The COVID-19 Vaccine Supply Chain is Particularly Vulnerable
These days, COVID-19 vaccine distribution is at the top of every nation’s agenda. To achieve the all-important herd immunity, we need to ensure that doses are distributed as efficiently and as securely as possible. Protecting the vaccine’s supply chain from criminal activities such as counterfeiting or from the possibility of mishandling, therefore, should be prioritized.
However, distributing as widely as needed by the concept of herd immunity while keeping the vaccine’s integrity is not an uncomplicated task. There are a lot of points of vulnerability in the supply chain. From cold storage requirements to criminal acts such as counterfeiting and IP theft, there are a lot of possible areas of failure that can affect a smooth distribution process.
It is of utmost importance, therefore, that an effective serialisation effort is implemented on the supply chain – one that would allow for traceability and monitoring with the aim of maintaining vaccine integrity and efficient mass distribution.
The Vaccines are Prone to Mishandling
With the development of COVID-19 vaccines, time was of the essence. The transmission rate of COVID-19 was so high that there were millions of lives on the line with each passing day that we don’t have the vaccine yet. Fortunately, pharmaceutical companies were able to develop, test, and rollout vaccines within the span of a year. This rushed nature of the vaccine makes it vulnerable to inefficiencies and even open to infiltration from bad actors.
Cold Storage
One particular problem with vaccines, Pfizer in particular, has a thermal requirement of -70 degrees Celsius. While the others have less stringent storage requirements, all of them still need to some refrigeration even during transport. Any less than the optimal storing conditions will certainly result in a compromised batch of vaccines that are ineffective or even unsafe to use.
Supply and Demand Miscalculations
There are more than 7.6 billion people in the world and at least 60% of that number needs to get inoculated by some version of the vaccine. That’s the minimum required amount for herd immunity to take effect that scientists and researchers have consensus on. Even the largest pharmaceutical companies do not have the capacity to produce quantities of that magnitude right away. At the current rate of rollout, it would be safe to say that we can expect the vaccination drives to go on for the next following months and maybe even years.
As such, there is a very real issue with supply. It makes it all the more important to make every dose that manufacturers can produce be utilized in the most efficient way. This means optimizing deliveries to cover the right amount of the population in one region so as not to cause under supply in others.
Pharmacovigilance-related Recalls
To quicken the pace of vaccine development for COVID-19, governments rolled back some regulatory requirements for pharmaceutical companies. Some experts worry that some vaccines might not actually be ready for administration to the mass market. With an overall market size of over 7 billion people, a couple of million sample size for testing purposes might not yield every possible side-effect.
It is important to note that this is not an issue that COVID-19 alone faces. Other vaccines, medicines, and pharmaceutical products have been recalled before due to pharmacovigilance.
Susceptible to Attacks from Bad Actors
Another possible area of inefficiency is one that’s instigated by individuals or organizations with dubious intentions. Whether it be for financial gain or for simple acts of sowing chaos, there are a lot of bad actors that are motivated to exploit COVID-19 vaccines for their own benefit.
Counterfeiting
Pharmaceutical products have always been a target for counterfeiters. At the onset of the pandemic, they were quick to produce facemasks that were often a bit cheaper than the ones made by legitimate manufacturers. The problem, however, is that they’re often not nearly as effective at preventing transmission. Because of this, COVID-19 related counterfeit products have become big business in such a short time.
According to the European Pharmaceutical Review, “in March and April, Homeland Security in the US identified 19,000 suspect COVID-19-related domain names and seized over $3.2 million linked to 494 shipments of mislabelled, fraudulent, unauthorised or prohibited COVID-19 test kits, treatment kits, homeopathic remedies, purported antiviral products and PPE.” More than 6.5 million products with inaccurate claims have also been flagged by online retail giant Amazon.
Counterfeit vaccines are even more troublesome. Patients inoculated by fake vaccines can potentially be exposed to a greater health risk because they’re not under the purview of regulatory bodies. But even if fake vials of the vaccine don’t cause any harm, the false sense of immunity can be very dangerous as well. In a way, counterfeit inoculations can make one feel safe in going out and interacting with other people without actually being immune to the virus.
There is some evidence that fake vaccines have already penetrated the supply chain. If this practice is left unchecked, it could deal a huge blow to our collective efforts to ending the pandemic.
Diversion of Shipments
Distribution needs to cast as wide a net as possible. This means allocating efficiently across the globe and delivering doses not just to developed nations who can afford to pay a premium, but to LMICs as well.
However, diversion is a very real epidemic in the supply chain. In this case, shipments meant to be delivered to LMICs, are diverted instead to developed nations who has better terms of payment. This can cause further delays in distribution and a further delay in the eradication of the virus on a global scale.
The Benefits of Traceability Systems through Vaccine Serialisation
Because of these vulnerabilities industry experts urge governments to implement serialisation mechanisms for all COVID-19 vaccines and their supply chains. A supply chain susceptible to counterfeiting, diverting, and mishandling is just too dangerous for something so crucial to global health where millions of lives and billions of dollars are at stake.
