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For the past few months, Joachim Kuhn has scrambled to rework his factories and rapidly ramp up production of temperature-controlled containers — a critical but often overlooked part of the global supply chain that will be needed to deliver Covid-19 vaccines around the world.

Container supplies are among the countless challenges facing companies that are part of a vast, behind-the-scenes global network planning to quickly transport huge numbers of Covid-19 vaccines. And each link in the proverbial chain —  from finding a spot to keep doses sufficiently cold to protecting them from heists — is equally important in order to ensure enough vaccines reach their far-flung destinations as quickly as possible.

“This is high noon for vaccination,” said Kuhn, chief executive officer of Va-Q-Tec, which rents containers and sells storage boxes for shipping pharmaceuticals and vaccines.

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The specially designed containers vary in size, but typically can hold thousands of doses of vaccines that must be stored at specific temperatures to remain effective over time. But with forecasts calling for billions of doses needed over the next couple of years, Va-Q-Tec and other container manufacturers are racing to meet unprecedented demand. The Germany-based company is growing its inventory of containers by 50% and attributes more than half of a 90% increase in sales of storage boxes this year to the pandemic.

“Everything depends on how many vaccines will be on the market, whether they require one shot or two shots, where they are produced and how much distribution is needed. And there will be high demand for safe transports,” he explained. “So there are many, many questions. Everybody has to think about how to handle this sensitive and precious cargo.”

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The pandemic has prompted the U.S. government and others across the globe to secure huge numbers of doses from Covid-19 vaccine manufacturers, who are pushing clinical trial timelines like never before in order to get their vaccines ready for use as soon as possible. One or more of these vaccines may be approved by regulators here and abroad in the months ahead.

The effort to distribute those vaccines has accelerated just as quickly. Just as container makers are squeezing more out of their production plants, vaccine makers are busy modeling transportation routes and storage conditions in many countries. Wholesalers are lining up warehouse space and trucks. And freight forwarders and airport managers are expanding security for what will immediately become the world’s hottest commodity.

“I’m more than 30 years in the business and thought I’d seen everything, but it’s an unchartered situation for all of us,” said Larry St. Onge, global life sciences and health care sector president at DHL, which provides a range of transportation services for pharmaceutical products. “The scale of the challenge is going to be very large and there will be a pressing need to eliminate bottlenecks.”

To transport Covid-19 vaccines globally, DHL estimates that about 200,000 pallet shipments and 15 million deliveries in cooling boxes will be required. And to make that happen, approximately 15,000 flights will be needed.

To be sure, transporting pharmaceuticals and vaccines that require temperature-controlled environments – such as containers, special freezers and storage facilities — has long been a big business. Before the pandemic, global spending on so-called cold-chain logistics was forecast to reach $17.2 billion this year, according to the Biopharma Cold Chain Sourcebook.

Most of that spending will be devoted to air freight, as opposed to ground and ocean shipping. Meanwhile, about $5 billion will be spent this year on insulated containers and instrumentation, the sensors and data loggers that are used to track shipments and temperatures, respectively, according to Nick Basta, founding editor of Pharmaceutical Commerce.

Such spending was already rising before the pandemic because of the growing number of biologic medicines, which also have special shipping and storage requirements. The total value of temperature-controlled pharmaceuticals is estimated at $341 billion, out of a total 2020 market of $1.3 trillion. Basta added that the overall value of cold-chain pharmaceuticals is expected to grow at approximately twice the rate of conventional medicines between 2018 and 2024.

This enormous spending — which is now likely to balloon even more during the Covid-19 crisis — reflects the complexities of the supply chain.

This is how it typically works: Vaccines are placed in storage boxes, which are then placed in temperature-controlled containers. The vaccine maker usually has an agreement with a freight forwarder, which is responsible for transportation or making arrangements for transportation, such as refrigerated trucking to distribution centers. From there, the containers are delivered to an airport, where they are stored in temperature-controlled facilities before being loaded on to airplanes.

But when it comes to Covid-19 vaccines, supply chain experts are planning with an incomplete picture. For instance, companies are still waiting to learn how long each vaccine will remain stable and, therefore, effective. They also have to consider the degree to which vaccines must be kept cold, depending on the technology used to develop each vaccine.

