COVID-19 Vaccination Failure Point Analysis - Deloitte

COVID-19 Vaccination Failure Point Analysis - Deloitte
Vaccination Failure
Point Analysis
JULY 2021
Document Overview


The purpose of this document is to provide a starting point for discussions around the effectiveness of COVID
vaccination efforts and key points of failure / leading practices related to logistics. This was developed based on
interviews conducted with Deloitte practitioners that have served organizations related to vaccinations across 7
countries, representing counties across North America, EMEA and APAC.

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Document Overview

  Topic                                                    Description

  Points of Failure                                        A detailed look at the potential failure points and leading practices related to COVID-19 vaccine logistics strategy across five key areas

  Bottleneck Layers                                        An overview of four bottle neck layers at vaccination sites with corrective and preventative action examples for each

  Key Themes                                               A summary of the key themes which emerged during stakeholder interviews related to the vaccination value chain including specific examples from different
                                                           regions and organization types

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Failure Mode Analysis Framework
Root cause failures for a CV-19 vaccine logistics strategy can be divided into five key areas relating to Manufacturing, Site
Operations, Market Dynamics, Shipping, and Data Management

                                                                                                                                                                                                                                                  Primary cause of failure           Secondary cause of failure

                     Manufacturing                                                                                               Site Operations                                                   Data Management

                     Off-shore                                                                                                                                                                                         Stakeholders       Refresh Rate
   Centralized                                Location   Throughput                                     Eligibility Criteria    Scheduling                       Vaccine Product Experience Level
    Strategy                                                                                                                                                                                                                                       Real Time Systems Integration
                                                                Facility                                Patient Readiness
                                                                                                                                                                                                                              Notification Requirements
                                                                                                                                                             Infrastructure Temp
       De-centralized      On-shore                                                                                  Unforeseen Circumstance                                                                                                                  Integration w/ Administration
                                            Operating Hours Shutdown                                                                                                                                                            Databases    Data Formats
                                                                                                                                                                                         Storage Requirements                                                 Mgmt System
       # of Units Produced                                   Availability       Training                                    Location Timing                                                                                                                      Data Interoperability
                                                                                                                                                           Materials            Duration
                                                                                       Staff            Allocation Collection
                                                                                                             / Delivery                                                                                                                              Automated Data Analytics
  Batch Metrics
                                                           Non-compliance w/ Protocols                                   Label / Barcode     Driver Access    Location         Type         Throughput                                           Cybersecurity
       Documentation       Release Schedule                                                                              Readers
                                                           Infrastructure        Temp                                                  Availability Training                                        Site Strategy
                           # of CMO’s & Suppliers
                                                                                           Storage Requirements                                                           Operating Hours    Shutdown                                           Counterfeit
    Vendor Management
                                                                    Materials            Duration                               Non-compliance w/ Protocols
                                                                                                                                                                                                                                                                      Root Cause Failures of a CV-19
                                                                                                 Vaccine Hesitancy                                                Inventory
                                                                                                                                                                                                                               Chain of Custody Management
                                                                                                                                                                                                                                                                      Vaccine Logistics Strategy
                                   Expanded Access Approved               EUA                                                                   Shelf-life        Strategy Manufacturing Release
                                                                                                                   Population                                                                           Courier Network Organizer
                                                                                                                                   Shipment Window
                  Marketing License Approval
                                                                                       # of Countries     # of Sites                                                                                                               Planning & Implementation
                                                                                                                                                                Primary      Secondary
                                                    Clinical Trials /                                                   Size
                                                                                                                                          Labelling                                                     Contract     Broker
                                                                                          # of Patients        Growth Rate
                                                                                                                                                                                                By End User By Supplier
                        Other Vax Manufacturers Freight Capacity                                                                                                     2-D Barcode
                                                                                                        Export / Import                  Physical Dimensions     Site Management                                                 Tracking /Monitoring
         Competition / Restrictions
                                                                                                                                    Packaging                                             By Courier By Developer Data Loggers / Temp Probes
                                                                   Union Strikes         Organized Crime
                                      Courier Capacity
                                                                                                    Political Affairs                            Scope of Usage Type      Provider                                  Intra-site Handling

