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

Research Facilities

  • 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.

Sample Management

  • 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.

Manufacturing

Production Plants

  • 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.

Regional Storage

Freezer Farms

  • 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.

Remote Transit

Ground Transportation

  • 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.

Remote Storage

  • 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.

Treatment Sites

  • 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.