Mock shipments of COVID-19 vaccine to test the federal government’s transportation and logistics planning have experienced spotty on-time performance, Pennsylvania Secretary of Health Rachael Levine warned a Senate subcommittee Wednesday.
Operation Warp Speed, a multiagency task force coordinating the national distribution to states, has already begun pre-positioning stockpiles of the first batch of vaccines made by Pfizer (NYSE: PFE) and German partner BioNTech and is expected to begin last-mile deliveries to designated administration sites within hours of the drug’s approval for emergency use. A Food and Drug Administration committee of independent experts is meeting Thursday to review the safety and efficacy of the Pfizer vaccine, which has shown 95% positive results in recent trials, with the agency likely to approve its recommendation within days.
Levine, who is also president of the Association of State and Territorial Health Officials, testified that during practice runs there frequently was a two-day lag between arrival of the vaccine and related supplies such as syringes, alcohol swabs and protective gear.
“In approximately a quarter of states, at least one significant issue arose during the mock shipment that requires attention prior to shipping the actual vaccine,” she said in prepared remarks to the Senate Commerce Subcommittee on Transportation and Safety. “Vaccine that arrives without the ancillary supplies required to administer it will delay the vaccination of key prioritized populations.”
OWS is procuring the ancillary supplies that McKesson Corp., the government’s central logistics coordinator, will assemble into kits to be paired with vaccine supplies at destination.
U.S. officials say they plan to deliver 40 million doses of the Pfizer vaccine and one from Moderna, which is up for FDA review next week, by the end of the year. The government prepurchased 100 million doses from each company, enough to immunize 50 million people because both products require two doses spread over three or four weeks.
States and other vaccine jurisdictions have the final say on where they want vaccines to be shipped. OWS, led by the departments of Defense and Health and Human Services, and Pfizer have been conducting dress rehearsals for delivering and dispensing vaccines to iron out any kinks, but Levine said they have had “varying levels of success.”
During a briefing Wednesday, Army Gen. Gus Perna, Operation Warp Speed’s chief operations officer, said daily briefings among governors, health officials and industry partners are identifying remaining issues that need to be resolved.
“We’re solving problems ahead of execution,” he said. “Does this mean perfection? No. What is important is the open communication and collaboration.
“I feel confident that we’ve done detailed planning. We’ve worked through rehearsals. We have checked the ‘what if?’ box and we continue to learn every day in preparation for eventual distribution.”
Executives at FedEx Express (NYSE: FDX) and UPS (NYSE: UPS), the primary express transportation providers for Pfizer and McKesson, said their companies are ready for the challenge after years of experience supporting pharmaceutical companies and extensive investments in cold-chain systems. Pfizer is managing its own vaccine distribution in coordination with OWS.
Last week, Perna and Moncef Slaoui, chief scientific adviser to OWS, visited one of UPS’s health care facilities in Louisville, Kentucky, to review supply lane plans, handling of ultra-low-temperature shipments and how UPS will manage its dry ice replenishment program.
“I believe they left feeling confident in our degree of readiness,” UPS Healthcare President Wes Wheeler said.
Drugmakers have been customers of FedEx and UPS for a long time, so vaccine distribution isn’t new territory, said Richard Smith, FedEx Express’ president of the Americas region, during an OWS summit at the White House on Tuesday.
“We know them well, we know their business well, we work well together. And we plan for these things every year. We jump into action and use our networks in times of disaster relief and deliver for good . . . into effected communities when that happens. So we’re well-versed in planning for this,” he said. “So we’ve spent a lot of time on that. I think a lot of the onus on protecting the vaccine is on the packaging side.”
UPS Healthcare is providing logistics support for eight of the 10 leading vaccines currently in clinical trials.
Both companies have mapped out tens of thousands of lanes across the country and globally to make sure they have the necessary capacity.
The vaccine rollout comes when parcel companies are trying to manage explosive growth in package volumes as people who are sheltering at home because of the pandemic spend their money shopping online. UPS on Monday delivered 34 million packages. But Wheeler said UPS’s transportation network is making the vaccine a priority, with capacity reserved in its air network, package hubs and ground terminals.
Pfizer/BioNTech’s vaccine, which relies on a new messenger RNA technology, must be stored at minus 70 degrees Celsius/94 Fahrenheit to maintain stability. Supply chains are set up to handle medicines and perishable foods at frozen, refrigerated and ambient temperatures, but Pfizer’s extreme temperature requirements complicate transportation and storage.
Pennsylvania intends to direct the Pfizer vaccine to large health systems that have ultra-cold storage capacity and the ability to vaccinate many adults in a short period of time before the drug spoils, Levine said. The state intends to use the Moderna product, which is kept at minus 20 degrees C, in more rural areas where health care providers lack the same cold-storage infrastructure and have smaller numbers of staff and patients to vaccinate at once.
Pfizer’s vaccine ships in quantities of 975 doses and can’t be broken down into smaller allotments. The company developed its own thermal shipping box to store dry ice and keep the vials deep frozen during transit.
FedEx, UPS cold chains
FedEx and UPS were busy this year building out pharmaceutical distribution infrastructure.
UPS recently invested in equipment to manufacture its own dry ice for refreshing containers moving through its main package hub in Louisville and to replenish dosing sites where needed. The facility can produce about 28,000 pounds of dry ice per day and UPS “will ship a box with 40 pounds of dry ice to all Pfizer dosing locations a day after the vaccine arrives,” Wheeler said.
UPS is also nearly finished installing extra-large coolers and freezers in the same facility for future storage of anticipated vaccines, has invested in a cryogenic freezer for subarctic storage and offers a program to supply portable mini-freezers from Stirling Ultracold for local administration sites where dry ice may not be available.
The Atlanta-based parcel delivery and logistics giant also opened new pharmaceutical-handling facilities in central and eastern Europe and the United Kingdom.
FedEx has more than 90 cold chain facilities around the world, anchored by its Cold Chain Center in Memphis, Tennessee, with more than 20,000 square feet of temperature-controlled storage. The integrated logistics company is expanding its network of ultra-low temperature freezers, Smith testified.
Sophisticated sensors and tracking technology enable UPS and FedEx to intervene and intercept any shipment if the temperature deviates from its acceptable range, the executives said.
UPS has a new command center for real-time shipment monitoring and also designed software that can detect network disruptions before they occur and recommend countermeasures in real time, Wheeler added.
Levine urged Congress to provide more funding to help states with vaccination, saying the $340 million allocated for states, territories and big cities to date is inadequate for the most complex immunization campaign in history. The Association of State and Territorial Health Officials is asking for $8.4 billion in emergency supplemental funding to help pay for infrastructure, cold chain management, personnel, public education and other needs.