Pandemic influenza preparedness framework: biennial progress report, 1 January 2020–31 December 2022

6-MONTH REPORT 12-MONTH REPORT 18-MONTH REPORT 24-MONTH REPORT 2020 2021 PANDEMIC INFLUENZA PREPAREDNESS FRAMEWORK BIENNIAL PROGRESS REPORT 1 January 2020 – 31 December 2021

Pandemic Influenza Preparedness Framework Biennial Progress Report 1 January 2020 – 31 December 2021 Pandemic Influenza Preparedness Framework: biennial progress report, 1 January 2020–31 December 2021 ISBN 978-92-4-005170-6 (electronic version) ISBN 978-92-4-005171-3 (print version) © World Health Organization 2022 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. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. 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Cover Page Image Credit: ©Tom Pietrasik iii CONTENTS Acronyms & Abbreviations iv PIP Framework implementation overview 3 Technical and financial implementation progress 6 Laboratory & Surveillance 8 Burden of Disease 10 Regulatory Capacity Building 11 Risk Communications and Community Engagement 12 Planning for Deployment 13 Influenza Pandemic Preparedness Planning 14 PIP Framework Secretariat 15 Stories from the Field 17 What's next for 2022-2023 27 Endnotes 36 Annex - Financial Report 37 iv BM BOD CC CVV DEP DG EQAP GBT GISRS HAI HLIP ICFS IDP ILI IMS IPPP ISST IVPP IVTM L&S MA MS NIC Biological Material Burden of Disease Collaborating Centre Candidate Vaccine Virus Planning for Deployment Director-General External Quality Assessment Programme Global Benchmarking Tool Global Influenza Surveillance and Response System Human Animal Interface High-Level Implementation Plan Interim Certified Financial Statement Institutional Development Plan Influenza-Like-Illness Incident Management System Influenza Pandemic Preparedness Planning Infectious Substances Shipping Training Influenza Virus with Pandemic Potential Influenza Virus Traceability Mechanism Laboratory and Surveillance Capacity Building Marketing Authorization Member State National Influenza Centre National Immunization Technical Advisory Groups National Pandemic Influenza Preparedness Plan National Regulatory Authority National Deployment and Vaccination Plan Partnership Contribution Public Health and Social Measures Pandemic Influenza Preparedness Pandemic Influenza Severity Assessment Provincial Public Health Laboratories Programme Support Costs Pharmacovigilance Quality Management Systems Risk Communications and Community Engagement Regulatory Capacity Building Severe Acute Respiratory Infection Shipping Fund Project Standard Material Transfer Agreement 2 United States Centers for Disease Control and Prevention Vaccine Composition Meeting Weekly Epidemiological Record World Health Assembly World Health Organization NITAG NPIPP NRA NDVP PC PHSM PIP PISA PPHL PSC PV QMS RCCE REG SARI SFP SMTA2 US CDC VCM WER WHA WHO ACRONYMS & ABBREVIATIONS 1The Pandemic Influenza Preparedness (PIP) Framework is an innovative public health instrument that brings together Member States, industry, other stakeholders and WHO to implement a global approach to pandemic influenza preparedness and response. The key goals include: to improve and strengthen the sharing of influenza viruses with human pandemic potential through the WHO Global Influenza Surveillance and Response System (GISRS), and to increase the access of developing countries to vaccines and other pandemic response supplies. The Framework includes a benefit-sharing mechanism called the Partnership Contribution (PC). The PC is collected as an annual cash contribution from influenza vaccine, diagnostic, and pharmaceutical manufacturers that use GISRS. Funds are allocated for: (a) pandemic preparedness capacity building; (b) response activities during the time of an influenza pandemic; and (c) PIP Secretariat for the management and implementation of the Framework. For pandemic preparedness capacity building, activities are implemented according to six outputs under one outcome in the High Level Implementation Plan (HLIP) II 2018-2023. The technical and financial investments of countries and other partners, including GISRS, play a critical role in advancing pandemic preparedness alongside PC investments. Collectively, resources are used to strengthen pandemic preparedness systems, knowledge and capacities. We thank countries and partners for their important role and contribution. The progress made and successes achieved are a result of joint collaboration on common objectives. The PIP PC funding model is described in HLIP II, Section 6. This reporting format addresses the recommendation from the 2016 PIP Review that WHO develop progress reports that present overall success metrics and infographics to illustrate progress in PIP Framework implementation. A progress report is published four times a biennium, and covers technical and financial implementation for HLIP II, as well as the PIP Secretariat. Milestones are reported every six months and indicators are reported yearly. All data are presented cumulatively from the beginning of each biennium, in this case, 1 January 2020. For financial implementation, progress is reported against biennial workplan allocations. Figures presented exclude WHO Programme Support Costs (PSC) unless otherwise stated. For the mid-year reports, income, expenditures and encumbrances are presented, and are based on WHO’s financial tracking system (GSM). For annual and biennial reports, income and expenditures are presented, in line with the yearly WHO Interim Certified Financial Statement (ICFS). Response to COVID-19 overshadowed implementation of all activities covered in this report. A central, recurring theme throughout the COVID-19 pandemic, has been the invaluable global asset that GISRS represents for the global response. The targeted capacity-strengthening activities supported by PIP have also been recognized, and despite slow-downs, some notable results and impact have been achieved, as reflected in this report. Care was exercised at all times to ensure that PIP PC funds were used to implement influenza specific capacity-strengthening activities, and periodic risk assessments were done to manage and, to the extent possible, minimize the impact of COVID-19 on PIP PC implementation. Many staff across WHO Clusters and Departments in all Major Offices support the implementation of the PIP Framework. Without their work, dedication and collaboration, there would be no progress to report on. We extend our sincere thanks to these staff for their invaluable work. The report is structured as a series of infographics as follows: For previous reports, see https://www.who.int/initiatives/pandemic-influenza-preparedness-framework/partnership-contribution INTRODUCTION 2 IMPLEMENTATION OVERVIEW 4 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 PIP PC collection (As of 31 December 2021) PERCENTAGE OF TOTAL PC RECEIVED FROM CONTRIBUTORS $252M CONTRIBUTED BY INDUSTRY b M IL LI O N U S$ 2012 a 30 25 20 15 10 5 0 TARGET 28M /YEAR 2013 2014 2015 2016 2017 2018 2019 2020 2021 99% 97% 98% 97% 97% 97% 97% 98% 55% a In 2012, contributions were made voluntarily. b Figure includes PSC. PC collection for prior year unpaid contributions, including 2021, is in progress. The figure does not include interest earned on Response Funds ($3.6M) during 2018-2021. PIP PC financial implementation for the biennium (As of 31 December 2021) PREPAREDNESS PIP SECRETARIAT RESPONSE 2020-2021 BIENNIAL BUDGET: $31.4M FUNDED: $23.4M BIENNIAL BUDGET: $5.8M FUNDED: $4.3M IMPLEMENTED: $3.1M TOTAL IN RESERVE (WITH PSC & INTEREST ACCRUED FOR 2018-21): $71.6M IMPLEMENTED: $16.8M Biennial budget Funded Implemented LEGEND L&S - 5,000 10,000 15,000 20,000 - 1,000 2,000 3,000 BOD RCCE - 1,000 2,000 3,000 - 1,000 2,000 3,000 DEP - 1,000 2,000 3,000 IPPP - 1,000 2,000 3,000 REG PIP Framework outcome indicators OUTCOME Improved global pandemic influenza preparedness and response through the implementation of the PIP Framework Indicator 2019 Baseline 2020 Status 2021 Target 2021 Status % of Member States with zoonotic influenza cases sharing IVPPs with GISRS (N=15) 71%c 75% N/A 80% % of PC recipient Member States reporting to FluNet (sustainability indicator) (N=41) 97% 88% ≥85% 90% % of PC recipient Member States reporting to FluID (N=41) 81% 73% 70% 71% % of Member States with BOD estimates considered by NITAG or other decision-making bodies (N=11) 11% 0% 40% 7% No. of PC recipient Member States that have implemented regulatory approach (N=48) 22 27 23 41 % of PC recipient Member States that developed or updated an IPPP (N=63) 52% 56% 75% 59% % of influenza vaccine & antiviral manufacturers that concluded an SMTA2 (N=32) 41% 44% 50% 44% % of Partnership Contributions received in the year of invoice (N=$28M) 58% 52% 100% 55% c 2019 indicator's result was reported to be 57% in the 2018-2019 PIP Biennial Progress Report. This result has since been corrected upon reviewing the data retrospectively. 5BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 PIP Framework governance SMTA2: SECURING PRODUCTS FOR FUTURE PANDEMIC RESPONSE PIP Biological Materialsd shared The COVID-19 pandemic continued to challenge all aspects of WHO's work in 2021, including implementation of the PIP Framework. As a result of on-going travel restrictions, the PIP Framework Advisory Group met in a virtual format for both its 2021 meetings (22-26 March and 7-11 October). Both meetings were preceded by Technical Briefings covering the Advisory Group’s work to date on Genetic Sequence Data, COVID-19 & influenza virus sharing, and the implementation of the Global Influenza Strategy. In addition, in welcoming 6 new members, the Secretariat provided a thorough briefing to introduce new members to the PIP Framework. The PIP Framework Secretariat is contributing to various initiatives undertaken to improve the response to a pandemic and better prepare for future health emergencies. In particular, there is continued engagement with stakeholders to discuss pandemic vaccine deployment activities with a view to operationalizing the SMTA2 terms and conditions that will apply when the next pandemic strikes. The Secretariat is also supporting WHO's work to develop a BioHub, the Global Genomic Surveillance Strategy, and the International Pathogen Surveillance Network, as well as work to support various Member State workstreams such as the Working Group on Preparedness and Response. PIP BMs RECORDED IN IVTM FROM 1 JANUARY 2020 TO 31 DECEMBER 2021: TOTAL SINCE 1 DECEMBER 2012: SMTA2 WITH VACCINE MANUFACTURERS SINCE 2013 SMTA2 WITH ANTIVIRAL AND DIAGNOSTIC MANUFACTURERS & ACADEMIC AND RESEARCH INSTITUTIONS 1373 25M 75 >75M >5M and <75M <5M pandemic production pandemic production pandemic production 29 250,00010M 168 DIAGNOSTIC KITS SYRINGES BENEFIT-SHARING OFFERS FROM ACADEMIC & RESEARCH INSTITUTIONS SMTA2 WITH ACADEMIC & RESEARCH INSTITUTIONS TREATMENT COURSES OF ANTIVIRALS Large / multi-national manufacturers Medium-sized manufacturers Small manufacturers VIRUS SUBTYPES RECORDED: A(H10N3), A(H1N1)V, A(H1N2)V, A(H2N3), A(H3N2)V, A(H5N1), A(H5N6), A(H5N8), A(H7N9), A(H9N2) PIP BMs RECORDED d For definition of ‘PIP Biological Materials’, see PIP Framework Section 4.1 (>420M DOSES)e ~10%of future pandemic production NEW: 5 new Category C SMTA2s signed in 2020-21 6 7 16 10 16of of ofconcluded concluded concluded e Estimate based on the use of existing technologies - figures may vary depending on the use of newer technologies. 6 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 IMPLEMENTATION PROGRESS 7BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 IMPLEMENTATION PROGRESS OUTPUT READING GUIDE NOTE TO READERS Please read this Output Reading Guide which provides clarity on the data reported in this section. Output name & statement Funds implemented cumulatively at deliverable level (excluding PSC) Indicators: progress updated annually. Results are presented against biennial targets (Baselines are as of 31 December 2017)Proportion of funds implemented from the biennial budget (gray denotes proportion of funds not implemented) Deliverable name Biennial budget & funds implemented cumulatively at Output level (excluding PSC) Highlights from January 2020 to December 2021 (as of 31 December 2021) Milestones: cumulative progress updated every six months since beginning of 2020 Laboratory & surveillance BIENNIAL BUDGET: OUTPUT: National influenza L&S systems contribute to GISRS for timely risk assessment & response measures IMPLEMENTED:$XM $XM DELIVERABLE A IMPLEMENTED $XM HIGHLIGHTS Risk and severity of influenza, including at the human- animal interface, are routinely assessed • Risk and severity assessments are critical to inform national and global preparedness, response and recovery measures during an epidemic or a pandemic. X WHO risk assessments of human infections with non- seasonal or animal influenza viruses were published. • X countries including X PC recipient countries from X regions reported their yearly influenza epidemic severity assessments to WHO. X% of these countries were trained by WHO in 2018-19. The number of countries reporting severity assessments decreased compared to 2019. This is likely due to the disruption to influenza surveillance caused by the COVID-19 pandemic and the sharp decline in influenza activity in 2020. • X% of countries globally conducted outbreak detection and response trainings in 2020. These trainings are critical for influenza readiness and have been integral in the national and sub-national response to COVID-19. X% X% MILESTONES