in Table II. In addition, vaccine manufacturers endeavour to ensure a reliable supply of safe and effective vaccines to communities worldwide. In certain cases they might provide adapted product pricing for emergency situations, in-kind donations to meet pressing needs, and funding to support emergency operations. Policies are specific to each manufacturer and programs to deal with humanitarian emergencies vary from a manufacturer to another. There are currently 145 vaccines and 239 vaccine presentations prequalified for quality, safety and efficacy by the WHO prequalification programme.28 Their manufacturer and related contact information for direct access is provided in Table III. 27

Of note, only organizations with a clear role in funding, supply & management, and procurement of vaccines were included. Entities only involved in these functions for vaccine-related equipment were excluded from the final list of active entities. 28 http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/ (last accessed 05.12.2016)

Finally, several bilateral donors are active in the context of humanitarian emergencies. Countries wishing to receive financial support for immunization can directly discuss potential options with donors present in the country. Given specificity of support to each donor and to each country circumstance, no further information for these entities is provided in this document. Table I Overview of key entities Role Organization Coordination 1. UNICEF 2. ICG 3. CDC 4. MSF 5. IFRC 6. Gavi 7. Global Fund 8. CERF 9. Bilateral Donors 10. Vaccine manufacturers √ √ √ √ √ √

Vaccine supply √ √

Funding √

Vaccine procurement to country √

In-country vaccine delivery √

Technical support √

√ √ √ √

√ √ √

Table II Organization specifics 1. UNICEF Description Role Vaccine supply & equipment coordination, management, funding, vaccine procurement to country, in-country vaccine distribution, technical support UNICEF provides rapid supply responses in emergency situations. UNICEF serves the following functions: ∙∙ Works with Governments and/or non-government entities (eg. partners with MSF or International movement (IFRC/ICRC) in conflict affected areas with limited access). ∙∙ Participates in health sector coordination and other coordination forums. ∙∙ Supplies vaccines, vaccine related devices such as safety boxes, syringes, and yellow cards in addition to cold chain equipment procurement and logistics. ∙∙ Provides technical support for forecasting, planning and monitoring vaccination campaigns as well as support in logistics and capacity building. ∙∙ Offers operational support for routine immunization, vaccination campaigns, outbreak response, training and social mobilization. ∙∙ Ensures rapid provision of a context-appropriate package of services, typically includes measles vaccination & distribution of vitamin A. Policy/ framework UNICEF acts in humanitarian emergencies under the guidance of: ∙∙ Core commitment for children in Humanitarian Action ∙∙ WHO guidelines for epidemic preparedness and response to measles outbreaks ∙∙ Resources for polio eradicators http://www.unicef.org/emergencies/ index_68710.html http://www.who.int/csr/ resources/publications/measles/ WHO_CDS_CSR_ISR_99_1/en/ http://www.polioeradication. org/Resourcelibrary/ Resourcesforpolioeradicators.aspx Vaccine covered Eligibility All vaccines as per national schedules (in emergency settings, mainly measles, polio, OCV). All countries, all children and women of child bearing age. Prior to shipment, recipient country must demonstrate that there is enough cold chain capacity and that custom clearance and regulatory approvals have been granted How to access support On request from country government, based on the agreed response plan endorsed by WHO / UNICEF, usually through UNICEF country and regional offices. Useful Links http://www.unicef.org/emergencies/

Role description

http://www.unicef.org/supply/

2. International Coordination Group for Vaccine Provision (ICG) Description Role Role description Mechanism to manage and coordinate the provision of emergency vaccine supplies and antibiotics to countries during major outbreaks. The ICG is an emergency vaccine stockpile managed by 4 partners: UNICEF, MSF, IFRC and WHO. In the context of humanitarian emergencies, it provides the following functions: 1. Receives request for vaccine from countries. 2. ICG secretariat at WHO circulates the request for stockpile use to the 4 partners to review and assess. 3. If request is granted, UNICEF procures the vaccines and injection materials needed and organizes delivery to the country, ideally within 7 days. Policy/ framework Vaccine covered Eligibility to support How to access support N/A The ICG stockpile currently covers 3 vaccines: meningitis, yellow fever and cholera. Any country facing an epidemic, as long as it fulfils ICG’s criteria for release of vaccine stocks. Procedure to access the vaccine stocks managed by ICG: ∙∙ Request to ICG secretariat at WHO headquarters through one of the 4 ICG member agencies. ∙∙ Decision to release vaccine stocks is grounded in evidence-based criteria that includes: epidemiological evidence of an outbreak, lab confirmation of pathogen, cold chain storage capacity, the country’s demonstrated capacity to conduct a vaccination campaign and an accompanying plan of action for mass vaccination. Yellow Fever: http://www.who.int/csr/ disease/meningococcal/icg/en/ Cholera: http://www.who.int/entity/csr/ disease/icg/ICG_OCV_Request_Form_ Cholera.doc?ua=1 Meningitis: http://www.who.int/csr/ disease/meningococcal/icg/en/ Useful Links http://www.who.int/csr/disease/icg/en/

