Report of the pandemic influenza vaccine deployment workshop, Washington DC, United States of America, 5-7 February 2019

Report of the Pandemic Influenza Vaccine Deployment Workshop Washington DC, United States of America, 5−7 February 2019 Report of the Pandemic Influenza Vaccine Deployment Workshop, Washington DC, United States of America, 5-7 February 2019 ISBN 978-92-4-001092-5 (electronic version) ISBN 978-92-4-001093-2 (print version) © World Health Organization 2020 Some rights reserved. This work is available under the Creative Commons Attribution- NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; (https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 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. 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In no event shall WHO be liable for damages arising from its use. iii Contents Acronyms .................................................................................................................................. iv Policy issues............................................................................................................................... v Introduction ............................................................................................................................... 1 The PIP Framework and the global availability of pandemic influenza vaccine .................. 2 Pandemic preparedness planning ............................................................................................ 3 Influenza in the Americas – regional mechanisms and lessons learned from 2009 .............. 5 NDVP: Structure and components ................................................................................... 11 PIP Deploy board game: simulating the vaccine deployment cascade ......................... 12 a) The games approach ................................................................................................ 12 b) Mission 1: National Deployment and Vaccination Plan (NDVP) ........................... 14 c) Mission 2: Legal and regulatory planning ............................................................... 14 d) Mission 3: Management of vaccine deployment and operations ............................. 14 e) Mission 4: Public communication in pandemic situations ...................................... 14 f) Mission 5: Human resources and security ............................................................... 15 g) Mission 6: Supply chain and waste management .................................................... 16 h) Mission 7: Post-deployment surveillance system and management of AEFI.......... 16 Evaluating PIP Deploy and improving national capacity on pandemic influenza deployment and vaccination activities .................................................................................... 17 Hot Wash: Sharing thoughts and learning experiences from PIP Deploy ................... 17 Moving forward towards an updated and effective NDVP ............................................ 19 Conclusion ............................................................................................................................... 20 Annex 1: Agenda ..................................................................................................................... 21 Annex 2. PIP Deploy game evaluation .................................................................................. 25 iv Acronyms AEFI Adverse event following immunization EPI Expanded Programme on Immunization IHR International Health Regulations GISRS Global Influenza Surveillance and Response System NDVP National Deployment and Vaccination Plan NRA National Regulatory Authority PAHO Pan American Health Organization PIP Pandemic Influenza Preparedness SMTA-2 Standard Material Transfer Agreement 2 TAG Technical Advisory Group WHO World Health Organization v Policy issues Pandemic influenza vaccines are a key means for supporting the control of an influenza pandemic and protecting vulnerable populations. Consequently, strengthening countries’ capacities to deploy vaccines and implement immunization campaigns in a timely and efficient manner is imperative for the success of a pandemic response. To support this process, WHO designed a training workshop which simulated critical aspects of planning for the deployment of pandemic vaccines – a table-top exercise in the form of a board game called PIP Deploy. Through an interactive and educational approach, workshop participants were invited to reflect on and learn about the main activities, the stakeholders involved and the main components of pandemic deployment operations. Participants from nine countries of the WHO Region of the Americas attended the Pandemic Vaccine Deployment Workshop in February 2019. Together, they discussed challenges foreseen in pandemic vaccine deployment activities, suggested how the lessons learned during the 2009 H1N1 influenza pandemic could be incorporated into national systems, reflected on the learning aspects of the simulation exercise, and discussed how to move forward after the meeting. Key recommendations based on lessons learned from the H1N1 pandemic influenza in 2009 • Include immunization as an integral part of pandemic planning as countries will benefit from having general pre-established operational and logistical protocols for pandemic influenza vaccination (Pandemic Preparedness Plan and National Deployment and Vaccination Plan). • Increase efforts to streamline future processes for the donation of pandemic influenza vaccines by various donors in order to ensure timeliness and equity of such endeavours. • Ensure the training (including communication skills) of health-care workers and strengthen social communication regarding the benefits of influenza vaccination. • Pandemic preparedness plans need to include open and effective communication strategies to build public confidence. • Encourage the establishment of active systems for reporting adverse events following immunization (AEFI) after pandemic vaccination. • Establish systems to facilitate the assessment of vaccine effectiveness and the impact of pandemic influenza vaccination campaigns. • Strengthen regulatory systems, which are critical for ensuring the timely deployment as well as the quality and safety of influenza products. • Leverage Expanded Programme on Immunization (EPI) systems that are already in place to support deployment operations and activities for both seasonal and pandemic influenza. PIP Deploy: Strengthening capacities and acquiring knowledge vi One of the main components of the workshop was the PIP Deploy table-top exercise – a simulation exercise in the form of a board game – which participants played on the second day of the meeting. According to participants, the game was an excellent tool for expanding knowledge on pandemic influenza deployment operations and their components. Participants highlighted that the game enabled them to reflect on their own systems and to identify gaps. It was stressed that the exercise stimulated critical thinking, teamwork and the exchange of experience among players. PIP Deploy was also referred to as an outstanding method for integrating technical knowledge into practice. Participants provided valuable feedback to further refine the game and requested that it be made available in different languages for use at national and local levels. Next steps The meeting was an opportunity for participants to consider specific actions that they could take to advance pandemic deployment and vaccination planning. Together, they identified key actions that could be implemented following the meeting. For WHO: • Identify national gaps in pandemic preparedness plans. • Strengthen understanding by Member States of requirements for vaccine donation, as set out in the terms of the Country Recipient Agreement. • Obtain feedback from countries to revise some of the existing documents and guidelines making them more user-friendly. • Update the guideline on the use of antivirals. • On the basis of the evaluations from the workshop in the Pan American Health Organization (PAHO), finalize PIP Deploy for use in other regional workshops. • Translate PIP Deploy into all six official United Nations languages, plus Portuguese, and make it available to WHO regions and countries. • Set up a pool of subject matter experts who will be available to support countries to develop/update their national deployment and vaccination plans (NDVPs). For PAHO Revolving Fund: • Analyse the feasibility of using the Revolving Fund to help countries enter into advanced purchase agreements for influenza pandemic vaccines. For countries: • Develop/update NDVPs on the basis of lessons learned in the workshop. • Strengthen collaboration between different sectors and stakeholders involved in pandemic influenza deployment operations. • Identify roles and responsibilities across sectors. • Strengthen regulatory systems to ensure timely allocation of pandemic supplies. • Conduct simulation exercises to test the plan. 1 Introduction Pandemic influenza is a major threat to global health security. In 2009, when the most recent influenza pandemic