                                                                                                                                         Supply Diversions Temp / Humidity
                                                                        Civil Unrest                                                                                                 Cold Storage        Distance from Storage to
                     Natural Disasters                                                                                                                                               Transfer Capability Administration Location
                                                                                                                          Physical Conditions
                                                                                        Disease Variants                                                                                                         Contents

                                          Market Dynamics                                                                                                        Shipping /           Documentation # of Units Product Format

            Adapted from Source: "Logistics by design: a framework for advanced therapy developers to create optimal Logistics Platforms," by S. Ellison and R. McCoy, 2018, Cell & Gene Therapy Insights, 2059-7800, p. 1027

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Points of Failure

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Point of Failure: Manufacturing

    Potential Points Of Failure                                                                                                     Leading Practices

                        Staff / Training                                                                                                        AR / VR Training Opportunity
                        Scaling vaccine manufacturing requires additional resources (especially                                                 New technologies have been leveraged to expedite the training process
                        operators) with the correct certifications and extensive training in order to                                           without sacrificing valuable time on the manufacturing floor
                        produce vaccines that are releasable

                                                                                                                                                Forward Projection of Deliveries
                       Vendor Management                                                                                                        As vaccine supply and manufacturing capacity stabilize, vaccine
                       As part of scaling production, several manufacturers have set up new                                                     manufacturers are giving governments better forecasts and added
                       manufacturing networks with CMO’s across the globe, which could prove                                                    visibility to their vaccine deliveries, which in turn helps these agencies
                       difficult to manage from a data visibility and control perspective                                                       structure their downstream processes

                        Batch Metrics                                                                                                           Cloud-Based Data Solutions
                        If vaccine manufacturers are still using paper batch records, the disposition                                           A cloud-based data transfer solution enables manufacturers to
                        process could be slowed down substantially and cause a bottleneck in the                                                streamline their production process and better coordinate between the
                        vaccine manufacturing process                                                                                           parent pharma companies and their CMO’s

                                                                                         Strategy                                               Facility                                      Vendor Management

                                                                  De-centralized                     Centralized           Throughput                          Operating Hours                                      # of CMO’s & Suppliers
                                                                    Off-shore                        On-shore                Location                          Shutdown
                                                                                        Release Schedule        Non-Compliance w/               Availability                 Temperature                Materials
                                                  # of Units Produced
                                                                                        Documentation                                           Training                     Infrastructure              Duration
                                                                        Batch Metrics                                                   Staff                                          Storage Requirements

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Point of Failure: Market Dynamics

    Potential Points Of Failure                                                                                                         Leading Practices

                     Vaccine Hesitancy                                                                                                                Understand Vaccine Hesitancy
                     While the reasons behind vaccine hesitancy vary by market and population                                                         Rather than supporting a vaccine mandate for employees, employers
                     group – whether it be mistrust of government, safety concerns, or religious                                                      should work with employees to better to understand where the hesitancy
                     reasons – all vaccination stakeholders will have to combat these notions in                                                      is coming from, and then address the different causes
                     order to reach herd immunity
                                                                                                                                                      Personalize Invitations
                                                                                                                                                      Making vaccination invitations personalized can be a key tool in boosting
                     Export / Import                                                                                                                  vaccine confidence and willingness to get vaccinated
                     Restrictions on imports / exports of vaccines and related supplies have
                     become a key concern for both manufacturers and vaccination programs, as
                     the global scope of the vaccination effort could be hindered by these policies                                                   Leverage Community-Based Vaccinators
                                                                                                                                                      For indigenous tribes that are more likely to be vaccine hesitant, having
                                                                                                                                                      the vaccinator be someone within that tribe or leveraging community
                                                                                                                                                      leaders can increase trust in the vaccination process
                     Natural Disasters & Weather
                     Governments and public health agencies have been eager to distribute
                     vaccines as they arrive rather than build vaccine inventories, which means                                                       Stockpile Ancillary Supplies to Mitigate Delays
                     that any disruptions in the supply chain due to weather or other natural                                                         Sites have suggested keeping a 20-day stockage of ancillary supplies to
                     events could lead to shortages and throw off supply forecasts                                                                    mitigate against supply delays; some sites are ordering a 5% overage on
                                                                                                                                                      ancillary supplies (especially needles / syringes) to build this stockpile