3. US Centers for Disease Control and Prevention (CDC) Description Role Role description Technical support in countries affected by a disaster, funding in some specific cases. At the request of governments or partners, CDC can provide technical assistance in affected countries. Technical support may include assessments, surveys, planning of immunization campaigns, guidance on target population to be vaccinated, assessment of cold chain capacity following a disaster, etc. Funding could also be done in specific cases to purchase vaccinesor to support program implementation. Policy/ Framework Vaccine covered Eligibility N/A N/A All countries affected by a natural or man-made disaster can apply for technical support. Funding may be restricted to specific areas or events. On request Useful Links

How to access support Notes

The Office of Foreign Disaster Assistance (OFDA) part of the United States Agency for International Development (USAID) is in charge of humanitarian response and coordinates US government partners (USG) response.

https://www.usaid.gov/whowe-are/organization/bureaus/ bureau-democracy-conflictand-humanitarian-assistance/ office-us

4. Médecins Sans Frontières (MSF) Description Role Role description Vaccine procurement to country, in-country distribution of vaccines, technical support Médecins Sans Frontières is an organization that delivers emergency aid to people affected by humanitarian emergencies. In the context of humanitarian emergencies, MSF provides the following vaccine supply functions: ∙∙ Routine vaccination ∙∙ Wide-scale outbreak response and vaccination campaigns ∙∙ Preventive vaccination campaigns (during or outside of humanitarian crisis situations) ∙∙ Vaccine campaign logistics, sensitization activities linked to campaigns ∙∙ Disease case management & surveillance ∙∙ Vaccine procurement and distribution within the country to areas where MSF implements vaccination activities Policy/ Framework Vaccine covered MSF acts in humanitarian emergencies under the guidelines of the Emergency Response Framework. ∙∙ In outbreak response and prevention of outbreak: according to the disease (if preventive according to epidemic prone disease(s) most at risk) ∙∙ In preventive vaccination in humanitarian emergencies: priority given according to highest public health threat and burden; mostly measles, DPT-Hib-HepB, OPV, PCV, OCV1, (YF, Typhoid, Meningitis A, Jap. Encephalitis are also considered) MSF support is available to any population Support from MSF is accessible based on discussions between the organization and authorities http://www.who.int/hac/about/erf_.pdf Useful Links

Eligibility How to access support

5. International Federation of Red Cross and Red Crescent Societies (IFRC) Description Role Role Description Vaccine procurement to country, technical support, direct service delivery in selected settings, funding to its national societies. The International Federation of Red Cross and Red Crescent Societies acts before, during and after disasters and health emergencies to meet the needs and improve the lives of vulnerable people. In the context of humanitarian emergencies, IFRC seeks to serve the following vaccine supply functions: ∙∙ Funds national societies of the federation to carry out social mobilization activities for vaccination campaigns including measles and rubella, polio, meningitis, yellow fever and cholera. ∙∙ Access to specific items through IFRC: purchase vaccines and equipment through IFRC emergency catalogue. ∙∙ Supports polio immunization efforts ∙∙ Procures in some contexts ∙∙ Works on demand creation, social mobilisation & campaign logistics Policy/ Framework Vaccine covered Eligibility How to access support IFRC is developing guidelines for distribution to the national societies on best practices for immunization in diverse settings. The IFRC support covers the following vaccines: measles, rubella and polio. IFRC support is available in regions affected by man-made or natural disasters. IFRC uses a variety of methods to support immunization activities, including using disaster relief emergency funds (DREF), emergency appeals, and project cooperation agreements with diverse partners. IFRC works with partner national societies who are the implementing partners for most activities. IFRC Emergency catalogue http://procurement.ifrc.org/catalogue/ Useful Links

6. Gavi, The Vaccine Alliance (Gavi) Description Role Role Description Funding Gavi, the Vaccine Alliance is public private partnership that aims to create equal access to new and underused vaccines for children living in the world’s poorest countries. In the context of humanitarian emergency, Gavi serves the following vaccine supply function: ∙∙ New Vaccine Support (NVS) –– Countries with NVS can request Gavi to re-route vaccines if applicable and revise the delivery plan. –– Countries can request for Gavi procurement of replacement vaccines in case vaccines have been destroyed or cannot be accessed. ∙∙ In humanitarian emergencies Gavi will apply its Health Systems Strengthening Support (HSS), operational support, co-financing & performance based funding with flexibilities. Support may be implemented through Civil Society Organisations (CSOs) in situations where the government and Alliance partners cannot reach certain areas, in full disclosure to the government. ∙∙ The policy includes provisions for situations of displaced people and refugees, including that countries can request additional vaccines to cater for an influx of refugees. Policy In the context of humanitarian emergencies, Gavi follows its policy Gavi and fragile states: a country by country approach. This policy is being revised in 2016/2017. Gavi’s support includes the following vaccines: HPV, polio, Japanese encephalitis, measles, measles-rubella, meningitis A, OCV, pentavalent, PCV, rotavirus, yellow fever. Gavi’s support applies to Gavi-eligible countries with GNI per capita of US$ 1,580 on average over the past three years (according to World Bank data published every year on 1 July). Flexibilities under this policy can be extended to Gavi supported countries in the following types of situations: 1. Countries with fragility 2. Short term emergency situations 3. Situations involving displaced people Flexibilities can be extended also to countries that are transitioning out of Gavi support. How to access support Request made by country government or Gavi in-country partners (WHO/UNICEF) Endorsed by country mechanisms for immunisation coordination (interagency Coordination Committee); mechanism coordinating emergency responses http://www.gavi.org/about/governance/ programme-policies/gavi-policy-onfragility-and-immunisation/ http://www.gavi.org/about/governance/ programme-policies/gavi-policy-onfragility-and-immunisation/ http://www.gavi.org/about/governance/ programme-policies/gavi-policy-onfragility-and-immunisation/ Useful Links

