There is no excuse for being ill-prepared to address the well-known challenges of rolling out a COVID-19 vaccine globally.
As I write this in May 2020, the ultimate impact of COVID-19 from a healthcare and economical perspective is still very difficult to predict, but it appears fair to assume that the world as we knew it won’t come back until we have a safe and effective vaccine and/or treatment. The global scientific community is working 24/7 to come up with solutions, some based on existing products and platforms while others are based on novel research efforts. Currently, over 100 vaccine candidates have been identified. It is likely that multiple vaccines with varying effectiveness will be available at some point in 2021.
Having spent more than 35 years leading operations across consumer pharmaceuticals, medical devices, and the pharma supply chain, in my mind I quickly fast forward to the day that the first vaccine is ready to launch. Billions of people will line up to be vaccinated all over the world in both developed and developing countries, and a whole new set of challenges will emerge: manufacturing scale up, supply chain, counterfeiting, ethical questions (who gets it first), and many more. It is critical that we begin to prepare for the availability of a COVID-19 vaccine on all these fronts now.
Temperature excursions can lead to a vaccine becoming ineffective, which means vaccinated people could be totally unprotected from a disease.
The Certainty of Temperature Monitoring
A lesser known but highly critical challenge for any vaccine supply chain relates to temperature monitoring. Vaccines are biological products and highly temperature sensitive. Almost all vaccines are labeled to be stored and transported between 2° and 8° Centigrade (36°and 46° Fahrenheit) at all times. Temperature excursions can lead to a vaccine becoming ineffective, which means vaccinated people could be totally unprotected from a disease unless they know with certainty that their vaccine was temperature-controlled from manufacturing all the way to the point of vaccination.
Temperature excursions with vaccines are very well documented. For example, in June 2012, a report from the Office of Inspector General (OIG) of the Department of Health and Human Services showed that 76% of the 45 selected healthcare providers’ offices evaluated for the CDC’s Vaccines for Children Program had vaccines that were exposed to temperatures outside the permitted range. The Inspector General found that as many as 20,252 vaccine doses were potentially compromised during the two-week study, conducted across four states.
Patients have no way to know if our vaccines are actually effective because heat damage is invisible to the naked eye.
Gaps in the U.S. Cold Chain Process
Currently, nothing protects us from future COVID-19 vaccines with temperature-induced defects being distributed and administered. Unforeseen high quantities of the new vaccines will overwhelm hospitals, physician practices and pharmacies. And their refrigeration capacity is already sub-optimal as proven by the OIG report.
The reality is that the transportation and storage of vaccines and medicines in the U.S. – from the time that they are manufactured to the time when they are administered to a patient (known in the industry as the cold-chain process) – is extremely fragile. We are reliant on the individual actions of manufacturers, distributors and health care providers with limited controls in place. Logically, the closer we get to the end of the supply chain (also called “the last mile”), the more potential gaps and risks there are in the system. Patients – in the case of COVID-19, all of us – will have no way to know if our vaccines are actually effective because heat damage is invisible to the naked eye.
Now is the time to consider a national regulation for the sake of public health and to avoid wastage.
Proven Solutions to Uphold Temperature Controls and Avoid Waste
The good news is that there are available, proven technologies to solve this cold chain challenge. Companies I have worked with are producing hundreds of millions of temperature indicators per year that are put on vaccine vials in many countries outside of the U.S. These cost-effective, visual indicators track the cumulative temperature exposure through the entire supply chain, starting with the manufacturer who affixes them to each vial. There are also companies that use sensors to track the temperature and humidity of pharmaceutical products as they move across the supply chain to alert managers to potential issues in real time.
One key reason that these technologies have not been used in the U.S. is that no single agency has oversight and accountability to ensure best practices for cold chain management. With no existing regulations at the federal level, a number of states, mostly inspired by local Boards of Pharmacies, have started to issue mandates for the monitoring of temperature-sensitive medications.
In addition, estimates of vaccine wastage in the U.S. are up to $150 million per year. In case of power outages affecting vaccine refrigerators, for instance, all vaccines in those refrigerators must be segregated and evaluated with the manufacturer according to CDC guidance. The visual indicators described earlier enable segregation of vaccines affected by temperature exposure from those that have not been, hence allowing the latter to still be used.
In summary, the technology exists to avoid vaccine wastage due to temperature excursions and to allow the healthcare professional – and the patient – to know at the time of vaccination whether its effectiveness is likely to have been compromised. With the anticipated roll-out of COVID-19 vaccines on a global scale, and the need to innovate and invest in these cold chains and other critical technologies, now is the time to consider a national regulation for the sake of public health and to avoid wastage.
There is no technology limitation to providing one solution for two critical supply chain issues: temperature monitoring and counterfeiting.
Counterfeits with Track & Trace Technology
Counterfeiting is another supply chain challenge that will most certainly affect future COVID-19 vaccines. There will be a painful shortage, especially in the beginning, and the strong demand will be too tempting for counterfeiters not to participate. Contrary to temperature monitoring, regulations do exist to protect us from counterfeit products. The Drug Security and Supply Chain Act (DSCSA) issued by the FDA set out a timeline to implement the tracking and tracing of all medicines at the unit level by 2023. There would be no better time to increase the sense of urgency and implement these regulations for the new vaccines.
There are many technologies available to deal with counterfeiting and to enable track and trace. Two-dimensional barcodes are often a cornerstone of the solution. Interestingly, GS1 – the organization responsible for barcode standards – has issued a data matrix configuration allowing for the integration of sensors with 2D-barcodes. Coincidentally, a pilot was started in North Carolina in late 2019 combining 2D barcodes with temperature sensing ink. These serialized labels with an encoded 2D matrix and temperature tracking feature can serve the needs of supply chain tracking, product authentication and temperature assurance. That means there is no technology limitation to providing one single solution and tackling the two critical supply chain issues: temperature monitoring and counterfeiting.
Here’s the bottom line.
The world was not prepared for the arrival of COVID-19 and is testing and learning its way out of this crisis. Knowing that vaccines will be available in the foreseeable future, there is now no excuse for being as ill-prepared to address well-known challenges such as temperature monitoring and counterfeiting. With continued investment and innovation in supply and cold chain technologies, we can be ready to start immunizing billions of people around the world and bring life back to “normal.”
Learn more about LLR’s industrial technology investment focus, including the supply chain, test & measurement, and track & trace sectors.