                                                                     Competition / Restrictions                                     Market License Approval                                            Natural Disasters       Disease Variants

                                          Other Vax Manufacturers                           Freight Capacity                    EUA                    Expanded Access

                                                     Courier Capacity                                               Clinical Trials /                   Approved
    Market Dynamics
                                                                            Growth Rate                                                                   Union Strikes                          Organized Crime
                                              # of Sites                                                   Vaccine Hesitancy
                                                                            # of Patients                                                                     Civil Unrest
                                        # of Countries
                                                                  Size                                                         Population                                    Political Affairs                             Import / Export

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Point of Failure: Site Operations

    Potential Points Of Failure                                                                                                            Leading Practices
                        Staff / Training                                                                                                                 Develop Wait List
                        As vaccination efforts and vaccine supply have scaled in certain                                                                 To mitigate appointment no-shows, smaller vaccination sites have
                        jurisdictions, the next bottleneck sites have hit is finding enough certified                                                    developed wait lists for those who can be contacted “last minute” and
                        and trained vaccinators to administer vaccines                                                                                   are willing to come in and get vaccinated with the extra doses

                                                                                                                                                         Expand Scope of Vaccinators
                                                                                                                                                         In order to increase the total throughput of a vaccination program
                        Site Strategy                                                                                                                    without sacrificing non-COVID related medical care, jurisdictions have
                        Jurisdictions have voiced concerns around how to select sites that will not                                                      leveraged military personnel, pharmacy techs, veterinarians, and other
                        interfere with other medical efforts (i.e. COVID care and non-COVID related                                                      such professions to help administer vaccinations
                        medical care), will be accessible to large swaths of the population, and will
                        be able to scale up throughput as vaccine supply increases                                                                       Utilize Vaccine Supply Control Tower
                                                                                                                                                         Certain jurisdictions have used personnel & systems to monitor vaccine
                                                                                                                                                         supply at each site and then shift supply between close-by sites to ensure
                                                                                                                                                         that maximum throughput is achieved, and no vaccine is wasted
                        Patient Readiness & Scheduling
                        For several jurisdictions, the scheduling process and technology are brand                                                       Market-Based Site Strategy Approach
                        new or adapted for COVID, which has made it a pain point across markets.                                                         In planning out vaccination sites, some markets have focused on
                        Patients have booked multiple appointments in some cases, and other                                                              leveraging GP offices that are well known and close to the priority
                        times, due to supply variability, appointments have been cancelled                                                               populations, while others have had employers fund and lead vaccination
                                                                                                                                                         efforts for their employees & surrounding communities

                                                                          Patient Readiness                                       Allocation Collection / Delivery                                    Staff

                                       Unforeseen Circumstance                             Scheduling            Specialist Instructions                    Location                   Availability
                                                                                                                                                                                                                 Non-Compliance w/
                                                   Eligibility Criteria                                                 Driver Access                        Timing                      Training                Protocols
    Site Operations
                                                                                  Type                    Shutdown                      Infrastructure                 Duration
                                                                                                          Operating Hours                  Temperature                 Materials
                                                                                                                                                                                                      Vaccine Product
                                                                                          Site Strategy                                            Storage Requirements                               Experience Lead

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Point of Failure: Shipping / Distribution

    Potential Points Of Failure                                                                                                     Leading Practices

                     Intra-site Handling                                                                                                                  Thaw Centrally then Distribute
                     Last-mile distribution challenges have been a concern across markets and                                                             Smaller vaccination sites often do not have the cold storage capabilities
                     vaccination site types, which is complicated by varied inventory, demand,                                                            to keep certain vaccines in inventory, and therefore several jurisdictions
                     and cold-chain storage capabilities among sites                                                                                      are thawing the vaccines at a centralized hub and then distributing to the
                                                                                                                                                          smaller sites

                     Cold-Chain Logistics
                                                                                                                                                          Detailed Cold-Chain Strategy
                     As the scope of vaccination efforts expand to rural and underdeveloped
                                                                                                                                                          To prevent vaccine spoilage due to temp diversions, strategies include
                     regions, maintaining the cold chain for vaccines is going to be a focal point
                                                                                                                                                          putting clear instructions on pallets, QR codes on the vials to track its
                     for manufacturers and public health agencies alike, as wasted or spoiled
                                                                                                                                                          progress, placing an alarm on the storage container, and connecting the
                     vaccine could hinder the vaccination effort and diminish public confidence
                                                                                                                                                          vaccination program’s data infrastructure with temperature tracking