Vaccine covered Eligibility

7. Global Fund Description Role Role Description Funding The Global Fund to fight AIDS, Tuberculosis and Malaria is a partnership organization designed to accelerate the end of AIDs, TB and Malaria. In humanitarian emergencies, the Global Fund may provide funding for TB vaccines. It provides support through the following ways: ∙∙ Support to preventive measures for tuberculosis. ∙∙ Procurement and distribution of health products. ∙∙ Grant can be used for security arrangements for transport, storage and distribution of drugs. Services may be covered by the grant depending on local context. Implementers will be chosen by the Global Fund Secretariat. Emergency funds can be in the form of an additional incremental funding topping up an existing grant or a new grant. Policy/ Framework The Global Fund follows the Guidelines On The Emergency Fund Special Initiative http://www.theglobalfund.org/ documents/core/guidelines/ Core_GuidelinesOnEmergencyFund_ Guideline_en/. Useful Links

Vaccine Covered Eligibility

Tuberculosis Global Fund emergency funding is available to populations under the following situations: ∙∙ Countries facing level 2/3 emergency (IASC); or WHO classified grade 2/3 emergency ∙∙ Targeted populations in the country where they originally resided are eligible to receive Global Fund financing (e.g. Syrian refugees in ineligible countries like Lebanon, Jordan and turkey)

How to access support

On request. Request should be the outcome of a dialogue between the country team and in-country partners involved in the emergency response.

8. CERF Description Role Role description Funding The Central Emergency Response Fund (CERF) is a humanitarian fund established by the United Nations General Assembly in 2006 and is a fast funding mechanism to support humanitarian response for people affected by natural disasters and armed conflicts. It provides rapid initial funding for life-saving assistance at the onset of humanitarian crises, as well as critical support for poorly funded humanitarian response operations. The fund is managed by OCHA. CERF pools contributions from donors – mainly governments, but also, foundations, companies, charities and individuals – into a single fund with a $450 million annual target. CERF hopes to reach an annual budget of $1 billion by 2018. . Policy/ framework Vaccine covered Eligibility CERF is guided in action by its related United Nations General Assembly Resolutions Typically measles, yellow fever, polio and other outbreak-prone diseases in emergencies CERF funds are channelled through UN agencies. To be eligible for support, requests must meet CERF’s life-saving criteria i.e. the needs are urgent and the proposed activities will save lives. Reactive mass vaccination campaigns are typically eligible. https://docs.unocha.org/sites/dms/ CERF/FINAL_Life-Saving_Criteria_26_ Jan_2010__E.pdf http://www.unocha.org/ cerf/about-us/who-we-are/ general-assembly-resolutions-0 Useful Links http://www.unocha.org/cerf/

How to access support

UN agencies are eligible to apply for grants and loans, based on http://www.unocha.org/cerf/resources/ priorities established under the leadership of the Humanitarian/ apply-cerf-funds Resident Coordinator (RC/HC) in the field, who drives the process. Sub‑grants can be made to governments or NGO implementing partners. UN agencies can apply jointly or bilaterally by submitting proposals to the field RC/HC who will submit an application package to the CERF Secretariat.

Table III Vaccine Manufacturers Manufacturer Bharat Biotech International Limited Bharat Biotech International Limited Bharat Biotech International Limited Bilthoven Biologicals Bilthoven Biologicals Biological E. Limited Mr. Lakshminarayana Neti, Chief Operating Officer – Vaccines Phone: +91 40 6738 8226 Lakshminarayana.neti@ biologicale.co.in Biological E. Limited Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Mr. Sai D. Prasad prasadsd@bharatbiotech.com Type Polio Vaccine - Oral (OPV) Bivalent Types 1 and 3 Polio Vaccine - Oral (OPV) Trivalent Polio Vaccine - Oral (OPV) Trivalent Polio Vaccine Inactivated (IPV) Polio Vaccine Inactivated (IPV) Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Pharmaceutical Form Liquid: ready to use Presentation Vial No. of Doses 20