occurred, it was estimated that between 105 000 and 395 000 people worldwide lost their lives.1 Additionally, due to its large impact, pandemic influenza can cause economic disruption and difficulties in sustaining essential services at national and global levels. Vaccines are a key measure for controlling and preventing the spread of influenza virus. Countries should have mechanisms in place to rapidly access, allocate, deploy and administer such vaccines in order to ensure optimal usage and no wastage. To help countries in their efforts to build the necessary capacity for efficient vaccine deployment in the event of a pandemic, the World Health Organization (WHO) is undertaking several training activities, including a series of regional workshops, in order to create a forum for sharing best practices, identifying strengths and weaknesses in current deployment plans and discussing future deployment preparedness needs. The meeting on Planning for Effective and Efficient Deployment of Pandemic Supplies was held on 5−7 February 2019 at the headquarters of the Pan American Health Organization (PAHO), in Washington D.C., United States of America. Sixty delegates participated, including delegates from nine countries (Brazil, Colombia, Dominican Republic, El Salvador, Haiti, Jamaica, Mexico, Paraguay and Suriname), representatives of WHO headquarters, PAHO, WHO country offices in the Americas, the United States Centers for Disease Control and Prevention (CDC) and the US Department of Health and Human Services. The overall objective of the meeting was to provide an engaging and interactive environment for countries to obtain a better understanding of critical components of a pandemic vaccine deployment plan, as recommended by WHO in Guidance on development and implementation of a national deployment and vaccination plan for pandemic influenza vaccines.2 Other objectives of the meeting included: • to reinforce the importance of pandemic influenza vaccines deployment in wider pandemic preparedness planning; • to stress the need for ensuring up-to-date national deployment and vaccination plans for pandemic influenza vaccines; • to raise awareness about in-country planning to ensure capacities and capabilities in view of effective and efficient deployment of pandemic vaccines; • to pilot-test the PIP Deploy table-top simulation game exercise. 1 Data extracted from: Influenza: are we ready? See: https://www.who.int/influenza/spotlight, accessed 22 October 2019. 2 See: https://apps.who.int/iris/bitstream/handle/10665/75246/9789241503990_eng.pdf;jsessionid=18604EFF6EFD42 118616E6D143E24287?sequence=1, accessed 22 October 2019. 2 The first day of the meeting comprised presentations to provide overall knowledge on the Pandemic Influenza Preparedness (PIP) Framework, lessons learned from the 2009 pandemic, and the importance of pandemic deployment plans. On the second day, country representatives participated in the PIP Deploy table-top exercise. The final day was dedicated to reflection on the new information participants had acquired and how the learning experience would benefit their national preparedness plans. The PIP Framework and the global availability of pandemic influenza vaccine The PIP Framework An after-review of the 2009 pandemic conducted by the International Health Regulations (IHR) Review Committee determined that the world is ill-prepared to respond to a severe influenza pandemic. A key recommendation issued by the committee was that Member States finalize and adopt the Pandemic Influenza Preparedness (PIP) Framework to ensure that WHO will have advance commitments for pandemic vaccine supply and delivery. The PIP Framework was adopted by the World Health Assembly in 2011. The framework is an innovative public health instrument that seeks to improve global preparedness and response to the next pandemic through its two benefit-sharing mechanisms. Its key goals include to improve and strengthen the sharing of influenza viruses with pandemic potential (IVPP) and to increase the access of developing countries to pandemic vaccines and other supplies. The Standard Material Transfer Agreement 2 (SMTA2), which is a benefit-sharing mechanism, is a legally binding supply agreement signed between WHO and an influenza product manufacturer that receives IVPP from the Global Influenza Surveillance and Response Network (GISRS). Through these agreements, manufacturers commit in advance to provide WHO with, among other products, a percentage of their real-time pandemic vaccine production, through a combination of donation and purchase at affordable pricing. WHO agrees distribute these vaccines to countries in need on the basis of public health considerations. The second benefit-sharing mechanism is the Partnership Contribution (PC), which is an annual monetary contribution to WHO from influenza vaccine, diagnostics and pharmaceutical manufacturers who use the GISRS. These payments, totaling some US$ 28 million annually, are used to help strengthen pandemic preparedness capacities where they are weak and to build a pandemic response fund. One of the areas funded by the collection of the PC is planning for effective and efficient deployment of pandemic vaccines. Concluding SMTA2 agreements is just one step in a much bigger process. To implement the SMTA2 vaccine supply commitments effectively WHO has to be prepared to deploy the vaccine and countries have to be prepared to receive it. Two projects are highlighted to show progress towards improving WHO and country deployment readiness, namely: 3 • The world’s first vaccine deployment simulation portal called PIP Deploy was created to assist with global deployment readiness. The board game table-top exercise tested during the workshop, also called PIP Deploy, is an evolution of the former tailored to country preparedness. • It is a condition for the receipt of vaccines that countries sign a Country Recipient Agreement (CRA), as was the practice in the 2009 pandemic. This document contains all the terms and conditions that must be met by a country in order to receive vaccine from WHO, including terms for licensing, use and distribution of these vaccines. An updated version of the CRA is being drafted to make it more user-friendly and the contents of the agreement will be shared with Member States through future regionally-coordinated meetings. Ensuring equitable access and timely allocation – from country request to vaccine administration Currently, through the SMTA2 process, approximately 420 million doses of pandemic vaccine, 10 million treatment courses of antivirals, 250 000 diagnostic kits and 25 million syringes will be available to countries in need in the event of a pandemic. According to current production capacities, however, not enough vaccine will be produced to vaccinate everyone globally, so WHO will decide how to apportion the vaccine to all countries in need on the basis of certain criteria. A WHO-coordinated process will ensure that the allocation of vaccines is based on criteria such as epidemiological risk and availability (production capacity and purchasing power), as well as country readiness to accept and deploy pandemic supplies in a timely manner and to implement successful immunization campaigns. To facilitate deployment operations at national level, countries are advised to develop, revise and test national deployment and vaccination plans (NDVPs) for pandemic influenza vaccines. Consequently, WHO is engaging in several activities to support countries in updating or developing their NDVPs. Discussions on this topic highlighted the need for WHO to leverage global partnerships that can support deployment operations and related surge needs in a pandemic. Additionally, it was recommended that countries and WHO country offices should strengthen their links with the national Expanded Programme on Immunization (EPI), which could be used to boost deployment plans from EPI systems that are already in place. Pandemic preparedness planning Importance of pandemic preparedness planning Pandemic influenza preparedness and response plans are used to describe operational strategies that should be applied at national and subnational levels when a pandemic arises. They are critical for mitigating the impact of a pandemic and for informing prompt decision- making. When available, these plans should be built on the previous plan for annual seasonal influenza, thus offering a unique opportunity to exercise and revise available plans. As of September 2018, 1013 countries globally either did not have pandemic influenza preparedness plans or these plans were not publicly available. Sixty-eight countries had published plans in or before 2009 and only 12 countries had updated and published their 3 See: https://extranet.who.int/sph/influenza-plan, accessed 22 October 2019. 