PISA trainings completed Outbreak detection & response trainings Meetings, workshops, joint investigation & risk assessments X X X countries from regions X X countries from regions X X countries from regions X X INDICATORS 20 18 20 17 20 19 20 20 20 21 X X XTarget X X X X 20 18 20 17 20 19 20 20 20 21 X X X XTarget X X X Number of risk assessments published Number of MS reporting PISA to WHO ≥ twice in a season 8 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Laboratory & surveillance BIENNIAL BUDGET: OUTPUT: National influenza L&S systems contribute to GISRS for timely risk assessment & response measures IMPLEMENTED:$20M $12.4M DELIVERABLE A DELIVERABLE B DELIVERABLE C MILESTONES MILESTONES MILESTONES IMPLEMENTED $4.7M IMPLEMENTED $3.8M IMPLEMENTED $1.8M HIGHLIGHTS HIGHLIGHTS HIGHLIGHTS Risk and severity of influenza, including at the human-animal interface, are routinely assessed Quality influenza virus detection capacity is sustained Countries are supported to consistently report influenza data to global platforms • Risk and severity assessments are critical to inform national and global preparedness. In 2020-21, 13 WHO risk assessments of human infections with non-seasonal or animal influenza viruses were conducted and published. • In 2020-21, 14 countries including 2 PC recipient countries reported their yearly influenza epidemic severity assessments to WHO. 18 trainings by 13 countries in 5 regions on the PISA tool were completed in the biennium. The number of countries reporting severity assessments has decreased 48% compared to the 2018-19 biennium. This was largely due to the disruption to influenza surveillance caused by the COVID-19 pandemic and the sharp decline in influenza activity. The PISA tool is being reviewed to address lessons learned during COVID-19. • Outbreak detection and response trainings are critical for pandemic influenza readiness. In 2020-21, 430 outbreak detection and response trainings were conducted in 61 countries from all 6 regions. This was a 71% increase in trainings conducted compared to the previous biennium. • In 2020-21, National Influenza Centres (NIC) were newly recognized by WHO in 2 countries, one of which is a PC recipient country – bringing the total number of NICs globally to 148 in 124 countries. Increasing capacity to NIC recognition was the first objective of using PC funds as set by the PIP Advisory Group in 2013. It improves data representativeness and facilitates a timely and effective response to an influenza pandemic. • Yearly EQAP panels were sent to countries to monitor, sustain, and drive improvements in virus detection capacity. In 2021, 127 countries participated. Of the participating countries, 105 (83%) correctly identified all non-seasonal influenza viruses, and 120 (95%) correctly identified all seasonal viruses. In the 2020-21 biennium, 4 countries participated for the first time. • In 2020, the 1st WHO EQAP panel for SARS-CoV-2 was distributed using the GISRS EQAP system. In addition, the EQAP included a panel for influenza antiviral susceptibility testing. These innovations showcase the continued efforts to meet emerging needs from influenza and other respiratory viruses of public health importance. • In 2020-21, 105 countries from 6 regions benefited from 122 laboratory training activities. These activities along with the yearly participation in the EQAP help improve and sustain quality national influenza virus detection capacity. • Of 194 WHO MS, 142 (73%) reported influenza surveillance data to FluNet and 116 (68%) reported to FluID. Most of these (96% and 88% respectively) reported consistently during the influenza season (data not shown) • Of the 41 PC L&S recipient countries, the proportion reporting to FluNet (90%) and FluID (71%) exceeded the indicator targets. Data sharing is critical to monitor influenza activity and to inform risk assessments. • In the 2020-21 biennium, 3 countries started reporting for the first time to FluNet, and 3 countries started reporting for the first time to FluID. The participation of more countries increases the representativeness of the global systems. WHO supports all countries to improve and sustain their surveillance and global collaboration efforts. • As of December 2021, 76 countries integrated COVID-19 into their sentinel surveillance systems for influenza and used an established influenza platform to share COVID-19 data. PISA trainings completed Regional meetings held to improve global surveillance systems Laboratory trainings, missions and visits completed Outbreak detection & response trainings Meetings, workshops, joint investigation & risk assessments 18 16 122 430 53 countries from countries from regions regions 13 105 5 6 countries from regions 61 6 countries from countries from regions regions 25 165 6 5 Trainings, missions & other types of support for surveillance provided 384 countries from regions 116 6 Regional bulletins published339 regions involved4 2021 EQAP status Contract signed EQAP sent out Results received Results shared with participating laboratories Results published in WER 27% 73% 40% 60% 48% 52% INDICATORS INDICATORS INDICATORS 20 18 20 17 20 19 20 20 20 21 10 17 50Target 30 30 37 24 Proportion of participating MS that were 100% correct for non-seasonal virus identification (N=110) 20 18 20 17 20 19 20 20 20 21 89% 86% 93% 90%Target 83% 83% 90% 20 18 20 17 20 19 20 20 20 21 13 12 27 51Target 14 14 34 96% 93% 95% 95%Target 95% 95% 95% 20 18 20 17 20 19 20 20 20 21 Number of WHO HAI risk assessments published Prop rtion of participating MS that we e 100% c rrect for non-seasonal virus identification (N=127) Number of MS reporting PISA to WHO ≥ twice in a season Proportion of participating MS that were 100% correct for seasonal virus identification (N=127) Proportion of PC recipient MS reporting to FluNet 20 18 20 17 20 19 20 20 20 21 84% 89% 97% 85%Target 88% 90% 85% Proportion of PC recipient MS reporting to FluID 20 18 20 17 20 19 20 20 20 21 51% 73% 81% 70%Target 73% 71% 60% Prop rtion of PC recipient MS reporting to FluNet ( =41) Proportion of PC recipient MS reporting to FluID (N=41) 9BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Laboratory & surveillance DELIVERABLE D DELIVERABLE E MILESTONES MILESTONES IMPLEMENTED $1.9M IMPLEMENTED $168K HIGHLIGHTS HIGHLIGHTS Countries are supported to share timely representative influenza samples with WHO CCs Influenza CVVs, virus detection protocols and reagents, and reference materials are routinely updated • In the 2020-21 biennium, 2440 zoonotic influenza viruses and other IVPPs were characterized by GISRS as of December 2021. The viruses were of 25 influenza A subtypes and originated from 28 countries. • Through the 4 VCM consultations in 2020 and 2021, characterization led to the development of 7 new CVVs for pandemic influenza preparedness. The selection and development of a zoonotic CVV is done to maintain a bank of viruses suitable for the immediate development of vaccines, including during a pandemic. • In the 2020-21 biennium, WHO published and updated 7 influenza virus detection protocols and guidance, including on molecular detection protocols, next-generation sequencing of influenza viruses for NICs, and guidance on maintaining concurrent influenza and SARS-CoV-2 surveillance including through the use of multiplex diagnostic kits. • 80% (12/15) countries that reported zoonotic influenza cases to WHO timely shared IVPPs with GISRS according to WHO guidance. WHO continuously encourages countries to share IVPPs with GISRS according to global guidance. • In 2021, 57 (29%) countries shared influenza viruses/clinical specimens at least once with WHO CCs, with 16 (8%) sharing timely two shipments with WHO CCs. The significant decrease in comparison with 2020 (63% and 31% respectively) was due to the unusually low influenza virus circulation. This may have resulted from the implementation of public health and social measures (PHSM) in response to the COVID-19 pandemic. • Using the SFP, 96 countries from all 6 regions made 259 shipments to WHO CCs in 2020- 21. The disruptions caused by the COVID-19 pandemic and the sharp drop in influenza activity in 2020 and 2021 resulted in reduced influenza sample sharing compared to the 520 shipments made in the previous biennium. WHO continues to advocate for countries to share influenza samples through regional meetings, global webinars and pre-VCM reminders. Trainings on infectious substance shipping completed Shipments made using the SFP Protocols and guidance reviewed, including translations VCM consultations completed new CVVs proposed 9 7 4 7 239 countries from countries from regions regions 24 96 3 6 43% 57% 52% 48% INDICATORS INDICATOR Proportion of MS with zoonotic influenza cases sharing IVPPs with GISRS 20 18 20 17 20 19 20 20 20 21 75% 71% 75% 80% Number of zoonotic viruses & other viruses of pandemic potential characterized by GISRS 20 18 20 17 20 19 20 20 20 21 605 864 1105 1335 Proportion of MS with two timely shipments of virus isolates/clinical specimens with CCs 20 18 20 17 20 19 20 20 20 21 36% 43% 44% 46%Target 31% 8% 44% Proportion of MS with zoonotic influenza cases sharing IVPPs with GISRS (N=15) Proportion of MS with two timely hipments of viru isolates/clinical specimens with CCs (N=194) Number of zoonotic viruses & other IVPPs characterized by GISRS 10 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Burden of Disease BIENNIAL BUDGET: OUTPUT: DELIVERABLE A DELIVERABLE B MILESTONE MILESTONE IMPLEMENTED $196K IMPLEMENTED $437K HIGHLIGHTS HIGHLIGHTS Number of countries in each burden of disease estimate development stage (N=194) Representative national, regional and global disease burden estimates are available Disease burden findings are communicated to national and international expert bodies in a format that promotes evidence- based decision making Influenza disease burden estimates are used for public health decisions IMPLEMENTED:$2M $633K • In 2020-21, 9 additional countries published BOD estimates since the last biennium, and 7 updated their previous findings - bringing the number of countries with published estimates based on data collected since 2011 to 48. Of the 48 countries, 69% (33) are low and middle income countries. This progress exceeded the biennial indicator target. In addition, 52 have either already calculated or established a plan to calculate their national BOD estimates. • Since 2011, 69 countries including 23 LMICs have shared their data for use in regional or global BOD estimates. Together with the US Centers for Disease Control and Prevention (US CDC), WHO is estimating the global influenza-associated hospitalization burden, with 53 countries and areas having contributed data to this project. • In September 2020, WHO convened a global meeting of influenza disease burden modelers to compare influenza-associated hospitalization estimates and methodologies, and to better understand the reasons for differences between currently available estimates. A formal comparison of global influenza-associated hospitalization estimates is underway in collaboration with Hong Kong University. • An influenza disease burden estimator tool has been developed in collaboration with Johns Hopkins University and will be published online. Often, countries have estimates of influenza-associated respiratory hospitalizations or deaths only. Using multipliers sourced from the literature, this web- based tool facilitates the estimation of influenza burden at all levels of disease severity (deaths, hospitalizations, mild/moderate cases) when data from only one severity level are available. • Since 2018, 11 countries reported sharing their BOD estimates with national decision-making bodies including 2 in 2020-21. BOD estimates are important for pandemic planning, as national authorities use burden estimates to prioritize the allocation of resources, and plan prevention and control measures such as vaccination programmes and clinical management strategies. • In 2021, a survey aimed at learning whether BOD studies inform policy found that authors from 14 of the 20 countries surveyed shared their findings with government officials.1 However, just five reported their results being considered in vaccine policy forums – with obstacles cited including COVID-19 pandemic disruptions, weak links between researchers and health authorities, and difficulties communicating the link between burden of disease and vaccine policy. Suggested ways of better communicating disease burden findings to policy makers included early and sustained engagement with policy makers, presenting findings to NITAGs, and annually updating BOD estimates and burden averted through vaccination to sustain awareness and interest. • Following the HLIP II Mid-Term Review2 completed in May 2021, a new indicator will be monitored starting in 2022 to track the number of countries that have developed or updated an influenza vaccination policy. Influenza vaccination policies reduce disease burden, hospitalization, and mortality in high risk groups. Moreover, establishing the infrastructure for seasonal influenza vaccination provides a foundation for pandemic influenza vaccine deployment. Implementation plan established in countries 32 BOD calculated in countries 20 BOD findings published in countries 48 77% 23% 61% 39% INDICATOR INDICATOR 20 18 20 17 20 19 20 20 20 21 21 35 36 Target 43 28 48 39 20 18 20 17 20 19 20 20 20 21 16% 40%Target 0% 30% 7%11% Number of MS with published disease burden estimates based on data