One of the most important aspects of serialisation is visibility. Serialisation allows governments and private organizations to monitor the movement of the vaccines in all crucial points of the supply chain.
Shipment Rerouting Prevention
The traceability technologies available now allow for monitoring from the manufacturing and packaging facility to vaccine administration centres. It’s even quite straightforward to implement. A simple QR-code, barcode, or any other ‘unique product identifier’ or UPI, printed on the packaging or the vial itself can already help track its movement in the supply chain. Scanning these codes could already tell inspectors where the vaccines were produced, where they have been, and most importantly, where they’re intended to go. This feature alone could thwart potential shipment rerouting.
Tamper-Proof Vaccine Integrity Monitoring
It could also benefit the supply chain by keeping important details such as temperature readings embedded in the codes. Current serialisation measures use QR or barcodes with anti-tampering features. Such measures could help maintain vaccine integrity across the supply chain.
Counterfeit Deterrence
With vaccine serialisation, individualised codes in the form of QR, barcode, or unique product identifiers (UPI) are issued to each vial or pack. The codes will then be scanned and at each point in the supply chain update the data such as temperature, origins, and even information at the point of inoculation. This unique code ensures that they’re one-of-a-kind preventing counterfeiters from replicating the vial or the codes themselves.
Through the codes, medical institutions would know exactly which vaccines are administered, to whom, when, and under what conditions together with a reminder of when the next dosage is due, if needed. This level of visibility across the supply chain should prevent counterfeits from entering the contaminating the vaccine stock.
Ease of Implementing Pharmacovigilance Measures
In case vaccines have been found to have unforeseen side-effects, supply-chain visibility also gives manufacturers and governments the ability to quickly track and halt the vaccines from reaching even more of the general population.
If necessary, recalls can be done efficiently because of the real-time traceability measures. The individual codes can even help in keeping track of the stock and making sure that there no loose vaccines in circulation.
Added Benefits of Track and Trace Systems
While there are clear benefits to serialisation such as combating counterfeits and inefficiencies, there are other more subtle benefits to it.
Performance Assessment
With traceability and monitoring capabilities come the ability to collect more data on vaccine efficacy. The basics, such as what kind of vaccine, demographics, and region, are already covered by the serialisation measures. This data, combined with other data sources such contact tracing and vaccine certification/passport technologies, can give us a clearer view of how the vaccine drive is faring.
This way, scientists have the unique ability to monitor how the vaccines are doing in different regions. The opportunity for data-gathering is massive in this case as the massive vaccine drives are going on in almost every nation in the world. Data scientists and researchers will also be able to compare and contrast certain relevant variables such as demographics and government types with vaccine distribution and efficacy.
This way, serialisation does not only maintain vaccine integrity, it also helps authorities come up with data-backed insights into a lot of other aspects of society. It is only then can authorities make science-based decisions on what steps and policies to take up next.
Demand Forecast
Performance assessment also gives rise to another benefit to serialisation – that is, forecasting future demand.
One of most important decisions policy makers must make is how many doses to order. With serialisation, governments can easily track how many vaccines have already been administered, how much is still in stock, and how much more to order.
What Still Needs to Be Done
While serialisation has many benefits, there are still some tweaks that need to made specifically for the COVID-19 vaccines. The methodologies prevalent in current traceability solutions are not entirely up to the task of covering a crisis of coronavirus’ scale and magnitude.
Standardized or Interoperable Systems
Perhaps the most important issue with today’s serialisation methodology is standardization. While there are standard formats already in place, they’re likely limited to the national systems. Different countries still use different serialisation systems.
With COVID-19 serialisation efforts, we need to actively avoid closed proprietary solutions. The focus must be put on an open, universal, and collaborative solutions.
For a global pandemic like COVID-19, there is a need for international cooperation to achieve a global herd immunity. Especially with problems like shipment rerouting and counterfeiting outfits that operate on an international scale, an efficient standardized data serialisation system can go a long way.
Fortunately, there are scalable standardized systems already in place. The GS1 standard is a great example. It’s a standardized information sharing and supply chain standard that is in use by over 2 million members across 110 countries. It’s a system that already has the framework and infrastructure in place for immediate rollout.
Another option is to make the systems interoperable. This means data from one serialisation database should be easily incorporated and interpreted in another allowing for a quick sharing of information between two different systems.
Mobile and Cloud-based
Standardization of serialisation methodologies, however, aren’t the end-all-be-all for an efficient vaccine distribution drive. One of the most crucial things to do for a successful vaccination campaign is to also make it available to far-flung areas and regions that are affective by the virus as well.
The problem here is that rural areas might not have the reliable infrastructure to operate a traceability system. Which is why we must ensure that the traceability systems we employ are mobile and cloud-based. This should allow for a timely updating even in remote locations that also need vaccine doses.
The pivot to mobile should also allow for apps that can perform other tasks in our COVID-19 response efforts as well. Apps used in the serialisation of the supply chain, for example, may also be utilized for contact tracing and vaccine certifications or passports.
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