Over 24 million cases of COVID-19 have been confirmed worldwide, including more than 800,000 deaths. There is a dire need for therapeutics and vaccines to fight the pandemic, and the biopharmaceutical industry has been working at a furious pace to develop effective products. While the accelerated development and manufacture of COVID-19 vaccines is a daunting task, the greatest challenge may lie in getting those vaccines to billions of people around the world.
A Complicated and High-Stakes Supply Chain at Unprecedented Scale
Distributing an effective COVID-19 vaccine to the global population will likely be the greatest logistical challenge since World War II. Delivery by air, which will be challenging given the shortage of air cargo capacity, can only occur to airports certified to receive pharmaceuticals, and these airports can only handle so much product at a given time.1 The vaccines will then be transported to distributors for allocation to hospitals, pharmacies, and vaccination centers, which have yet to be established. Enhanced security will be required to prevent theft of the valuable products, and many will also require specialized low-temperature packaging and shipping conditions.
The level of distribution required is unprecedented. For comparison, 174.5 million doses of flu vaccines were supplied to the U.S. market between September 2019 and February 2020.2 The U.S. government’s Operation Warp Speed hopes to distribute 300 million doses by January 2021.
This is not an easy ask. For diseases such as polio and measles, using UN agencies and country networks, vaccination levels did not reach 85–90%, and in some cases barely reached 70%.3 Given the mutation potential of SARS-CoV-2, vaccination levels above 90% may be needed. Additionally, more than one vaccine may be required, and multiple doses of a given vaccine may be needed to ensure effectiveness.
Since all of the doses needed to treat everyone will not be available immediately, it will be necessary to prioritize recipients.4 Ensuring efficient and equitable distribution among countries may also be a challenge if governments mandate that doses produced within their borders be strictly for domestic consumption.1
A tracking system will also be needed to manage orders, demand needs, inventory, dosages administered, and safety in real time.4 Once the first doses are administered, it will be crucial to follow up with each person to ensure they receive booster shots as appropriate.
Numerous Uncertainties
The biopharmaceutical industry has been working at a furious pace to develop effective vaccines, with three vaccines presently in phase III clinical trials, dozens more in early clinical stages, and well over a hundred in preclinical development.1 Uncertainties abound about the production and delivery of COVID-19 vaccines: the timeline to approval, the quantity of doses needed, raw material availability, and the global temperature-controlled capacity.
Based on a number of considerations, McKinsey concluded that seven to nine, and possibly even up to 20, new vaccines could be approved over the next few years, with several products available for prioritized populations between the fourth quarter of 2020 and the first quarter of 2021.5 Vaccine manufacturers have announced they will have the ability to produce 1 billion doses by the end of 2020 and 9 billion doses by the end of 2021.
To help get ahead of the situation, the National Governors Association has urged governors to start planning the exact processes and procedures that will be used for operations, administration, and logistics, starting with leasing warehouse space, and securing freezers for vaccine storage.
U.S. health officials recently announced that the government intends to purchase enough vaccines for the entire population, cover the cost of distribution, and ensure that they are provided free, with no co-pays, to all Americans. The U.S. Centers for Disease Control and Prevention have exercised an option in an existing 2016 contract with drug distributor McKesson, already the country’s vaccine wholesaler, to designate McKesson as the nation’s primary distributor of COVID-19 vaccines and related supplies.6 Under the option’s terms, the CDC would direct the delivery of vaccines and supplies to hospitals and clinics, leveraging the firm’s established infrastructure for the distribution of childhood vaccines, as they previously did for H1N1 vaccines in 2009–2010.
Transportation Capacity Limitations
Assuming the raw material challenges can be overcome, companies that commercially produce COVID-19 vaccines, whether in glass vials or plastic prefilled syringes, will rely heavily on others, from manufacturing plants to distributors.
The grounding of millions of passenger flights around the world has reduced international belly cargo capacity significantly. In response, over 100 carriers have converted passenger aircraft for cargo-only operations shipments.7 Shipping prices have also skyrocketed and are expected to remain high and volatile due to these capacity shortages and uncertainties associated with demand.1 Freight rates could even rise further, because vaccines could potentially be ready to ship when several smartphone and electronics product launches are scheduled.8
However, because most COVID-19 vaccines will require storage at 2–8 °C and potentially –80 °C, this approach will require the development of novel solutions for establishing and maintaining low to very low temperatures in the entirety of these aircrafts. Restrictive measures regarding the movement of goods, implemented as a result of the pandemic, could also potentially impact the shipment of vaccines across borders.
