Continuing efforts to develop a COVID-19 vaccine signify that its completion is just on the horizon. Due to massive global demand, however, and the urgent need for the vaccine, mass distribution may present a formidable challenge to the cold chain.
The COVID-19 pandemic has resulted in severe impacts on both the economies and mortality rates of different countries. Experts are currently fast-tracking the vaccine development process in the hopes of ending the pandemic quickly and restoring the world to normality. There are currently more than 200 coronavirus vaccines being developed across the globe, with significant efforts underway to speed the process.
Russia is one of the forerunners for Vaccine development. It has introduced Sputnik V, the first registered coronavirus vaccine, as stated by President Vladimir Putin. Several efficacy and safety concerns have been raised due to the premature approval of the vaccine citing Russia’s bypass of the phase 3 trial completion. Meanwhile, other forerunners, BioNTech-Pfizer, and Moderna have successfully administered a second dose of their vaccine to more than 75% of the people who participated in their study. Pfizer administered their second doses to 35,771 people, enrolling 42,113 participants out of 44,000 for the Phase 3 Trial. Meanwhile, Moderna has issued their second shot to 25,640 people, out of an estimated 30,000 enrolled participants.
Despite several concerns from the international community, Russia has proceeded with the first distribution of their vaccine. Pilot batches of Sputnik V have been issued to all Russia Regions, with some regions receiving a relatively small supply, between 42 to 44 doses. Distribution and delivery proved to be complicated, as observed by some Russian regional authorities, due to the specialized temperature requirements during storage and transportation.
Vaccines generally need to be stored at deep-freeze temperatures to maintain their integrity. The various coronavirus vaccines in development have different temperature requirements. Sputnik V must be kept at -18 °C (-0.4 °F), the Pfizer at -70 °C (-94 °F), and the Moderna at -20 °C (-4 °F).
When they become widely available, the corona virus vaccines will be distributed to cities and countries through the cold chain. A strong and seamless cold chain is needed for the proper delivery of vaccines globally. Unless all countries receive a steady supply of the vaccines through the cold chain, covid-19 will not be eliminated.
Current condition of the cold chain
The emergence of modern technologies has permitted a high level of management and visibility in every aspect of today’s cold chain. The pharmaceutical cold chain is often utilizes multiple staff members, working carefully to ensure the precise delivery of cargo to the point of demand. Pharmaceutical cargo is transported from the manufacturing site to storage warehouses via trucks, ships, and planes, until it reaches the healthcare facilities. It is crucial for the entire process to have minimal, to no, errors due to the extreme sensitivity of the shipment. A flaw in the chain can render an entire shipment obsolete, resulting in the loss of millions of dollars, and possibly lives.
Some cold chain facilities have vapor-charged cryogenic systems and temperature-controlled package mechanisms that allow careful transport from the manufacturer to its destination. Maintaining the quality of the pharmaceutical cargo is prioritized throughout the cold chain transport.
Several key regulations are outlined in the European Union (EU) guidelines on Good Distribution Practice for Medicinal products for human use that serve as the basic requirement for pharmaceutical distribution. The regulations highlight and support the primary temperature and logistics management, through temperature regulation, equipment performance, validation, and lane qualification. It is crucial for products to be traceable all the way from their point of origin. Dependable recall systems should also be in place for effective isolation of specific batches of product that experienced excursions or other pharmaceutical errors.
Since there is significant monetary investment in the transport of items through the cold chain, stakeholders are keen on finding new ways to reduce costs. This consideration paved the way for the use of multi-cell trailers as one method for cost control. These are refrigerated trailers where insulated curtains serve as partitions to create different temperature zones. This allows for the delivery of products with different temperature requirements.
The demand for visibility, reliability, and maintained quality urges cold chain stakeholders to outsource various advanced equipment to ensure efficiency in the process. New facility designs are being drafted, along with racking systems. Automation is also being explored in some warehouses to reduce human contact in the cold chain that might interfere with temperature-sensitive cargo. IT infrastructures and front-end sensors are being installed to better monitor and track shipments as they move along the supply chain. The installation of high-grade equipment also allows for easier and more accurate extraction of data for reports.