Typically, vaccines are stored at 2 to 8 degrees Celsius, but some Covid-19 vaccines may require much colder temperatures, anywhere from -20 to -80 Celsius. Moderna, for instance, expects its vaccine to be shipped at -20 Celsius, while Pfizer is working on a vaccine that must be stored at -70 Celsius.

Pfizer, meanwhile, developed its own thermal shipping boxes that can hold up to 5,000 doses for up to 10 days if stored at the point of vaccination at the proper temperature. But the boxes, which would be shipped in containers, should not be opened more than twice a day and not open for more than one minute at a time, another example of supply chain challenges.

Generally, most temperature-controlled containers can hold vaccines for a few days, although dry ice is used to keep vaccines from thawing out for another few days. Such requirements, however, add still more pressure on each link in the supply chain to properly store doses and also move shipments quickly from one destination to the next.

“The problem is there’s not even remotely enough capacity in the system to service that and it’s a critical system and that’s what everybody is scrambling to look at,” said Mark Sawicki, chief executive officer at Cryoport, which specializes in cold-chain logistics services. “There’s not enough inventory of temperature-controlled containers to support anticipated systems.”

“There aren’t millions of square feet of -80 Celsius storage space in the world. You can’t use a massive cold box at an airport like you would use for bananas. It doesn’t exist, he added. “But if you have countless doses of vaccines with limited storage capacity, how do you address that? And any accumulation at airport locations with limited storage for that temperature range also creates a risk.”

“There’s very little tolerance for mistake.”

Neel Jones Shah, global head of air carrier relationships, Flexport

“There’s very little tolerance for mistake,” said Neel Jones Shah, executive vice president and global head of air carrier relationships at Flexport, a freight forwarder. “What if a vaccine isn’t loaded on a plane right away and sits out for a period of time? It may have to be destroyed if the temperature went out of range. What if you don’t have enough refrigerated trucks to handle a shipment or refrigerated storage facilities when a shipment lands? ”

Planning is made still more complicated by changing flight trends. Fewer passenger planes are flying due to the slowdown in air traffic caused by the pandemic. For the past three decades or so, drug makers shipped about half of their products in the bellies of passenger planes, but as much as 80% of that capacity has disappeared, according to Jones.

More than 30,000 aircraft flew pharmaceuticals last year, according to the International Air Cargo Association. By April, roughly 18,000 aircraft were grounded, and overall cargo volume could decline by 14% to 31% in 2020. The association is working with another industry organization, Pharma.Aero, to find ways to safely and efficiently move Covid-19 vaccines in and out of airports.

“One of the biggest challenges we’re facing is capacity, the space on airplanes,” said Emir Pineda, manager of aviation trade and logistics at Miami International Airport. “Today, most markets in the world are closed. We don’t have passenger airlines flying to many places at the level as we did before. And we don’t know when or how much of it will come back. It’s very worrisome.”

Pineda has another concern: preventing heists. Theft is hardly a new worry for drug makers and their transportation partners, but anxiety is running high because any Covid-19 vaccine will be extremely valuable. Pineda is forming a task force with members of the security, police, real estate, land, and planning departments of the airport, which will then work with airlines, truckers, and storage companies.

Pfizer, for instance, is adding extra security and background checks on everyone involved in each step of the process for transporting vaccines. Moreover, each box of vaccines will have a GPS tracker placed inside, a step the company has not taken before. In the past, the company would simply place a GPS in each truck to ensure the vaccines followed the planned routes over the estimated travel time.

“We’ll be able to monitor the shipment from the time it leaves the plant to where it needs to get to,” said Tanya Alcorn, who heads the Pfizer supply chain team. “We have a control tower — a digital system that looks at temperatures and locations of all boxes plotted against a route. The system will push alerts to our phones and computers if there’s a deviation in temperature or the driver is not following course or at a place on time.”

Such concerns are magnified when distributing to other parts of the world, supply chain experts said.  On top of the usual security issues, some poorer countries may lack certain forms of infrastructure, whether it is refrigerated storage facilities at airports, a sufficient number of refrigerated trucks, appropriate cold storage in hospitals, or passable road conditions in certain areas.

“Each country may work differently,” explained Roddy Martin of TraceLink, which develops technology to mitigate diversion and counterfeiting. “There will be this mad scramble, especially in low-income markets where verification is harder. How will you know a vaccine is not a counterfeit or has been diverted? The angst around all this  — everything in the supply chain, for that matter  — is going to be on orders of magnitude higher than we’ve previously seen.”

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