collected since 2011 (N=194) Proportion of MS with burden of disease estimates that have been considered by NITAG or other decision-making bodies (N=14) 2 countries Shared/communicated BOD estimates to decision-making bodies 11BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Regulatory capacity building BIENNIAL BUDGET: OUTPUT: DELIVERABLE A DELIVERABLE B MILESTONES MILESTONES IMPLEMENTED $963K IMPLEMENTED $717K HIGHLIGHTS HIGHLIGHTS Refinements made to WHO GBT Countries WHO-benchmarked Countries self-benchmarked IDP follow-up visits National regulatory capacity for pandemic influenza products is strengthened Adoption of regulatory pathways that accelerate approval for use of pandemic influenza products is promoted Timely access to quality-assured influenza pandemic products is supported IMPLEMENTED:$2.9M $1.7M • In 2020-21, 2 countries increased their regulatory capacities based on WHO benchmarking assessments. This met the PIP biennial target and translates to more countries having national capacities for regulatory oversight. Additionally, 11 countries conducted self-benchmarking assessments of key regulatory capacities, and 2 underwent WHO benchmarking assessments. • WHO, together with Swissmedic, conducted 3 capacity-strengthening training workshops for 27 countries from 5 WHO regions. These trainings focused on the use of methods and procedures in quality management systems (QMS), marketing authorization (MA), and pharmacovigilance (PV), in accordance with international standards. This collaboration continues to strengthen countries’ regulatory capacities for approval of products for pandemic preparedness and response. • An article written by WHO was published in Frontiers in Medicine3 analyzing countries’ regulatory preparedness status, and the gaps and challenges in proposing strategic regulatory solutions for future pandemic preparedness. It found that only 10 countries that underwent benchmarking out of 84 had implemented all sub- indicators for regulatory preparedness. Promoting good regulatory practices and reliance in countries with limited regulatory preparedness continues to be a priority. • In the 2020-21 biennium, WHO continued to support countries to implement their defined regulatory pathways based on WHO guidelines. Well exceeding the biennial target of 23 countries, 41 countries developed country roadmaps and follow-up plans for the implementation of pathways required for the timely approval of products. Additionally, work was implemented regionally to promote coherence and consistency. For example, 13 Anglophone and Francophone countries in the WHO African Region participated in workshops on implementing WHO guidelines on regulatory preparedness for MA provision of pandemic influenza vaccines in non- vaccine producing countries. • 25 countries from 2 regions attended 11 regulatory capacity building workshops on accelerated regulatory pathways in 2020-2021. This awareness-raising strengthens regulatory harmonization on MA approaches and processes. • As of December 2021, 24 PIP-supported countries signed the Collaborative Registration Procedure agreement, of which 2 signed in 2020-21. This brings the global total to 59 countries by December 2021. Common registration approaches will simplify and streamline regulatory actions at the time of the next pandemic. WHO regulatory preparedness guidelines translated to all languages5 Workshop/training conducted to implement the PIP regulatory guidelines linking national IPPP & NDVP for pandemic influenza vaccines 11 8 countries regions 25 2 2 11 8 countriesregions83 IDP implementation & technical support activities 18 countries regions 41 6 47% 53% 35% 65% INDICATOR INDICATOR Number of PC recipient MS which strengthened national regulatory capacity to oversee pandemic influenza products (N=16) 20 18 20 17 20 19 20 20 20 21 1 3 8 Target 7 4 8 6 Number of PC recipient MS that have implemented a defined regulatory approach that enables timely approval for use of pandemic influenza products (N=48) 20 18 20 17 20 19 20 20 20 21 0 6 23 Target 27 10 41 22 Number of PC recipient MS which strengthened national regulatory capacity to oversee pandemic influenza products (N=16) Number of PC recipient MS that have implemented a defined r gulatory a proach that enables timely approval for use of pandemic influenza produ ts (N=48) 12 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Risk Communications & Community Engagement BIENNIAL BUDGET: OUTPUT: Tools and guidance are available for countries to enhance influenza risk communication and community engagement IMPLEMENTED:$2.6M $716K DELIVERABLE A Countries and frontline responders have access to resources for influenza risk communication, community engagement and social science-based interventions Technical assistance is provided to countries to plan and exercise influenza risk communication and community engagement IMPLEMENTED $257K IMPLEMENTED $459K DELIVERABLE B MILESTONE MILESTONES INDICATOR INDICATOR HIGHLIGHTS HIGHLIGHTS • In 2020-21, 56 webinars and meetings were conducted to strengthen key RCCE capacities relevant for COVID-19 and pandemic influenza - including influencing risk perceptions, using evidence for strengthening community resilience systems, and COVID-19 stigma. Additionally, regions tailored their support activities to regional and country contexts. In the WHO Western Pacific Region, webinars focused on using multi-source listening systems and social media for risk assessment; and in the WHO Region of the Americas, workshops stressed the role of risk communications in the roll-out of relevant guidelines for country-level adaption. • OpenWHO continues to grow as a global learning platform for pandemic influenza preparedness and response. Over 228,000 users from 193 countries completed one of 23 influenza courses on OpenWHO. The platform continues to support the COVID-19 pandemic knowledge transfer, with over 6.35 million enrollments across 42 different courses. • A new course on Influenza Prevention and Control was launched in 2021. Targeted towards health workers, it provides an overview of the importance of influenza vaccination, and seasonal influenza vaccination types, administration, and target groups. This launch was coupled with advocacy events to promote uptake and use of the platform. Trainings, missions and other types of technical support provided involving Influenza guidance/courses available on OpenWHO OpenWHO advocacy & marketing events RCCE factor mapped in priority country Global partnership & network for effective RCCE capacity 56 23 3 0 0 1 regions6 partners plans of action available 2 5 82% 18% 62% 38% 20 18 20 17 20 19 20 20 20 21 3,475 9,922 25,000 Target 192,111 12,500 228,754 39,724 Number of users who completed Open-WHO influenza modules 20 18 20 17 20 19 20 20 20 21 0 10 130Target 51 100 5951 Number of MS that utilized RCCE support for influenza preparedness or response Number of users who completed Open-WHO influenza modules Number of MS tha utilized RCCE support for influ nza pre aredness or response 13BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Planning for Deployment BIENNIAL BUDGET: OUTPUT: Plans for effective & efficient deployment of pandemic supplies are optimized IMPLEMENTED:$1.2M $379K DELIVERABLE A DELIVERABLE B DELIVERABLE C IMPLEMENTED $166K IMPLEMENTED $28K IMPLEMENTED $185K A common approach to manage global deployment operations is developed and regularly tested with stakeholders and deployment partners National deployment planning process is revised and updated Technical assistance to develop policies for sustainable influenza vaccine procurement and production is provided to countries 70% 30% 74% 26% 70% 30% HIGHLIGHTS HIGHLIGHTS HIGHLIGHTS • WHO initiated a project to estimate national, regional, and global needs for pandemic influenza preparedness medical products and identify gaps in global preparedness for availability and access of such medical countermeasures. Using foresight methodologies, this analysis will also inform product allocation and deployment strategies, and the development of operational plans for product deployment. • Global focus remains on the COVID-19 pandemic response with stakeholders and MS heavily involved in the deployment of COVID-19 vaccines. Thus, despite no specific gains in this Deliverable, lessons from COVID-19 will be beneficial to inform future influenza pandemic preparedness. • Guidance and tools developed through PC implementation were leveraged to facilitate country planning and deployment of COVID-19 vaccines. Lessons learned from the development of COVD-19 NDVPs are being used to adapt and update guidance on developing influenza NDVPs. • Thirty-four countries conducted COVID-19 Vaccine Post-Introduction Evaluations with a view of reviewing and adjusting vaccine deployment operations. Lessons learned from these are being incorporated into updated guidance and operational protocols. • During the 2020-21 biennium, Serbia completed its sustainability assessment, thus allowing the country to identify opportunities and challenges for sustaining its local production of influenza vaccines. • WHO plans to capture COVID-19 lessons learned, including the impact of advanced technologies and the establishment of additional production capacities, to inform sustainable influenza vaccine procurement and production activities moving forward, including updating the sustainability assessment checklist. • WHO continues to provide technical resources, including through the influenza vaccination toolbox, to support Member States with developing or strengthening their influenza vaccination programmes. MILESTONES MILESTONES MILESTONES INDICATOR INDICATOR Training, mission, visit & other type of technical support provided 1 country country country region region region 1 1 0 1 1 0 Training, mission, visit & other type of technical support provided to update NDVP Global guidance tool revised PIP Deploy tool refinement to facilitate planning, allocation and coordination Advocacy meeting for a common approach completed 1 1 0 0 20 18 20 17 20 19 20 20 20 21 1 1 5 Target 6 3 66 Number of simulation exercises conducted to test global deployment of pandemic influenza vaccines and other products 20 18 20 17 20 19 20 20 20 21 6 8 10Target 9 8 98 Number of MS that have undergone a national analysis of influenza vaccine procurement or production sustainability Country engagement & concurrence Kick-off meeting completed Draft report completed Stakeholders workshop held (1 country) Final sustainability assessment report available (3 countries) Number of simulation exercises conducted to test global deployment of pandemic influenza vaccines and other products Number of MS that have undergone a national analysis of influenza vaccine procurement or production sustainability 14 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 DELIVERABLE A Countries are supported to develop, test and update their pandemic influenza preparedness plan Influenza Pandemic Preparedness Planning BIENNIAL BUDGET: OUTPUT: National pandemic influenza preparedness & response plans are updated in the context of all-hazards preparedness and global health security IMPLEMENTED:$2.7M $983K MILESTONE HIGHLIGHTS • Of the 63 IPPP PC recipient countries in the 2020-21 biennium, 37 (59%) now have a plan based on WHO’s Pandemic Influenza Risk Management guidance. This is an increase of 4 PC recipient countries with an up-to-date plan in 2020-21. • Three countries exercised their IPPPs in 2020- 21 focusing on laboratory readiness, outbreak response, and multi-sectoral coordination. These exercises will support the iterative improvements of emergency preparedness and response protocols taking into account lessons from the COVID-19 response. • Twenty-four countries are in the process of developing or updating their plans. This progress in the biennium shows that despite the primary focus being on the COVID-19 response, countries are sustaining operational planning for an influenza pandemic. • WHO initiated a collaborative process to update the Pandemic Influenza Risk Management guidance with a broader respiratory pathogen focus for countries to update their national plans. WHO published two papers4,5 focusing on its country-level support during the first year of the COVID-19 pandemic showcasing the operational breadth and intensity of cooperation. Key lessons and recommendations from the COVID-19 pandemic response including WHO's actions will inform updated guidance. IMPLEMENTED $983K Planning meeting held/workshop completed IPPP written or revised IPPP endorsed 24 27 5 IPPP exercises completed in 3 countries region 3 2 63% 37% Number of PC recipient MS developing/ revising their IPPP since January 2018 INDICATORS 20 18 20 17 20 19 20 20 20 21 12% 35% 75%Target 56%60% 59% 65% Proportion of PC recipient MS that developed or updated a pandemic influenza preparedness plan since 2014 (N=63) 20 18 20 17 20 19 20 20 20 21 2% 10% 50% Target 3% 30% 5% 30% Proportion of PC recipient MS that exercised their pandemic influenza preparedness plan in 2020 (N=63) Proportion of PC recipient MS that developed or updated an IPPP according to WHO guidance (N=63) Proportion of PC recipient MS that exercised their IPPP in 2020-21 (N=63) 15BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 PIP Framework Secretariat BIENNIAL BUDGET: OUTPUT: The PIP Secretariat leads, manages and supports implementation of the PIP Framework IMPLEMENTED:$5.8M $3.1M DELIVERABLE A DELIVERABLE B DELIVERABLE C IMPLEMENTED $1.3M IMPLEMENTED $772K IMPLEMENTED $1.1M Promote the effective implementation of the PIP Framework in a changing environment Collect, implement, monitor, and report on the Partnership Contribution Negotiate and plan to operationalize the Standard Material Transfer Agreements 2 (SMTA2) MILESTONES MILESTONES MILESTONES HIGHLIGHTS HIGHLIGHTS HIGHLIGHTS Meetings held and reports submitted to WHO DG or governing bodies to support implementation of Section 7 (Governance and review) of the PIP Framework Number and status of documents/reports developed for the World Health Assembly Status in annual project management cycle Number of SMTA2s in negotiation 17 Advocacy materials/events completed to promote the PIP Framework to stakeholders 26 • The opening day of WHA 74 in May 2020 marked the 10th anniversary of the adoption of the PIP Framework. The Director-General recognized this in his opening remarks, thanking MS and stakeholders for their continued commitment to this unique partnership. Several new communications products were developed to commemorate this special event including a feature article posted on the WHO website, an article in the WHO COVID-19 Weekly Operational Update, an article in the UN News Special, and a brochure highlighting key achievements. • Due to the COVID-19 pandemic, the PIP Advisory Group held all its meetings virtually. Technical Briefings on different subject were held in advance of the meetings to allow the Secretariat to share information and thorough updates while still allowing time for discussion during the abbreviated meeting format. • While the COVID-19 pandemic challenged the PIP Framework's advocacy efforts for influenza, the Secretariat and the Advisory Group continued to engage with GISRS, industry, civil society, databases and initiatives. • 45 ‘Stories from the Field’ were published in the Influenza Newsletter in 2020-21. The stories shed light on the impact of PC investments at the country, regional, and global level, including the collateral benefits PC investments have had for the COVID-19 response. • 10 monitoring visits both in-person and virtual were conducted, where discussions focused on sustaining HLIP II implementation. • In 2021, a Mid-Term Review of HLIP II2 was completed to assess progress and determine if adjustments were needed to improve implementation. Revisions to the HLIP II monitoring and evaluation framework were completed following the review.6 • 2022-23 biennium workplans were approved in November 2021 after a comprehensive development process including external review by the Partnership Contribution Independent Technical Expert Mechanism. The workplans, targeting 82 PC recipient countries will build on achievements from the previous two biennia and will consider experiences and lessons learned from the COVID-19 pandemic, and continue to leverage national and international investments in pandemic influenza preparedness. • In 2020-21, 6 SMTA2s were concluded: 1 with a manufacturer of influenza vaccines and 5 with academic and research institutions. • Initiated in November 2020, a series of meetings were held to discuss pandemic vaccine deployment activities with a view towards operationalizing the SMTA2 supply commitments • In order to ensure that pandemic vaccine supply agreements are up to date and can be implemented efficiently during a pandemic, the Secretariat started reviewing those SMTA2s signed by manufacturers more than 4 years ago. One review with an early signatory is close to being finalized. Early scoping/ Under discussion In process (draft reports) Final & published 0 0 758% 42% 40% 60% 29% 71% Reporting Implementation PC implementation updates published in newsletter Site monitoring visits 45 10 Monitoring Invoices sent by 30 June Work plan compliance checks: PC funds distributed by 31 December Jan - June July - Dec INDICATOR INDICATOR 20 18 20 17 20 19 20 20 20 21 34% 38% 50%Target 44% 41% 44%41% With manufacturers of vaccines and/or antivirals 3 With manufacturers of other pandemic related products 0 With academic & research institutions 0 Proportion of Partnership Contributions received in year of invoice Proportion of influenza vaccine and antiviral manufacturers that concluded an SMTA2 (N=32) 55% Planning 0 BASELINE 100% ($28 M) TARGET Photo credit: WHO/Gregor Donaldson 17BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 STORIES FROM THE FIELD 18 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 “First time” achievements in pandemic influenza preparedness in two regions with high humanitarian and public health vulnerabilities, 2014-2021 The African and Eastern Mediterranean regions suffer a large burden of humanitarian vulnerabilities. Nine out of the 10 United Nations system-wide scale ups in response to emergencies occurred in these two regions since 2014. The two regions also have 21 out of the 28 (75%) countries with active health clusters highlighting the considerable challenges for addressing population health needs. Since the beginning of PC implementation in 2014, investments were made in laboratory and surveillance capacities for strengthening pandemic influenza preparedness including in the WHO African and Eastern Mediterranean Regions. Despite the multiple emergencies experienced in these two regions, significant gains were made as shown below. The gains represent global solidarity to ensure that populations everywhere, regardless of context, are supported to strengthen their preparedness for a future influenza pandemic. The work operationalizes equity, which is at the heart of the PIP Framework, and WHO’s mandate to serve the vulnerable. Increasing the number of NICs to facilitate global influenza monitoring and public health risk management Four NICs were newly recognized by WHO in 3 African countries and 1 Eastern Mediterranean country, bringing the total number to 33 NICs in 31 countries in these two regions. Increasing the number of NICs was recognized, by the PIP Advisory Group in 2013, as the first objective for use of PC funds. Increasing the participation of countries in GISRS means that data and viruses shared are more representative for risk assessment and public health action. It will also facilitate a timely and effective response to an influenza pandemic as more countries will be able to rapidly detect a novel influenza virus. Sharing influenza viruses to contribute to global surveillance and vaccine development Fifteen countries started sharing influenza viruses or clinical specimens with WHO CCs since 2014 in the African and Eastern Mediterranean Regions (respectively 12 and 3 countries). By sharing seasonal influenza viruses, countries increase the geographic representativeness of viruses available to inform the yearly composition of influenza vaccines. Through the sharing of seasonal influenza viruses, countries also show their capability to share IVPPs when the need arises. +4 countries +15 countries African Region Eastern Mediterranean Region Not applicable 19BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Participating in WHO yearly EQAP to accurately detect emerging influenza viruses Due to the continuous threat of pandemic influenza, quality laboratory diagnostics are essential. EQAP helps laboratories monitor, sustain and improve influenza virus detection capacity and performance standards. Since 2014, 5 African and 3 Eastern Mediterranean countries started participating in the WHO EQAP. EQAP helps WHO and GISRS institutions to focus capacity-strengthening initiatives to where they are most needed, and to ensure confidence in the underlying systems providing critical data for decision-making. Sharing data to monitor influenza activity and inform risk assessments Fifteen countries from the African and Eastern Mediterranean Regions started reporting epidemiological data to WHO’s influenza surveillance platform “FluID”, 6 started reporting virological data to “FluNet”, and 6 started reporting data to both platforms. The participation of more countries increases the geographical representativeness of the data in these two global systems. Routine data availability also means that situational analyses and risk assessments are up to date. These are critical for national and global preparedness. Reporting influenza severity indicators to enable timely severity assessments and associated response recommendations WHO’s PISA platform was developed to monitor and assess the severity of yearly influenza epidemics, so that when the time comes, it can also be used for pandemic influenza monitoring. Since its launch in 2017, 13 countries from the African and Eastern Mediterranean regions (respectively 10 and 3) have started reporting to the PISA platform. Country participation will streamline monitoring during the next pandemic, and the historical data will assist countries to determine the timing, scale, emphasis, intensity and urgency of the pandemic response actions needed. Building resilient systems WHO congratulates countries for these gains. However, the work is not done. Due to the humanitarian and fragile contexts in many countries, time is needed to stabilize participation in influenza preparedness systems. The COVID-19 pandemic also shed light on existing gaps in preparedness and the need to revisit surveillance platforms and approaches to be resilient within a broader acute respiratory disease context. +8 countries +27 countries +13 countries 20 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Expanding the network: Togo gains National Influenza Centre The influenza laboratory at the Institut National d’Hygiene (INH) has gained WHO recognition as a National Influenza Centre, joining the network of laboratories that form the backbone of GISRS in the African Region. In the WHO African Region, only 13 out of the 31 laboratories that contribute influenza data to GISRS are recognized as NICs. Despite the ongoing pressures of the COVID-19 pandemic, in mid-2021, following a series of trainings, assessments and ongoing support facilitated by the PIP PC, the influenza laboratory at the Institut National d’Hygiene (INH) in Lomo, Togo was recognized as an NIC. This marks a major milestone for influenza surveillance and laboratory readiness for Togo. Setting a path for readiness The process started in 2018 with an official request being filed by the Ministry of Health for INH to be recognized by WHO. Influenza laboratory experts from Cameroon and Cote d’Ivoire then visited the laboratory to conduct a gaps and needs assessment. This assessment formed the basis for a rigorous programme of capacity building for laboratory quality management and core laboratory functions. Collaboration with experts across the region was critical for experience sharing and has expanded the network so that other laboratories in the region can initiate the process themselves and also be recognized as NICs. Recognition during COVID-19 COVID-19 created many roadblocks for onsite engagement and for the laboratory themselves as borders were closed, restricting access to reagents and external support and the increasing COVID-19 testing burden challenged overwhelmed systems. Additionally, diagnostics capacities were heavily prioritised for COVID-19 response. However, Togo was able to maintain its influenza testing capacity with continuous support from WHO and regional experts. After follow-up assessments in late 2020, the laboratory, having achieved its requirements received national NIC designation and recognition by WHO in 2021. This has paved the way to further enhance national capacity for influenza diagnostics and other respiratory viruses and boost the country’s laboratory network development. The efforts are already paying off with Togo’s continuous participation in WHO’s EQAP. Togo’s participation in GISRS means that more data and more viruses are being represented in national, regional, and global risk assessments. This important achievement is a culmination of years of work and support from the PIP PC and supports stronger national pandemic preparedness in the long term. Assessing laboratory performance in the face of the COVID-19 pandemic. Image credit: WHO Country Office, Togo 21BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Bolivia leverages influenza capacities for COVID-19 Bolivia has received capacity-building support through the PIP PC since 2014. Now the country is reaping the rewards as it leverages strengthened capacities in surveillance, epidemiological analysis, risk communication and clinical care to deliver its COVID-19 pandemic response. Key areas where pre-pandemic PIP support is really paying off include: • Early response. Previous training and simulations on timely intervention for unusual respiratory events helped shape the country’s early response to the pandemic, informing the identification, clinical care, isolation and risk communication of the first recorded cases of COVID-19. • Clinical care. Existing capacity to care for severe cases of influenza in sentinel hospitals combined with pre- pandemic training in intensive care helped direct the clinical care of severe cases of COVID-19. • Biosafety. Biosafety training held months before the pandemic built widespread skills, quantified the national need for personal protective equipment, and enabled the development of biosafety manuals for hospitals, laboratories and isolation centres, which are now being used for COVID-19. • Laboratory diagnosis. Before the pandemic, Bolivia had three laboratories, including a WHO-recognized NIC, with molecular capacity to diagnose respiratory