Various transportation modes are also being explored and optimized for a more effective cold chain. Air travel is the common choice for pharmaceutical cargo transport, however, some companies are shifting to steamships, due to the improved ability to track locations and manage temperatures in containers.
Cold chain preparation for COVID-19
Along with the development of the vaccines, experts are also working on fortifying the cold chain in order to handle the looming mass distribution.
Simon White, Pfizer’s director for global quality support, emphasizes the importance for aid agencies to have quality, cohesive and robust supply channels not only to maintain the integrity of the vaccine, but also to maintain their brand quality. White notes that, “Ultimately, it’s the Pfizer label on the box, and if there’s an issue, it’s going to be Pfizer that has to face the outcome, the implications, and the consequences.” Stringent quality agreements will be set up by Pfizer with partner aids to ensure that the partners’ distribution channels would be able to uphold the quality of Pfizer’s vaccines.
Various logistic giants and countries are currently in the process of preparing cold chains and freezer farms to accommodate the massive influx of vaccines.
Most pharmaceutical companies do not own the necessary distribution fleets for their products. In order to deliver the vaccines, pharma companies need to have close coordination with a logistics service provider, overseeing a massive system of audits and quality assurance. In this type of relationship, the pharma company would act as a consultant, due to their knowledge in temperature control and logistics. Meanwhile, auditors have the task of making sure that the containers and equipment remain consistent across a wide area of operations.
Logistics giant DHL states that it might take 15,000 flights, 200,000 movements by shipping staff, and 15 million deliveries in specialized cooling boxes to deliver 10 billion vaccine doses.
Currently, FedEx has been working with government agencies regarding the distribution of the COVID-19 vaccines. It has previously worked with various agencies for the speedy delivery of personal protective equipment and other medical supplies. This initiative is part of the public-private partnership called Project Airbridge. The company possesses a vast global shipping network equipped with the necessary tools to take on the gigantic task.
The shipment of vaccines will be more challenging to ship than the PPE equipment they delivered before. A consistent, cold temperature is needed all throughout the process to ensure that vaccines maintain their potency. Once the vaccines experience a temperature excursion, they might lose effectivity that may result in the necessity for the revaccination of patients, losing thousands of dollars due to wasted vaccines.
Currently, FedEx has 90 cold chain facilities that can store cargo to keep them cool when not in transit. One of those is the FedEx Cold Chain Center at the FedEx Express Hub. It is 20,000 square feet wide, so cargo can be stored in this facility within three different temperature ranges: frozen, cold, and controlled room temperatures.
For remote areas and developing countries, the specifics of isothermal packaging and temperature control need to be managed in order to ensure the quality of the vaccines during transport.
Challenges facing the pharmaceutical cold chain
There will be an immediate increase in delivery demand once one or more vaccines have been approved. According to the International Air Transport Association, just a single dose to 7.8 billion people would take 8,000 747 cargo aircraft. In order to deliver the vaccines globally, as air cargo will be the primary delivery method. Regions with warm climates and limited cold chain facilities will face additional challenges in delivering the vaccines. Air transport, however, is not entirely flawless in transporting vaccines. IATA notes that 25% of vaccines were degraded prior to reaching their target location due to mishandling and improper shipping. Efforts are expected to grow tighter since the looming vaccine distribution may coincide with the holiday shipping rush.
Stringent temperature requirements also need to be maintained throughout the shipping process. The high-quality vaccines being developed will likely need extreme care during transport.
There should also be increased visibility in the supply chain data for everyone involved. In order to pinpoint potential roadblocks, investment in advanced technology is vital.
Despite the challenges, cold chain industries have had months to prepare for widespread distribution. Multiple facilities have been set-up in different parts of the globe. Due to the delicate nature of the vaccine, however, mishaps and errors can still occur, but, given the ample preparation time, mass distribution should not cause too much strain on the cold chain.