What Would Data Modelling Requirements for a Covid-19 Vaccine Ready for Distribution & Delivery Look Like?

vaccine-information-iot-platform

As news around the successful clinical trials of frontrunner candidates for the Covid-19 vaccines brought something positive to look forward to, conversations are now turning towards the manufacturing, distribution and delivery of the vaccines. The scale of the task that lies ahead, planning, mobilizing resources, putting in place infrastructure required, providing the information required and the sheer logistics involved is unprecedented.

Distribution and delivery of multiple vaccines that will emerge from the approval process and go into production is complicated by various factors. From the need to establish trust, counter misinformation, offer transparency, meet safety requirements, monitor storage temperatures and more. When it comes to distribution & delivery there will be a mountain of questions to address and challenges to resolve in a very short time span especially given the stakes involved with the current pandemic. There hasn’t been a time when the pressure to get it right has been higher nor a time when the speed of delivery was as urgent. However, there also hasn’t been a time when information systems and technology has been as evolved and solutions could be modelled and deployed with speed & flexibility to adapt.

As an IoT Platform for everyday consumer products, one of the configuration features we have is being able to model information requirements around an entity or item for example, a single vial / dose of a vaccine, a batch of vaccines produced on a specific date or even the patient or recipient to whom the dose has been administered to. Using the Entity Creator and Data Model Designer, you can define the information attributes structuring a data model for each of these entities and also define associations or relationships between them modelling a real world requirement / process. Through this process, every one of those vaccine doses would have a digital record of itself securely accessible over the web that could be updated as the dose / batch moves from manufacturing through distribution.

This brings up the question “if we were to model the data requirements for a covid-19 vaccine ready for distribution, what could that possibly include to address some of the requirements and challenges around distribution and delivery?”. While this is a question as a technology provider and not healthcare professionals we may not be in a position to detail accurately, here are some more basic factors that we envision can be addressed in the data modelling for a vaccine candidate going into manufacturing:

Serialization

With this specific pandemic and vaccination initiative, the ability to gather and maintain data at a granular level right down to the single dose level is going to be very important. Being able to identify every dose individually through a unique identifier encoded into a smartphone readable data matrix for example can help in various areas from authentication, counterfeit prevention, location tracking, tracking administration of prime & booster doses and more. It also creates trust knowing the manufacturer and authorities have visibility and track the vaccine at an individual dose level. Serialization can help enable authentication solutions which can be made accessible by healthcare professionals or the patient to safeguard against counterfeit vaccines. The Pharmaceutical Sterilization and Traceability standards by GS1 offer clear guidelines for defining serialization requirements –

Batch Level Information Tracking

In any vaccine related data model, batch level attributes such as the batch number, LOT number, date of manufacture, use by date, expiry date, target market or geographical data for which the batch is intended for would be important. Especially in addressing safety, these LOT level attributes are important. They can determine traceability requirements, tracking within the supply chain, target locations where the LOT was intended for and more.

Attributes to manage LOT level recalls can also be included within the data model to manage efficient recalls and notifications for very specific LOTs that may not be safe to administer without impacting the larger supply or delivery process.

Tracking & Traceability Attributes

The ability to gather traceability data as the vaccine moves from manufacturing through the supply chain will also have a significant impact. Being able to scan and update business events as the vaccine moves through the supply chain can offer a level of visibility into the reach and effectiveness of vaccine programs. It can help identify timelines, progress while also ensuring doses are not diverted where they shouldn’t be. The uses go beyond logistics and visibility purposes and making this accessible to people in general will help establish greater trust. The GS1 EPCIS standard offers the right guidelines for incorporating traceability into the data model at a LOT level or down to an individual dose level.

Storage & Safety Information Attributes

With early information coming out on the ultra-cold chain storage requirements which will be critical for some of the vaccine candidates, storage will be a key area to address within the data model. One aspect would be making available very detailed instructions and information on how to correctly store and transport the vaccine. Another could be the possibility of monitoring the batches or shipments of the vaccine in real-time using time-temperature sensors or smart packaging technologies like the Avery Dennison TT Sensor Plus label which can log temperature readings at regular intervals. These arrays or logs within the data model can be used to trigger alerts on LOTs that may not be properly stored, transported and even used to update safety status of specific LOTs prior to them being administered. Similarly, other connected packaging technologies like anti-tamper NFC tags, trusted NFC authentication tags, geo location beacons used inside shipping containers can all be used to transmit and store and make available information to enable safer delivery.   

