Cold Chain

By Cindy Gisler, Product Marketing Manager, Analytics What will happen and how we can help you keep your vaccines safe. More than 100 teams around the world are working to develop and test a vaccine for the virus that causes COVID-19. As of December 4th, there are 23 candidates in Phase 1 clinical trials, 16 in Phase 2, and 13 in Phase 3 — 7 vaccine candidates have been approved in various jurisdictions around the world (these numbers are rapidly changing as vaccine candidates are moving towards approval.)*. As vaccine are being approved in various jurisdictions, these same jurisdictions are preparing for the daunting task of distribution of millions of doses of vaccine; all under a continuous cold chain and chain of custody. As the world anticipates a clinically-approved vaccine in the coming months, jurisdictions around the world prepare for the daunting task of distributing hundreds of millions of doses; all under a continuous cold chain and chain of custody. In the United States, the strategy for distributing the COVID-19 vaccine has been given the code name Operation Warp Speed (OWS). The goal of this operation is to quickly deliver safe and effective vaccine doses to the American people beginning January 1, 2021. At the heart of OWS are multiple critical components under an umbrella of communication and stakeholder guidance. It occurs at many levels; state, tribal and local jurisdictions, as well as special populations, the private sector partners and the public at large. Operation Warp Speed is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics. Components to a timely distribution Six critical components make up OWS and benchmark a successful and timely distribution as COVID-19 vaccines become available: Prioritizing the population Allocation of the vaccine Distribution of the vaccine* Administration Safety, effectiveness, uptake and second doses Vaccine recovery Along with the logistical considerations that come with managing these components the need for ongoing feedback and information is crucial for the success. Monitoring, tracking and reporting on vaccine supply Understand vaccine uptake, use and coverage Understand vaccine effectiveness; monitoring and reporting Operation Warp Speed phases The rollout of OWS will most likely take a phased approach and be reliant on the availability of clinically approved vaccines and initial vaccine distribution successes. Phase 1 (Limited doses available) There most likely will be constrained vaccine supply Highly targeted administration will be required to achieve coverage in priority populations Phase 2 (Large number of doses available) It’s likely there will be sufficient supply available to meet demand This increased vaccine supply will increase access A broad administration network will be required (including surge capacity) Phase 3 (Continued vaccination and shift to a routine strategy) There will likely be excess vaccine supply A broad administration network for increased access will be in place As we enter Phase 3, the population is on its way to a herd immunity against SARS Cov-2. The report to congress detailing the purpose and strategy of OWS can be found on the US Department of Health and Human Services website. As alluded to, the underlying challenge for OWS, as well as similar initiatives in other countries, is the daunting task of distributing hundreds of millions of doses of vaccine under a continuous cold chain (as well as the security involved). Cole-Parmer is working hard to support this challenge with a wide range of Vaccine Cold Chain solutions and resources. *Most COVID-19 vaccine, particularly in Phase 2, will move from the manufacturer through a distributor to the administration sites but some vaccines will ship directly from the manufacturer to the administration site (due to challenging cold chain logistics).