An insider’s view of the ultra-low cold chain in action.
Both the Moderna and Pfizer/BioNTech vaccines are mRNA-based, which means they require storage at ultra-low temperatures. Manufacturers may be prepared on the R&D side, but this is not true across distribution and at the point of care. Most clinics and pharmacies are set up for +2º to +8º (standard refrigerator) cold storage, with only a small portion equipped with -20º storage (standard freezer).
Development of mRNA-based vaccines has been ongoing. But currently, there are no recommended storage guidance or standards for ultra-low temperature vaccine handling. The scale and level of collaboration required for COVID-19 vaccine ramp-up, from production to distribution to point of care injection, is unprecedented and gaps at all steps of the cold chain must be closed quickly.
At Thermo Fisher Scientific, with decades of experience in cold chain management, we are actively collaborating with FedEx, UPS, and large pharma manufacturers, as well as increasing production of existing ultra-low storage units to manage demand and ensure availability. We are currently manufacturing more than 70 units per day and that number is expected to increase.
The existing cold chain for vaccine distribution is not set up for large-scale transport of product that must be kept at ultra-low temperatures. To close this gap, generation and sharing of data on vaccine stability and handling is needed. Can the vaccines be thawed? Can they be used at lower temperatures for short periods of time? More questions like this are the most important data we all need to understand. Close collaboration with cold chain partners – from manufacturers to FedEx and UPS – to quickly develop standards and reproducible best practices are helping to accelerate this process.
Gaps in storage post-transport also arise. Very few pharmacies and clinics have the right equipment for storing and dispensing mRNA vaccines and other vaccines requiring very low temperature storage. We continue to gather a better understanding of the needs of these new customers, and train them in proper use by offering aids to help navigate the product and get acquainted with it. ULT freezers manage heat removal with refrigerants that support ultra-low temperatures and are very robust in design. This requires users to interact a little differently to ensure conditions are maintained. For example, ULT freezers have very different closure mechanisms than refrigerators, and therefore require a standard frost removal due to the temperature differentials. Cryo gloves should also be always worn when working with this equipment. Variations like these show education and training at the point of care is critical.
R&D is also ramping up to address the need to accelerate innovation at the point of care. Interesting developments on the horizon include units with different features and are easier to use and maintain (plug and play).
The COVID-19 pandemic has dramatically accelerated the timeline for cold chain storage and distribution. We are trying to build and fly the plane at the same time, a challenge we welcome.
Find out more at thermofisher.com/vaccinestorage