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Clarkston Consulting Senior Project Manager, Swati Patel, Featured on LabManager

Durham, NC | February 3, 2021

Senior Project Manager at Clarkston Consulting, Swati Patel, quoted on supply chain and ultralow cold storage for the COVID-19 vaccine by LabManager. An excerpt from the article is included below:

The preparation of the COVID-19 mass vaccination campaign currently underway requires a cold supply chain built around the storage temperature requirements of the two vaccines: -70°C±10°C for Pfizer’s BNT162b2, and 20°C±5°C for Moderna’s mRNA-1273. The ultralow temperatures of Pfizer’s vaccine pose additional supply chain challenges.

Keeping the ULT Supply Chain Intact
For the US and Canada, most doses are being shipped by road and air from the production site in Kalamazoo, MI, and the distribution center in Pleasant Prairie, WI. Depending on the distance, they will either directly reach the point of use, or FedEx’s and UPS’ distribution hubs in Memphis, TN, and Louisville, KY, respectively. From there, the supply chain might include one or more stops at intermediate storage facilities. In some cases, states (like New York, for example) may even set up additional regional storage facilities.

To maintain ultralow temperatures, distribution will use minus 80 freezers for storage, and thermal-controlled containers for transporting the vaccine from one point to the next. Both will be equipped with temperature monitors and data loggers that keep track of any temperature fluctuations out of the allowed range.

“ULT freezers provide long-term preservation at precise temperatures and have a typical life span of 10-15 years. Chest freezers last longer and are more efficient than upright models,” says Swati Patel, senior project manager at Clarkston Consulting. “The downside is that they use a significant amount of energy, the equivalent of a single-family home, which can mean higher running costs. Space can also be an issue, depending on how many are needed.” …

Because of the scarcity of ULT freezers in the last mile of the cold supply chain, temperature-controlled containers are more likely to be used. Considering their limitations, however, timing becomes particularly important. “With temperature-controlled containers, the vaccine has to be administered within a shorter time frame in order to not lose its potency. The challenge is making sure you have the patients lined up when the time comes,” says Patel. …

“Since Pfizer vaccine containers are broken into 975 doses each, currently they are being shipped to locations that can administer all of them to the essential workers in the area. Many regional facilities are banding together so they can share them across their facilities, while others have procured the cold storage equipment needed to store them. Lastly, others are lining up the people so they can administer the doses within five days of receiving it,” says Patel

COVID-19 Vaccines Without ULT Storage Requirements 
Right now, these stringent ULT cold chain requirements are unique to Pfizer’s vaccine. Moderna’s has a storage temperature of -20°C—above the ultralow range—and can remain stable at 2°-8°C for 30 days and at room temperature for up to 12 hours.

“In terms of distribution strategy, I think Moderna’s vaccine might be better suited for smaller rural towns, as they often don’t have the ability to handle the really low temperatures required by Pfizer’s,” says Patel. …

However, Patel warns, when vaccines are stored in 2-8°C fridges, the temperature range is much narrower and there is much less room for fluctuations. This will require more stringent monitoring of these fridges to ensure stability of the vaccines.

At the same time, as the mass vaccination campaign continues and new candidates are authorized for distribution, the role of ULT freezers in the cold supply chain will be less important. That, however, doesn’t mean that they will remain empty: “I don’t think that the need for ULT freezers is going to go away,” says Patel. “The medical advances of mRNA technology and personalized medicine will require some level of refrigeration as you transport them to patients, so they’re going to continue to be used.”

Read the full article highlighting ultralow cold storage and the COVID-19 vaccine supply chain here.