Liquid: ready to use

Vial

Liquid: ready to use

Vial

Liquid: ready to use Liquid: ready to use Lyophilised active component to be reconstituted with liquid active component before use Lyophilised active component to be reconstituted with liquid active component before use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use

Vial Vial Two vial set (active + active)

1 5 1

Two vial set (active + active)

Biological E. Limited Biological E. Limited Biological E. Limited Biological E. Limited Biological E. Limited Biological E. Limited Biological E. Limited

Tetanus Toxoid Tetanus Toxoid Japanese Encephalitis Vaccine (Inactivated) Japanese Encephalitis Vaccine (Inactivated) Diphtheria-Tetanus (reduced antigen content) Diphtheria-Tetanus (reduced antigen content) Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Tetanus Toxoid

Vial Vial Vial Vial Vial

1 10 1 1 1

Liquid: ready to use

Vial

Liquid: ready to use

Vial

Biological E. Limited

Liquid: ready to use

Vial

Biological E. Limited

Liquid: ready to use

Vial

Manufacturer Biological E. Limited

Type Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Diphtheria-TetanusPertussis (whole cell) Diphtheria-TetanusPertussis (whole cell) Artur Roberto Couto Artur@bio.fiocruz.br Tel.: (21) 3882 9305 Fax: (21) 2564 2344 Yellow Fever Yellow Fever

Pharmaceutical Form Liquid: ready to use

Presentation Vial

No. of Doses 5

Biological E. Limited

Liquid: ready to use

Vial

Biological E. Limited Biological E. Limited BioManguinhos/ Fiocruz

Vial Vial Vial + Ampoule

1 10 10

BioManguinhos/ Fiocruz

Vial + Ampoule

BioManguinhos/ Fiocruz

Yellow Fever

Two vial set (active + excipient)

Centro de Ingenieria Genetica y Biotecnologia Centro de Ingenieria Genetica y Biotecnologia Centro de Ingenieria Genetica y Biotecnologia

Miladys Limonta Fernández, Ph.D. miladys.limonta@cigb.edu.cu Dr. Eulogio Pimentel, eulogio. pimentel@cigb.edu.cu Dra. Marta Ayala, marta. ayala@cigb.edu.cu

Hepatitis B

Vial

Hepatitis B

Liquid: ready to use

Vial

Haemophilus influenzae type b

Liquid: ready to use

Vial

Manufacturer Chengdu Ms. Meng Li, limeng3@ Institute of sinopharm.com Biological Mr. Jinfeng Su, sujinfeng@ Products Co.,Ltd sinopharm.com Chengdu Institute of Biological Products Co.,Ltd Chiron Behring Vaccines Private Ltd.

Type Japanese Encephalitis Vaccine (live, attenuated)

Presentation Two vial set (active + excipient)

No. of Doses 1

Japanese Encephalitis Vaccine (live, attenuated)

Two vial set (active + excipient)

Rabies

Vial

CSL Limited Eubiologics Co., Ltd. Federal State Unitary Enterprise of Chumakov Institute of Poliomyelitis and Viral Encephalitides of Russian Acad. Med. Sci. Federal State Unitary Enterprise of Chumakov Institute of Poliomyelitis and Viral Encephalitides of Russian Acad. Med. Sci. Federal State Unitary Enterprise of Chumakov Institute of Poliomyelitis and Viral Encephalitides of Russian Acad. Med. Sci. Rachel Park rachel.park@ eubiologics.com Phone: (82) 10 4262 8187

Influenza, pandemic H1N1 cholera: inactivated oral

Vial Vial

10 1

Yellow Fever

Lyophilised active component to be reconstituted with excipient diluent before use

Ampoule

Yellow Fever

Lyophilised active component to be reconstituted with excipient diluent before use

Ampoule

Yellow Fever

Lyophilised active component to be reconstituted with excipient diluent before use

Ampoule

Manufacturer GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA

Type Hepatitis B Hepatitis B Hepatitis B Polio Vaccine Inactivated (IPV) Polio Vaccine Inactivated (IPV) Polio Vaccine - Oral (OPV) Monovalent Type 3 Polio Vaccine - Oral (OPV) Monovalent Type 3 HPV HPV Measles, Mumps and Rubella

Pharmaceutical Form Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with liquid active component before use Liquid: ready to use

Presentation Vial Vial Vial Vial Vial Vial Vial Vial Vial Vial

No. of Doses 1 10 20 1 2 10 20 1 2 1

GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA

Diphtheria-TetanusPertussis (acellular) Polio Vaccine - Oral (OPV) Monovalent Type 2 Polio Vaccine - Oral (OPV) Monovalent Type 2 Rotavirus Rotavirus Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b

Vial Vial Vial Plastic Tube Applicator Two vial set (active + active)

1 20 10 1 1 1

GlaxoSmithKline Biologicals SA

Two vial set (active + active)

GlaxoSmithKline Biologicals SA

Pneumococcal (conjugate)