Administration Instructions

Under usual circumstances vaccines are delivered through established channels like vaccine programs and primary healthcare centres. The covid-19 pandemic poses new challenges in being able to efficiently and quickly deliver the vaccines. It will involve hundreds of millions of doses to billions of doses across all demographics. In many developing countries or locations where primary healthcare centres are insufficient, this could mean training and mobilizing volunteers or groups of people in safely injecting and delivering the vaccine doses. While modelling solutions, with today’s technology this can easily be done using video content or audio visual formats loaded in multiple languages to make this available directly through the product or packaging. The data model should include a structure to deliver content for safely administering the vaccine.

Education & Truth

In the age of misinformation, conspiracies, anti-vaccine campaigns and unsure people, ability to provide truth, factual information and educational content along with the vaccine is another area the data modelling can address. If effective educational content and trustworthy information from the manufacturer can be made accessible through the vaccine packaging digitally via a quick smartphone scan or digital link, increased trust can be established. While people are exposed to all kinds of information from unreliable sources and remain undecided or anxious in a doctors waiting room, direct information from the manufacturer can be assuring.  

Globalized Information Delivery

The modelling for information around the delivery and distribution of some of these vaccines will have to take into consideration the information around it will have to be organized and delivered across different parts of the world. This would mean making it available in multiple languages, taking into consideration various geographical requirements, regulations, certifications and addressing the information or safety norms of each region. Digitization of labelling information will help address many of these needs in the short timeframe that has been imposed by the urgent need for vaccines.

Healthcare Record Keeping Data

Visibility into how many people have been immunized is going to be important for healthcare professionals and governments. Just as important for many individuals will be having a clear record or proof of immunization which is easily accessible when required. Whether someone is planning to board a flight, resume classes in a school or apply for a travel visa a number of activities for some time to come will depend on an individual’s Covid risk status. Systems that can tie an individual’s identity whether through a government ID, healthcare record etc. to a vaccine dose ID / serial number that is verifiable, could serve as a pass or enabler for many systems.

Sustainability Information

This massive effort will unfortunately also end up in the disposal of billions of glass vials, bottles, caps, syringes, needles and packaging material being added to the planets already critical waste problem. However, if thought through and done right, instructions for disposal, recycling, labelling the recyclable components, identifying them, collecting them and measuring what is returned to the circular manufacturing chain can be planned and built into the data model, some of the sustainability issues can be mitigated.  

One Vaccine Dose, One Data Record, One Identifier Code, Many Applications

We’ve mentioned tracking, traceability, logistics information, administrator information, patient information and multiple applications for different stakeholders in this scenario but how much space is there on a vaccine label, packaging or vial to make all this available? Something to consider in modelling which addresses this concern is the GS1 Digital Link standard which is a game changer in identification and connecting products to the web. In a nutshell, a single code printed on the packaging can be used to identify the vaccine dose connecting it to the web through a standardized URL format containing the product identifiers like the barcode number, LOT number etc. and be used to deliver all the different data we have discussed in earlier points within the context of who is scanning it and what data they need about the item. All these different applications can be enabled through a single code on the packaging.

Managing Information Change & Moving Targets in Unchartered Territory

The last point in considering what a data model would look like for the distribution & delivery of a Covid-19 vaccine is incorporating the flexibility to manage information change during the distribution & delivery process. We are in unchartered territory and there are situations where manufacturers do not know, cannot confirm or capture every information variable that needs to be made available. In a scenario like we have today, there are a number of “unknowns” simply because there hasn’t been enough time to ascertain certain information. For example the shelf life of a vaccine. The expiry date at this point could be assumed as 6 months however, a year down the line, scientists may have data to confirm the shelf life is 12 months. There could a situation where a particular certification within a certain country was not approved at the time of initial distribution of the vaccine but that certificate has now been acquired and the information needs to be made available to people there.

Making this information digitally accessible instead of print would imply the information can be updated and augmented as time goes by. This is one of the key advantages of being able to deliver information through the packaging in a digital format using a code. The information available around the vaccine dose even to the manufacturer can change as time goes by. Being able to update that information once the vaccine is already out in the market and make real-time changes is powerful.

In Conclusion

The information requirements around vaccine distribution is vast and complex. At the same time, we’ve never been as well equipped in terms of technology to capture  and model these information requirements at such a granular level offering new levels of safety, visibility, transparency and efficiency in the process. We’ve never had so many well defined global standards and frameworks that will enable the kind of global distribution efficiency as we have today. We can only remain optimistic that the next phase of getting the vaccines to where they are needed as safely and efficiently as possible will be as impressive as the extraordinary effort to developing them has been.