4 plans, according to WHO’s checklist released in January 2018.4 These numbers signal a need to accelerate pandemic preparedness planning. To support countries in their preparedness efforts, WHO developed a series of guidance tools, including those on: • a checklist for pandemic influenza risk and impact management;4 • pandemic influenza risk management;5 • essential steps for developing/updating a national pandemic influenza preparedness plan;6 • a practical guide for developing and conducting simulation exercises to test and validate pandemic influenza preparedness plans.7 Pandemic influenza risk management – global tools and approach Based on experience from the 2009 influenza pandemic, WHO revised the characterization of pandemic phases and developed a risk-based approach to pandemic influenza risk management. This new approach recognizes that “individual countries may be exposed to the pandemic influenza viruses at different times, have different case and case fatality rates, surveillance and response capacities, and vulnerabilities”.8 Therefore, Member States are encouraged to have more flexibility when developing their preparedness plans to account for the national situation and local needs. The risk-based approach to pandemic influenza takes into account a continuum of four pandemic phases (interpandemic, alert, pandemic, transition) which are determined at global level, and considers corresponding preparedness, response and recovery phases from the country perspective, all underlined by national risk assessments. The Pandemic influenza risk management guidance, released by WHO in 2017, details several activities that should be implemented at country level to support the preparedness, 4 A checklist for pandemic influenza risk and impact management: building capacity for pandemic response. Geneva: World Health Organization; 2018 (http://apps.who.int/iris/bitstream/handle/10665/259884/9789241513623- eng.pdf?sequence=1, accessed 4 January 2019). 5 Pandemic influenza risk management. A WHO guide to inform & harmonize national & international pandemic preparedness and response. Geneva: World Health Organization; 2017 (https://www.who.int/influenza/preparedness/pandemic/influenza_risk_management_update2017/en/, accessed 22 October 2019). 6 Essential steps for developing or updating a national pandemic influenza preparedness plan. Geneva: World Health Organization; 2018 (https://www.who.int/influenza/preparedness/pandemic/essential_steps_influenza/en/, accessed 22 October 2019). 7 A practical guide for developing and conducting simulation exercise to test and validate pandemic influenza preparedness plans. Geneva: World Health Organization; 2018 (https://www.who.int/influenza/preparedness/pandemic/simex_influenza_preparedness_plans/en/, accessed 22 October 2019). 8 Pandemic influenza risk management. A WHO guide to inform & harmonize national & international pandemic preparedness and response. Geneva: World Health Organization; 2017:31. 5 response and recovery phases under six essential components of the Emergency Risk Management for Health (ERMH), namely: • policies and resource management; • planning and coordination; • information and knowledge management; • logistics and infrastructure; • health and related services; • community capacities. To support national authorities to revise or develop their national pandemic preparedness and response plans on the basis of the risk-based approach, WHO has developed A checklist for pandemic influenza risk and impact management.4 From this checklist, PAHO and CDC delegates highlighted the essential and desirable elements for strengthening surveillance, investigation and assessment. The main components of this process are: • laboratory; • seasonal influenza (interpandemic) surveillance; • non-seasonal (novel) influenza surveillance; • outbreak investigation; • pandemic surveillance; • risk and severity assessment. Participants stressed that, as vaccines will not be available at the beginning of a pandemic, antivirals will most likely be the only medical intervention during the initial response and may also need to be prioritized among targeted groups. To support the work on this area, WHO is currently updating its guideline on the use of antivirals which is incorporating new treatments that are available. Influenza in the Americas – regional mechanisms and lessons learned from 2009 Lessons learned from pandemic influenza vaccination in Latin America and the Caribbean Several countries in the Americas experienced the 2009 pandemic influenza. At the time, they had moderate-to-robust capacity for surveillance and case management, but weak or nonexistent vaccination deployment plans and vaccination strategies. The challenges associated with the lack of these plans demonstrated that planning for pandemic supply deployment is critical to speed up the implementation of immunization campaigns and processes can be speeded up if such plans exist before the pandemic occurs. According to recommendations of the Strategic Advisory Group of Experts (SAGE) on Immunization in 2009, seven groups should be prioritized for immunization interventions at the time of the pandemic: health workers, pregnant women, the population of 6 months of age or older with a history of chronic disease, healthy young adults (> 15 and < 49 years), healthy children (< 15 years old), healthy adults (> 49 and < 65 years), and adults over 65 years. 6 However, due to limited vaccine supply, the Technical Advisory Group (TAG) in PAHO recommended the vaccination of three groups considered at highest risk of pandemic influenza: health workers, pregnant women, and the population of 6 months of age or older with a history of chronic disease The regional plan for pandemic response focused on three main elements: • immediate support to countries with no experience with seasonal influenza vaccine; • technical cooperation for the elaboration of national pandemic vaccination plans of action; • assistance in pandemic vaccine acquisition. Additionally, PAHO organized important workshops and developed guidelines, including on AEFI. It also promoted training activities that involved officers from EPI and national regulatory agencies. During the 2009 influenza pandemic, there were three ways to access pandemic vaccine in the Americas, namely: • through the PAHO Revolving Fund; • directly from manufacturers; • through WHO. The primary goal during a pandemic vaccine deployment is to implement immunization activities within seven days, starting from the vaccine request. In 2009, for the 19 countries/territories in the Americas, the interval between vaccine reception and initiation of vaccination activities ranged from 1 to 39 days, with a median of 11 days. Countries in the region required strong support to access pandemic vaccines. It was observed that those with previous acquisition capacity obtained vaccines much more quickly than those who had to deal with excessive bureaucracy or complicated pathways to receive donated vaccines. In this regard, PAHO officials emphasized the need for simplified processes to access the WHO pandemic vaccine stockpile. Additionally, it was stressed that the 2009 pandemic response presented several communication challenges, especially in addressing specific needs from targeted groups. From those, pregnant women were highlighted as having been one of the most difficult groups in terms of response to the immunization campaigns because of rumours around the safety of the vaccine. Moreover, it was recognized that improved database mechanisms and information management systems are needed to estimate high-risk groups accurately. It was noted that the number of people with chronic conditions was greatly underestimated. PAHO representatives stressed that most countries in Latin America and the Caribbean had developed AEFI surveillance systems as part of their monitoring of regular vaccination activities. However, because of the complexity of the pandemic vaccination campaign, there 7 was a need to strengthen both national committees on events supposedly attributable to vaccination or immunization (ESAVI) and active surveillance mechanisms. The importance of the PAHO Revolving Fund in improving vaccine access, including for pandemic vaccine, in the Americas The Revolving Fund (RF) of PAHO is a cooperation mechanism for the joint procurement of vaccines, syringes and related supplies for participating Member States. Through the RF, for over 30 years, participating Member States have been assured a continuous supply of high- quality products for their immunization programmes. During the 2009 influenza pandemic, the PAHO RF procured over 20 million doses of pandemic vaccine for 23 countries in Latin America and the Caribbean, covering all targeted groups prioritized by the Americas TAG. As different seasonal influenza vaccines and production cycles are recommended for the southern and northern hemispheres, strong coordination needs to be in place to ensure availability of supply. To facilitate this mechanism, the roles and responsibilities of countries, manufacturers and RF include the following: Several challenges and potential solutions were identified during the 2009 influenza pandemic, including: Challenges: • Short formulation-to-market cycle • Managing expectations at country level • Unplanned volumes present difficulties • Aligning country forecasted demand with suppliers’ production schedules • Short shelf-life vaccine Potential solutions: • Contiguous communications