                     Supply Diversions
                     Given the high value currently placed on vaccines due to supply vs. the
                     global demand, it is expected that organized crime and other such groups
                     will attempt to divert, steal, or counterfeit supply

                                                     Physical Conditions                           Packaging                                               Labeling                                   Shipment Window
                                                                                                                 Site Mgmt
                                Supply Diversions                                         Type                                            2-D Barcode                                            Shelf-Life
                                                                     Temp / Humidity                             Physical Dimensions                                                                                  Manufacturing Release
                                                                                       Provider                                                 Primary               Secondary          Inventory Strategy
    Shipping /                                                                                                   Scope of Usage

   Distribution                                                                                                                   By end user
                                       Documentation                                                       Distance from
                                                                                                           Storage to                                         By developer                                Courier Networks
                                                                         Product   Cold Storage                                   By supplier                                     Organizer
                                                                         Format                            Administration                                     Data loggers /                              Contract
                                               # of Units                          Transfer
                                                                                                           Site                   By courier                  Temp probes           Broker
                                                                                   Capability                                                                                                                                  Chain of Custody
                                                              Contents                     Intra-site Handling                           Tracking / Monitoring                        Planning & Implementation                 Management

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Point of Failure: Data Management

    Potential Points Of Failure                                                                                         Leading Practices

                          Data Interoperability                                                                                        National Immunization Registrar
                          Consolidating and transferring data across stakeholders and systems has                                      Leveraging one centralized database for patient immunization records
                          been a ubiquitous issue for vaccination programs, which has led to a lack                                    would allow for easy tracking of who has received a vaccine, which
                          of data visibility (for who has been vaccinated), inaccurate supply                                          vaccine they received, and whether they received the first or second
                          forecasts, and an inability to perform reporting and analytics

                          Real-Time Systems Integration                                                                                Consistent Data Reporting Requirements
                                                                                                                                       Aligning on data reporting and formats would assist jurisdictions in
                          Due to the de-centralized nature of most healthcare systems’ technology
                                                                                                                                       managing different technology systems between sites and localities, and
                          infrastructure, getting near real-time data has been almost impossible,
                                                                                                                                       would enable easier data analysis on the back-end
                          which means that decision-makers are basing their choices off lagged or
                          inaccurate data

                                                                                                                                       Flexible Technology Solutions
                                                                                                                                       Given the rapid pace to scale up vaccination efforts, technology solutions
                                                                                                                                       which are adaptable and can integrate with various systems, both old and
                                                                                                                                       new, have proven critical to vaccine program success

                                                                        Data Interoperability                                            Security

                                                                                        Data Formats
                                                                  Databases                                                                         Cybersecurity
                                                                                       Integration w/ Administration     Counterfeit
                                                                                       Mgmt System
    Data Management
                                                                                                Refresh Rate

                                                                                                   Real-Time Systems Integration                               Automated Data Analytics

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Bottleneck Layers

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Bottleneck Layers Identified at Vaccination Sites

           Bottleneck                                      Description                    Corrective Actions Taken                                       Potential Preventative Actions
                                            Sites have limited visibility into   • Pharma companies & CMO’s have                     • Implement inventory strategy that smooths vaccine supply to sites
       Vaccine Supply                       how much supply they will get          collaborated to increase supply                   • Clear communications strategy around allocation decisions & supply
       (On-Hand &                           and when it will arrive, which       • Federal governments have increased window           forecast
       Forecast                             impacts their appt scheduling,         for allocation visibility
       Visibility)                          staffing, and overall throughput

                                            There are an increasing number       • Leverage military staff (although certification   • Adjust / waive regulations to streamline certifications for add’l
       Number of                            of vaccinators needed at sites,        will still be an issue)                             vaccinators
2      Certified                            which requires getting them          • Discontinue certain non-COVID related             • Explore capacity of jurisdiction and potential opportunities to expand
                                            certified in the jurisdiction and      medical work                                        scope
       Vaccinators                          potentially taking them away
                                            from other medical work

