COVID -19 VACCINATION DELIVERY PROGRAM – Here come the vaccines…still early days, patience and attention to details crucial.
This post is a follow up on my LinkedIn post dated 12 th October 2020 entitled "COVID-19 Vaccination Program – the role of governance.
The focus of COVID-19 pandemic management globally in 2021 will be on a "vaccination delivery program." The above picture is from an article in the Economist publication – The World in 2021 <sup>1</sup>.
Many developed countries have placed advance orders with multiple vaccine companies in advance of these vaccines receiving regulatory approval in due course.
Securing access to vaccines is an essential first step. Then comes the hard reality of getting the vaccine into the arms of those who need them as safely and quickly as possible.
Several vaccine developers (Pfizer BioNTech, Moderna, and AstraZeneca) have claimed a high efficacy level in Phase three clinical trials. This week, Pfizer BioNTech receive approval from the UK for use beyond clinical trials. Other vaccine companies are waiting for similar approvals in several developed countries. With Pfizer BioNTech approval, the race to get vaccines into the arms of the targeted population has moved into high gear.
Governments will be pushing their vaccine delivery program hard for an ambitious rollout. Governments will be hoping that the vaccine rollout will be the beginning of getting this pandemic under control, especially in the Northern hemisphere, where cases and death numbers have spiraled in the wrong direction.
Simultaneously, hard-hit industries such as airlines, tourism, international education, and other businesses dependent on people's movement will be leaning heavily on the vaccination program's positive impact to re- start a new normal.
Those responsible for their country's COVID- 19 vaccine delivery program should be painfully aware of this program's scale and complexity. The multiple, inter-related, inter- dependent, moving parts and the pressure to be ready by no later than late December 2020 or early 2021 is anything but business as usual.
Successfully executing any country's vaccine delivery program will require the highest level of "implementation expertise and discipline"and a fit for purpose strategy, plan, and target operating model.
Questions Remain
Regulatory authorities have deemed "approved" vaccines are safe and reported efficacy levels to have validity. There are further questions that need answers as part of a post clinical trial rollout.
There are still unanswered questions for these vaccines, such as:
• How long does the immunity last?
• Will it protect people from getting infected?
• If they are infected, will it prevent them from becoming severely ill?
• Will it stop them from becoming infectious?
• Will it successfully provide herd immunity for the general population?
The vaccination delivery program's design can provide answers. But to do so, it will need to capture data that provide information such as:
• Who, when, where, and how many were vaccinated?
• Which vaccines did they receive?
• For those vaccinated, who, when, where, and how many still got infected?
• Who, when, how many, and what side effects reported?
• When and how many vaccines have we ordered, arrived, and released to vaccinators?
• Who did the vaccination, when, and where?
• Did the cold chain remained intact, or was it compromised? If compromised, who received these compromised vaccines?
• How much vaccine stock have we got left?
• What is the level of vaccine wastage, and why?
Information and technology systems and platform (ITSP)
In my 23 rd September 2020 post, I outlined "a disciplined approach to develop and deliver the COVID-19 vaccination program." Having a target operating model is an important pre-requisite for a systematic and disciplined approach for implementation. The alternative is confusion, chaos, and delays.
One of the twelve elements of a target operating model is information and technology.
A fit for purpose and integrated Information and technology systems and platform (ITSP) is vital to provide data that can answer questions that still need to be answered.
Countries planning for a late December 2020 or early 2021 start to their vaccination rollout must, by now, have the ITSP's business case for investments (new or building on existing solutions) approved, vendors selected, and well advanced in implementation. If not, delayed implementation of the ITSP is inevitable, which in turn could delay the whole vaccination program.
Implementation of large information and technology systems and platforms, especially in government departments, is notoriously renowned for delays, costs overrun, and still end up with solutions that are still not fit for purpose.
Guiding principles for ITSP
Regardless of whether the proposed solution is to build a new or modifying an existing platform, certain principles are necessary for success. These principles are:
- Experienced and competent implementation governance and executive team
- Getting the requirements, architecture, and design right
- Essential ITSP applications
- Taking an open, modular, flexible, and agile design approach
- The right solutions partner(s)
- Early and continued involvement of users.
<span style="color:#2196f3">1.Governance and Executive team</span>.
Getting the right people to govern and execute this complex exercise is the single most important success factor.
There need to be skills, experience, up-to- date knowledge (health, vaccine delivery, and large scale complex ITSP implementation), and diverse backgrounds at the governance and executive level.
Other considerations when selecting the team that is commonly overlooked include:
• Avoid picking those who already have full and busy "business as usual" responsibilities.
• Avoid those with no experience in implementing large complex ITSP with tight timeframes.
• Avoid those who cannot cope with ambiguity and constant change.
• Avoid those who are too slow or stubborn to learn and pivot.
• Avoid those who cannot operate as part of a team, no matter how experienced or good they are technical.