Vial

Manufacturer GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA

Type Hepatitis A (inactivated) Hepatitis A (inactivated) Influenza, seasonal

Pharmaceutical Form Liquid: ready to use Liquid: ready to use Liquid: ready to use

Presentation Vial Vial Vial

No. of Doses 1 1 10

GlaxoSmithKline Biologicals SA

Measles, Mumps and Rubella

Lyophilised active component to be reconstituted with excipient diluent before use

Vial

GlaxoSmithKline Biologicals SA

Polio Vaccine - Oral (OPV) Trivalent

Liquid: ready to use

Vial

GlaxoSmithKline Biologicals SA

Polio Vaccine - Oral (OPV) Trivalent

Liquid: ready to use

Vial

GlaxoSmithKline Biologicals SA

Polio Vaccine - Oral (OPV) Bivalent Types 1 and 3

Liquid: ready to use

Vial

GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA GPO-MBP Co., Ltd.

Polio Vaccine - Oral (OPV) Bivalent Types 1 and 3 Polio Vaccine - Oral (OPV) Monovalent Type 1 Polio Vaccine - Oral (OPV) Monovalent Type 1 Pneumococcal (conjugate) Japanese Encephalitis Vaccine (live, attenuated)

Liquid: ready to use

Vial

Liquid: ready to use Liquid: ready to use Liquid: ready to use Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use Liquid: ready to use Liquid: ready to use

Vial Vial Vial Two vial set (active + excipient)

10 20 1 4

Green Cross Corporation Green Cross Corporation Green Cross Corporation

Ahram Song Phone: +82-31-260-1973 ahramjui@greencross.com overseas@greencross.com Haiyan Nan Phone: +82-31-260-9106; hynan@greencross.com

Influenza, seasonal Influenza, pandemic H1N1 Influenza, seasonal

Vial Vial Vial

10 1 1

Manufacturer GreenSignal Bio Pharma Limited Dr P. Murali md@gsbpl.com / murali@gsbpl.com Phone +91 9444411253 Haffkine Bio Pharmaceutical Corporation Ltd Haffkine Bio Pharmaceutical Corporation Ltd Haffkine Bio Pharmaceutical Corporation Ltd Hualan Biological Bacterin Co., Ltd Institut Pasteur de Dakar Mr. Shomu Pal Manager Marketing HBPCL, Parel, Mumbai 12 Phone: +9124146419 mkt@vaccinehaffkine.com

Type BCG

Pharmaceutical Form Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use

Presentation Vial + Ampoule

No. of Doses 20

Polio Vaccine - Oral (OPV) Trivalent Polio Vaccine - Oral (OPV) Monovalent Type 1 Polio Vaccine - Oral (OPV) Bivalent Types 1 and 3 Influenza, seasonal

Vial

Liquid: ready to use

Vial

Liquid: ready to use

Vial

Liquid: ready to use

Vial

Yellow Fever

Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use Liquid: ready to use Liquid: ready to use

Vial

Institut Pasteur de Dakar

Yellow Fever

Vial

Institut Pasteur de Dakar

Yellow Fever

Vial

Janssen Vaccines Corp. Janssen Vaccines Corp. Janssen Vaccines Corp.

Olga Popova OPopova@its. jnj.com

Hepatitis B Hepatitis B Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Hepatitis B BCG

Vial Vial Vial

1 10 1

Janssen Vaccines Corp. Japan BCG Laboratory

Liquid: ready to use Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use

Vial Ampoule

1 20

LG Life Sciences

Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b

Vial

Manufacturer LG Life Sciences

Type Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Hepatitis B Hepatitis B Hepatitis B Hepatitis B Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b

Pharmaceutical Form Liquid: ready to use

Presentation Vial

No. of Doses 10

LG Life Sciences LG Life Sciences LG Life Sciences LG Life Sciences LG Life Sciences

Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Lyophilised active component to be reconstituted with liquid active component before use Lyophilised active component to be reconstituted with liquid active component before use Liquid: ready to use

Vial Vial Vial Vial Two vial set (active + active)

1 2 6 10 1

LG Life Sciences

Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b

Two vial set (active + active)

MedImmune

Matthew Downham downhamm@medimmune. com Jules Millogo jules.millogo@ merck.com

Influenza, pandemic H1N1 Measles, Mumps and Rubella

Sprayer

Merck Vaccines

Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use Liquid: ready to use Liquid: ready to use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use

Vial

Merck Vaccines Merck Vaccines Merck Vaccines National Center of Infectious and Parasitic Diseases National Center of Infectious and Parasitic Diseases National Center of Infectious and Parasitic Diseases

Rotavirus Haemophilus influenzae type b HPV BCG

Plastic Tube Vial Vial Ampoule

1 1 1 10

BCG

Ampoule

Diphtheria-Tetanus

Vial

Manufacturer National Center of Infectious and Parasitic Diseases National Center of Infectious and Parasitic Diseases National Center of Infectious and Parasitic Diseases National Center of Infectious and Parasitic Diseases National Center of Infectious and Parasitic Diseases Novartis Vaccines & Diagnostics Ltd Novartis Vaccines & Diagnostics Ltd Novartis Vaccines and Diagnostics Novartis Vaccines and Diagnostics GmbH Novartis Vaccines and Diagnostics S.r.l. Novartis Vaccines and Diagnostics S.r.l. Novartis Vaccines and Diagnostics S.r.l. Novartis Vaccines and Diagnostics S.r.l. Novartis Vaccines and Diagnostics S.r.l. Sharon McHale Sharon.McHale@seqirus.com