                                            As vaccination efforts expand        • Certain jurisdictions have thawed or              • Plan cold-storage footprint and distribution strategy (e.g. centralized
                                            outside of population dense            reconstituted the vaccine centrally and then        store/thaw site)
       Cold-Chain                           areas, there will be increased         distributed to the smaller sites                  • Invest in add’l cold-storage capabilities
3                                           pressure to maintain the cold                                                            • Prioritize vaccines with less restrictive cold-chain req’s to rural /
                                            chain in places without much                                                               smaller areas
                                            storage infrastructure

                                            Jurisdictions will have to find a    • Open up GP practices for vaccinations since       • Plan and structure vaccination sites to provide access for all populations
                                            balance between maximizing             they are usually closer to the desired            • Design de-centralized strategy to leverage smaller sites focused on
                                            throughput at vaccination sites        populations                                         certain populations (e.g. large places of employment)
       Vaccination Site                     and ensuring all populations will    • Leverage mobile sites that can be stood up
       Accessibility                        be able to access the site             and taken down quickly

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Vaccination Levers and Constraints for Government

     Overview of Vaccination Levers for Governments to Consider                                                                  Tradeoffs between Levers
                                                                                                                                 You generally get two without incremental time or
                                                                                         Inventory Control                       technology investments
     UK Start                         UK Trend                                           Maintaining centralized control of
                                                                                         vaccine inventory to prevent
     US Start                         US Trend                                           vaccination sites from hoarding doses   • High Throughput + Inventory Control
                                                                                                                                  In order to keep tight grips on inventory while increasing throughput,
                                                                                                                                  this can ultimately lead to vaccine supply being concentrated in
                                                                                                                                  population dense and affluent areas. These areas have an easily
                                                                                                                                  accessible and willing population as well as the technology infrastructure
                                                                                                                                  to maintain oversight of vaccine supply, but at the expense of vaccine
                                                                  Connected                                                       distribution equity.
                                                                   Levers in
                                                                  Vaccination                                                    • Equitable Distribution + Inventory Control
                                                                    Effort                                                        Pushing equitable distribution of vaccine is already a difficult task given
                                                                                                                                  the discrepancy in resources available to different populations, but also
                                                                                                                                  adding in the layer of inventory control makes the process even more
                                                                                                                                  tedious. It will be more difficult to scale up throughput across the
                                                                                                                                  country while still maintaining both equity and oversight
                                                        High Throughput + Equitable
                                                                                                                                 • High Throughput + Equitable Distribution
                                                                                                                                  A focus on maximizing throughput and equitable distribution will mean
                                                                                                                                  that the government will most likely have to “open the floodgates” for
                                                                                                                                  vaccine distribution and enroll a higher number of vaccine providers.
         Vaccination Volume                                                           Distribution Equity                         This lack of control could lead to wastage, fraud, and hoarding and the
                                                                                      Ensuring that vaccines are being
         Driving the highest throughput for                                                                                       country would be more impacted by manufacturing delays or other
                                                                                      distributed and administered equitably
         vaccinations by closing the gap between                                                                                  supply shocks
                                                                                      across population demographics and
         doses available and doses administered
                                                                                      rural / urban areas

It is important for governments to clearly define and communicate the priorities of their vaccination program to inform their vaccine distribution strategy and
gain public trust
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Key Themes

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Four themes have emerged as we’ve spoken to Deloitte stakeholders

      Bottleneck                             Access & Willingness           Staffing & Resource Availability              Emergency Preparedness                        Ecosystem Management
                                                                                                                                & Planning
                                   Is there enough vaccine supply for the   Are there enough certified vaccinators Is there a backup plan in case of weather    How does data flow between public and
                                     population, do the vaccination sites     to meet demand, do stakeholders       delays or natural disasters, do sites have private stakeholders, who is responsible for
                                     reach all populations, and does the      have enough staff to keep up with     processes in place in case of equipment     maintaining the vaccination systems, and
                                      population want to get vaccinated          data reporting requirements        or technical failure, and how to mitigate how are decisions made between local and
                                                                                         and logistics                 against fraud, theft, and counterfeit               federal stakeholders

