Commentary: Operation Warp Speed logistical plan takes ‘whole-of-America approach’

In addition to McKesson, there will be an army of private and public sector companies providing key logistical and supply chain support. UPS Healthcare and FedEx are the major subcontractors.

You have seven manufacturers. Six have advance orders in production and have 22 manufacturing plants in 13 states and three countries: the U.S., Canada and the Netherlands. You also have subcontractors providing logistics support, helping secure both the upstream supply chain raw materials as well as the making of the vaccine supporting equipment.  

Major Gen. Christopher J. Sharpsten is the deputy director for supply, production and distribution for Operation Warp Speed. He said the mission is to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January.

“We really view this as a ‘whole-of-America approach,’” Sharpsten said. “We know we would not be able to accomplish this mission without the unparalleled expertise of HHS scientists and CDC groundwork, as well as what we consider the DOD’s expertise in planning and logistics. So that combined with the ingenuity, the understanding, the innovation of American industry as well as academia, we think this is a magical set bringing all this together allowing us to achieve this mission in a really unprecedented time. This is a function of when the vaccine will be approved and how much production has taken place. Until that happens, based on the estimates we have, I would not disagree with what Dr. [Moncef] Saloui has stated in October publicly that all Americans could be immunized by June.”

Mission breakdown

The first challenge facing the companies in charge of the transportation of the vaccines is maintaining the vaccine’s temperature. This is not easy. Why? Vaccines are both temperature and UV light sensitive. If it gets too warm, the integrity of the vaccine can be compromised and become ineffective. It needs to be transported in what’s called a cold or cool chain. This logistics chain is designed to maintain a product’s quality from the time it is manufactured until the point of administration. In medical terms, this is defined as the efficacy of a product. If a vaccine’s temperature strays and becomes warm, that effectiveness is compromised.

This cold/cool chain is an extremely delicate balancing act because it requires precise control of the vaccine’s temperature. As we know, there are many vaccines in trial, and in the end, you could have one or several given Food and Drug Administration (FDA) approvals. The temperatures of the possible vaccines vary and can be required to be stored at temperatures as low as minus 70 to 80 degrees Celsius. There are also time limits on how long the vaccines can be kept unfrozen or at room temperature.

The critical pieces supporting this chain are the packages and containers that will house the doses and hold them at their critical temperatures during storage and transport. These doses will be placed in special packaging or third-party packaging that fall into two categories: active and passive. “Active” packing consists of powered large containers or boxes that contain an air-conditioning unit that is either electrically charged or gas charged so the unit can maintain a certain temperature. “Passive” packaging consists of specialty boxes that can be finely tuned insulators or containers that use dry ice to maintain temperature.

Sharpsten explained the safety and the efficacy of a vaccine will be determined through science and data. This not only includes the clinical trials but also the stability studies being run by the manufacturers. Both will be a part of the FDA review process.

“Once we have clear guidelines from the FDA, they will be published under the emergency use authorization,” he said. “Once we move into the distribution and administration phase in the delivery of the vaccine, we intend to apply that same discipline with science and data to the distribution efforts — to each company being used. We will use the existing pharmaceutical companies that routinely deliver biologic and drug products and leverage their expertise in maintaining proper handling and cold chain management.”

Sharpsten explained the efficacy assurance requirement of the vaccine will be broken down into two different perspectives. The first one is from the manufacturing and shipping point of view.

Cold chain system      

Just like the flow of trade is essentially a network of pipes where products flow, the logistical chain has its network — a hub-and-spoke system.

The main hubs are the plants where the vaccines are being manufactured and packaged. The spokes are the methods of transportation for the vaccine. Trucks pick up the containers and boxes from the manufacturing plant and transport the doses to freezer farms or to distribution facilities. If the vaccines need to travel further distances, those containers and boxes are transported by truck to the airport where they are loaded on planes and flown to their destination city. There another truck loads the containers off the plane and transports the doses to the distribution facility. The entirety of this logistical supply chain is an extremely delicate balancing act.

“The pharmaceutical industry routinely deals with a multitude of products — cold chain products.  We are working in conjunction with those companies to understand the current technology, the current techniques and the procedures,” explained Sharpsten. “In all cases we will be using passive monitoring devices on each vaccine shipment. There will be monitoring of temperature of all vaccine products throughout the distribution system.”

Operation Warp Speed will monitor the Pfizer vaccine with a passive technology device created by Pfizer. The other products, if approved by the FDA, will use a different passive monitoring device.

“If the product falls out of tolerance while it is in the distribution channel, that container will essentially be quarantined,” said Sharpsten. “We’ll monitor the inventory of vaccine product from the manufacturer to the administration site through our database system. If a shipment potentially goes bad, we’ll have a contingency plan in place to make up for that loss.”

Sharpsten explained these devices monitor the temperature over time and when it gets to a point where the package is out of tolerance, a red indicator will light up.