Type Diphtheria-Tetanus

Pharmaceutical Form Liquid: ready to use

Presentation Vial

No. of Doses 20

Diphtheria-Tetanus (reduced antigen content) Diphtheria-Tetanus (reduced antigen content) Tetanus Toxoid

Liquid: ready to use

Vial

Liquid: ready to use

Vial

Liquid: ready to use

Vial

Tetanus Toxoid

Liquid: ready to use

Vial

Influenza, pandemic H1N1 Influenza, seasonal

Liquid: ready to use

Vial

Liquid: ready to use

Vial

Influenza, pandemic H1N1 Rabies

Liquid: ready to use

Vial

Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use

Vial

Diphtheria-TetanusPertussis (whole cell)Haemophilus influenzae type b Diphtheria-TetanusPertussis (whole cell)Haemophilus influenzae type b Influenza, pandemic H1N1 Haemophilus influenzae type b

Vial

Liquid: ready to use

Vial

Liquid: ready to use

Vial

Liquid: ready to use

Vial

Meningococcal ACYW-135 Lyophilised active (conjugate vaccine) component to be reconstituted with liquid active component before use

Two vial set (active + active)

Manufacturer Panacea Biotec Ltd. Ms Navita Khanna navitakhanna@ panaceabiotec.com

Type Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b John Roberts John.Roberts@pfizer.com. Pneumococcal (conjugate) Pneumococcal (conjugate)

Pharmaceutical Form Liquid: ready to use

Presentation Vial

No. of Doses 10

Panacea Biotec Ltd.

Liquid: ready to use

Vial

Pfizer Pfizer Pfizer

Liquid: ready to use Liquid: ready to use

Vial Vial Vial + Ampoule

4 1 1

Meningococcal ACYW-135 Lyophilised active (conjugate vaccine) component to be reconstituted with excipient diluent before use Mr. Mahendra Suhardono mahendra@biofarma.co.id Polio Vaccine - Oral (OPV) Monovalent Type 1 Measles Liquid: ready to use Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use Liquid: ready to use Liquid: ready to use

PT Bio Farma (Persero) PT Bio Farma (Persero)

Vial Vial

20 20

PT Bio Farma (Persero) PT Bio Farma (Persero) PT Bio Farma (Persero) PT Bio Farma (Persero) PT Bio Farma (Persero) PT Bio Farma (Persero)

Polio Vaccine - Oral (OPV) Bivalent Types 1 and 3 Diphtheria-TetanusPertussis (whole cell) Diphtheria-Tetanus (reduced antigen content) Diphtheria-TetanusPertussis (whole cell)Hepatitis B Diphtheria-TetanusPertussis (whole cell)Hepatitis B Measles

Vial Vial Vial

10 10 10

Liquid: ready to use

Vial

Liquid: ready to use

Vial

Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use

Vial

PT Bio Farma (Persero) PT Bio Farma (Persero) PT Bio Farma (Persero) PT Bio Farma (Persero)

Polio Vaccine - Oral (OPV) Trivalent Polio Vaccine - Oral (OPV) Trivalent Diphtheria-Tetanus Tetanus Toxoid

Vial

Liquid: ready to use Liquid: ready to use Liquid: ready to use

Vial Vial Vial

20 10 10

Manufacturer PT Bio Farma (Persero) PT Bio Farma (Persero) PT Bio Farma (Persero)

Type Tetanus Toxoid Hepatitis B Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Polio Vaccine - Oral (OPV) Bivalent Types 1 and 3 Tetanus Toxoid Francoise Griguer francoisegriguer@ sanofipasteur.com Yellow Fever

Pharmaceutical Form Liquid: ready to use Liquid: ready to use Liquid: ready to use

Presentation Vial Uniject Vial

No. of Doses 20 1 5

PT Bio Farma (Persero)

Liquid: ready to use

Vial

PT Bio Farma (Persero) PT Bio Farma (Persero) Sanofi Pasteur SA

Liquid: ready to use Liquid: ready to use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Lyophilised active component to be reconstituted with liquid active component before use Lyophilised active component to be reconstituted with liquid active component before use Liquid: ready to use

Vial Uniject Vial

20 1 10

Sanofi Pasteur SA

Haemophilus influenzae type b

Vial

Sanofi Pasteur SA

Haemophilus influenzae type b

Two vial set (active + excipient)

Sanofi Pasteur SA Sanofi Pasteur SA Sanofi Pasteur SA Sanofi Pasteur SA Sanofi Pasteur SA

