With lifesaving COVID-19 vaccines finally en route to state administration sites, the guiding principles for officials in charge of managing the supply chain are adaptability and maintaining a consistent flow of doses to health care facilities.
Army Gen. Gus Perna, the chief operating officer for the Operation Warp Speed partnership between government and industry, said Saturday that Defense Department logisticians held back 500,000 doses so they can adjust deliveries for potential contingencies that arise.
Just under 3 million doses are being shipped from Pfizer Inc.'s PFE facilities in Kalamazoo, Michigan, and Pleasant Prairie, Wisconsin, this week. Pfizer is managing the physical distribution on its own in close conjunction with Perna's team.
The delivery of the first vaccines could be the beginning of the end to a national nightmare that has claimed nearly 300,000 lives in nine months, but "we have a lot of work to do," Perna said during a press conference. "We are not taking a victory lap. We know that the road ahead of us will be tough. We know situations will occur. But we will figure it out, together, collectively, in a whole-of-America approach to solve the problems."
The general said he anticipates supply chain disruptions even though McKesson Corp. MCK, the U.S. government's third-party logistics provider, and transportation providers FedEx Express FDX and UPS UPS have extensive experience storing and shipping biologic drugs at very cold temperatures and supporting multiple-shot vaccine regimes.
The Pfizer/BionNTech vaccine approved Friday night by the Food and Drug Administration for emergency use requires two doses, 17 to 21 days apart, for maximum effectiveness.
In addition to holding some doses in reserve, Operation Warp Speed is waiting to dispatch the next 2.9 million doses as a precaution against any production glitches and so administration sites don't have to store the ultra-cold products too long.
Pfizer's vaccine needs to be kept at minus 70 degrees Celsius and many local health care facilities will only be able to use dry ice and normal refrigeration because they don't have sophisticated deep freezers.
"We don't have absolute confidence in the cadence. Not because Pfizer or Moderna or the supporting manufacturers that fill finishes aren't diligent in their process, but it is such a delicate process we want to ensure perfection in the vaccine because we don't want to have anything going into an arm that would be a problem," Perna said.
The FDA is set to review Moderna Inc.'s MRNA new COVID vaccine for safety and efficacy on Thursday.
Planners also regulated the flow of the initial doses to ensure that the vaccine goes to places with ultra-cold freezer capability, which are primarily located at large hospitals, research centers and state-designated distribution hubs.
"We think as early as three weeks from now we can be delivering vaccines to all providers, as directed by the states, for example to the local pharmacies. … Hopefully following with the Moderna vaccine we will begin to blossom expansion of delivery throughout the states to ensure greater access to the vaccine," Perna told reporters.
"I see the reserve dwindling down every day as we move forward, as we gain more confidence in the execution and uptake. My goal is to drive that down because we want no vaccines on the shelf," he said, adding that by mid-January or mid-February there could be less need to regulate the flow so carefully.
But Perna insisted that delivery of weekly allocations to states will continue to be based on what the FDA has approved for final distribution after postproduction quality checks, not on estimated volumes.
"At the end of the day, it does not count until the FDA has approved it. And I will not allow those estimates to go forward because I want people to focus on what is actually available, develop the plans and ensure we're ready to administer.
"So accounting for the numbers has to be very precise," he said.
States determine how many doses of their weekly allocation they want going to each of their designated sites.
The vaccines will marry up at dosing sites with ancillary kits of syringes, alcohol swabs and diluent that are separately shipped by UPS.
Vaccine shipments are being transported by truck from Pfizer's plant and freezer farm to nearby drop sites and airports. From there, FedEx and UPS cargo planes will take them to their respective hubs in Memphis, Tennessee, and Louisville, Kentucky, to route across the country.
Los Angeles International Airport tweeted Sunday night that a FedEx plane with vaccines had already touched down there.
Click here for more FreightWaves/American Shipper stories by Eric Kulisch.
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