COVID-19 Vaccination Failure Point Analysis - Deloitte
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Introduction Document Overview Purpose 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. Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 2
Document Overview Contents Topic Description Introduction 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 Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 3
Introduction Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 4
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 Security # of CMO’s & Suppliers Storage Requirements Operating Hours Shutdown Counterfeit Staff 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 Investigational # 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 Distribution 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 Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 5
Points of Failure Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 6
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 Manufacturing Release Schedule Non-Compliance w/ Availability Temperature Materials # of Units Produced Protocols Documentation Training Infrastructure Duration Batch Metrics Staff Storage Requirements Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 7
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 Investigational Market Dynamics Growth Rate Union Strikes Organized Crime # of Sites Vaccine Hesitancy # of Patients Civil Unrest # of Countries Size Population Political Affairs Import / Export Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 8
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 Throughput Operating Hours Temperature Materials Location Vaccine Product Site Strategy Storage Requirements Experience Lead Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 9
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 devices 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 Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 10
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 Stakeholders Notification Requirements Refresh Rate Real-Time Systems Integration Automated Data Analytics Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 11
Bottleneck Layers Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 12
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 1 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 / Storage 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 4 Accessibility be able to access the site and taken down quickly Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 13
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 Distribution • 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 Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 14
Key Themes Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 15
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 Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 16
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 Stakeholder • 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 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 Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 17
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 Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 18
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 Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 19
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 Copyright © 2021 Deloitte Development LLC. All rights reserved. COVID-19 Coalition 20
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