The impact of these common mistakes is easy to spot. There will be a plethora of advisory, governance, steering, and committees with unclear roles. Likewise, the program will swell in numbers of managers all pursuing their silo program "monitoring." There will be endless meetings, discussions, briefings, reports, chasing irrelevant distractions that make no meaningful impact on the overall program. Unrealistic deadlines will be set, ignored, and re-set.
All of the above will contribute to confusion, frustrations, cost, and finally, delays. The crunch time will come when it will become apparent to a Secretary of Health or Minister of Health that the failure to stand up a fit for purpose ITSP is putting the government's vaccination delivery program at risk. The panic alarm bells will ring, and the"calvary" called in, which usually involves costly external consultants" to rescue this part of the vaccine delivery program.
Program displaying these warning signs requires an urgent re-set of the governance and executive team with new talent.
2.Getting the requirements, architecture, and design right
The vaccination delivery program will need to provide information to answer a wide range of questions like those set out above. Ensuring that these questions are appropriate is essential as they will drive the program's requirements, architecture, and design. Those signing off the ITSP requirements, architecture and, the design need to satisfy themselves on:
• What questions need to be answered about this program?
• Why are these questions being asked?
• What decisions will be made with these answers?
• Who will need the answers?
• When and how often will the answers be needed?
The answers to these questions will form the basis for requirements. In turn, these requirements will inform the architecture of what and how the various essential components integrate. Design can then work out the detailed functionality of each component.
The covid-19 vaccination program has some significant complexities, including:
• Some of the early approved vaccines use novel mRNA technologies requiring two doses within a relatively short time frame. Also, they require ultra-cold temperature for storage, which will be a key determinant of transport, storage, and pack sizes. Countries are already adopting a multi vaccines approach. At this stage, scientific work has not been done on whether people can switch and mix different types of vaccines. A multiple vaccine portfolio has an impact on who, where, how, logistics, and storage.
Changes to ITSP requirements are inevitable as more is learned with time. Appropriate and timely governance sign-off of any subsequent changes in "requirements" is fundamental. With any change in requirements, there is ample potential for "scope creep." Changes in requirements need to pass the "why, what questions is it addressing, and who is asking for these changes.
Many programs' common mistake is not getting the appropriate sign off on these design requirements before and during development. Consequences are not just cost escalation, delays, distractions but unnecessarily the development of an ITSP that is not fit for purpose.
Governance oversight and sign-off of the ITSP requirements during procurement, selection, and implementation are common weak links in major ITSP programs. Paying attention to getting the requirements, architecture, and design right can often be the difference between success and failure.
3.Essential ITSP applications
Typically, any vaccination delivery program's ITSP will need to have three broad applications:
- Clinical management
- Population management
- Inventory management
Each of these applications requires integration with each other. Each application will need to be implemented at national, regional, and local levels. Some of the functions, reporting, and information requirements will be unique, while others will be common.
Where information requirements are common, the architecture and design need to ensure that information is captured once digitally to enable seamless and efficient sharing across other applications and different parts of the health system.
Clinical management
Clinical management of any vaccination delivery program is focused on the clinical well-being of the person vaccinated. Ideally, organizations providing vaccinators should already have appropriate electronic clinical management systems.
A core part of this application will be the appointment and patient management modules. Appointment bookings information should be integrated with the "inventory management" application to ensure smooth ordering and vaccine stock availability. The patient management module has the patient health record and is key to tracking the well- being of the patient.
Depending on the vaccine delivery strategy, people's information will need to be shared with national (and/or regional) systems. What, when, and how such information is shared should have been covered in the requirements, architecture, and design phase. Minimum information of the person vaccinated that needs to be captured at the time of vaccination includes:
a) Name, personal (age, gender, ethnicity) and other details: • National identification number (if applicable) • Name of primary care doctor (if any) • Contact details (including emergency contacts) • Any underlying health conditions (heart conditions, cancer, diabetes, respiratory illness, etc.)
b) Name of vaccine administered
c) Date and time vaccinated - 1<sup>st</sup> (and 2<sup>nd</sup> dose where applicable)
d) Manufacturer's identification reference number
e) Place of vaccination
f) Name of vaccinator
g) Any immediate adverse reactions
The "consent" document signed by the vaccinator and vaccinated person on the day of vaccination is the logical place to record the above information, and a copy (hardcopy or electronically) provided to the vaccinated person.
Population management
Population management of any vaccination delivery program is focused on the well-being of the population vaccinated.
This particular application needs to be available at both local organizations administering the vaccine and national organization responsible for the overall vaccination delivery program. Some countries may involve regional organizations and add another layer of complication in the requirements, architecture, and design phases.
At the local level, this population management application should provide information at a summarised level based on the detailed individual information from the clinical management application. The summarised information of the population vaccinated can then be shared with a national organization at a summarised level. When, how often, the content and level of summarised information need to be agreed upon between local and national organizations.
