Transforming Vaccine Storage: The Changes Shaping the Healthcare Cold Chain During COVID-19

Thanks to the ongoing rollout of COVID-19 vaccines, the phrase cold chain has entered the mainstream vocabulary. Outlets like Scientific American and Business Insider have even produced explainers for their audiences.                                                                                                                                                    

Most decision makers in healthcare are already familiar with the need to keep vaccine vials at low temperatures, so they will be more interested in direct updates from the Centers for Disease Control and Prevention (CDC). With the COVID-19 vaccination program rollout being faster and larger than any previous vaccination program, providers are paying close attention to vaccine handling, storage, and monitoring.

Multiple Vaccines Call for Flexible Planning

The COVID-19 vaccines currently being administered globally all have different storage and monitoring requirements. For example:

• The Pfizer-BioNTech vaccine must be kept at ultra-low temperatures, between -80°C/-112°F and -60°C/-76°F, and used within five days of being thawed in a refrigerator.
• The Moderna vaccine requires a frozen cold chain and must be shipped at -20°C/-4°F. It can be stored at that temperature for six months and refrigerated between 2°C/35.6°F and 8°C/46.4°F for up to 30 days.
• The Oxford-AstraZeneca vaccine can be distributed using the more common refrigerated cold chain, allowing vaccines to be shipped and stored between 2°C/35.6°F and 8°C/46.4°F at all times.

Healthcare providers have to take these different cold-chain requirements into account when planning their vaccine storage and distribution.

Vaccines Are Being Distributed Under Emergency Use Authorizations

To get people inoculated sooner, COVID-19 vaccines have been made available before they were approved by the U.S. Food & Drug Administration (FDA). Instead, the FDA issued an Emergency Use Authorization (EUA) allowing the vaccines to be used after a Phase 3 clinical efficacy trial if “the known and potential benefits outweigh the known and potential risks of the vaccine.” A EUA is only issued for vaccines “for which there is adequate manufacturing information to ensure quality and consistency,” including cold-chain requirements.

Vaccine distribution under a EUA means that providers should get detailed storage and handling information for each vaccine from its corresponding EUA Fact Sheet for Healthcare Providers and manufacturer information.

Most importantly, a EUA means these vaccines are shipping at a speed and scale never before seen under modern cold-chain infrastructures. Understanding the evolving requirements and recommendations from the CDC is critical to successful inoculation efforts.

Vaccine supplies have been limited during the early months of the rollout, so healthcare professionals have made hard decisions about inoculation priority. The CDC and the National Institutes of Health (NIH) have issued recommendations to make sure that vaccine doses are allocated equitably. Based on a framework from the National Academies of Sciences, Engineering, and Medicine (NASEM), the CDC identified several groups that are at higher risk and/or essential for maintaining COVID-19 response, including healthcare personnel, workers at long-term care facilities, people with high-risk medical conditions and adults aged 65 and older.

The priority distribution recommendations take cold-chain requirements into account because handling for some vaccines demands specialized equipment. For example, a CDC workgroup report says a vaccine that requires an ultra-low cold chain “will necessitate most vaccines be administered at centralized sites with adequate equipment and high throughput. Vaccinating healthcare personnel at centralized sites with high throughput is the best allocation of the initial supply.”

Vaccine Providers Must Go Through an Application and Onboarding Process

Since priority groups are receiving initial supplies of the vaccine, doses are first going to the providers who serve those groups. The CDC established a COVID-19 Vaccination Program for providers who want to administer the vaccines. That program includes “specific logistical requirements, including requirements for vaccine storage and handling, product tracking, administration, and reporting.”

Providers need to work with their state and local health departments to make sure they have the latest updates on the requirements for distributing the vaccines.

Administration of COVID-19 Vaccines Will Scale Up Over Time, Moving to Nontraditional Vaccination Scenarios

When available doses are limited during this initial phase, inoculation is strategically targeted through providers that have specialized equipment, such as hospitals.

Once there is enough supply to meet demand, especially of vaccines with frozen or refrigerated cold-chain requirements, distribution will increase to a broader administration network of pharmacies, urgent care and walk-in clinics, doctors’ offices, and public health and mobile clinics.

These smaller providers may have limited refrigeration setups. They may also be administering vaccines in drive-through or outdoor clinics, possibly in inclement weather conditions. In these nontraditional vaccination scenarios, proper vaccine handling and monitoring are even more important.

Given these new factors for COVID-19 vaccines—multiple vaccines, emergency use authorization, an application process for distribution, and nontraditional vaccination scenarios—healthcare providers need to plan carefully. Their vaccine storage may need to be upgraded to maintain the cold chain in unusual conditions and meet new requirements. They also need to stay informed since the situation changes almost daily.

If you’re ready to learn more about the current and evolving CDC recommendations for vaccine storage and monitoring and how they impact healthcare providers, read the e-book from Emerson, Are You Ready for the COVID-19 Vaccine?

If you are looking for a new approach to your vaccine cold chain and vaccine monitoring system, learn more about Emerson's Lumity wireless data logger.

Disclaimer: This resource is based on current CDC guidance published as of November 2020. It does not replace specific COVID-19 vaccine regulations or specific vaccine manufacturer requirements. You should rely on any applicable law and industry best practices to determine the detailed requirements for handling, tracking, storing, and administering vaccines, which may differ based on the vaccine and manufacturer.