“Pfizer developed a special shipping box that uses dry ice to hold between 975 doses and 4,875 doses of vaccine,” said Sharpsten. “This shipping container is essentially 20 inches by 20 inches by 24-inch box with different thermal layers in it, and these shippers have what’s called a passive time temperature indicator to maintain cold-chain quality control. Pfizer will ship packages with dry ice.”

Tanya Alcorn, Pfizer’s vice president of biopharma global supply chain, has publicly said Pfizer will make its own dry ice. 

According to tests by Pfizer, unopened these Pfizer shipper boxes maintain minus 80 C for up to 10 days. Operation Warp Speed received a sample of the shipper at headquarters and has been going over the product daily. “We are picking it apart and putting it back together to make sure we understand it,” said Sharpsten.

Cold chain freezer capacity

The second problem Operation Warp Speed is focused on is vaccine administration. It is concurrently planning with the states and territories and major metropolitan areas. There are a total of 64 jurisdictions, each with hundreds of administrative sites, across the United States.

“Some states are moving at an exceptional pace and are doing great things. With other states, where they may lack necessary expertise on a pandemic response, we are providing additional assistance to them. We are required. So we really do view this as a whole-of-America approach,” explained Sharpsten. “We need to make sure they have sufficient cold-chain capacity at those sites to receive, store and administer the vaccines.”

The needs of these sites fall under two certain criteria: how much product the task force needs to send to them and how fast can they can administer those vaccines to patients.

Sharpsten gave a possible scenario. “The minimum shipment of a Pfizer shipment is 975 doses. So once the vaccines thaw, they can essentially be kept at [2 to minus 8 C] for five days. Most administration sites can do that. So if they can administer 975 doses within five days, ultra-low-temperature cold storage is not really a problem or requirement because they will go through the doses before the shipment expires.”

As far as the supply of ultra-cold freezers versus demand in the United States, Sharpsten said the task force is reviewing the response plan.

“We are taking down the state asks so we can assist them in determining the best locations for vaccination administration sites. Freezer capacity at minus 20 C and minus 80 C is a priority for these sites. So we are working with jurisdictions on how to best implement that Pfizer vaccine.”

Because of how the Pfizer product is shipped and must be stored, Sharpsten said Operation Warp Speed is emphasizing the importance of bringing the people to the vaccine, as opposed to bringing the vaccine to the people. 

If a more stable vaccine, one that could be stored at 2 to minus 8 C with stability of up to three months, that vaccine could, according to Sharpsten, be easily distributed far and wide to small doctors’ offices, etc. Johnson & Johnson’s vaccine would require storage at minus 20 C to be stable for two years and in the 2 to 8 C range for upward of three months.

Moderna and AstraZeneca have stated they expect their vaccine to require storage at minus 20 C/minus 4 degrees Fahrenheit, which most commercial freezers can reach.

Freezer farms

Freezer farms are also part of this logistical equation for the trucking industry. These farms will be either destinations for storing vaccines or cross-docking a few hours before it moves on to its destination. DHL has built a 20,000-square-foot freezer farm in Indianapolis. Both UPS and FedEx have “freezer farms” to store vaccines.

“To complement our existing cold-chain capabilities in support of the vaccine distribution, we are also exploring a combination of solutions including stationary freezers, temperature-controlled ocean containers and refrigerated trailers,” FedEx said on its COVID-19 readiness.            

Worries of a freezer truck crunch

With the volume of doses expected to be on the road, fears of freezer truck shortages have been a topic of discussion in various logistical forums. Concerns of medicines and frozen food taking a back seat to the vaccine are another. When asked about these worries, Sharpsten said, “It is hard to anticipate but we do not expect any hiccups in the movement of other drugs or food industry channels.”

Sharpsten said there are ongoing calls to address any possible distribution problems. “We are having calls with the leading companies and professional associations out there to better understand the market and which capabilities exist.

“As far as distribution capacity, we assessed it with our industry partners, McKesson, FedEx and UPS Healthcare, and they tell us that we are in a good position,” Sharpsten said. “These companies can scale up or scale down capacity based on requirements and orders and they don’t foresee any problem. FedEx and UPS think there might be a crunch on routine airlift capability during the holiday season but since COVID-19 products are receiving a higher priority of service, they have guaranteed essentially white-glove service that vaccine delivery will definitely not be impacted. Matter of fact, they are guaranteeing almost 24-hour delivery to administration sites once we hit the main hubs at Nashville and Louisville.”

FedEx said once approved, COVID-19 vaccines and related shipments will be the top priority for the FedEx Express network, with support provided by FedEx Logistics and FedEx Custom Critical teams.

The related shipments referenced by FedEx are the associated ancillary kits (syringes, needles and alcohol swabs) that will move concurrently with the vaccine. The flood of these products into the trucking system has sparked concerns of a possible trucking bottleneck. Sharpsten said Operation Warp Speed is confident in the logistics flow.