with ministries on variations in vaccine cycles • Briefing of ministries on epidemiological and production cycles • Early release of international tender (before WHO defines composition) and subsequent award • Timely placement of vaccine purchase order Country • Demand plan • Arrival confirmation • Product nationalization and customs clearance • National distribution • Contribution (4.25%) Manufacturers • Quality • Timely supply • Lower price • Freight and insurance • Quarterly review of performance and long- term arrangements (LTAs) PAHO RF • Demand and consolidation plan • Joint international tender • Allocation of supply and allotment • Purchase orders • Coordination and monitoring of shipments • Payment to producers and billing to countries 8 To overcome these challenges, PAHO’s RF recommends that countries enhance their capacity adequately to plan the demand for vaccine and other ancillary items, as this leads to a more appropriate supply. As the RF intensifies efforts to strengthen its capacity to procure vaccines and make them available for the next pandemic, it is engaging in several activities, including: • preparation through global, regional and national partnerships, i.e. WHO/GPEI, WHO/EYE, etc.; • a continuous improvement process of influenza vaccine supply chain from one season to the next; • strengthening annual demand planning processes for seasonal influenza and all antigens (with transformation to an automated process); • developing framework arrangements with pandemic suppliers for application if and when needed. Discussions on this topic indicated that the PAHO RF should consider implementing advanced purchase agreements for influenza pandemic vaccine. Regulatory capacity-building for pandemic influenza vaccine deployment The influenza A(H1N1) pandemic of 2009 demonstrated that national regulatory authorities (NRAs) in many countries did not have the required resources to manage the various legal and regulatory matters for importing and licensing pandemic influenza vaccines. Having appropriate legal and regulatory steps is critical for the importation and use a pandemic vaccine or any related medical item both before and during an event. Approximately 40% of the countries in the Americas have legal frameworks to define the structure of NRAs which inspect and control the importation and local distribution of vaccines or other medical products. In the countries where this structure is not in place, the Ministry of Health performs the NRA role. Strengthening regulatory systems is vital to ensuring timely access, quality and safety of products used in immunization activities or antiviral treatments in a pandemic. Regulatory preparedness for public health emergencies is a core component of regulatory system strengthening (RSS) and has a high impact across all regulatory functions – national regulatory systems, registration and marketing authorization, licensing establishments, market surveillance and control, vigilance, oversight of clinical trials, regulatory inspection, laboratory testing and NRA lot release. Consequently, PAHO has been conducting training and developing guidance to support countries in the Americas region to strengthen their regulatory capacities. Monitoring and evaluation are also being carried out to identify possible gaps in national regulatory systems – a process that can trigger supportive technical collaboration. Four countries in the continent produce influenza vaccines: Brazil, Canada, Mexico and the USA. The limited production capacity in the Americas represents a challenge to countries who rely on availability from global supply. It was emphasized that NRAs and regulatory frameworks should take into account the different forms of vaccine acquisition in the country – from manufacturers, from United Nations’ agencies or from the PAHO RF. 9 Additionally, the regulatory systems should include provisions on both donated and purchased pandemic supplies and pre-approval of seasonal and pandemic influenza products. The presentation highlighted the main regulatory challenges seen in health emergencies, including: • Regulators are normally not involved in the beginning of the discussions, thus hindering timely and effective access to health emergency products. • Each country has different procedures for particular emergency situations. However, in the Americas this situation is less of a concern as most of the countries have different regulations for emergency and non-emergency events. Additionally, as many supplies are acquired through the PAHO RF, the conditions applied to the national importation of these supplies are the same, reducing the number of regulatory measures required in the country. • The time needed for manufacture and for reformulating a product can cause delay when there is a change in formula. Several country representatives highlighted that, due to limitations by laws and regulations, seasonal influenza vaccines often arrive late in the country. Additionally, in some countries (e.g. El Salvador), regulations hinder the importation of vaccines with an expiry date of less than 12 months, which is usually the case for influenza vaccines. To overcome some limitations and the low pace of regulatory systems, some countries, such as the Dominican Republic, have adopted specific regulations to facilitate the importation of vaccines in emergencies. In other countries, such as Suriname, a reliance system is planned, in which vaccines could be pre-registered to facilitate and speed up the procurement process in the case of a pandemic. The seasonal influenza vaccine programme as preparedness for pandemic influenza vaccine deployment The existence of a seasonal influenza programme would allow countries to develop capacities that are relevant to a deployment and vaccination response in case of an influenza pandemic. These capacities would include an understanding of the regulatory documents for an influenza vaccine (as a seasonal influenza vaccine would pass through the national regulatory review and approval) and health-care workers’ familiarity with the vaccine (routes of administration, handling, messages to target populations). Among WHO regions, PAHO has the highest number of Member States with seasonal influenza programmes in the national immunization schedule. PAHO Member States are advised to follow the SAGE/PAHO 2004−2018 recommendations, as follows: • Member States should strengthen their surveillance systems in order to determine: • the influenza disease burden cost-effectiveness of influenza vaccine introduction; • the best vaccination strategy to use, the formulation and when to use it (especially in tropical countries) 10 • Member States should establish a seasonal influenza vaccination policy that seeks to vaccinate: • the elderly, individuals with chronic illness, and pregnant women; • children aged 6−23 months; • health workers. Despite the advances of seasonal influenza programmes in the Americas Region, some challenges remain. These include: • inconsistencies between policies and uptake of the influenza vaccine; • the need for annual vaccination; • the generally moderate effectiveness of the available vaccines; • the task of defining the best timing and formulation to use in tropical countries; • the diversity in vaccination target groups • vaccine hesitancy, mainly because of the circulation of misinformation on the internet and social media; • the poor quality of information systems; • challenges in recording the number of doses administered (numerator) with the information systems available; • the complexity of defining the number of eligible individuals (denominator) with chronic conditions and the number of health-care workers; • the fact that few countries have electronic registries; • vaccine financial and related costs. Participants emphasized that seasonal influenza vaccine strategies may vary by country, but they are often part of routine immunization programmes in which intense and short vaccination campaigns are implemented during winter. Doses not used in the campaigns are further applied until they reach their expiry date. Additionally, there was discussion that, if a country wants to introduce seasonal influenza into its EPI and does not have a burden of disease study, it can use similar studies or WHO recommendations – which would support instructions that should come from the national TAG. Furthermore, experts from PAHO mentioned that one of the main seasonal influenza vaccination strategies is to introduce the vaccine to all targeted groups at once if resources are available. Group work and roundtable discussions Country representatives had the opportunity to work together in groups and discuss their NDVP’s and overall pandemic preparedness plans, highlighting the challenges and strengths of their national capacities. The discussions highlighted the importance of multisectoral planning under a multi-hazards approach. Since the 2009 influenza pandemic, several countries have undertaken to improve their surveillance systems significantly, have increased participation within the GISRS, and have strengthened molecular laboratory capacities. However, these improvements have not been reflected in many NDVPs which are yet to be updated. 