Population management applications need to be able to provide insights into the effectiveness of the vaccination program at the population level. Information needs to be available to answer questions for various segments of the population, such as:
- level of immunity (being infected, minimizing the severity of illness if infected, and preventing transmission)
- duration of immunity, and
- any side effects
insights on population impact provide important feedback on the effectiveness of the overall vaccine strategy. These insights will form part of any governments' overall management of this pandemic and decide to re-open borders resume social, economic, and community activities.
Inventory management
An inventory management application is a necessary and vital enabler for any vaccination delivery program. It is not the "glamourous" part of the overall vaccine delivery program. But if inventory management basics are not done well, it can cause delays, wastage, frustrations, and public embarrassment. When it's failure seriously jeopardize the vaccine program, it could be a career-ending oversight for both politicians and senior public officials.
This application is focused on the status and details of: • orders, • receipts, • issues, and • the balance on hand.
The inventory management application is necessary for different parts of the health system involved in delivering this vaccination program – national, regional, and local. Integration requirements between these levels should have been built into the architecture and design phase. Any lack of integration will result in duplication and gaps in information.
At least one of the front runner vaccines (Pfizer) has challenging ultra-cold storage requirements, pack sizes, and handling requirements. These unique features will significantly influence the distribution, transport, storage, and inventory systems can provide vital, timely information on what's in stock, what's on order, what's been issued, and what's being received. Without a fit for the purpose inventory system, opportunities for storage and handling error resulting in wastage is greater for vaccines like Pfizer's.
For example, Pfizer's vaccines require ultra- cold freezers of minus 70 degrees Celsius. In such freezers, this vaccine can last for six months. Transportation of this vaccine is in a specially designed cooler box that holds trays with 975 doses in vials. These cooler boxes packed with dry ice can last ten days without being open. Once opened, it can last 15 days but requires topping up with dry ice every five days provided the box is opened not more than twice a day for no more than a minute at a time.
Any vaccination program will have a certain level of wastage from three common sources – closed vial wastage, avoidable open vial wastage, and unavoidable open vial wastage. The range of wastage can vary from 5% to 50% 2 . With mRNA vaccines like Pfizer's, the potential for wastage at the higher end cannot be discounted, especially in the early phases of rollout. Having a fit for purpose inventory management application throughout the cold chain could be an important part of the mitigation against this possibility.
4. Open, modular, and agile approach
The potential for ongoing changes in vaccines for this virus will invariably require changes to any ITSP system. Therefore, the architecture and design need to anticipate and accommodate such changes seamlessly.
Both the architecture and design approach need to be:
• open (allowing for changes to existing or new applications from existing or new developers),
• modular (allowing for easy decoupling, changes, and addition of new applications), and
• agile (ability to accommodate changes in requirements easily, efficiently, and quickly).
5.Right solution partner(s)
The procurement process (closed, open, and selective) may challenge selecting the right solution partner(s).
Most will promise much in their proposals, but some will fall short of expectations during the evaluation of their proposals. Others may come close to meeting the original requirements during evaluation but struggle during implementation. Others may do a reasonable job implementing the original requirements but have great difficulty coping with subsequent changes to requirements (scope or timeframe).
Finding the right solution partner(s) is an exercise in a compromise between costs, requirements fit, implementation capability, and responsiveness to changing requirements.
6. Early, continued, and meaningful involvement of users
Too many ITSP implementations fail through lack of early, continuous, and meaningful users' involvement.
It is good practice for users to be involved in the requirements, architecture, design, and developments and testing of prototypes. The challenge is getting the right users, listening to their feedback and suggestions even after the ITSP has gone live.
The positive impact of users' involvement goes beyond developing a fit for purpose solution. Users involved in the program are normally the champions in promoting and supporting other users during implementation.
In this vaccination program, the two most prominent user groups are the vaccinators (example, doctors, nurses, pharmacists) and the people receiving the vaccinations (example, health professionals, border, quarantine, elderly, and those with immune- compromised conditions).
Final word
A successful COVID-19 vaccination program is considered a significant driver to re-open economies and societies. The pressure to stand up to a successful program in 2021 will be enormous. A successful vaccine delivery program requires the exemplary implementation of the many essential moving parts of the program.
One of them is a fit for purpose ITSP. It is probably not the most glamorous compared with the science of some fantastic breakthroughs in vaccine development.
However, a poorly implemented ITSP can be costly, delay, and frustrates the vaccination rollout. If these delays and frustrations contribute to a crisis of confidence for the public, apart from the ritualistic heads will roll, and careers will end badly, it could delay the broader plan to re-start the post COVID world.
It pays for politicians and senior public officials responsible for a successful vaccination delivery program to pay appropriate attention to this less than glamorous part of the program.
If the ITSP program is not where it needs to be, corrective actions need to be taken with urgency to prevent further delay to the whole vaccination program.
Chai Chuah
7th December 2020
Wellington, NEW ZEALAND
Notes: