Logistics & Supply Chain Management
COVID Vaccination Serialisation – The Journey So Far
Alf Goebel, CEO, advanco, examines how successful the pharmaceutical serialisation and track-and-trace sector has been in overcoming the multiple logistical challenges posed by the global COVID vaccination roll-out. The leading provider for Level 3 and Level 4 Item Level Serialisation, advanco was acquired by Parabellum Investments, led by Founder and Chief Executive, Rami Cassis, in 2020. The global COVID pandemic has been one of the worst disasters we have collectively faced for generations, resulting in hundreds of thousands of deaths, disabilities, and losses of livelihoods. However, in an exercise which underlines just how effective the pharmaceutical sector can be when it needs to perform under pressure, several manufacturers managed to successfully develop vaccines in less than 12 months – an extraordinary achievement, given it has historically taken around a decade, or longer, to develop new vaccines. With regulators also acting with urgency to provide full sign-off for them to be used on the public, the pressure is now on to manufacture more doses of COVID-19 vaccines than any other vaccine in history to inoculate enough people to achieve global vaccine immunity, with the ultimate aim of putting an end to COVID once and for all. Together with this mammoth, global, manufacturing pressure goes the need to provide cast-iron serialisation, or track-andtrace, services for this medicine. The need for complete reliance that the vaccine is the real deal is essential. We have already seen instances of forged vaccines. Only at the start of February this year were 3000 fake vials of COVID vaccine seized in China, an operation resulting in the arrest of 80 people. With depressing predictability, I am confident this is just the tip of the iceberg, with further fake vaccines being produced across the world at this very moment in time. The pharmaceutical serialisation sector has therefore had to step up more than ever 84 INTERNATIONAL PHARMACEUTICAL INDUSTRY
before. Not only does the global vaccine roll-out need track-and-trace technology, delivered accurately and swiftly, this huge task has had to be done in addition to the sector’s “day-job” of serialising the routine, everyday medicines and medical equipment needed across the world to battle the globe’s collective ailments and diseases. How successful has this mammoth COVID vaccination serialisation operation been so far? And what, if anything, needs improving to ensure the programme remains a success in the weeks and months ahead? Addressing the Challenges of COVID Serialisation Before we assess how successful, or otherwise, global vaccine serialisation efforts have been so far, we firstly need to set the scene. To ensure the vaccinations – some of which need to be prepared, stored, and shipped in temperatures as low as minus 80 degrees Celsius – can be handled in the specific manner called for, the pharmaceutical sector has had to quickly learn, adapt, and implement some major changes to its processes. It is likely these changes will need to continue to evolve to cope with the expected long-term fallout of the pandemic, with no guaranteed end-date in sight, new strains being discovered with alarming regularity and the lifespan of the vaccines still not known for sure – meaning the jabs may have to be given repeatedly across the world. One of the major issues that the pandemic has highlighted is the practical difficulties of implementing serialisation processes being faced by manufacturers who rely on their own in-house systems. Prior to the pandemic, such producers were well-versed in producing their own drugs and medication. While some of these products might have called for specific conditions, the chances are that nothing too extreme was required. However, when it comes to some of the COVID vaccine types, the entire cold chain process, covering everything from production and packaging requires the product to be produced, stored,
and distributed at anywhere between minus 20 and minus 80 degrees Celsius. Some of the manufacturers quickly realised that these conditions came with a whole set of new problems they had not dealt with before, especially relating to serialisation. The technology needed to cope with these extreme temperatures just did not exist – whether this was implementing the serialisation codes or being able to physically scan and read them. These were major issues which needed to be solved with speed. Bear in mind this was all being figured out while the eyes of the world were watching, with manufacturers facing intense pressure to produce the vaccine and ship it out to all four corners of the world a lot more quickly. Additionally, the volume of vaccines needed has placed pressure on global supply chains for materials such as glass vials, syringes, and stabilising agents. The solution to these challenges has been found to be based around technology that can track the progress of serialised items as they proceed through all stages of their lifecycle. This allows all essential information to be captured during packaging and warehouse operations, controlling the full process-flow, tracking and logging events and exceptions to a central repository, allowing manufacturers to report and optimise all processes. Fighting the Counterfeiters The intense, global demand for a COVID vaccine has led to the dangers of counterfeiters manufacturing their own deadly solution – one which could cost lives. When you look at the wider counterfeiting operation in the pharmaceutical sector, it is predicted that 10% of pharma products worldwide are counterfeit, with the global counterfeit drug market exceeding an eyewatering $75bn. Research further estimates that the death toll caused as a result could increase to 10 million people by 2050. Pharmaceutical counterfeiting has been a deadly problem since the advent of the pharmaceutical sector itself. However, the pandemic has shone a new spotlight onto Summer 2021 Volume 13 Issue 2