                                   • Market Dynamics                        • Manufacturing                         • Manufacturing / Site Operations          • Manufacturing
                                     − Population                             − Staff, Strategy                       − Facility                                 − Vendor Management
 Primary Causes                    • Site Operations                        • Site Operations                       • Market Dynamics                          • Site Operations
 of Failure                          − Facility, Patient Readiness            − Staff, Strategy                       − Natural Disasters                        − Intra-site handling
                                                                                                                                                               • Data Management
                                                                                                                    • Shipping                                   − Data interoperability, real-time
                                                                                                                      − Physical Conditions,                       systems integration
                                                                                                                        Shipment Window

                                   • Population                             • Staff (Manufacturing)                 • Facility (Manufacturing / Site Ops)       • Vendor Management
                                     − Vaccine Hesitancy                      − Availability, Training                − Shutdown                                  − # of CMO’s and Suppliers

 Secondary                         • Facility                               •    Strategy (Manufacturing)           • Natural Disasters (Market Dynamics)       • Intra-Site Handling
 Causes of                           − Location, Operating Hours                − Offshore, De-Centralized            Physical Conditions (Shipping)              − Cold-Storage Transfer Capability, Distance
                                                                                                                      − Payload shock, temp / humidity              from Storage to Site
 Failure                           • Patient Readiness                      •    Staff (Site Operations)
                                     − Eligibility Criteria, Scheduling         − Availability, Training            • Shipment Window (Shipping)                • Data Interoperability
                                                                                                                      − Shelf-life, manufacturing release         − Databases, Data Formats
                                                                            •    Facility (Site Operations)                                                     • Real-Time Systems Integration
                                                                                − Type, Throughput                                                                − Stakeholders

 Stakeholders                      • Federal & Local Health Agencies        • Vaccine Manufacturers                 • Vaccine Manufacturers
                                                                                                                                                                • Vaccine Manufacturers
 Impacted                          • Vaccination Sites                      • Federal & Local Health Agencies       • Federal & Local Health Agencies
                                                                                                                                                                • Federal & Local Health Agencies
                                   • Healthcare Providers                   • Vaccination Sites                     • Vaccination Sites

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Access & Willingness

    Is there enough vaccine supply for the population, do the vaccination sites reach all populations, and does the population
    want to get vaccinated

What we’ve heard around…
                  Vaccine Supply & Forecasts                                            Vaccination Strategy                                                  Vaccine Hesitancy

  • Supply has been very unstable with certain                    • We are leveraging 15 smaller vaccination sites and then the local    • Our mobile unit has only 25% of the 75+ population we
    vaccines. We are working on a two-week forecast                 pharmacies, which is a different strategy from testing where we        targeted signed up for vaccination. This can be attributed to a
    window, and that has led to stakeholder                         used mass sites. We have found it is more effective to have            lack of computer literacy, promotion / comms failure, and
    management challenges – EMEA Vax Site                           places close to people so they can walk – EMEA Vax Site                general distrust – USA Vax Site
  • Since governments are not keeping inventory of                • Companies are reluctant to allow employee downtime for               • Important to get community leaders onboard, but not always
    vaccines, any shipping delays will be a bigger deal             vaccination, so they want the programs brought to them.                going to be easy. Our team went to one church and the pastor
    and will have an immediate impact on vaccine                    Logistically, this has been a lot easier with larger corporations,     said he would tell his congregation not get vaccinated – USA
    supply – Vax Manufacturer                                       so they are seeing higher allotments of vaccine – EMEA Vax             Vax Site
  • We have the opposite issue to shortages – vaccine                                                                                    • For the most part, our indigenous populations will be hesitant
    supplies are arriving at a rate faster than expected,         • Communication to eligible individuals has been a bottleneck, as        to get vaccinated unless it is done by someone in their tribe –
    so our initial user volume assumptions are broken               we currently send personalized invitations via mail – EMEA Vax         APAC
    and has led to technology scaling issues – APAC Vax             Stakeholder                                                            Vax Stakeholder
                                                                                                                                         • Our government has struggled to determine when is the right
                                                                                                                                           time to address vaccine hesitancy: should we start now or
                                                                                                                                           wait until supply ramps up? – EMEA Vax Stakeholder

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Staffing & Resource Availability