viruses. When COVID-19 hit, these laboratories provided a vital platform for expansion through training and supervision. Over the past year, the country’s network of molecular biology laboratories capable of diagnosing respiratory viruses, including SARS-CoV-2, has grown to 12. The NIC provides a central link that also ensures quality control for the network as a whole. • Epidemiological analysis. The Severe Acute Respiratory Infection (SARI) case form and Pan American Health Organization influenza sentinel information system that Bolivia routinely uses for influenza served as models for developing a national COVID-19 case information system. Bolivia looks forward to continued collaboration under PIP. Priorities include using the expanded laboratory network to keep up its surveillance of novel respiratory viruses including influenza, and to strengthen its capacity for genetic sequencing. Hospital staff receive training in biosafety measures for the care of SARI cases. Image credit: Sandra Mallo, PAHO communicator Bolivia 22 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Syria boosts influenza preparedness despite multiple crises Despite the disruptions and difficulties created by a protracted humanitarian crisis and the ongoing COVID-19 pandemic, Syria’s Ministry of Health successfully launched its first comprehensive National Pandemic Influenza Preparedness Plan (NPIPP). Development of the new plan was overseen by the Syrian National Influenza Committee—a new entity established by the MOH to ensure a whole-of government and whole-of- society approach to influenza preparedness and response that coordinates action across all sectors and stakeholders. A multisectoral venture The committee includes representatives from a range of government ministries and directorates, including health, communicable disease, agriculture, education, the interior, and military medical services, as well as representatives from WHO country and regional offices. Together, this multisectoral committee is responsible for developing, maintaining, testing, evaluating and revising the NPIPP. Its work is supported by multiple partners, including WHO with support from the PIP PC. Throughout 2021, despite the huge operational restrictions and economic difficulties caused by the ongoing humanitarian emergencies and COVID-19 pandemic, the committee worked to develop the NPIPP. It conducted field visits and held technical consultations (both virtual and in-person) and considered lessons learned from the 2009 A(H1N1) and ongoing COVID-19 pandemics. And it aligned its plan with WHO guidance on pandemic preparedness and response, particularly with regards to integrating surveillance for multiple pathogens. To that end, in parallel with the committee's work on the NPIPP, Syria has successfully established an integrated laboratory and sentinel surveillance system that has enhanced detection and monitoring capacities for both influenza viruses and SARS-CoV-2. In November 2021, a final draft of the NPIPP was agreed to by all members of the committee and endorsed by the Syrian government. The final plan includes a detailed operational component identifying timeframes and responsibilities to guide preparedness and response capacity building for influenza outbreaks in human and animals Next steps The process of developing the NPIPP has increased both the MOH and broader Syrian government’s commitment towards influenza preparedness and response. Through the PIP PC, WHO will continue to support the country to test, evaluate and refine the plan over the next two years. Planned activities include a simulation exercise in 2022 to test the plan and identify areas for further strengthening. In addition, the government is planning to use the NPIPP as a blueprint for enhancing preparedness, readiness and response to other priority health threats, including COVID-19 and other respiratory pathogens. Influenza and SARS-CoV-2 laboratory testing through the integrated surveillance approach at the new laboratory in Aleppo. Image credit: WHO Country Office, Syria 23BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Ukraine ramps up mortality monitoring during the COVID-19 pandemic In April 2021, Ukraine became the first non-EU/EEA country in WHO’s European Region to share weekly mortality data through the European Mortality Monitoring project (EuroMOMO). EuroMOMO aims to detect and measure excess deaths related to seasonal influenza, pandemics and other public health threats. It compiles data from 29 European countries or subnational regions to provide real-time monitoring of deaths in Europe. EuroMOMO increases the European capacity to assess the impact of disease outbreaks and other events with an impact on public health and it has been instrumental in monitoring excess mortality through the COVID-19 pandemic. Supported by the PIP PC, Ukraine joined EuroMOMO in 2016. Since then, the Public Health Center of the Ministry of Health of Ukraine (PHC) has been working with the State Statistics Service of Ukraine (Ukrstat) to put the project into practice by developing an implementation plan for collecting and sharing mortality data across the country. In 2019, following a WHO/Europe and EuroMOMO mission to Ukraine and a series of high-level meetings with PHC and Ukrstat, an agreement was reached for Ukrstat to share all-cause mortality data with PHC each month. This year, in the midst of the COVID-19 pandemic, further negotiation with the Ministry of Justice enabled a significant step up in this mortality data sharing from once a month to once a week. Since April 2021, Ukraine has shared weekly mortality data with EuroMOMO. The data include deaths by age group, both at country level and disaggregated per region. The data are published online every week, through the PHC newsletter and the EuroMOMO Bulletin. They are also provided to the Ministry of Health to prioritize health service response and to inform policy decisions around which interventions to use and which vulnerable groups to target first. Ukraine’s participation in EuroMOMO marks a major milestone in mortality monitoring for the country which was made possible through the coordinated actions and efforts of the PHC, the Ministry of Health, EuroMOMO, and the PIP PC. Find out more: EuroMOMO Pooled number of deaths, all ages Graph shows the pooled weekly total number of deaths in the data-providing EuroMOMO partner countries, including Ukraine, and subnational regions in all age groups for the weeks 13 to 52 (5 April to 31 December 2021). Image credit: EuroMOMO (euromomo.eu) 2022 24 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Integration and expansion: Leveraging influenza systems for the COVID-19 response Since early 2020, Nepal has been working to expand and adapt its epidemiological and laboratory influenza surveillance networks to enable an effective COVID-19 response. Integration has long been at the heart of pandemic preparedness and response capacity building in Nepal, supported by the PIP PC. For example, since 2018, the country has linked its influenza-like illness (ILI) and SARI sentinel surveillance network with the sites in its Early Warning, Alert and Response System to enable greater disease surveillance coverage. When the COVID-19 pandemic spread in early 2020, Nepal’s Ministry of Health and Population again used integration to enable a more effective response, acting quickly to adapt and expand existing influenza surveillance systems on three fronts so that they could also be used to detect and monitor the new virus. 1. Expanding the laboratory network The NIC at the National Public Health Laboratory became the first reference laboratory for SARS- CoV-2 testing in January 2020 when the first case was diagnosed. Under the guidance of the NIC, Nepal quickly expanded its network of SARS-CoV-2 diagnostic laboratories, reaching 104 provincial public health laboratories (PPHLs) by December 2021. To ensure quality throughout the network, the PPHLs adapted the WHO EQAP focusing on proficiency panels, parallel testing of samples, monthly re-testing, and on-site reviews. 2. Harmonizing surveillance networks Following a kick-off meeting in October 2021, Nepal began a multisectoral process involving human and animal health authorities to harmonize its surveillance networks for influenza and SARS-CoV-2. Authorities integrated sentinel surveillance across both viruses, thus expanding the existing influenza laboratory surveillance network to include the PPHLs being used for SARS- CoV-2 testing. Coupled with retrospective testing using multiplex testing kits from the US CDC, further training and validation of laboratory staff and processes ensured concurrent surveillance of both high-risk pathogens would be maintained and sustained, and that outbreaks of influenza and SARS-CoV-2 would be detected quickly and accurately. 3. Building capacity for genetic sequencing In March 2021, led by the Nepal NIC and supported by WHO, the National Pathogen Genetic Sequencing Consortium was established to boost capacity to sequence both influenza and SARS-CoV-2 viruses. In October 2021, the consortium became operational; and by mid-December, members of the consortium had sequenced around 100 genomes of SARS-CoV-2 and had detected and confirmed the latest SARS-CoV-2 variant of concern, Omicron. Data from the consortium are now being regularly shared with GISAID, a global sequencing data sharing platform. The steps taken by Nepal to integrate and expand their influenza and SARS-CoV-2 surveillance networks at a national and provincial level are a testament to the multisectoral commitment to effective respiratory pathogen detection and monitoring in the country. They have proved vital in supporting the COVID-19 response over the past two years, and will further support influenza preparedness and response in the years to come. WHO representative for Nepal handing over the Oxford Nanopore MinION Gene Sequencer and reagents to the director of the National Public Health Laboratory. Image credit: WHO Country Office, Nepal 25BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Strengthening local preparedness for influenza and COVID-19 in Cambodia The COVID-19 pandemic response in Cambodia has accelerated the development of local preparedness capacities that will help enable effective decision-making during any influenza pandemic. Cambodia’s Master Plan for COVID-19 emphasizes, among other things, the need to strengthen local preparedness so that all provinces are ready for a quick response to any new outbreak of COVID-19, influenza or other respiratory pathogen. With technical and operational support from WHO, including through the PIP PC, the Ministry of Health is delivering a package of activities at provincial levels designed to strengthen local capacities for surveillance, risk assessment and rapid response. This includes: • training and coaching in multisource surveillance; • webinars on using risk assessment within an incident management system (IMS); • simulation exercises in contact tracing; and • conducting intra action reviews. These activities do appear to be improving local preparedness. For example, the surveillance training has improved understanding of surveillance concepts and increased the use of surveillance data to understand and respond to epidemiological situations in each province. In provinces with sentinel ILI & SARI sites, national and provincial focal points have improved their analysis of multiple sources of information, including health facility consultation rates and test positivity rates as a means for monitoring disease trends. The IMS webinars have similarly boosted local capacities, supporting provincial health leaders to recognize the value of using risk assessments to inform decision-making. Building on this, the country aims to transition to provincial- led risk assessments. The simulation exercises have also been beneficial. In these, participants were tasked with going into the field and investigating cases, tracing contacts, and obtaining health- centre data as part of a multi-source approach to rapid response. These exercises significantly enhanced cross- sectoral collaboration for contact tracing between health and non-health sectors and strengthened the country’s whole-of-society approach to pandemic response. Experience in delivering the local preparedness activities in Cambodia suggests that provincial capacities are best developed one step at a time, using methods such as follow-up meetings and regular on-site coaching to build confidence and capability. Looking ahead, the goal is to achieve strong provincial capabilities in using multisource surveillance data for risk assessments that will ensure effective operational and strategic decision-making during the ongoing and any future pandemic. So far the local preparedness activities have been delivered in 18 out of 25 provinces, with the remaining seven due to be covered by early 2022. Community level outbreak investigation training. Image credit: WHO Country Office, Cambodia 26 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 A tale of two pandemics: improvements in regulatory performance between the 2009 influenza A(H1N1) pandemic to the COVID-19 pandemic For nearly a decade, through the PIP PC, WHO has invested in regulatory strengthening to ensure timely access to quality pandemic products. But has this investment paid off? A comparison of regulatory performance in two pandemics suggests that it has. When a pandemic strikes, national regulatory