Vaccine Traceability, Serialization and Sample Supply Chain for COVID-19 Vaccines
Vaccination, which everyone has been talking about since WHO declared the COVID-19 pandemic, has now started on a global scale. Each country conducts a vaccination program that takes care of the social and economic interests of its people. Until the injection, the supply chain management, security, and transparency of this program is a process that needs to be analyzed well. There are developments day by day related to the process, which requires enormous responsibilities at every step. In our article, we tried to explain in full detail how to ensure vaccine traceability, in particular for COVID-19 vaccines. We also explain how to manage the supply chain.
Many countries have regulations for traceability and serialization in the pharmaceutical industry. However, for vaccines, traceability has not yet become obligatory in most countries. The main reason for this is that the supply chain of vaccines has various difficulties from production onwards. Storing and transporting under appropriate conditions, managing the implementation program are examples of these difficulties.
What Is Vaccine Traceability and Why Is It Important?
Imagine that there is a product that all people living on the planet want to achieve in the same period. Also, imagine that they can easily copy packaging and it looks like water, which most people have no difficulty reaching. What do you think is the extent of counterfeiting and black-market activities that cartels can do in this product? No doubt it would be too much. The states purchase each vaccine from the manufacturer at prices that we cannot call very affordable. It looks like a simple product, but it’s quite valuable. You can visualize the counterfeiters rubbing their hands with glee, right?
No more than a handful of companies can produce the COVID-19 vaccine in early 2021. In the best-case scenario, it will take 2 or 3 years for all people to get access to the vaccine. Don’t you think counterfeiting and the black market have focused on the COVID-19 vaccine? Absolutely, yes. Serializing produced vaccines and making them traceable is the only tool we can use to prevent all these illegal activities.
Vaccine traceability systems track all movements of the vaccine throughout its life cycle. The answer to the questions of what, where, when and for what purpose, that vaccines undergo from production to injection to the individual, including cold chain conditions, is only possible with an accurate vaccine traceability system. Moreover, traceability can provide information about whether the cold chain conditions of each vaccine have deteriorated in the supply chain. Vaccine traceability systems, which can be integrated with digital tools during the implementation of vaccine programs, are also the guarantors of transparency.
How to Serialize Vaccines?
We call ampoules or vials to small glass bottles in which vaccines filled in liquid form. According to the choice of the market or manufacturer, they package vials in cartons individually or in groups. Serialization of individually packaged vaccines is the ideal implementation for traceability operations. However, in the scenario that you package vaccines in groups, it becomes difficult to ensure traceability. The serialization of each vial in grouped packages and the establishment of a hierarchy of cartons containing vaccines is also a requirement to ensure traceability in the supply chain. Therefore, in vaccine traceability implementations, it is recommended to serialize each carton during the production phase.
There is another method for vaccine serialization if you cannot perform the recommended implementation. This method is to apply preprinted labels which pre-serialized and aggregated, to the inside or top of the carton carrying the grouped vials.
The data matrix code found in each vaccine ensures the traceability of the supply chain. Vaccine serialization is usually done by applying a data matrix code to the label during wrap-around labeling. Furthermore, aggregation of containers (container, box, case, pallet, etc) in which vials are transported and applying the serialized SSCC label make traceability processes more practical.
Tracking Cold Chain Conditions of Vaccines in the Supply Chain
Vaccines are usually stored and distributed under cold chain conditions. We need cold chain conditions for COVID-19 vaccines produced so far. A vaccine that breaks the cold chain has lost its ability to be a safe vaccine and has lost its effectiveness. It may not be beneficial, and it may also cause harm. For this reason, before injection, it is necessary to check whether the cold chain of the vaccine is protected.
You can determine whether the vials with 2D codes protected the cold chain or not thanks to the integration of systems that report ambient temperatures of the coolers. The system must warn the personnel, if ambient values, such as temperature and humidity, go beyond the specified ranges.
Requirements for Traceable Vaccine Supply Chain
You must serialize each element that may be a data source in the operation to establish a vaccine traceability system. Once you meet this prerequisite, you must record every transaction in the supply chain, preferably with mobile devices, and send the data to a cloud server for processing.
Software running on a cloud server should constantly analyze the data, observe whether cold chain conditions and inform the responsible person in case of an exception.
Another important requirement is to record the entire process from production to the injection of the vaccine to the individual and to secure the supply chain of the relevant vaccine by crypto after the injection.
VISIOTT’s Vaccine Traceability System Solutions
VISIOTT is your close by solution provider with knowledge and experience for country-level vaccine traceability system implementations. It is one of the system designers and developers of Turkey, which implements the most comprehensive vaccine traceability system implementation in the world. Please contact our sales team for more detailed information about VISIOTT’s vaccine traceability system solutions, which has the capacity to design and produce solutions that meet operational specifications for serialization, aggregation, and cold chain tracking.