    Are there enough certified vaccinators to meet demand, do stakeholders have enough staff to keep up with data
    reporting requirements and logistics

What we’ve heard around…
                      Number of Vaccinators                                        Stakeholder Management                                                 Resource Training

  • A federal agency came in and staffed their site with          • It is amazing how users can find ways to not follow standard     • Call center staffing and training has been a large burden,
    military vaccinators, but it was difficult going                operating procedures, leading to data issues such as recording     especially when dealing with people who are not computer
    through the bureaucracy of the state’s certification            two vaccinations against the same individual. This shows the       literate – USA Mass Vax Site
    process to make sure everyone has the same                      need to human-proof the technology – APAC Vax Stakeholder
                                                                                                                                  • For operators, training has been a big concern in terms of
    training / licenses – USA Vax Site
                                                                  • Stakeholder management and internal communication has           scaling vaccine production. Batches cannot be released if the
  • Currently vaccinators are only certified healthcare             been a key concern, as there have been patients arriving at     operator does not have certain certifications, which can take a
    personnel (e.g. doctor, nurse), but there is                    vaccination sites which are not prepared to serve them – EMEA   long time to obtain – EMEA Mfg Stakeholder
    increased momentum to include pharmacy workers                  Vax Stakeholder
    as well – EMEA Vax Site
  • We originally underestimated the number of
    vaccinators required, which has led to staffing
    issues and a lack of clarity around processes –
    EMEA Vax Stakeholder

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Emergency Preparedness & Planning

    Is there a backup plan in case of weather delays or natural disasters, do sites have processes in place in case of equipment
    or technical failure, and how to mitigate against fraud, theft, and counterfeit

What we’ve heard around…
                              Supply Delays                                             Equipment Failures                                              Fraud, Theft, & Counterfeit

  • Weather has been a huge factor on logistics, as               • It has been a rare occurrence, but in a few instances the site      • In middle-income countries, we have already seen issues
    there have been weeks we receive no doses and                   had needles & syringes that were failing as part of the ancillary     around diversions of supply and counterfeit. This will require
    others where we receive double the number of                    materials package from federal government. Therefore, the site        more investment to keep supply chain secure –
    doses – USA Mass Vax Site                                       order always includes a 5% overage – USA Mass Vax Site                Vax Manufacturer
  • Our site keeps a 20-day stockage of ancillary
    supplies to mitigate against supply delays – USA
    Mass Vax Site
  • Our government was originally building a vaccine
    inventory buffer to mitigate supply variability, but
    then had to end the effort due to political pressure
    – EMEA Vax Site

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Ecosystem Management

    How does data flow between public and private stakeholders, who is responsible for maintaining the vaccination systems,
    and how are decisions made between local and federal stakeholders

What we’ve heard around…
                        Data Interoperability                                            Data Ownership                                              Stakeholder Responsibilities

  • The jurisdiction’s scheduling tool was not built to           • We have had a lot of confusion around which systems we should     • Even now we are still trying to figure out the governance
    interface with other systems, which has led to                  be using, who should be trained, and who should have access –       structure between federal and local agencies. Usually, all
    issues around false links / appointments being                  USA Vax Site                                                        healthcare policy decisions are centralized, and the local
    made as well as an inability to pull data out on the                                                                                agencies are responsible for implementing the policy – APAC
                                                                  • With separate and independent supply chains set up across the
    back end to do analysis – USA Vax Site                                                                                              Vax Stakeholder
                                                                    globe, it has been difficult to determine what data is in their
  • Each local health agency has their own system for               control and what isn’t – Vax Manufacturer                         • The federal government put all the last-mile responsibility on
    logging administration data, and there is very little                                                                               local agencies and did not assist with facilitating the data
                                                                  • Data regulations have been inhibiting the exchange of data
    data interoperability with federal systems, which                                                                                   exchange, which has made the process increasingly difficult –
                                                                    across the country and between medical professionals and
    could be a big issue as they scale – APAC                                                                                           EMEA Vax Site
                                                                    government stakeholders – EMEA Vax Site
    Vax Stakeholder
  • The federal & local systems do not connect, which
    has resulted in manual efforts to ask for data and
    switch it over to the other system – EMEA Vax Site

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