authorities (NRAs) are responsible for ensuring that people have timely access to quality medicines, vaccines and diagnostics. A critical part of this role lies in providing timely MA to avoid delays in access to and uptake of products. In 2009, during the influenza A(H1N1) pandemic, 96 countries were eligible to receive vaccines through the WHO deployment initiative, but only 75 received vaccines. The remaining 21 (22%) did not ultimately provide MA or accept pandemic products because of liability and legal issues, poor regulatory readiness or limited operational capacity to deploy. After the pandemic, WHO conducted a gaps and needs assessment and selected 10 of the 21 countries for regulatory strengthening through the PIP PC. An additional 38 countries with limited regulatory capacities were also identified for PIP PC support. Since then, WHO has used a multi-pronged approach to strengthen regulatory readiness for an influenza pandemic in these countries, including issuing policy and technical guidance, benchmarking NRA performance and capacity-building to fill gaps, delivering planning workshops and mentoring NRA staff. In 2016, as part of its efforts to facilitate accelerated approval, WHO published guidance on MA options for countries that don’t produce vaccines (full review, fast-track review, reliance and recognition). WHO worked with countries and regional bodies to build their understanding of what these options are, identify country needs and help NRAs choose an approach that works for them. Ten years after the 2009 influenza pandemic, the world is now experiencing another respiratory disease pandemic: COVID-19. Have WHO’s investments improved regulatory processes? The answer is an undeniable ‘yes’: By 30 June 2021, 47 out of the 48 PIP PC recipient countries had authorized one or more COVID-19 vaccines (one country did not seek COVID-19 vaccines for non-technical reasons). For the 45 countries with data, 87% provided timely MA within 15 days of emergency use listing by WHO. Nine of the ten countries that did not receive pandemic influenza vaccines during the 2009 pandemic have authorized one or more COVID-19 vaccines, with eight doing so in a timely fashion. There is little doubt that WHO technical support, enabled in part by the PIP PC, contributed to the improved performance of NRAs during the COVID-19 pandemic. More lessons are being learnt from COVID-19 that will help countries and partners continuously improve their regulatory capacities for future emergencies including an influenza pandemic. The PIP PC will continue to support regulatory strengthening to prepare for the next pandemic. A health worker administers a COVID-19 vaccine in Luanda, Angola. Image credit: WHO / Booming - Carlos Cesar 27BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 WHAT’S NEXT FOR 2022-2023 28 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 PLANNED FOR 2022-2023 Laboratory & surveillance • Strengthen national, regional and global influenza surveillance platforms to ensure timely and quality data for influenza risk assessment and management. Maximize coherence between surveillance systems for different acute respiratory infections including COVID-19. • Support the designation, recognition and maintenance of NICs, and conduct influenza virus EQAP. Provide refresher trainings and mentoring for laboratory staff as needed. • Update pandemic influenza risk assessment tools including Tool for Influenza Pandemic Risk Assessment, PISA, and the Pandemic Special Studies protocols based on COVID-19 lessons. • Promote multi-sectoral risk assessment using ‘OneHealth’ approaches for influenza at the human-animal interface. • Advocate and facilitate timely sharing of seasonal influenza viruses and IVPPs, including use and maintenance of IVTM 2.0. 43 2countries including NEW countries $18.2M$ biennial budget INDICATORS 1. Proportion of MS with zoonotic influenza cases sharing IVPPs with GISRS 2. Proportion of PC recipient MS reporting to FluNet 3. Proportion of PC recipient MS reporting to FluID Proportion of PC recipient q¬ƑĚƎūƑƥĿŠijƥūGŕƭsĚƥ 20 18 20 17 20 19 20 20 20 21 84% 89% 97% 85%Target 88% 90% 85% Proportion of PC recipient MS reporting to FluNet 90%Target 20 22 20 23 20 18 20 17 20 19 20 20 20 21 13 12 27 51Target 14 14 34 20 22 20 23 65Target Proportion of MS with two timely shipments of virus isolates/clinical specimens with CCs 20 18 20 17 20 19 20 20 20 21 36% 43% 44% 46%Target 31% 8% 44% roportion of S ith t o ti ely ship ents of virus isolates/clinical speci ens ith s 20 22 20 23 50%Target Proportion of MS with ǕūūŠūƥĿČĿŠǷƭĚŠǕîČîƙĚƙ sharing IVPPs with GISRS 20 18 20 17 20 19 20 20 20 21 75% 71% 75% 80% 20 22 20 23 20 18 20 17 20 19 20 20 20 21 10 17 50Target 30 30 37 24 Proportion of PC recipient MS reporting to FluID 20 22 20 23 70Target 95%Target96% 93% 95% 95%Target 95% 95% 95% 20 18 20 17 20 19 20 20 20 21 Proportion of participating MS that were 100% correct for seasonal virus identification 20 22 20 23 80%Target Proportion of PC recipient MS reporting to FluID 20 18 20 17 20 19 20 20 20 21 51% 73% 81% 70%Target 73% 71% 60% Proportion of PC recipient MS reporting to FluID 20 22 20 23 Proportion of participating MS that were 100% correct for non-seasonal virus identification (N=110) 20 18 20 17 20 19 20 20 20 21 89% 86% 93% 90%Target 83% 83% 90% Proportion of participating MS that were 100% correct for non-seasonal virus identification (N=110) 20 22 20 23 95%Target sƭŞċĚƑūIJǕūūŠūƥĿČDŽĿƑƭƙĚƙ & other viruses of pandemic ƎūƥĚŠƥĿîŕČĺîƑîČƥĚƑĿǕĚēċNj GISRS 20 18 20 17 20 19 20 20 20 21 605 864 1105 1335 20 22 20 23 1.2 Number of MS reporting PISA to WHO ≥ twice in a season 1.1 Number of WHO HAI risk assessments published 1.4 Proportion of participating MS that were 100% correct for seasonal virus identification 1.3 Proportion of participating MS that were 100% correct for non-seasonal virus identification 1.5 Proportion of MS with two timely shipments of virus isolates/clinical specimens with WHO CCs 1.6 Number of zoonotic viruses & other IVPPs characterized by GISRS Note: WHO IVPP sharing guidance published in 2017. This is a monitoring indicator. No target established. Note: This is a monitoring indicator. No target established. 29BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 PLANNED FOR 2022-2023 PLANNED FOR 2022-2023 Burden of Disease Regulatory capacity building • Publish and communicate the use of the influenza pyramid tool to enable countries with limited data to estimate the comprehensive influenza burden, including estimation of death and hospitalization that can be averted. • Strengthen capacities of countries and regions to enumerate BOD including for non-respiratory influenza disease. • Support and mentor countries to move from BOD data availability to policy including for vaccine use and other preventive measures for high-risk groups. • Maintain a global BOD steering committee to drive collective action, and engage academic partners to promote a collaborative research agenda including for economic burden. • Technically support priority countries to review, evaluate and benchmark regulatory capacities following the COVID-19 response and implementation of their IDPs. • Based on COVID-19 lessons, support NRAs to implement QMS guidelines, plan MA provision for pandemic influenza vaccines in non-vaccine producing countries and strengthen PV functions including through the newly launched competency-based trainings and simulation exercises. • Develop a harmonized approach for benchmarking NRA system/functions, streamline tools and build a global cadre of assessors. • Utilize innovative solutions for capacity-building, engagement, and advocacy to strengthen national and regional regulatory systems, including through the WHO Academy, and the newly established “Coalition of Interested Parties” network. All countries eligible in line with HLIP II criteria $1.4M$ biennial budget $2.5M$ biennial budget INDICATORS INDICATORS 2. Number of MS that developed or updated an influenza vaccination policy 1. Number of MS with published disease burden estimates based on data collected since 2011 2. Number of PC recipient MS that have implemented a defined regulatory approach that enables timely approval for use of pandemic influenza products 1. Number of PC recipient MS which strengthened national regulatory capacity to oversee pandemic influenza products 48 countries 20 18 20 17 20 19 20 20 20 21 21 35 36 Target 43 28 48 39 20 22 20 23 50Target 16Target Number of PC recipient MS which strengthened national regulatory capacity to oversee pandemic influenza products (N=16) Num�er o� �� recipient �� which strengthened national regulatory capacity to oversee pandemic influenza products (N=16) 20 18 20 17 20 19 20 20 20 21 1 3 8 Target 7 4 8 6 20 22 20 23 20 18 20 17 20 19 20 20 20 21 20 22 20 23 10Target 48Target sƭŞċĚƑūIJ¡ ƑĚČĿƎĿĚŠƥq¬ƥĺîƥ ĺîDŽĚĿŞƎŕĚŞĚŠƥĚēîēĚǶŠĚē ƑĚijƭŕîƥūƑNjîƎƎƑūîČĺƥĺîƥĚŠîċŕĚƙ timely approval for use of pandemic ĿŠǷƭĚŠǕîƎƑūēƭČƥƙɚsʏȅȉɛ 20 18 20 17 20 19 20 20 20 21 0 6 23 Target 27 10 41 22 20 22 20 23 New indicator for 2022-237 30 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 PLANNED FOR 2022-2023 Risk communications & community engagement • Promote use of established EPI-WIN communities of practice (faith, youth and workforce) for influenza preparedness and response by using lessons learned for effective community engagement during COVID-19. • Establish influenza infodemic social listening projects in 10 countries using Early Artificial Intelligence Response with Social Listening by building an influenza digital taxonomy, country advocacy, training in social listening and integrated analytics, and implementation. • Strengthen policy dialogue capacities at country level. Apply the policy capacities to enhance the uptake of influenza disease trends, burden findings and pandemic plans to inform disease control and preparedness policies. • Expand SocialNet (emergency RCCE responder network) in four regions and incorporate recent training innovations including simulations and boot camps. All countries eligible in line with HLIP II criteria $2.2M$ biennial budget INDICATORS 1. Number of users who completed OpenWHO influenza and related RCCE modules 2. Number of MS that utilized RCCE support for influenza preparedness or response 3. Number of pilot countries that have active social digital listening for acute respiratory infections 4. Number of groups from the EPI-WIN communities engaged in pandemic influenza preparedness initiatives 20 18 20 17 20 19 20 20 20 21 3,475 9,922 25,000 Target 192,111 12,500 228,754 39,724 sƭŞċĚƑūIJƭƙĚƑƙDžĺū completed Open-WHO ĿŠǷƭĚŠǕîŞūēƭŕĚƙ 20 22 20 23 250,000Target 20 18 20 17 20 19 20 20 20 21 0 10 130Target 51 100 5951 sƭŞċĚƑūIJq¬ƥĺîƥƭƥĿŕĿǕĚē ¤ /ƙƭƎƎūƑƥIJūƑĿŠǷƭĚŠǕî preparedness or response 20 22 20 23 160Target 20 18 20 17 20 19 20 20 20 21 3. Number of pilot countries that have active social digital listening for acute respiratory infections (add endnote 11) 20 22 20 23 8Target 20 18 20 17 20 19 20 20 20 21 4. Number of groups from the EPI-WIN communities engaged in pandemic influenza preparedness initiatives (add endnote 11) 20 22 20 23 10Target New indicator for 2022-238 New indicator for 2022-239 31BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 PLANNED FOR 2022-2023 Planning for deployment • Conduct an analysis using foresight scenario methodologies to estimate national, regional, and global needs and gaps for pandemic influenza preparedness products (vaccines, antivirals, and therapeutics) to inform product allocation and deployment strategies, and operational plans for product deployment. • Develop and update vaccine deployment guidance based on COVID-19 lessons including operational frameworks, guidance on accessing pandemic influenza products, tools to support allocation of response products, and procedures to facilitate global response operations. • Facilitate countries in all six regions to update their NDVPs based on COVID-19 lessons and updated approaches to account for deployment operations according to different scenarios and allocation complexity. • Review and update the vaccine local production sustainability checklist. Broaden the application of the checklist to countries with local production of influenza vaccines beyond the nine that already completed the sustainability assessment. All countries eligible in line with HLIP II criteria $1.6M$ biennial budget INDICATORS 2. Number of MS that have undergone a national analysis of influenza vaccine procurement or production sustainability 3. Number of Member States that developed or updated a pandemic influenza NDVP PLANNED FOR 2022-2023 Influenza pandemic preparedness planning • Review and update existing IPPP guidance based on COVID-19 response, and develop an operational pandemic resource pack including relevant guidance, tools, and training materials for countries to use in updating national IPPPs. • Develop and maintain a roster of trained experts to support countries in updating and testing IPPPs and associated respiratory pathogen preparedness plans. • Facilitate countries in all six regions through workshops, training, technical assistance and exercises to develop, update and test their plans. • Finalize the GISRS pandemic response plan, including component plans for NICs, Essential Regulatory Laboratories and CCs, and develop and conduct simulation exercises to test various components of the GISRS response. INDICATORS 1. Number of PC recipient MS that developed or updated a pandemic influenza preparedness plan