11 Countries also highlighted the efforts carried out to increase seasonal influenza immunization coverage among high-risk groups, and especially pregnant women which is a group that has low immunization rates. This demonstrates the need for strengthening targeted risk communication strategies that aim to increase awareness regarding the safety of the vaccine. For pregnant women, this can involve the participation of health-care workers during neonatal treatment and in gynaecologists’ medical associations. Additionally, according to studies conducted in El Salvador, other members of the family, including husbands, should be sensitized to the importance of the vaccine for pregnant women. Participants also indicated there are challenges in establishing collaboration between the human and animal sectors although this is crucial to advancing influenza virus research. Furthermore, delegates stressed the need to strengthen regulatory systems which can pre- approve influenza products and speed up procurement mechanisms. Strengthening NDVP knowledge through play NDVP: Structure and components WHO’s Guidance on development and implementation of a national deployment and vaccination plan for pandemic influenza vaccines9 states that an NDVP should include the following chapters and considerations: 1. Vaccination strategies • Identify the factors that have an impact on vaccine strategies. • Describe the main planning considerations that are relevant to vaccination strategies. 2. Management and organization of pandemic vaccine deployment and vaccination operations • Describe key recommendations on how to define and plan an effective managerial framework for efficient deployment and vaccination operations. 3. Legal and regulatory planning for vaccine deployment • Describe key considerations to help the chief of logistics: • Understand the importance of existing legal and regulatory requirements at the international and national level prior to a pandemic event. • Ensure that appropriate authorities comply with all legal and regulatory requirements and complete procedures related to import, warehousing, packaging, shipping and using pandemic vaccine and related products before vaccine is needed. 4. Communication and information management for vaccine deployment • List key types of data relevant for management information and communication systems to ensure that these can inform rapid decision-making throughout deployment and vaccination operations. 5. Human resources and security for deployment and vaccine operations 9 Guidance on development and implementation of a national deployment and vaccination plan for pandemic influenza vaccines. Geneva: World Health Organization; 2012 (http://www.who.int/iris/handle/10665/75246, accessed 22 October 2018). 12 • State the main planning considerations needed to ensure availability of a suitable, adequately trained and protected workforce throughout the stages of pandemic deployment and vaccination. 6. Public communication plans • Draft a communication plan spanning all stages of vaccine deployment and vaccination activities. 7. Supply chain management • Plan to ensuring effective supply chain management operations. 8. Managing waste • Describe how to plan and manage the safe disposal of expected and additional medical equipment and/or consumables such as injection equipment, including the needles or sharps and syringes, vaccine vials and other types of hazardous medical waste that are generated during a pandemic response. • List basic provisions on how to record details of the management of waste in the country’s management information system, 9. Post-deployment surveillance and management of adverse events following immunization • Describe key considerations on how to incorporate planning for a post- deployment surveillance system to monitor AEFI in national deployment and vaccination plans, including establishing managerial functions that are needed for such a system to function. • List key indicators for evaluating such systems. 10. Termination of deployment and vaccination operations • Describe activities that should be planned the termination of deployment and vaccination operations. PIP Deploy board game: simulating the vaccine deployment cascade PIP Deploy is the first ever simulation/game/table-top exercise for strengthening countries’ capacities for pandemic influenza deployment activities. PIP Deploy’s learning objectives include: 1. To provoke discussion on key gaps in preparation for, or updating of, national pandemic influenza deployment plans. 2. To enable conversations on best practices on in-country governance and operations for pandemic influenza vaccine deployment. 3. To better understand country training needs and barriers to future participation in simulation exercises. a) The games approach The game focused on Timoa, a fictitious country which needs to strengthen its preparedness and response capacity to deal with an influenza pandemic. To support the learning process, seven scenarios and missions were presented to the players with fictitious scenarios of pandemic vaccine deployment which could also happen in a real-life setting. The game’s design concept included: 13 • a combination of serious game, collaborative learning and simulation; • collaboration and cooperation through problem-solving; • collaborative learning through game fun, features and questions. Before the start of the game, participants watched an animated video with the instructions about dynamics of the game. Players had to complete seven missions. For each mission there was: • an animated video introducing a challenging scenario; • a brainstorming session in which teams were asked to provide inputs and solutions to specific tasks; • a board-game session; • a synthesis of key concepts discussed in the mission and rewards as take-away messages. Participants were divided between two rooms, with each room having one board on which the game was played and four teams of players. In most teams, all players came from the same country but one team consisted of players from Brazil (1), Colombia (2) and Jamaica (1) as these countries did not have enough delegates at the meeting to form separate teams. The logical flow of the game is illustrated in Figure 1. Figure 1. PIP Deploy – the game from start to finish 14 b) Mission 1: National Deployment and Vaccination Plan (NDVP) After the mission scenario was explained, each team had approximately 20 minutes to analyse Timoa’s NDVP and to find gaps in its structure and in the content of specific chapters, taking as references the WHO template for NDVP and WHO’s Guidance on development and implementation of a national deployment and vaccination plan for pandemic influenza vaccines. Following the brainstorming session, teams came together to play the game in which they could collect resource cards by answering questions about the NDVP’s development, structure, components, approval process, and the involvement of partners/stakeholders. During this mission, participants could reflect on the status and comprehensiveness of their own NDVP. In general, country representatives stressed the need to revise/update their national plans and to involve sectors which had yet not been involved. Another issue raised in discussion was that the NDVP should contain a realistic budget and timeline for deployment operations, always considering the quality and safety of pandemic supplies. c) Mission 2: Legal and regulatory planning For the second mission participants were invited to reflect on Timoa’s regulatory system and its ability to import vaccines from different sources, including WHO. Participants had to consider the various documents that would be needed to authorize the entry of a vaccine at national level and decide which processes needed to be in place to ensure smooth customs clearance and deployment operations within the country. Participants highlighted the fact that countries without previous experience of seasonal or pandemic influenza could seek international cooperation mechanisms to support the introduction of the vaccine. d) Mission 3: Management of vaccine deployment and operations During this mission, players were asked to reflect on the main roles and responsibilities of key actors of deployment operations – Incident Commander, Chief of Logistics, Chief of Vaccinations – and to identify possible collaboration mechanisms between the government of Timoa and the WHO country office. It was stressed that, in a large-scale campaign, a high number of AEFI may be reported in a short time, thereby requiring further investigation, especially if clusters of cases are detected. If this occurs, the country should contact the WHO country office which will be able to give further details about the performance of the vaccine in other countries. e) Mission 4: Public communication in pandemic situations On this mission, participants were asked to reflect on the public and risk communication principles and strategies in a pandemic situation. 