Typhoid (Polysaccharide) Polio Vaccine - Oral (OPV) Bivalent Types 1 and 3 Diphtheria-TetanusPertussis (whole cell) Diphtheria-TetanusPertussis (whole cell) Diphtheria-TetanusPertussis (whole cell)Haemophilus influenzae type b

Vial Vial Ampoule Vial Two vial set (active + active)

20 20 1 10 10

Sanofi Pasteur SA

Diphtheria-TetanusPertussis (whole cell)Haemophilus influenzae type b

Vial + Ampoule

Sanofi Pasteur SA

Polio Vaccine - Oral (OPV) Monovalent Type 1

Vial

Manufacturer Sanofi Pasteur SA

Type Measles

Pharmaceutical Form Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use

Presentation Vial

No. of Doses 10

Sanofi Pasteur SA

Polio Vaccine Inactivated (IPV)

Vial

Sanofi Pasteur SA Sanofi Pasteur SA

Polio Vaccine - Oral (OPV) Monovalent Type 2 Polio Vaccine - Oral (OPV) Trivalent

Liquid: ready to use Liquid: ready to use

Vial Vial

20 10

Sanofi Pasteur SA Sanofi Pasteur SA Sanofi Pasteur SA

Polio Vaccine - Oral (OPV) Trivalent Polio Vaccine - Oral (OPV) Trivalent Measles, Mumps and Rubella

Vial Vial Vial

10 20 1

Sanofi Pasteur SA

Measles, Mumps and Rubella

Vial

Sanofi Pasteur SA

Diphtheria-TetanusPertussis (acellular)Hepatitis B-Haemophilus influenzae type b-Polio (Inactivated) Influenza, pandemic H1N1 Rabies

Vial

Sanofi Pasteur SA Sanofi Pasteur SA

Liquid: ready to use Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use Liquid: ready to use Liquid: ready to use

Vial Vial

10 1

Sanofi Pasteur SA Sanofi Pasteur SA Sanofi Pasteur SA

Diphtheria-Tetanus Diphtheria-Tetanus Diphtheria-Tetanus (reduced antigen content)

Vial Vial Vial

10 20 10

Manufacturer Sanofi Pasteur SA

Type Meningococcal A+C

Pharmaceutical Form Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use

Presentation Two vial set (active + excipient)

No. of Doses 10

Sanofi Pasteur SA Sanofi Pasteur SA Sanofi Pasteur SA Sanofi Pasteur SA Sanofi Pasteur-USA Sanofi Pasteur-USA Sanofi Pasteur-USA Sanofi Pasteur-USA Sanofi Pasteur-USA Sanofi Pasteur-USA

Tetanus Toxoid Tetanus Toxoid Polio Vaccine - Oral (OPV) Monovalent Type 3 Influenza, seasonal Influenza, seasonal Influenza, seasonal Influenza, seasonal Influenza, seasonal

Vial Vial Vial Vial Vial Vial Vial Vial Vial Two vial set (active + excipient)

10 20 20 10 1 10 1 10 1 10

Meningococcal ACYW-135 Liquid: ready to use (conjugate vaccine) Meningococcal ACYW-135 Lyophilised active (polysaccharide) component to be reconstituted with excipient diluent before use Influenza, pandemic H1N1 Influenza, pandemic H1N1 Mr. Parag Deshmukh, Phone +91 20 26602401, parag. deshmukh@seruminstitute. com Rubella Rubella Liquid: ready to use Liquid: ready to use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use

Sanofi Pasteur-USA Sanofi Pasteur-USA Serum Institute of India Pvt. Ltd.

Vial Vial Vial

1 10 1

Serum Institute of India Pvt. Ltd.

Vial

Serum Institute of India Pvt. Ltd.

Rubella

Vial

Serum Institute of India Pvt. Ltd.

Rubella

Vial

Manufacturer Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd.

Type Polio Vaccine - Oral (OPV) Trivalent Polio Vaccine - Oral (OPV) Bivalent Types 1 and 3 Diphtheria-Tetanus Diphtheria-Tetanus Diphtheria-Tetanus Diphtheria-Tetanus (reduced antigen content) Diphtheria-Tetanus (reduced antigen content) Diphtheria-Tetanus (reduced antigen content) Diphtheria-TetanusPertussis (whole cell) Diphtheria-TetanusPertussis (whole cell) Diphtheria-TetanusPertussis (whole cell) Tetanus Toxoid Tetanus Toxoid Tetanus Toxoid Measles, Mumps and Rubella

Pharmaceutical Form Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use

Presentation Vial Vial Ampoule Vial Vial Ampoule

No. of Doses 20 20 1 10 20 1

Liquid: ready to use

Vial

Liquid: ready to use

Vial

Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Liquid: ready to use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use

Ampoule Vial Vial Ampoule Vial Vial Vial

1 10 20 1 10 20 1

Serum Institute of India Pvt. Ltd.

Measles, Mumps and Rubella

Vial

Serum Institute of India Pvt. Ltd.

Measles, Mumps and Rubella

Vial

Serum Institute of India Pvt. Ltd.