Some U.S. companies have been bringing products into Canada and then trucking them into the United States.2 Others are relying on chartered private planes to deliver finished drug products. Neither approach is feasible on the scale required for the distribution of COVID-19 vaccines.
However, one answer would be for the pharmaceutical industry to combine a distributed manufacturing approach with multiple manufacturing sites in different regions. This would minimize distribution needs through a multimodal transport solution.7 It may also be possible to ship the vaccines in bulk. For vaccines that reach the market later in 2021 and beyond, shipment in less-than-container-loads (LCLs) for transport by ocean may also be feasible.8
Maintaining Temperature Control
Maintaining the cold chain will be a crucial issue for COVID-19 vaccines, which poses a significant problem in many parts of the world. Low temperatures must be maintained whether a vaccine is being delivered to a wealthy, densely populated city or a poor, sparsely populated rural area. In 2005, the World Health Organization estimated that up to 50% of vaccines are wasted globally every year, in large part due to a lack of temperature control and the logistics to support an unbroken cold-chain.9 One estimate pegs the loss of cold-chain biopharma products to temperature-related supply chain issues at $35 billion.10
To avoid these historic levels of spoilage, vaccine manufacturers must ensure they use only thermal shippers and temperature-controlled containers certified to meet the international regulations for the handling of temperature-sensitive products, such as EU Good Distribution Practices and the U.S. Federal Drug Administration’s, the WHO’s, and IATA’s standards for temperature-sensitive products. Since there are only a handful of providers who manufacture these certified packaging solutions, continual availability of containers will be crucial.
Most COVID-19 vaccines in development require a temperature-controlled environment of –70°C. This may require a high-performing active thermal shipper. Putting those shippers into an active air cargo container can extend the duration to more than 10 days.11 With the expected delays associated with air cargo transport and the extended durations required for remote deliveries, advance planning and lease forecasting will be crucial to ensure an adequate supply of containers for COVID-19 vaccine distribution with-out negatively affecting distribution of other pharmaceuticals.12 Container providers will also need to find creative ways to manage one-way drops in more rural or remote locations and the return transport of the empty container so it can be put back into service efficiently. Trucks that provide refrigerated transportation for the pharma industry will also have to comply with the varying storage requirements of different vaccines.
Maintaining the cold chain upon delivery to distributors/distribution centers will also be crucial. Cold-chain compliance requires a reliable supply of electricity, access to refrigeration and, for some vaccines, advanced freezers that can reach extremely low temperatures. In the United States, the available cold storage capacity is estimated to be just 15%.14 Companies that make temperature-controlled containers are working to boost production and pre-condition them in advance of the expected surge in demand.3
Planning for an Approval
With the extreme uncertainty about which vaccines will be approved and when, flexibility, adaptability, and collaboration will be essential for achieving the mammoth task of delivering multiple viable vaccines to nearly 8 billion people over a few years.
Manufacturers must be flexible with capacity, potentially even making it available to competitors if their vaccine is not approved and a rival company’s is. They must also be prepared for variances in demand, depending on the course of the pandemic.5 Shippers and distributors must be prepared to handle different vaccines with different storage and handling requirements. Governments must design distribution programs that also take into account the requirements of different vaccines, as well as the available capacities, capabilities, and resources of the various localities under their jurisdictions.
Equally important, all stakeholders must consider the entire supply chain — from product shipment, to healthcare provider consultations, to vaccine administration — and collaborate to ensure that COVID-19 vaccines are delivered.5 Partnerships between industry and individual governments are accelerating vaccine development and manufacturing, but global cooperation is also needed on everything from raw materials to vaccine distribution.
Contingency plans must be in effect so that companies can adapt when problems arise in both manufacturing and distribution.2 In particular, companies need to be prepared to rescue vaccine shipments for which delivery is delayed (or affected in some way) so that temperature excursions do not occur. This will depend heavily on container providers and their ability to track excursions and provide visibility and alerts, allowing the vaccine manufacturer to intervene.14
How Boyle Transportation Can Help with Transportation
For COVID-19 vaccine manufacturers, Boyle Transportation offers a strategic approach to logistics and transportation that includes highly trained and experienced employees, advanced technologies to ensure validated temperature control and product tracking from pickup to delivery, and extensive risk-management systems. We emphasize quality, are committed to continuous improvement, and are transparent about our operations; we provide extensive metrics reporting, in-transit visibility, and milestone updates to our clients. Boyle’s nearly 50 years of experience providing logistical support to government agencies and transporting defense materials led us to establish enhanced security protocols beyond what is typically needed to transport drugs but may be key if vaccine supply cannot keep up with demand. Challenges of great importance are commonplace to Boyle.