15 The importance of having a communications plans which encompasses risk communications strategies and activities was highlighted. Additionally, it was stressed that a spokesperson should be identified and trained to deliver messages that clarify the safety of the pandemic influenza vaccine and the target population of the vaccination campaign. The messages should also prevent or address rumours that may arise during the vaccination campaign. Regarding the messages directed to the public, the communications plan should consider: • a mix of platforms (newspapers, radio, television, social media, Internet) able to deliver the messages to targeted groups; • use of national and local languages, as appropriate, according to national and local preferences; • clear and nontechnical jargon which can be easily understood; • use of locally relevant technologies for public communication (such as mobile telephones). Participants mentioned that it is important to identify focal points and “champions” (e.g. athletes, artists, etc) who can advocate on behalf of the vaccine and vaccination campaign. Moreover, the engagement of medical associations and health-care workers was pointed out to be critical to the success of the immunization drive, especially among specific targeted groups such as pregnant women. As uncertainties may arise in the case of pandemic influenza, it is important that public communications consider: • what is known, what is not known and what response agencies are doing to learn more; • avoiding having spokespersons state certainties and absolutes; • encouraging the public to continue getting updated advice from available websites, hotlines, etc. as events are continually changing. Participants also noted that tailored communication approaches should be used at the community level and that information on AEFI should be communicated. f) Mission 5: Human resources and security Deployment of pandemic influenza vaccine in seven days and rapid vaccination of the target population require numerous additional personnel with the correct skill-set who are trained, motivated and supported. For this reason, consideration of human resources and security is crucial to the success of pandemic influenza deployment and vaccination activities. On this mission, players were asked to provide recommendations as to how Timoa should prepare to ensure skilled, trained and healthy human resources. Additionally, they were tasked to reflect about means to protect equipment, facilities, vaccine and ancillary items. Participants highlighted that a KAP (knowledge, attitudes and practice) survey among health- care workers could help show what they know about pandemic influenza, thereby supporting decisions about interventions and training. Additionally, because the health of health-care workers is key to the sustainability of the health system, health personnel should be prioritized in vaccination activities and in antiviral treatments when applicable (i.e. those 16 persons exposed to the virus or with symptoms). Players also stated that the well-being of staff includes that of their families because staff will be more likely to stay on the job if they know their family members are taken care of. g) Mission 6: Supply chain and waste management On this mission, players were tasked to discuss and provide recommendations on the supply chain and waste management activities to Timoa’s appointed Incident Commander and Chief of Logistics. It was stressed that quality control measures play a crucial role in supply chain management since vaccines must be stored in the correct places at the correct temperature. Quality control activities should foresee a temperature control inventory with stability studies to determine if a vaccine can still be used after being exposed to high temperatures (> 2−8). Additionally, vaccines should be adequately discarded, and their disposal must be monitored to ensure that safety measures are adopted and to avoid inappropriate use of the vaccines. Participants also pointed out the importance of management information systems in supporting supply chain operations. h) Mission 7: Post-deployment surveillance system and management of AEFI This mission aimed to enable participants to evaluate post-deployment surveillance systems and to identify activities for termination of deployment and vaccination operations. Teams were requested to provide recommendations on a post-deployment surveillance system and the management of AEFI and adverse events of special interest (AESI). It was highlighted that a dual surveillance system – both active and passive – should be in place in the case of pandemic influenza. Even though the passive system is more sensitive and less costly, the active surveillance system is more specific and allows for the rapid capture of eventual adverse events following immunization. Participants also noted that a process for communicating information on reported AEFI and the safety profile of the vaccine used should be in place. Additionally, an expert committee should be identified to evaluate AEFI and, if there are serious cases, a reference laboratory should be involved for further investigation. As the seasonal influenza vaccine effectiveness study in the region has demonstrated challenges in collecting information on people who are vaccinated, experts suggested that improvements in the information systems for influenza vaccination should be considered. They also stressed that documenting the lessons learned, describing both positive and negative operations, provides essential information for a future emergency response. 17 Evaluating PIP Deploy and improving national capacity on pandemic influenza deployment and vaccination activities Hot Wash: Sharing thoughts and learning experiences from PIP Deploy Overall, participants found the game an innovative and interactive tool that expanded their knowledge on deployment and vaccination planning. They highlighted that the objectives of the game were clear and, although the scenarios proposed were from a fictitious country, they were able to reflect on their own national systems. Additionally, they stressed that working in a group allowed for the exchange of knowledge and experiences. “It was an excellent method for considering the steps needed in a national deployment and vaccination plan” (participant from Suriname). It was also stated that, since pandemic vaccine deployment activities involve a sophisticated structure with different roles and responsibilities, countries often do not know the specificities of their deployment systems. This has an impact on the success of the national deployment and vaccination plan. For this reason, participants mentioned that the game was instrumental in making the players think about the different roles (e.g. NRA, Incident Commander, Chief of Logistics, Chief of Vaccination etc.) that must be carried out at the national level. “It helped us understand the multiple roles and responsibilities and how to best articulate them” (participant from Colombia). “It would be very interesting to replicate in Mexico these exercises that strengthen communication between institutions and stimulate the evaluation of possible risks during an influenza pandemic” (participant from Mexico). For countries which have not yet introduced seasonal influenza vaccine into their health systems, the game was considered an excellent tool to give an overview of the different steps required for influenza deployment and vaccination activities and to explain how best to act in challenging situations that may be encountered when implementing vaccination. “The exercise was a great method to get an overview of what is needed (in terms of deployment activities) when we introduce the vaccine in our country” (participant from Haiti). Country representatives also mentioned that the scenarios presented in the game and the dynamics proposed stimulated teamwork and critical thinking. They highlighted that the discussions about the game and the infographics distributed at the end of each mission would be supporting tools for updating their NDVPs. “The materials distributed will help us update our plan. We will give greater emphasis to components such as budget and legal framework” (participant from Paraguay). It was also stressed that through the game players were able to identify gaps in their own systems and consider how to tackle those gaps. 18 “The game was very useful for consolidating knowledge and identifying gaps” (participant from Jamaica). “It offers an opportunity to reflect on the important and missing elements of our own plans” (participant from Dominican Republic). Participants noted that PIP Deploy was an entertaining way to learn about and discuss pandemic vaccine deployment. They stressed that planning is sometimes too abstract and the game scenarios helped them to think concretely about real-life situations. “It was an exciting dynamic. (…) We were not aware of all the missing parts of our plan. (…) This game makes the planning exercise easier” (participant from Dominican Republic). Delegates also described how the game was a valuable tool for understanding deployment activities at national level best and that it could be leveraged to regional and local levels. “It will be very