The COVID-19 pandemic has exemplified the need for cold storage treatment of time and temperature sensitive materials. Vaccines and drugs typically require cold storage conditions during manufacturing and distribution – exceeding -80 degrees Celsius in certain cases.
The Cold Chain: Storage Solutions for the Lab, the Clinic, and the Road interactive infographic follows product developments in the cold chain of sample management – from research, to manufacturing, to regional storage and remote transit.
This post serves as a chronology of the interactive infographic, tracking developments and citing sources in this vitally important product area.
Research and Development
The US government has deals with 6 vaccine developers, in varying stages of clinical testing and FDA approval, aiming to have over 800 million available for distribution in 2021.
Clinical Testing Sites
The first COVID-19 Vaccines, BNT162b2 from Pfizer/BioNTech and mRNA-1273 from Moderna, have been awarded emergency use authorization from the US FDA, based on positive clinical trial data.
The Pfizer/BioNTech vaccine requires deep-freeze storage in packs containing 975 doses at -70° C, and demonstrates challenges when breaking down into small batches for distribution to individual care sites. Additionally, the vaccine can only be moved four times and has a shelf life of 5 days at +4° C refrigerator temperatures.
The US government has ordered 200 million doses of the EUA FDA approved vaccines from Pfizer/BioNTech and Moderna, necessitating massive scale-up of vaccine manufacturing and storage.
QA/QC Testing Sites
Early batches of Pfizer/BioNTech vaccine manufacturing raw materials failed to meet necessary standards, pushing supply chain and predicted shipments back.
Global Distribution Sites
Shipping of the first vaccines from Pfizer/BioNTech have been downgraded from the expected 100 million to 50 million by the end of 2020, due to supply chain disruptions.
United Parcel Service Inc (UPS) is building two large freezer farms, one in Kentucky and one in the Netherlands near UPS hubs, housing 600 ultra-low temperature freezers and the capability to store 48,000 vials of vaccine each, at -80° C or above.
Regional Distribution Sites
Pfizer/BioNTech are depending on two final assembly and distribution centers, one in Kalamazoo Michigan, and another in Puurs, Belgium, for the US supply and Europe supply accordingly.
Local Supply Sites
The cold-chain manufacturer AeroGlobal is preparing to provide 125-dose storage containers to Walgreens and CVS, which plan to distribute vaccines to nursing home residents.
FedEx and UPS will be involved in distributing Pfizer’s recently approved vaccine, although issues such as storage resources and holiday traffic may cause challenges.
Roughly one half of vaccines to be produced by AstraZeneca will be distributed to low- and middle-income countries, including 500 million doses to India and 300 to world health organizations which help to supply vaccines and logistics for the poorest nations.
Nursing homes plan to partner with chain or local pharmacies and provide on-site treatment sites, although logistics and resources issues may complicate this plan.