It is likely that, to get vaccines into these areas, the ultra-cold shipments will have to be taken out of their special packaging, broken up into smaller lots, and transported various distances—maybe a few miles, maybe a few hundred. That will start a countdown clock ticking on the vaccine’s viability. The recipients might be small clinics that possess only normal refrigerators. Or they might be local pharmacies or individual doctors’ offices, if they exist—218 of the 3,141 counties in the US have no doctor at all. Two nationwide pharmacy chains have contracted with HHS to administer Covid-19 vaccines in nursing homes.
“Some of this is going to be received by a clerk at a CVS or a Walgreens pharmacy, somewhere in rural America, who’s had very little cold-chain training or expertise,” predicts Joseph Battoe, CEO of Varcode, a Chicago-based company making barcodes that record when a medical package’s cold chain has been broken. “The challenges are extraordinary.”
(No doubt taking note of this, Moderna announced in its preliminary data release that its vaccine formula can remain stable at 2 to 8 degrees Celsius, or 36 to 46 degrees Fahrenheit, for up to 30 days. “The temperature of a standard home or medical refrigerator,” the company noted in its statement, in a tone inches away from smug.)
There may be a tech fix coming. AeroSafe Global, based in Rochester, New York, manufactures complex frozen and refrigerated packaging for biologics and tissues, and it also made packaging for delivery of some Covid-19 vaccine formulas to some trial sites in the US. (The company declined to identify which vaccine companies it worked with.) Temperature-controlled boxes can be customized, according to Jay McHarg, AeroSafe’s CEO. “We ship heart valves in a container the size of a jewelry box,” he says.
One solution for the problem of breaking a large frozen shipment into smaller tranches, he said, might be as simple as a smaller container that holds the vaccine at the same low temperature. Another might be a less complex container, similar to a tote bag or a suitcase, that holds 100 or so doses at the refrigerator temperature in which the vaccine lasts a few days. “You tell the box what temperature it is going to be held at, by the coolants you use,” he said. “The box doesn’t care what temperature you specify.”
The challenge, of course, is that customization costs money. AeroSafe’s thermal shippers are complex—they incorporate internal data loggers that report whether the package stayed frozen throughout transport, and also link to cloud-based demonstration and training videos for workers at the locations receiving the vaccine—and thus are not disposable. Once whatever product they contain has been removed or used up, the company’s staff picks up the boxes, reconditions them, and deploys them again. If AeroSafe’s containers became part of the pandemic-vaccine supply chain, it is not clear who would pay for their customization.
States are already running short of money: They’ve received $200 million so far in Covid-19 federal stimulus funds, yet Hannan’s organization and the Association of State and Territorial Health Officials estimate that deploying vaccines across the US will require more than $3 billion. (Companies making vaccines have received $10 billion through the government’s Operation Warp Speed.) Further Covid-19 funding is hung up in congressional negotiations that have been delayed by the election chaos; any potential agreement is receding further into the lame-duck session.
Yet boxes of vaccine could be on the move shortly, and some of the product they contain will be headed for the rural areas where health care authorities feel they are not equipped to receive it. At this point, no jurisdiction’s health officials know which vaccine will arrive, nor how much, nor exactly when. “It’s like we’re trying to build a house when we haven’t been given the architectural plans,” Lewandowski says. “And when I go to grab for a hammer, maybe I come up with pliers instead.”
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