Pfizer is marshaling a massive new cold-storage supply chain to handle the delicate dance of transporting limited doses of its coronavirus vaccine from manufacturer to any point of use within two days.
Experts say it will be a “Herculean effort” requiring several new technologies to work in flawless concert to safely deliver every dose of the drug. Pfizer said it plans to ask the U.S. Food and Drug Administration for emergency use authorization next week, when it has the required two months of safety data.
The vaccine will be formulated, finished and placed in cold storage in the pharmaceutical giant's Kalamazoo, Michigan, facility, its largest such plant in the country. During the shipment and storage, the vaccines must be kept at 94 degrees below zero Fahrenheit in order to maintain optimal efficacy. Each package can contain 1,000 to 5,000 doses.
From there, the vaccines will be packed below dry ice inside thermal containers expressly designed by the company for this vaccine’s delivery.
The packages will be shipped via air to major distribution hubs and then delivered by ground transport to dosing locations, which “may include hospitals, outpatient clinics, community vaccination locations and pharmacies,” Pfizer spokesperson Kim Bencker told NBC News in an email. Some vaccines will also be shipped from a separate distribution center in Pleasant Prairie, Wisconsin.
Each package will be equipped with a GPS-tracked thermal sensor to monitor location and temperature, which the company says will “proactively” prevent “deviations” — such as accidents or theft.
The company is bypassing its usual wholesale distribution partners, including McKesson, which is also the main partner for the government’s Operation Warp Speed vaccine project, and spent over $2 billion to create its own direct distribution network.
Once the packages are delivered, receivers can store them in ultra-low temperature freezers for up to 6 months, inside a refrigeration unit for up to 5 days, or they can refill the box with new dry ice for up to 15 days of storage.
It's a delicate operation. The company has told the CDC that it recommends the thermal shippers are not opened more than twice per day, and should be closed within 1 minute.
“We have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring,” Bencker said. “Our distribution is built on a flexible just-in-time system, which will ship the frozen vials to the point of vaccination.”
The company announced Monday morning that long-awaited initial results in its blind trial, which had been expected to be released before the end of October, showed more than 90 percent efficacy. Pfizer said it had briefed President-elect Joe Biden's transition team, as well as President Donald Trump's administration.
While the positive news was greeted with cheers and relief, logistics experts say the drug giant has its work cut out.
Gen. Gustave Perna, the chief operating officer for the government’s Operation Warp Speed, which is tasked with distributing the vaccine, said Sunday on CBS' "60 Minutes" that tracking and tracing every dose will require the use of a program called Tiberius that links databases from shipping companies and the government, a capability that didn’t exist two months ago.
Experts caution that each new piece of technology raises the difficulty factor for this operation.
“Onshelf availability for a typical grocery product is 95 percent. That is achieved with decades-old supply chain arrangements and tried and tested technologies,” Tom Goldsby, a logistics professor at the University of Tennessee, said in an email. “Here, the stakes are much higher and the room for error is so small."
Because the vaccine requires two doses, it must be delivered to the right place at the right time and in the right shape, twice.
Pfizer's vaccine and others still in development all require subzero temperatures — and rely on several ingredients that are facing their own supply pressures.
Dry ice demand is up from various pharmaceutical makers working on vaccines and an increase in home food delivery. Supply is down as carbon dioxide, from which dry ice is made, is also down. The gas is captured during ethanol production, which has slowed as travelers drive less.
Standard glass vials will shatter in the extreme cold needed to preserve the doses, so glass manufacturer Corning has partnered with the government to create a special line, for which production is “ramping up to address any supply shortages that may emerge,” spokeswoman Gabrielle Bailey told NBC News in an email.
Success will require a range of private and public partners to work together in perfect concert to get two bull's-eyes.
‘We will rely on professionals across the full spectrum of the supply chain from the military to civilian sector manufacturers, distributors ... transportation providers … and the health care organizations called upon to achieve this Herculean effort,” Goldsby said. “Vulnerabilities at any point in this chain can seriously reduce the effectiveness of this whole effort.”
Pfizer CEO Albert Bourla said Monday it would be up to government health authorities to decide who gets the limited quantity vaccine and when.
By the end of 2020, Pfizer will produce enough doses for 25 million people, Bourla said, adding that sensitive groups and first responders may be able to walk in to pharmacies and receive the vaccine by the middle of 2021.
Next year, it will produce enough doses to vaccinate 630 million, with a large ramp-up in production in the later part of the year. The population of the earth is estimated at 7.8 billion.
It is unknown yet what percentage of people need to be inoculated from the coronavirus before “herd immunity,” in which sufficient numbers of a population are vaccinated so that community spread is unlikely.
“With 1,000 people dying every day in the U.S., there’s no time to lose,” Bourla said.