Should Pfizer and BioNTech secure emergency approval for their coronavirus vaccine, the companies would face a distribution challenge unlike any other.
The experimental shot, which Pfizer and BioNTech said this week was more than 90% effective in preventing COVID-19, must be shipped at ultra-cold temperatures. Demand for the vaccine, if approved, would be both immediate and global, far outstripping what the companies will initially be able to provide.
Distribution would initially involve about a dozen trucks per day leaving a Pfizer plant in Kalamazoo, Michigan, as well as 20 planes taking flight daily around the world, a company spokesperson said.
Shippers like DHL, FedEx and UPS would be tapped to transport the vaccine across the U.S., where Pfizer expects to be able to deliver product to "points of use" within one to two days, according to the spokesperson.
Pfizer and BioNTech haven’t yet asked the Food and Drug Administration for emergency use authorization, choosing to wait until they have sufficient safety data in hand, likely by next week. An emergency review by the agency would probably take one to two weeks.
Currently, Pfizer and BioNTech estimate they can make about 50 million doses this year, and as many as 1.3 billion doses in 2021. The vaccine is given via two shots, so 50 million doses would cover 25 million people.
"It's not going to be massively available," said Pfizer CEO Albert Bourla, on a recent company earnings call. "It's going to be targeted in its availability. As we move into the first months of 2021 then we are going to have much more massive distribution of the vaccine around the world," he added.
Pfizer, which agreed to provide 100 million doses to the U.S. for nearly $2 billion, said it would work with the federal government to determine where its vaccine would be distributed first. Initially, the focus would be on sending supplies to hospitals, outpatient clinics, community vaccination locations and pharmacies.
Unlike other leading coronavirus vaccine developers, Pfizer did not work with the U.S. government on testing and manufacturing of its shot and will not use McKesson, the Trump administration's distribution partner for its Operation Warp Speed vaccine initiative, to allocate its shot.
Instead, Pfizer will ship frozen vaccine vials directly from its plants to points of vaccination. The strict cold chain requirements for the vaccine was one reason why Pfizer chose not to use McKesson, Pfizer said.
Pfizer and BioNTech's vaccine must be kept at minus 70 to 80 degrees Celsius, requiring dry ice to maintain. Other vaccines don't need to be kept as cold, typically requiring temperature ranges of 2 to 8 degrees Celsius, or minus 20 degrees Celsius.
To help keep the vaccines cold throughout shipping, Pfizer designed a special shipping box that can maintain a storage temperature of minus 70 degrees Celsius for up to 10 days.
"The intent is to utilize Pfizer strategic transportation partners to ship by air to major hubs within a country/region and by ground transport to dosing locations," the spokesperson said.
The boxes will be outfitted with a GPS tracker that will allow Pfizer to track the shipments from a control tower, so the company can ensure shipments don't thaw. The shipping box can be refilled with dry ice at the dosing location to keep the vaccine sufficiently cold.
With supplies limited, keeping the cold chain intact is critical. Typically, drugmakers report spoilage rates for vaccines of between 5% to 20% due to inadequate temperature control, Glenn Richey, the chair of the supply chain management department at Auburn University, said in a statement.
In addition to solving distribution hurdles, Pfizer is also working to ramp up manufacturing to expand supply next year, including ensuring it has sufficient raw materials on hand and capacity to manufacture.
"We have worked closely with our suppliers as we ramped up production of a potential COVID-19 vaccine," the company spokesperson said. "At this time, we do not anticipate supply concerns for vaccine components, although of course a disruption of the supply environment is always possible during a pandemic."
DHL, FedEx and UPS have spoken publicly about participating in coronavirus vaccine distribution but have largely avoided talking about the companies they're working with, although Pfizer has confirmed the logistics companies are part of its distribution team.
UPS is working to build out a freezer farm in Louisville, Kentucky, that will help with the distribution of the vaccines, according to Bloomberg. FedEx has an airplane fleet of 600, as well as 90 cold storage facilities around the world.
Logistics companies are confident in their ability to handle a coronavirus vaccine, but Auburn's Richey noted distribution will still put a strain on the country's supply chain infrastructure.
There is "still time to act," Richey said. "But it will likely take an all-hands-on-deck, tightly coordinated effort by federal, state and local government working hand in hand with private industry to pull it off.