since 2014 2. Number of PC recipient MS that exercised their pandemic influenza preparedness plan 65 2countries including NEW countries $2M$ biennial budget Number of simulation exercises conducted to test global deployment of pandemic influenza vaccines and other products 20 18 20 17 20 19 20 20 20 21 1 1 5 Target 6 3 66 � � � �� i � �i� i t t t t ���� � ��� � �� i i i t t 20 22 20 23 10Target 5 Number of PC recipient MS that developed or updated a pandemic influenza preparedness plan since 2014 (N=63) 20 22 20 23 20 18 20 17 20 19 20 20 20 21 12 45Target 37 Number of MS that have undergone a national analysis of influenza vaccine procurement or production sustainability 20 18 20 17 20 19 20 20 20 21 6 8 10Target 9 8 98 �u��e� of �� ��a� �ave undergone a national analy is of influenza vaccine procurement or production �u��aina�i�i�� 20 22 20 23 12Target 20 22 20 23 20 18 20 17 20 19 20 20 20 21 2 20Target 3 20 18 20 17 20 19 20 20 20 21 20 22 20 23 6Target 1. Number of simulation exercises conducted to test global deployment of pandemic influenza vaccines and other products Revised indicator11 Revised indicator12 New indicator for 2022-2310 32 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Afghanistan Angola Burundi Benin Burkina Faso Bangladesh Bolivia (Plurinational State of) Bhutan Central African Republic China Cameroon Colombia Costa Rica Dominican Republic Algeria Egypt Ethiopia Fiji Gabon Ghana Guinea Gambia Guatemala Guyana Honduras Haiti Indonesia India Iraq Jordan Kenya Cambodia Lao People's Democratic Republic Lebanon Liberia Sri Lanka Madagascar Mali Myanmar Mongolia Mozambique Mauritania Malawi Niger Nigeria Nicaragua Nepal Pakistan Peru Philippines Democratic People's Republic of Korea Rwanda Senegal Sierra Leone Somalia South Sudan Suriname Syrian Arab Republic Chad Togo Timor-Leste Morocco Sudan United Republic of Tanzania Uganda Viet Nam Yemen South Africa Zambia Democratic Republic of the Congo Congo Papua New Guinea Côte d’Ivoire Armenia Georgia Kazakhstan Republic of Moldova Turkmenistan Ukraine Kyrgyzstan Tajikistan Uzbekistan Kiribati PC recipient countries by Output in 2022-20231 1 For BOD, RCCE, and DEP, in addition to global activities benefiting all countries, countries can apply for PC funding support 33BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Afghanistan Angola Burundi Benin Burkina Faso Bangladesh Bolivia (Plurinational State of) Bhutan Central African Republic China Cameroon Colombia Costa Rica Dominican Republic Algeria Egypt Ethiopia Fiji Gabon Ghana Guinea Gambia Guatemala Guyana Honduras Haiti Indonesia India Iraq Jordan Kenya Cambodia Lao People's Democratic Republic Lebanon Liberia Sri Lanka Madagascar Mali Myanmar Mongolia Mozambique Mauritania Malawi Niger Nigeria Nicaragua Nepal Pakistan Peru Philippines Democratic People's Republic of Korea Rwanda Senegal Sierra Leone Somalia South Sudan Suriname Syrian Arab Republic Chad Togo Timor-Leste Morocco Sudan United Republic of Tanzania Uganda Viet Nam Yemen South Africa Zambia Democratic Republic of the Congo Congo Papua New Guinea Côte d’Ivoire Armenia Georgia Kazakhstan Republic of Moldova Turkmenistan Ukraine Kyrgyzstan Tajikistan Uzbekistan Kiribati 82 6 REGIONS PC RECIPIENT COUNTRIES GLOBAL INFLUENZA STRATEGY 2019 – 2030 PIP implementation contributes to the preparedness goal: mitigating the impact of pandemic influenza. HOW? By making progress on three of the six high-level measures: • Countries with capacities to detect and share influenza viruses, and report data to global platforms • National, regional and global measures of burden and routine systems to measure severity • Countries developing, updating, implementing and exercising pandemic plans EXAMPLE OF PIP SUPPORT: Countries are supported to estimate disease burden and to use the information for evidence-based decision making. INTERNATIONAL HEALTH REGULATIONS (2005) PIP implementation contributes to one strategic pillar: building and maintaining State Parties’ core capacities as required under the IHR (2005). HOW? By being aligned with and guided by the requirements of four core capacities: • Laboratory • Surveillance • National health emergency framework • Risk communications EXAMPLE OF PIP SUPPORT: Country IHR core capacity scores are used to deliver tailored national risk communication system-strengthening activities. WHO GENERAL PROGRAMME OF WORK 2019 - 2023 PIP implementation contributes to 1 Billion more people better protected from health emergencies. HOW? By working directly in >70 low-and- middle income countries each biennium to strengthen pandemic influenza preparedness. EXAMPLE OF PIP SUPPORT: Countries are encouraged to conduct influenza surveillance, to participate in GISRS, and to share information globally to enable more representative and timely risk management. HEALTH SYSTEMS STRENGTHENING / UNIVERSAL HEALTH COVERAGE PIP implementation contributes to two health system components: • Access to medicines, vaccines and health products • Service access and quality HOW? By improving the distribution system to ensure access to health products at the time of an emergency, and by strengthening evidence-based influenza control programmes. EXAMPLE OF PIP SUPPORT: Countries are supported to implement a defined regulatory approach and deployment strategy that enables timely approval and use of pandemic influenza products. SUSTAINABLE DEVELOPMENT GOALS PIP implementation contributes to Goal 3 Target D: early warning, risk reduction and management of national and global health risks. HOW? By helping countries, through WHO’s facilitation role, to bring different emergency risk management components together for pandemic influenza. EXAMPLE OF PIP SUPPORT: Countries are supported to develop holistic pandemic influenza plans that link with other national strategies for emergency preparedness and response. PIP Framework improves pandemic preparedness & response Adapting to the changing landscape and lessons learned from the COVID-19 pandemic 34 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 PIP Framework: Context for sustainable impact GLOBAL INFLUENZA STRATEGY 2019 – 2030 PIP implementation contributes to the preparedness goal: mitigating the impact of pandemic influenza. HOW? By making progress on three of the six high-level measures: • Countries with capacities to detect and share influenza viruses, and report data to global platforms • National, regional and global measures of burden and routine systems to measure severity • Countries developing, updating, implementing and exercising pandemic plans EXAMPLE OF PIP SUPPORT: Countries are supported to estimate disease burden and to use the information for evidence-based decision making. INTERNATIONAL HEALTH REGULATIONS (2005) PIP implementation contributes to one strategic pillar: building and maintaining State Parties’ core capacities as required under the IHR (2005). HOW? By being aligned with and guided by the requirements of four core capacities: • Laboratory • Surveillance • National health emergency framework • Risk communications EXAMPLE OF PIP SUPPORT: Country IHR core capacity scores are used to deliver tailored national risk communication system-strengthening activities. WHO GENERAL PROGRAMME OF WORK 2019 - 2023 PIP implementation contributes to 1 Billion more people better protected from health emergencies. HOW? By working directly in >70 low-and- middle income countries each biennium to strengthen pandemic influenza preparedness. EXAMPLE OF PIP SUPPORT: Countries are encouraged to conduct influenza surveillance, to participate in GISRS, and to share information globally to enable more representative and timely risk management. HEALTH SYSTEMS STRENGTHENING / UNIVERSAL HEALTH COVERAGE PIP implementation contributes to two health system components: • Access to medicines, vaccines and health products • Service access and quality HOW? By improving the distribution system to ensure access to health products at the time of an emergency, and by strengthening evidence-based influenza control programmes. EXAMPLE OF PIP SUPPORT: Countries are supported to implement a defined regulatory approach and deployment strategy that enables timely approval and use of pandemic influenza products. SUSTAINABLE DEVELOPMENT GOALS PIP implementation contributes to Goal 3 Target D: early warning, risk reduction and management of national and global health risks. HOW? By helping countries, through WHO’s facilitation role, to bring different emergency risk management components together for pandemic influenza. EXAMPLE OF PIP SUPPORT: Countries are supported to develop holistic pandemic influenza plans that link with other national strategies for emergency preparedness and response. PIP Framework improves pandemic preparedness & response Adapting to the changing landscape and lessons learned from the COVID-19 pandemic 35BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 36 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Endnotes 1. https://www.who.int/news/item/03-02-2022-new-who-survey-investigates-how-influenza-burden-studies-influence-policy. 2. Mid-term review of the High-Level Implementation Plan of the Pandemic Influenza Preparedness Framework (https://cdn.who.int/media/docs/default-source/pip-framework/hlip-ii-mtr-31may2021.pdf?sfvrsn=ba821892_1) 3. Khadem Broojerdi A, Alfonso C, Ostad Ali Dehaghi R, Refaat M and Sillo HB (2021) Worldwide Assessment of Low- and Middle-Income Countries' Regulatory Preparedness to Approve Medical Products During Public Health Emergencies. Front. Med. 8:722872. doi: 10.3389/fmed.2021.722872 4. Samaan G, McPherson M, Eidman J, Obubah O, Baptiste J-P, Kuppens L, Von Harbou K, Sembiring MF, Acharya S and Graaff P (2022) The World Health Organization's Actions Within the United Nations System to Facilitate a Whole-of-Society Response to COVID-19 at Country Level. Front. Public Health 9:831220. doi: 10.3389/fpubh.2021.831220 5. Micaela Pereira Bajard, Nicola Stephens, Johan Eidman, Kathleen T. Warren, Paul Molinaro, Constance McDonough-Thayer, Rafael Rovaletti, Shambhu P. Acharya, Peter J. Graaff and Gina Samaan. Serving the vulnerable: the World Health Organization's scaled support to countries during the first year of the COVID-19 pandemic. Front. Public Health Accepted: 31 Jan 2022 6. PIP PC Preparedness High-Level Implementation Plan II 2018-2023, 2021 Revision (https://www.who.int/publications-detail-redirect/9789240041349) 7. Following the HLIP II Mid-Term Review, this indicator was introduced for monitoring starting in 2022. 8. Following the HLIP II Mid-Term Review, this indicator was introduced for monitoring starting in 2022. The baseline of 8 Member States is as of December 2021 not December 2017. 9. Following the HLIP II Mid-Term Review, this indicator was introduced for monitoring starting in 2022. The baseline of 10 Member States is as of December 2021 not December 2017. 10. Following the HLIP II Mid-Term Review, this indicator was introduced for monitoring starting in 2022. The baseline of 0 Member States is as of December 2021 not December 2017. 11. Following the HLIP II Mid-Term Review, this indicator was revised to monitor the number (not proportion) of Member States. Monitoring of this revised indicator will start in 2022 12. Following the HLIP II Mid-Term Review, this indicator was revised to monitor the number (not proportion) of Member States. Monitoring of this revised indicator will start in 2022. 37BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 ANNEX: FINANCIAL REPORT 38 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Table A.1: PIP Partnership Contribution received from each manufacturer (2012 - 2021) Status as of 31 December 2021 CONTRIBUTORS TOTAL CONTRIBUTIONS (US$) Sanofi Pasteur 65,771,765 Glaxosmithkline (GSK) 58,575,209 Hoffmann - La Roche and Co. Ltd. 55,508,819 Seqirus 17,876,129 Novartis 15,292,743 Medimmune 9,084,280 Kaketsuken (K M Biologics) 5,246,845 Research Foundation for Microbial Disease of Osaka University (BIKEN) 5,232,172 Denka Seiken Co. Ltd. 3,701,399 Kitasato Daiichi Sankyo Vaccine Co. Ltd.( Daiichi Sankyo Vaccine CO.Ltd.) 2,754,559 G C Pharma (Ex-Green Cross Corporation) 2,721,945 CSL Limted 2,667,745 Instituto Butatan 1,625,753 Shanghai Institute of Biological Products Co., Ltd. 738,968 Sinovac Biotech Ltd. 709,008 Hualan Biological Bacterin Co., Ltd. 653,188 Fluart Innovative Vaccines LTD 503,670 S K Bioscience 490,148 Becton Dickinson and Company (BD) 341,432 Institute of Virology, Vaccines and Sera Torlak 294,582 Adimmune Corporation 261,834 Beijing Tiantan Biological Procucts Co. Ltd. 235,234 Baxter International Inc. 209,238 Changchun Institute of Biological Products Co., Ltd. CNBG 208,231 Saint-Petersburg Scientific Research Institute of Vaccines & Sera 168,888 DiaSorin Molecular LLC 155,658 Omninvest Vaccine Manufacturing, Researching & Trading Ltd. 149,518 Alere Inc. 117,159 Takeda Pharmaceuticals Internatioanl GmbH 109,554 Focus Diagnostics, Inc. 83,844 Beijing Bio-Institute biological Products Co. Ltd (BBIBP) 76,787 Qiagen 61,512 Serum Institute of India Ltd. 44,620 China National Biotec Group 20,000 Princeton Biomeditech Corporation 19,588 Government Pharmaceutical Organization (GPO) 19,588 Institute of Vaccines and Medical Biologicals (IVAC) 19,588 Quidel Corporation 17,572 Cadila Healthcare Ltd. (R&D Center) 17,538 Cepheid 15,353 Vabiotech 15,230 Response Biomedical Corporation 14,806 Fast Track Diagnostics 13,045 Indevr, Inc. 11,674 NPO Petrovax Pharm 10,246 Medicago Inc. 7,439 Nanotherapeutics 5,337 Nanosphere Inc. 4,984 PT Bio Farma (Persero) 4,984 Protein Sciences Corporation 4,984 UMN Pharma Inc. 2,799 Lanzhou Institute of Biological Products 2,174 $251,899,365* ($222,919,792 NET OF PSC) *The figure does not include interest earned on Response Funds of $3,649,049 from 2018-2021. 39BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 O ut pu t D el iv er ab le 20 20 -2 1 A pp ro ve d bu dg et Fu nd s di st rib ut ed fo r 2 02 0- 21 a Ex pe nd itu re 20 20 -2 1 Im pl em en ta tio n on 20 20 -2 1 ap pr ov ed bu dg et (% ) Ba la nc e fu nd s La bo ra to ry & S ur ve ill an ce ( L& S ) R is k an d se ve rit y of in flu en za a re ro ut in el y as se ss ed 6 ,4 99 ,4 07 4 ,9 56 ,2 91 4 ,7 14 ,9 36 73 % 2 41 ,3 55 Q ua lit y in flu en za v iru s de te ct io n ca pa ci ty is s us ta in ed 6 ,3 02 ,0 84 4 ,5 76 ,4 75 3 ,7 96 ,5 20 60 % 7 79 ,9 55 C ou nt rie s ar e su pp or te d to c on si st en tly re po rt in flu en za da ta to g lo ba l p la tf or m s 3 ,4 83 ,1 41 2 ,4 90 ,8 21 1 ,8 05 ,5 15 52 % 6 85 ,3 06 C ou nt rie s ar e su pp or te d to s ha re ti m el y re pr es en ta tiv e in flu en za s am pl es w ith W H O C C s 3 ,3 71 ,2 97 2 ,3 34 ,9 87 1 ,9 07 ,1 41 57 % 4 27 ,8 46 In flu en za C V Vs , v iru s de te ct io n pr ot oc ol s an d re fe re nc e m at er ia ls a re ro ut in el y up da te d 3 50 ,6 60 2 43 ,9 55 1 68 ,7 10 48 % 7 5, 24 5 To ta l f or L &S 2 0, 00 6, 58 9 1 4, 60 2, 52 9 1 2, 39 2, 82 2 62 % 2 ,2 09 ,7 07 Bu rd en o f D is ea se (B O D ) R ep re se nt at iv e na tio na l, re gi on al a nd g lo ba l d is ea se bu rd en e st im at es a re a va ila bl e 8 64 ,6 00 5 25 ,9 50 1 95 ,8 03 23 % 3 30 ,1 47 D is ea se b ur de n fin di ng s ar e co m m un ic at ed to n at io na l an d in te rn at io na l e xp er t b od ie s in a fo rm at th at p ro m ot es ev id en ce -b as ed d ec is io n m ak in g 1 ,1 18 ,6 00 6 32 ,9 50 4 37 ,2 97 39 % 1 95 ,6 53 To ta l f or B O D 1 ,9 83 ,2 00 1 ,1 58 ,9 00 6 33 ,1 00 32 % 5 25 ,8 00 Re gu la to ry C ap ac ity B ui ld in g (R EG ) N at io na l r eg ul at or y ca pa ci ty fo r p an de m ic in flu en za pr od uc ts is s tr en gt he ne d 1 ,4 93 ,6 25 1 ,3 46 ,1 73 9 63 ,3 97 65 % 3 82 ,7 76 A do pt io n of re gu la to ry p at hw ay s th at a cc el er at e ap pr ov al fo r u se o f p an de m ic in flu en za p ro du ct s is p ro m ot ed 1 ,3 61 ,6 25 1 ,3 39 ,1 72 7 17 ,2 16 53 % 6 21 ,9 56 To ta l f or R EG 2 ,8 55 ,2 50 2 ,6 85 ,3 45 1 ,6 80 ,6 13 59 % 1 ,0 04 ,7 32 Ri sk C om m un ic at io n & Co m m un ity En ga ge m en t (R C C E) C ou nt rie s an d fr on t- lin e re sp on de rs h av e ac ce ss to g ui da nc e, to ol s an d in te ra ct iv e re so ur ce s fo r r is k co m m un ic at io n, c om m un ity e ng ag em en t, an d so ci al sc ie nc e- ba se d in te rv en tio ns fo r i nfl ue nz a 1 ,2 04 ,4 25 8 32 ,7 50 4 58 ,3 91 38 % 3 74 ,3 59 Te ch ni ca l a ss is ta nc e fo r r is k co m m un ic at io n, c om m un ity en ga ge m en t a nd s oc ia l s ci en ce -b as ed in te rv en tio ns is pr ov id ed to c ou nt rie s to fa ci lit at e in flu en za in te rv en tio ns an d ad dr es s va cc in e he si ta nc y 1 ,3 94 ,0 00 1 ,0 46 ,7 50 2 57 ,5 64 18 % 7 89 ,1 86 To ta l f or R CC E 2 ,5 98 ,4 25 1 ,8 79 ,5 00 7 15 ,9 55 28 % 1 ,1 63 ,5 45 Table A.2: Fund allocation and expenditure for staff and activities 1 January 2020 - 31 December 2021 40 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 O ut pu t D el iv er ab le 20 20 -2 1 A pp ro ve d bu dg et Fu nd s di st rib ut ed fo r 2 02 0- 21 a Ex pe nd itu re 20 20 -2 1 Im pl em en ta tio n on 20 20 -2 1 ap pr ov ed bu dg et (% ) Ba la nc e fu nd s Pl an ni ng fo r D ep lo ym en t (D EP ) A c om m on a pp ro ac h to m an ag e gl ob al d ep lo ym en t op er at io ns is d ev el op ed a nd re gu la rly te st ed w ith st ak eh ol de rs a nd d ep lo ym en t p ar tn er s 6 08 ,7 00 4 49 ,5 43 1 84 ,9 52 30 % 2 64 ,5 91 Te ch ni ca l a ss is ta nc e to d ev el op p ol ic ie s fo r s us ta in ab le in flu en za v ac ci ne p ro cu re m en t a nd p ro du ct io n is p ro vi de d to c ou nt rie s 1 06 ,8 00 5 3, 40 0 2 7, 96 1 26 % 2 5, 43 9 N at io na l d ep lo ym en t p la nn in g pr oc es s is re vi se d an d up da te d 5 48 ,7 00 4 59 ,5 43 1 66 ,4 17 30 % 2 93 ,1 26 To ta l f or D EP 1 ,2 64 ,2 00 9 62 ,4 86 3 79 ,3 30 30 % 5 83 ,1 56 In flu en za P an de m ic Pr ep ar ed ne ss P la nn in g (I P P P ) C ou nt rie s ar e su pp or te d to d ev el op , t es t a nd u pd at e th ei r pa nd em ic in flu en za p re pa re dn es s an d re sp on se p la n 2 ,6 68 ,9 31 2 ,1 19 ,2 25 9 83 ,0 30 37 % 1 ,1 36 ,1 95 To ta l f or IP PP 2 ,6 68 ,9 31 2 ,1 19 ,2 25 9 83 ,0 30 37 % 1 ,1 36 ,1 95 To ta l f or P re pa re dn es s O ut pu ts 3 1, 37 6, 59 5 2 3, 40 7, 98 5 1 6, 78 4, 85 0 53 % 6 ,6 23 ,1 35 U nd is tr ib ut ed fu nd sb 2 3, 23 2, 22 0 In p ro ce ss fo r 2 02 2 di st rib ut io nc 1 4, 65 8, 27 7 P SC (1 3% ) o n Pr ep ar ed ne ss F un ds 2 ,1 82 ,0 30 - G ra nd T ot al f or P re pa re dn es s 3 1, 37 6, 59 5 2 3, 40 7, 98 5 1 8, 96 6, 88 0 60 % 4 4, 51 3, 63 2 PI P Se cr et ar ia t Pr om ot e th e ef fe ct iv e im pl em en ta tio n of th e P IP Fr am ew or k in a c ha ng in g en vi ro nm en t 2 ,5 56 ,8 75 1 ,8 74 ,2 69 1 ,0 63 ,2 64 42 % 8 11 ,0 05 C ol le ct , i m pl em en t, m on ito r a nd re po rt o n th e Pa rt ne rs hi p C on tr ib ut io n 2 ,2 04 ,7 50 1 ,6 16 ,7 48 1 ,3 15 ,7 25 60 % 3 01 ,0 23 N eg ot ia te a nd p la n to o pe ra tio na liz e th e St an da rd M at er ia l T ra ns fe r A gr ee m en ts 2 (S M TA 2) 1 ,0 90 ,6 67 8 19 ,6 95 7 71 ,9 35 71 % 4 7, 76 0 To ta l f or P IP S ec re ta ria t O ut pu t 5 ,8 52 ,2 92 4 ,3 10 ,7 12 3 ,1 50 ,9 24 54 % 1 ,1 59 ,7 88 U nd is tr ib ut ed fu nd sb 1 ,2 12 ,4 18 In p ro ce ss fo r 2 02 2 di st rib ut io nc 3 ,2 29 ,6 39 P SC (1 3% ) o n P IP S ec re ta ria t F un ds 4 09 ,6 20 - G ra nd T ot al f or P IP S ec re ta ri at 5 ,8 52 ,2 92 4 ,3 10 ,7 12 3 ,5 60 ,5 44 61 % 5 ,6 01 ,8 45 R es po ns e fu nd s (in cl ud in g P SC ) 6 8, 01 2, 28 0 A nn ua l i nt er es t e ar ne d on re sp on se fu nd s fo r 2 01 8- 20 21 3 ,6 49 ,0 49 To ta l f or R es po ns e Fu nd s - - - - 7 1, 66 1, 32 9 G ra nd T ot al f or P IP 3 7, 22 8, 88 7 2 7, 71 8, 69 7 2 2, 52 7, 42 4 61 % 1 21 ,7 76 ,8 06 d a F un ds d is tr ib ut ed re fe rs to fu nd s av ai la bl e fo r 2 02 0- 21 im pl em en ta tio n in g lo ba l, re gi on al a nd c ou nt ry -l ev el w or k pl an s. b U nd is tr ib ut ed fu nd s in cl ud e Pa rt ne rs hi p C on tr ib ut io ns re ce iv ed a ft er fu nd s fo r 2 02 0- 21 w or k pl an s w er e di st rib ut ed . c F un ds a re b ei ng d is tr ib ut ed fo r 2 02 2 w or k pl an im pl em en ta tio n. d I nc lu de s R es po ns e Fu nd s (U S$ 7 1, 66 1, 32 9) w hi ch w ill o nl y be u se d at th e tim e of a p an de m ic . 41BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 Fig. A.1: Interim certified financial statement as of 31 December 2020 AN – 60478, 61722 and 60856 – 31.12.2020 – Interim.doc . Pandemic Influenza Preparedness (PIP) – Secretariat, Preparedness and Response Interim Financial Statement as at 31 December 2020 (expressed in US dollars) Secretariat - 10% Response - 30% Preparedness - 70% Total Opening Balance - 1 January 2020 3,794,557 55,995,730 29,663,235 89,453,522 Revenue Receipts from: Adimmune Corporation 6,656 17,972 41,933 66,561 Beijing T iantan Biological Products Co., Ltd 2,441 6,589 15,376 24,406 Denka Seiken Co., Ltd 37,718 101,838 237,623 377,179 Fluart Innovative Vaccines Ltd. 6,656 17,972 41,933 66,561 GlaxoSmithKline (GSK) 599,049 1,617,432 3,774,009 5,990,490 Green Cross Corporation 26,624 71,886 167,734 266,244 Hoffmann-La Roche and Co., Ltd 488,114 1,317,908 3,075,118 4,881,140 Hualan Biological Bacterin Co. Ltd. 6,656 17,971 41,934 66,561 Inst ituto Butantan, Brazil 54,468 147,062 343,145 544,675 Kaketsuken 55,468 149,762 349,445 554,675 Kitasato Daiichi Sankyo Vaccine Co. Ltd. 37,718 101,838 237,623 377,179 Medimmune 55,468 149,762 349,445 554,675 Princeton Biomeditech Corporation 222 599 1,398 2,219 Quidel Corporation 944 2,547 5,945 9,436 Research Foundation for Microbial Diseases of Osaka University 55,468 149,762 349,445 554,675 Saint Petersburg Scientific Research Institute of Vaccines and Sera 8,207 22,160 51,706 82,073 Sanofi Pasteur 758,648 2,048,349 4,779,481 7,586,478 Seqirus 323,166 872,547 2,035,945 3,231,658 Serum Institute of India Ltd. 222 599 1,398 2,219 Shanghai Institute Of Biological Products Co., Ltd. 2,441 6,589 15,376 24,406 Sinovac Biotech Ltd. 9,193 24,820 57,913 91,926 SK Bioscience 11,094 29,952 69,889 110,935 Takeda Pharmaceuticals International GmbH 2,441 6,589 15,376 24,406 Total received 2,549,082 6,882,505 16,059,190 25,490,777 Interest - 1,111,472 - 1,111,472 - Total Revenue 2,549,082 7,993,977 16,059,190 26,602,249 Expenditure 2020 1,762,627 - 7,432,248 9,194,875 - Balance as at 31 December 2020 4,581,012 63,989,707 38,290,177 106,860,896 I certify that the above statement reflects correctly the revenue and expenditure recorded in the WHO Global Accounting System. Jane Stewart Director Accounts 03 March 2021 42 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 AN – 60478, 61722 and 60856 – 31.12.2020 – Interim.doc Page 2 Sum of Expense Expense Type Total (USD) Staff Costs 1,396,752 Equipment, Vehicles and Furniture 5,293 Contractual Services 139,242 Travel 11,530 General Operating Costs 7,030 Programme Support Costs (PSC) 202,780 Total 1,762,627 Statement of Financial Performance-by Donor/Award Entity : 'WHO' , From date : '01- JAN-2020 , To date : '31-DEC-2020' , Award Number : '60478' Sum of Expense Expense Type Total (USD) Staff Costs 3,032,152 Medical Supplies and Materials 648,339 Equipment, Vehicles and Furniture 20,173 Contractual Services 1,711,467 Travel 191,637 Transfers and Grants 846,416 General Operating Costs 127,027 Programme Support Costs (PSC) 855,037 Total 7,432,248 Statement of Financial Performance-by Donor/Award Entity : 'WHO' , From date : '01-JAN- 2020' , To date : '31-DEC-2020' , Award Number : '61722' 43BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 AN – 60478, 61722 and 60856 – 31.12.2021 – Interim.doc Pandemic Influenza Preparedness (PIP) – Secretariat, Preparedness and Response Interim Financial Statement as at 31 December 2021 (expressed in US dollars) Se cre tariat - Re sponse - Pre pare dne ss - 10% 30% 70% Total Opening Balance - 1 January 2021 4,581,012 63,989,707 38,290,177 106,860,896 Revenue Re ce i pts from: Adimmune Corporation 6,048 16,330 38,102 60,480 Denka Seiken Co., Ltd 34,272 92,533 215,912 342,717 DiaSorin Molecular LLC 12,597 34,010 79,359 125,966 Fluart Innovative Vaccines Ltd. 6,048 16,330 38,102 60,480 GlaxoSmithKline (GSK) 544,316 1,469,652 3,429,188 5,443,156 Government Pharmaceutical Organization (GPO) 424 1,143 2,668 4,235 Green Cross Corporation 24,192 65,318 152,408 241,918 Hoffmann-La Roche and Co., Ltd 443,517 1,197,494 2,794,154 4,435,165 Hualan Biological Bacterin Co. Ltd. 6,048 16,330 38,102 60,480 Indevr, Inc. 424 1,143 2,668 4,235 Institute Of Vaccines And Medical Biologicals (IVAC) 900 2,429 5,668 8,997 Instituto Butantan, Brazil 50,400 136,079 317,517 503,996 Kaketsuken 50,400 136,079 317,517 503,996 Kitasato Daiichi Sankyo Vaccine Co. Ltd. 34,272 92,533 215,912 342,717 Medimmune 70,559 190,511 444,524 705,594 Research Foundation for Microbial Diseases of Osaka University 50,400 136,079 317,517 503,996 Response Biomedical Corp 939 2,535 5,915 9,389 Sanofi Pasteur 1,058,830 2,858,840 6,670,629 10,588,299 Seqirus 399,366 1,078,288 2,516,006 3,993,660 Serum Institute of India Ltd. 202 544 1,270 2,016 Shanghai Institute Of Biological Products Co., Ltd. 2,218 5,987 13,971 22,176 Sinovac Biotech Ltd. 6,048 16,330 38,102 60,480 SK Bioscience 14,112 38,102 88,905 141,119 Takeda Pharmaceuticals International GmbH 2,218 5,987 13,971 22,176 Total received 2,818,750 7,610,606 17,758,087 28,187,443 Interest - 61,016 - 61,016 Total Revenue 2,818,750 7,671,622 17,758,087 28,248,459 Expenditure 2021 1,797,917 - 11,534,632 13,332,549 Balance as at 31 December 2021 5,601,845 71,661,329 44,513,632 121,776,806 I certify that the above statement correctly reflects the revenue and expenditure recorded in the WHO Global Accounting System. George Kyriacou 22 February 2022 Table A.2: Interim certified financial statement as of 31 December 2021 44 BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 AN – 60478, 61722 and 60856 – 31.12.2021 – Interim.doc Page 2 Sum of Accounting Amount Expenditure Type Total (USD) Staff Costs 1,460,471 Equipment, Vehicles and Furniture 4,849 Contractual Services 118,641 Travel 2,164 General Operating Costs 4,952 Programme Support (Indirect) Costs 206,840 Total 1,797,917 Statement of Financial Performance-by Donor/Award Entity : 'WHO' , From date : '01- JAN-2021' , To date : '31-DEC-2021' , Award Number : '60478' Sum of Accounting Amount Expenditure Type Total (USD) Staff Costs 4,668,699 Medical Supplies and Materials 594,204 Equipment, Vehicles and Furniture 8,073 Contractual Services 3,410,328 Travel 223,020 Transfers and Grants 1,198,676 General Operating Costs 104,639 Programme Support (Indirect) Costs 1,326,993 Total 11,534,632 Statement of Financial Performance-by Donor/Award Entity : 'WHO' , From date : '01- JAN-2021' , To date : '31-DEC-2021' , Award Number : '61722' 45BIENNIAL PROGRESS REPORTPandemic Influenza Preparedness Framework 1 January 2020 - 31 December 2021 World Health Organization 20 Avenue Appia 1211 Geneva 27 Switzerland PIP Framework Secretariat pipframework@who.int www.who.int/initiatives/pandemic-influenza-preparedness-framework