interesting to also have this dynamic at territorial level where the capacities and experiences are often limited” (participant from Colombia). Additionally, country representatives suggested that PIP Deploy could be translated into other languages so that countries could easily apply it within their national structures. “It would be wonderful to have a French version of this game” (participant from Haiti). Participants also recommended that, as a tool in a pilot phase, some improvements could be considered, including: • having shorter and more specific questions in the board game session; • making the scenarios/challenges in the brainstorming session clearer and more precise; • having more time for discussion in the brainstorming session: • having experts on public communications/risk communication as either team members or facilitators; • adapting the game for use at local level (e.g. training of epidemiologists, regulators, etc.); • considering the scenario of a multiple-dose pandemic vaccine (rather than a single dose) and its implication on deployment operations; • having clear instructions on the benefits of the resource cards; • adapting the game to regional specificities; • increasing interaction among participants following an incident command; • combining the presentations and the game missions that are about the same subject on the same day; • having facilitators/game masters previously trained on the game’s components and messages; • having tasks that fit better with the scenarios presented. It was mentioned that a board game could be developed to strengthen overall pandemic preparedness capacities rather than being limited to deployment operations. Moreover, 19 participants proposed increased interactions between WHO regions, thereby advancing the exchange of experiences and learning. Moving forward towards an updated and effective NDVP Country representatives were asked to reflect on their national plans and the possible timelines to develop/update them. Some participants mentioned that, despite the existence of a pandemic preparedness plan at national level, the NDVPs require updates or even development from the beginning. In these cases, a national committee or workshop may be organized in the upcoming months to bring together key stakeholders who can support the development of the NDVPs. Once plans are finalized, countries are advised to test them in simulation exercises. Some challenges related to the design of the NDVPs were underscored, including social and political aspects and the high turnover of human resources involved in the process. Moreover, it was indicated that some countries need to update their demographic census in order to have more precise estimates of the targeted populations for vaccination drives. National representatives highlighted the importance of strengthening the relationship with the private sector and involving it in the deployment planning where applicable. It was mentioned that some countries need to strengthen capacities at the local level, as deployment operations usually happen at this level with support from regional and national authorities. In general, delegates noted the need to update their public communications and risk communication plan, especially in countries where there is a high influx of tourists and migrants who may add a burden on pandemic supplies. Participants indicated that regulatory systems which facilitate the importation and deployment of vaccines in case of pandemic influenza need to be enhanced. Furthermore, country representatives acknowledged the importance of involving multiple stakeholders in deployment planning and capacity-strengthening together with support from WHO. In summary, the representatives from the eight countries participating in the meeting suggested that stronger efforts will be made in 2019 to develop/update their NDVPs. 20 Conclusion Since the last influenza pandemic in 2009, WHO has undertaken several activities to ensure the availability of pandemic supplies and to strengthen countries’ capacities on pandemic influenza preparedness. As part of these efforts, the workshop was an excellent opportunity for the participating countries in the Americas to gain a greater understanding of the necessary capacities for national deployment and vaccination operations for pandemic influenza vaccines. A prerequisite for access to WHO-secured vaccines, the NDVP was recognized as a critical operational document that allows countries and responders to act efficiently by defining the processes and structures required for rapidly delivery of pandemic vaccine and for vaccination of the target population. Despite strong immunization systems in several countries of the Americas, the workshop showed that only a limited number have an updated and publicly available NDVP. Consequently, countries should enlarge their group of stakeholders to develop or update their plans, which should reflect current demographics, infrastructure, policies and approaches to tackling a pandemic. Additionally, they should build on existing seasonal influenza programmes, which provide opportunities to ensure operational readiness for some of the pandemic deployment and vaccination operations. By using the PIP Deploy table-top exercise, countries could assess their deployment systems, strengthen knowledge on deployment and vaccination operations, and identify gaps and activities that need to be enhanced at the national level. The table-top exercise was commended for being an excellent learning tool on NDVPs. Moving forward, WHO and PAHO will continue to engage with countries, building on the technical expertise exchanged in the workshop, to guarantee that vaccines and ancillary items are available promptly to those in need. 21 Annex 1: Agenda PANDEMIC PREPAREDNESS AND VACCINE DEPLOYMENT Washington, D.C., USA 5-7 FEBRUARY 2019 Room B 5 February 2019 830-900 Registration Presenter/participants 900-910 Welcome and opening remarks Sylvain Aldighieri, Deputy Director, Health Emergency Department (PAHO) Plenary 910-930 Overview of agenda & objectives Introduction of participants Housekeeping Rakhee Palekar, Health Emergencies Department (PAHO) 930-940 PIP Framework Overview Anne Huvos, Manager HQ/IPR Influenza Preparedness & Response (HQ/WHE/IHM/IPR) 940-955 Stockpile governance: From country request to vaccine administration Tim Nguyen, Team Leader Stockpile Governance Team & Manager a.i. Support for Response Unit (HQ/WHE/IHM/SFR) 955-1005 Importance of pandemic preparedness planning Rakhee Palekar, Health Emergencies Department (PAHO) 1005-1035 WHO tools for pandemic preparedness planning and the Pandemic Influenza Risk Management guidance Applying the pandemic influenza preparedness checklist Weigong Zhou, Medical Officer HQ/IPR Influenza Preparedness & Response (HQ/WHE/IHM/IPR) 1035-1100 Coffee and group photo All 1100-1125 PAHO recommendations for updating pandemic preparedness plans PAHO and WHO CC at U.S. CDC 1125-1205 Group work in country-teams In breakout groups 1205-1305 Lunch 1305-1330 Group work in country-teams cont. In breakout groups 22 1330-1400 Discussion of group work findings Plenary 1400-1415 Lessons learned from pandemic vaccine deployment during 2009 influenza-pandemic Alba Maria Ropero, Immunization, (PAHO) 1415-1445 Regulatory capacity building for pandemic influenza under the PIP Framework Maria Luz Pombo, Vaccines and Biotechnological Products (PAHO) 1445-1500 Seasonal influenza vaccine program as preparedness for pandemic influenza vaccine deployment Alba Maria Ropero, Immunization, (PAHO) 1500-1515 Importance of PAHO Revolving Fund in improving vaccine access, including pandemic vaccine John Fitzsimmons, Revolving Fund (PAHO) 1515-1530 Coffee 1530-1630 Roundtable discussion of challenges related to pandemic vaccine deployment Moderator: Maria Luz Pombo, Vaccines and Biotechnological Products (PAHO) 1630-1645 Wrap up 1700-1830 Reception 23 6 February 2019 900-910 Recap of day 1 and day 2 objectives Ioana Ghiga, Technical Officer, PIP Deployment – Stockpile Governance Team, Infectious Hazard Management Department (IHM) (HQ/WHE/IHM/PAT) PIP Deploy Game 910 -930 DEP guidance and checklist Ioana Ghiga,Technical Officer, PIP Deployment – Stockpile Governance Team, Infectious Hazard Management Department (IHM) (HQ/WHE/IHM/PAT) 930-940 Introduction to the Game Plenary (facilitated by Game Developers) 940-1045 Mission 1: National Deployment and Vaccination Plan Plenary & in breakout groups 1045-1100 Coffee Plenary & in breakout groups 1100-1140 Mission 2: Legal and Regulatory Planning Plenary & in breakout groups 1140-1230 Mission 3: Management of Vaccine Deployment Operations Plenary & in breakout groups 1230-1330 Lunch Plenary 1330-1435 Mission 4: Public Communication in a Pandemic Situation Plenary & in breakout groups 1435-1450 Coffee Plenary & in breakout groups 1450-1525 Mission 5: Human Resources and Security Plenary & in breakout groups 1525-1600 Mission 6: Supply Chain and Waste Management Plenary & in breakout groups 1600-1630 Mission 7: Post-deployment surveillance system and management of AEFI Plenary & in breakout groups 1630-1700 Game Hotwash Plenary 24 7 February 