“In terms of any impact to the other pharmaceuticals or drug industry as well as the food industry, no, we are not anticipating any issues at this time,” he said.

Cold chain sky movement

The challenge of cold chain extends to the skies as well. The Federal Aviation Administration (FAA) has rules on how much dry ice can be on planes. Concerns of how much vaccine could be loaded onto planes was also voiced by those in the logistics community. When asked about the worry, Sharpsten said it’s been a focus in the logistical discussions.

“For dry ice, we are really only talking about the Pfizer product so it is only one of six vaccine potential candidates that could come out,” said Sharpsten. “We rely on UPS and FedEx expertise to get this done. If they subcontract out and decide to use crews from United, Delta, etc., it would be incumbent on them to ensure that they adhere to those FAA regulations. The U.S. government has not stipulated how that should go.”

If UPS and FedEx subcontract air logistics out, companies like SkyCell that partner with United Caro would be tapped to use their hybrid containers for vaccine transport. SkyCell in turn would use a life-science logistics company to move the containers to the airport.

Within the United States, SkyCell containers travel door to door. The containers arrive at the pharmaceutical manufacturer’s dock door, where the container is moved into a cold room, where the pallets are loaded. 

SkyCell containers come in two sizes, the 1500 and 2500. The numbers stand for the cubic liter displacement. Each holds one U.S. pallet of vaccine. Most pharma shipments are packed to about 3 or 3.5 feet high. In the U.S., pallets are usually 4 feet by 2.5 feet. In Europe, they are smaller, 47 inches by 31.5 inches. The company can move more than 24,000 pallets annually. These containers do not use dry ice to keep the medicines; they move cool/frigid.

“The first wave of shipments, the Pfizer vaccine, require deep frozen temperatures at minus 70 to minus 80 Celsius. This severely limits the amount of vaccine that can be sent regardless of container size,” explained Larry Tillem, director at SkyCell North America. “The Adenovirs vaccines like those being developed by J&J could move at plus 2 to plus 8 Celsius from the start. In essence, once temperatures reach below freezing, they limit the amount of vaccines per container.

“In the case of the COVID-19 vaccine, because of the temperature conditions, scrutiny in ensuring no temperature fluctuations must be felt the whole way through the logistical process,” stressed Tillem. “There is no cutting of corners.”

Once loaded, the container is transferred onto a cool truck, then moved to the airport. The container is then stored in a cool room at the designated airline where the container will be loaded onto the plane. Once the container arrives at the designated location, it is picked up by a cool truck and taken to its destination.

These containers are loaded onto airlines that have earned special certification to transport pharmaceutical and health care products. The certification is from the International Air Transport Association’s Center of Excellence for Independent Validators in Pharmaceutical Logistics. Delta Cargo was the first U.S. passenger carrier to earn such certification in 2017. American, AmeriJet, DHL and United Cargo also have certifications.

During an Operation Warp Speed weekly distribution working group call with McKesson, UPS and FedEx, Sharpsten said they learned the FAA has established a dry ice shipping working network. FedEx is a part of that working network.

“Working with the FAA, FedEx has significantly increased our capability to carry dry ice aboard our cargo aircraft, allowing us to service more health care shippers,” explained Smith. “On average, we now transport approximately 500,000 dry ice shipments a month.”

Security of vaccine transport

 After hacking attempts by foreign adversaries to steal vaccine information, the logistical security of the vaccine is paramount. Operation Warp Speed includes a security and assurance team. 

“This is a high priority for us. This team is embedded from members of not only the military but also members of Health and Human Services that do this on a daily basis,” explained Sharpsten. “I would tell you at Warp Speed, all modes of transportation are important and they will be secure through a whole-of-government, whole-of-industry approach. Our security efforts incorporate numerous interagency partners both local and federal. They do include the U.S. Marshals Service that is on board here with us at Operation Warp Speed for transportation security.  

“The whole-of-government approach we are using leverages each organization’s inherent capabilities in accordance with their authorities. Our intent is to leverage all of that to ensure that we see the threats that are out there and then we mitigate those risks in advance of us actually moving product over the road movement or through the air field movement as well,” he said. 

Sharpsten emphasized the mission of this logistics cold chain is to have a comprehensive approach to the planning with the jurisdictions on how they are going to receive and administer their vaccines.

“It is not necessarily that the federal government is telling a state or a major city how to do something,” said Sharpsten. “It’s about understanding their process so that we can ensure we deliver to them in the appropriate manner with the appropriate product. It’s really a hand-in-hand development of their plans so we can optimize their delivery and really increase uptake of shots to the American people. That’s the only thing we care about — making sure every American has the opportunity for a COVID-19 vaccine.”

The millions of faceless scientific and logistical workers involved in this mission will go down in history. For that, our nation thanks you.

 *UPS declined to comment because of its company quiet period. McKesson did not respond to emails for comment.