Measles, Mumps and Rubella

Vial

Serum Institute of India Pvt. Ltd.

Hepatitis B

Vial

Manufacturer Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd.

Type Hepatitis B Hepatitis B Hepatitis B Measles

Pharmaceutical Form Liquid: ready to use Liquid: ready to use Liquid: ready to use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use

Presentation Ampoule or Vial Vial Ampoule or Vial Vial

No. of Doses 1 10 1 1

Serum Institute of India Pvt. Ltd.

Measles

Vial

Serum Institute of India Pvt. Ltd.

Measles

Vial

Serum Institute of India Pvt. Ltd.

Measles

Vial

Serum Institute of India Pvt. Ltd.

Haemophilus influenzae type b

Vial

Serum Institute of India Pvt. Ltd.

Measles and Rubella

Vial

Serum Institute of India Pvt. Ltd.

Measles and Rubella

Vial

Serum Institute of India Pvt. Ltd.

Measles and Rubella

Vial

Serum Institute of India Pvt. Ltd.

Measles and Rubella

Vial

Serum Institute of India Pvt. Ltd.

Diphtheria-TetanusPertussis (whole cell)Hepatitis B

Ampoule

Manufacturer Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd.

Type Diphtheria-TetanusPertussis (whole cell)Hepatitis B Diphtheria-TetanusPertussis (whole cell)Hepatitis B Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Polio Vaccine - Oral (OPV) Bivalent Types 1 and 3 Polio Vaccine - Oral (OPV) Trivalent Diphtheria-TetanusPertussis (whole cell)Haemophilus influenzae type b

Pharmaceutical Form Liquid: ready to use

Presentation Vial

No. of Doses 10

Liquid: ready to use

Vial

Liquid: ready to use

Vial

Serum Institute of India Pvt. Ltd.

Liquid: ready to use

Vial

Serum Institute of India Pvt. Ltd.

Liquid: ready to use

Vial

Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd.

Liquid: ready to use Liquid: ready to use Lyophilised active component to be reconstituted with liquid active component before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with liquid active component before use Lyophilised active component to be reconstituted with liquid active component before use Lyophilised active component to be reconstituted with liquid active component before use

Vial Vial Vial + Ampoule

10 10 1

Serum Institute of India Pvt. Ltd.

Meningococcal A Conjugate

Vial + Ampoule

Serum Institute of India Pvt. Ltd.

Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b

Vial + Ampoule

Serum Institute of India Pvt. Ltd.

Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b

Vial + Ampoule

Serum Institute of India Pvt. Ltd.

Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b

Vial + Ampoule

Manufacturer Serum Institute of India Pvt. Ltd.

Type Influenza, pandemic H1N1

Pharmaceutical Form Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use Liquid: ready to use Liquid: ready to use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use Lyophilised active component to be reconstituted with excipient diluent before use

Presentation Vial + Ampoule

No. of Doses 1

Serum Institute of India Pvt. Ltd.

Influenza, pandemic H1N1

Vial + Ampoule

Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd.

Polio Vaccine Inactivated (IPV) Polio Vaccine Inactivated (IPV) Polio Vaccine Inactivated (IPV) BCG

Vial Vial Vial Vial

5 2 1 20

Serum Institute of India Pvt. Ltd.

Influenza, seasonal

Vial + Ampoule

Serum Institute of India Pvt. Ltd.

Meningococcal A Conjugate (paediatric)

Vial + Ampoule

Manufacturer Shantha Biotechnics Limited Shantha Biotechnics Limited Shantha Biotechnics Limited Shantha Biotechnics Limited Shantha Biotechnics Limited Shantha Biotechnics Limited Shantha Biotechnics Limited Shantha Biotechnics Limited Shantha Biotechnics Limited Shantha Biotechnics Limited Statens Serum Institut

Type Hepatitis B

Pharmaceutical Form Liquid: ready to use

Presentation Vial

No. of Doses 6

Hepatitis B

Liquid: ready to use

Vial

Hepatitis B

Liquid: ready to use

Vial

Hepatitis B

Liquid: ready to use

Vial

Hepatitis B

Liquid: ready to use

Vial

Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b Diphtheria-TetanusPertussis (whole cell)Hepatitis B-Haemophilus influenzae type b cholera: inactivated oral

Liquid: ready to use

Vial

Liquid: ready to use

Vial

Liquid: ready to use

Vial

Tetanus Toxoid

Liquid: ready to use

Vial

Tetanus Toxoid

Liquid: ready to use

Vial

BCG

Lyophilised active component to be reconstituted with excipient diluent before use Liquid: ready to use Liquid: ready to use

Two vial set (active + excipient)

Statens Serum Institut Valneva Sweden AB

Polio Vaccine Inactivated (IPV) cholera: inactivated oral

Vial Vial + Buffer Sachet

1 1

Informations clés

Organisation Organisation mondiale de la santé (OMS)

Type de document Technical Documents

Date d'adoption 14 août 2017

Source Organisation mondiale de la santé