2019 900-930 Recap of day 2 and day 3 objectives Ioana Ghiga, Technical Officer, PIP Deployment – Stockpile Governance Team, Infectious Hazard Management Department (IHM) (HQ/WHE/IHM/PAT) Plenary Countries situation analysis 930-1030 Self-assessment of NVDP plans and defining next steps In breakout groups 1030-1100 Coffee 1100-1200 Self-assessment of NVDP plans and defining next steps In breakout groups 1200-1300 Lunch 1300-1430 Country presentations of gaps and next steps Plenary Closing session 1430-1500 Summary and conclusions Wrap up and next steps Tim Nguyen, , Team Leader Stockpile Governance Team & Manager a.i. Support for Response Unit (HQ/WHE/IHM/SFR) 25 Annex 2. PIP Deploy game evaluation Evaluation grid for participants (Numbers in red indicate the number of responses in each category) Please express your opinions The game play met my individual objectives and was relevant to my job: Yes: 28 No: 0 Missing response: 2 The duration of the exercise was: (please circle your answer): correct: 17 too short: 8 too long: 3 Missing: response: 1 What are the 3 most important things you learned from this experience? (Please see Hot Wash section of the report) Rate from 1 to 4: 1 indicating strong disagreement with the statement and 4 strong agreement Statement Do not Strongly agree agree The game play was well organized and structured 1 2: 2 3: 19 4: 9 The instructions were clear and comprehensive 1 2: 7 3: 20 4: 3 The exercise scenario was adequately designed for its use 1 2: 3 3: 16 4: 11 Participants were encouraged to play an active role in the game 1 2 3: 12 4: 18 The videos and briefings helped me understand and become engaged in the scenario 1 2: 1 3: 10 4: 19 The game documents (injects, scenarios, cards) are adequately designed for their use 1 2: 2 3: 13 4: 14 Handouts were relevant 1 2: 1 3: 10 4: 17 The exercise helped me to identify some of my strengths as well as some of the gaps in my understanding of response systems, plans and procedures 1 2: 1 3: 8 4: 21 The level and mix of disciplines and participants included the right people for this game play 1 2: 1 3: 20 4: 9 The exercise improved my understanding of my role and function during an emergency response 1 2: 1 3: 11 4: 18 At the end of the exercise, I learned one or more things which will allow me to increase preparedness and readiness for deployment of pandemic influenza vaccine in my country 1 2 3: 10 4: 20 I would recommend playing this game to my colleagues 1 2: 1 3: 4 4: 25 What are the main strengths and areas for improvement of the PIP Deploy game? 26 Strengths • The game triggers participants’ engagement • Several countries have experience with the seasonal influenza vaccine • Existing rapid response teams • Available lessons learners from the 2009 pandemic Areas for improvement • NDPS are not up to date • Law and regulations • More involvement of health colleagues • Risk Communication • Surge capacity for vaccination, as demand increases • Security and safety of vaccines and healthcare workers • Monitoring and evaluation • Update national capacity on human resources • Revise and update existing NDVPs Please share any recommendation(s) you have to improve similar exercises in the future • Use such exercises in future workshops • Make the game more adaptable for implementation at the national and local levels. • Participants should include communication experts 27 Annex 3. List of Participants Name Last Name Country Profile Work Title Dr. Lely Guzmán Brazil Focal Point PAHO Focal Point PAHO Dra. Juliana Barbosa Ramirez Colombia Laboratory technician Profesional Especializada Direccion de Redes Dra. Claudia Milena Cuellar Segura Colombia Epidemiologi st Direccion de Epidemiologia y Demografia del Ministerio Dra. Reina Leonor Morales de Acosta El Salvador Regulator DNM Dra. Beatriz Elizabeth Clara de Doratt El Salvador Regulator Jefe de Registro y Visado de la DNM Dr. Herbert Xavier Abarca Valle El Salvador Epidemiologi st Colaborador Tecnico de la Unidad de Vigilancia de la Salud Dra. Nora Maria Villatoro de Martinez El Salvador Immunization focal point Jefe de Centro Nacional de Biologicos Lic. Patricia Geaninne Gutierrez Landaverde El Salvador Logistics professional Jefe de Unidad de Abastecimiento Lic. Delmy Lisseth Recinos El Salvador Laboratory technician Coordinadora del Area de Laboratorio Clinico del LNR Dra. Ilse Maria Julia Herbas Rocha Mexico Immunization focal point Supervisor Médico en el Centro Nacional para la Salud de la Infancia y la Adolescencia (CENSIA) Q.F. B Alicia Mena Lopez Mexico Regulator Subdirectora ejecutiva de licencias sanitarias Dra. Rosaura Idania Gutierrez Vargas Mexico Epidemiologi st Jefa de Departamento de Análisis de Información 28 Dra. Irma López Martínez Mexico Logistics professional Directora de Diagnóstico y Referencia MsC Gisela Barrera Badillo Mexico Laboratory technician Subdirectora ejecutiva de licencias sanitarias Dra. Maria Jose Ortega Soler Paraguay Laboratory technician Departamento de Virologia, Laboratorio Central de Salud Publica Q.F. Jose Maria Cardozo Baruja Paraguay Regulator Direccion Nacional de Vigilancia Sanitaria Dra. Soraya Araya Yampey Paraguay Immunization focal point Directora del PNEI y PAI Lic. Otilia Saucedo Paraguay Logistics professional Programa Ampliado de Inmunizaciones PAI - Responsable del centro Nacional de Vacunas (CNV) Dra. Marta Von Horoch Paraguay Epidemiologi st Direccion General de Vigilancia de la Salud Dra. Fabiana Michel Paraguay Focal Point PAHO Focal Point PAHO Dra. Nurys Elizabeth De Castro Escaño Republica Dominicana Laboratory technician Bioanalista del Departamento de Virologia del Laboratorio Nacional de Salud Publica 29 Dra. Delia Nais Castillo Republica Dominicana Epidemiologi st Analista del Departamento de Alerta y Respuesta de la Dirección General de Epidemiología y coordinadora de la vigilancia de influenza y otros virus. Doctora en Medicina General con especialidad en Análisis de Datos en Epidemiologia, experiencia en vigilancia, alerta y respuesta de influenzas y otros virus respiratorios. Dra. Carmin Natalia Rodríguez Republica Dominicana Regulator Coordinadora Medico de la Subdireccion de la Direccion General Medicamentos, Alimentos y Productos Sanitarios Dra Antolina Damaris Rodriguez Republica Dominicana Immunization focal point Tecnico Epidemiologo del porgrama ampliado de inmunizacion PAI Dr. Raphael Maxi Haiti Immunization Conseiller technique a l'unite de Coordination Nationale du Pogramme Elargi de Vaccination Mrs. Guerline L. Guillaume Haiti Regulator Assitant-chef de section au service des Medicaments Essentiels, DPM/MT Dr. Gerard Joseph Haiti Laboratory technician, Influenza Coordonnateur de la Surveillance Epidemiologique, LNSP 30 Dr. Wilnique Pierre Haiti Epidemiologi st Responsible de la Preparation a la Grippe Pandemique au niveau national, DELR Dr. Gue Edmond Haiti PAHO Immunization focal point Focal Point PAHO Dr. Karen Lewis-Bell Jamaica Punto Focal PAHO Punto Focal PAHO Mr. Radjesh Ori Suriname Epidemiologi st Coordinator Biostatistics at Bureau of Public Health Ms. Meryl Letitia Maes Suriname Immunization focal point Coordinator National immunization Project Ms. Tilotmadebie Ramlal Suriname Logistics professional Acting Senior Technician of the Bacteriology/Virology. Department of the Central Laboratory and National IATA Shipper/Trainer. Focal Point at the Central Laboratory for Yellow Fever and other arboviruses laboratory Mr. Merril Wongsokarijo Suriname Laboratory technician The National TB Laboratory Manager Mr. Vinoj Sewberath Misser Suriname Regulator Pharmacist Dr. Vic Veguilla CDC Health Scientist Dr. Erica Dueger CDC Epidemiologist Mr. Collin Weinberger CDC Senior Global Health Office from the Office of Global Affairs 31 Mr. Bhagawan Das Shrestha EMRO EM/RGO/W HE/IHM Public Health Officer Dr. Belinda Herring AFRO AF/RGO/WH E/IHM Technical Officer (Avian Influenza) Ms. Alexandra Kontic WHO HQ/WHE/IH M/PIP Secretariat Technical Officer Mr. Tim Nguyen WHO HQ/WHE/IH M/PAT Team Lead, Stockpile Governance, Manager a.i. (Speaker) Ms. Ioana Ghiga WHO HQ/WHE/IH M/PAT Technical Officer (Speaker) Ms. Viviane Bianco WHO HQ/WHE/IH M/PAT Consultant Dr. Weigong Zhou WHO HQ/WHE/IH M/IPR Medical Officer (Speaker) Dr. Anne Huvos WHO HQ/WHE/IH M/IPR Manager, Influenza Preparedness & Response (Speaker) Ms. Dorothy Leab GaneshAid Game Executor Ms. Anne-Sophie Vandamme GaneshAid Game Executor Dr. Maria Luz Pombo WDC HSS/MT Advisor, Vaccines & Biotechnological Products (Speaker) Mr. Murilo Freitas WDC HSS/MT Specialist, Regulatory Affairs Mrs. Alba Maria Ropero WDC FPL/IM Advisor, Immunization (Speaker) Dr. Alba Vilajeliu WDC FPL/IM Consultant Mr. John Fitzsimmons WDC PAHO Revolving Fund (Speaker) Dr. Rakhee Palekar WDC PHE/IHM Influenza Team Lead (Speaker) 32 Dr. Juliana Leite WDC PHE/IHM Laboratory Specialist Dr. Angel Rodriguez WDC PHE/IHM Influenza surveillance Specialist (Speaker) Dr. Myrna Charles WDC PHE/IHM CDC Officer on Detail Ms. Angella Smith WDC PHE/IHM Project Support Specialist, PIP Ms. Alexandra Rajs WDC PHE/IHM Administrative Assistant 33 Profiles: Epidemiologist Laboratory technician Regulator Immunization focal point Logistics professional