The drugmakers behind the COVID-19 vaccine approved Wednesday by United Kingdom authorities are studying whether it can be transported at higher temperatures than minus 94 degrees Fahrenheit (minus 70 Celsius), which would ease logistics challenges for getting people immunized, BioNTech CEO Ugar Sahin said.
In an interview on CNN shortly after the U.K. became the first Western nation to approve public use of the vaccine from U.S. pharmaceutical giant Pfizer (NYSE: PFE) and German partner BioNTech, Sahin said people in the U.K. could begin getting vaccinations by early next week.
The two companies already have produced 50 million doses for potential distribution by the end of the year after receiving up-front orders from governments ahead of regulatory approval in an effort to speed up the normal time frame for launching immunization programs.
Forty million doses of that stockpile, enough to vaccinate 20 million people, are allocated for the U.S., where the Food and Drug Administration is scheduled to meet Dec. 10 to decide on granting emergency use authorization. Pfizer/BioNTech say clinical trial data shows their vaccine is 95% effective at protecting against COVID-19. Federal officials told governors in a recent call that Operation Warp Speed, the logistics task force led by the departments of Defense and Health and Human Services, could launch U.S. delivery by Dec. 15, according to CBS News.
British Health Secretary Matt Hancock told the BBC that 800,000 doses would be immediately available in the U.K. Pfizer/BioNTech will supply 40 million doses to the U.K. through 2021.
Pfizer and BioNTech will coordinate with governments but manage the distribution of their temperature-sensitive vaccine,with delivery handled by major express carriers FedEx Express (NYSE: FDX) and UPS (NYSE: UPS).
“This is the early phase of pandemic supply. Of course the early phase of pandemic supply is a logistical challenge for all of us,” Sahin said outside the company’s headquarters in Mainz, “not only the storage and transportation of the vaccine, but also getting the people to the right places at the right time and ensuring that they can come back for the second vaccination.”
Pfizer/BioNTech developed a new technology that relies on a fragile genetic material called messenger RNA and must be deep frozen to maintain stability. Keeping it at ultra-cold temperatures requires specialty freezers that are not in wide supply beyond hospitals, research facilities and large pharmacy chains. Many cold-storage warehouses, refrigerated trucks and airport facilities are also not designed to handle ultra-cold temperatures.
Pfizer has developed a special thermal cooler that can keep vaccines at minus 112 degrees F (minus 80 C) for up to 10 days. It can be kept at 35.6 to 46.4 degrees F for five days once the package is opened.
Shipping the Pfizer/BioNTech product, and temporarily storing it at local administration sites, will require large amounts of dry ice to maintain its integrity. UPS and FedEx, for example, have added dry ice manufacturing capability at their giant package hubs in Memphis, Tennessee, and Louisville, Kentucky, to repack shipments and supply local facilities.
Pfizer says its just-in-time delivery system will minimize the need for long-term storage anywhere.
“We are working at analyzing other transportation temperatures including minus 20 Celsius (minus 4 degrees F). We are evaluating whether the vaccine is stable at 2 to 8 degrees Celsius [regular refrigerated temperature starting at 35.6 F] for a longer time,” Sahin said. “And what we’re also already working on is a second-generation formulation which might allow us transportation at even room temperature.”
The company will develop additional data in the next few months about the ability to transport the vaccine at a less severe temperature. “The second generation will be available, most likely, in the second half of 2021.”
BioNTech has mRNA production sites in Mainz and Idar-Oberstein, Germany, and will increase its manufacturing capacity in 2021 once a third site in Germany opens. Pfizer’s manufacturing site in Puurs, Belgium, will be largely responsible for supplying the U.K.
Sean Marett, BioNTech’s chief commercial officer, told CNN doses for the UK were being packed very quickly in thermo coolers at the Purr facility, and will be shipped by truck or plane.
The Puurs site is being used primarily for European supply, but will also serve as backup supply to Pfizer’s U.S. plant in Kalamazoo, Michigan.
On Friday, United Airlines operated a charter flight with the first shipment from Belgium to Chicago to preposition the vaccine for U.S. distribution, The Wall Street Journal reported.