As a result, Boyle Transportation not only ensures uniformity, reliability, and the high-quality delivery of crucial pharmaceutical products, we can provide — even under crisis situations — access for our customers to markets and people all across the United States, including COVID-19 vaccines when they are available. Our advanced temperature-controlled trailers are outfitted with premium specifications and technologies and undergo extensive calibration and validation in accordance with USP <1079>, which confirms that all sensors are accurate and proves the efficacy of the trailer’s temperature control.
Boyle Transportation provides a digital chain of custody to our customers, including driver credentials, electronic temperature readings, and shipment status reporting en route. Boyle also leverages real-time communication technology to track each vehicle’s location, route, and estimated time of arrival (ETA), as well as its temperature throughout transportation. If we incur a mechanical issue, or if the temperature veers outside the predetermined tolerance, an alert is communicated both to the professional drivers and our 24/7 operations center. That way, we can take action immediately and mitigate the risk of any effect on the product. Customers have complete visibility into shipment information.
How CSafe Global Can Help with Temperature-Controlled Containers
Products that require transportation at –70 °C may require bundled solutions combining Boyle’s validated temp controlled vehicles and CSafe Global’s thermal shipping solutions. CSafe is the only provider of both active and passive temperature-controlled containers and has tested the effectiveness and duration of the combined solution for deep-frozen product shipments. With telemetry devices installed in our active container fleet, we will be able to transmit real-time data to a custom visibility platform 24/7. Customers and the CSafe support team have the ability to monitor payload and ambient temperatures, door opening events, container location, and more throughout a shipment. If any reading deviates from the preset requirements, the system alerts users to allow for any needed intervention.
In addition to providing complete shipment visibility, CSafe is able to assure container availability using our artificial intelligence lease forecasting system. This system will be critical in the COVID-19 vaccine distribution effort by using historical lease data, current customer orders, customer forecasts, container maintenance schedules, and more to tell our logistics team where to drop our containers and when. We won’t have to stockpile CSafe containers waiting for an order and putting further strain on the supply chain. Instead, we are able to efficiently and cost-effectively deliver them to customers in perfect condition for every shipment — every time.
References
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Murray, Brendan and Riley Griffin. “The World’s Supply Chain Isn’t Ready for a Covid-19 Vaccine.” Bloomberg. 25 Jul. 2020. Web.
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Chen, Elaine. “Drugmakers Race to Build Covid-19 Vaccine Supply Chains.” Wall Street Journal. 30 July 2020. Web.
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Nadqujar, Prasad. “Air logistics for Covid-19 vaccine.” The Stat Trade Times. 27 Jun. 2020. Web.
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Spiro, Topher and Zeke Emanuel. “A Comprehensive COVID-19 Vaccine Plan.” Center for American Progress. 28 Jul. 2020. Web.
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Agrawal, Gaurav, Michael Conway and Adam Sabow. “On pins and needles: Will COVID-19 vaccines ‘save the world’?” McKinsey. 29 Jul. 2020. Web.
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Hopkins, Jared S. “McKesson Tapped to Distribute Coronavirus Vaccines in U.S.” The Wall Street Journal. 14 Aug. 2020. Web.
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Gruber, Andrea. “Transport of vaccines by air.” Logistics Update Africa. n.d. Web.
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Knowler, Greg. “Capacity-constrained air cargo raises red flag for COVID-19 vaccine distribution.” Journal of Commerce. 24 Jul. 2020. Web.
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“Monitoring vaccine wastage at the country level.” World Health Organization. May 2005. Web.
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Nawrat, Allie. “Pandemic logistics: resolving manufacturing and distribution challenges.” Pharmaceutical-Technology.com. 6 Aug. 2020. Web.
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Frattaruolo, Emilio. “COVID-19 Vaccine Distribution: Packaging an End to the Pandemic.” Parcel Blog. 13 Aug. 2020. Web.
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“Digital Transformation Webinar.” CSafe Global. 12 Aug. 2020. Web.
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Brooks, Kristin. “Is Blockchain Key to COVID-19 Vaccine Distribution?” Contract Pharma. 5 Aug. 2020. Web.
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CSafe Global Selects Cloudleaf as Strategic Partner to Deliver a New Digital Visibility Platform. CSafe Global. 23 Jul. 2020. Web.
