As the seasons change and winter approaches, records for new COVID-19 cases continue to be broken nearly every day. Fortunately, due to the efforts of researchers around the world, several major vaccines are now being actively distributed.
Healthcare pharmacists must ensure that they are fully prepared to properly store and administer large volumes of these critical vaccines as soon as they arrive. An integral part of this preparation process is having systems in place to maintain vaccines at their required temperatures.
With trends and information changing daily, keeping a pulse on the latest guidance for vaccine preparation can be a time-intensive task. In October 2020, the CDC released their new COVID-19 Vaccination Program Playbook, designed to advise healthcare professionals and their partners on how to best plan and operationalize a vaccination response to COVID-19.
We’ve extracted some key insights from the comprehensive playbook, and here’s what you need to know:
Vaccination Provider Eligibility/Enrollment
For authorization to receive/administer the COVID-19 vaccine, facilities must first enroll in the federal COVID-19 Vaccination Program facilitated through their jurisdiction's immunization program. To enroll successfully, providers must sign and adhere to various essential conditions. These terms include strict requirements for vaccine storage/management and necessitate active temperature monitoring of medical refrigerators/freezers at all times. As part of the agreement, providers must also keep all records related to COVID-19 vaccine management for a minimum of 3 years, or longer as required by law.
Storage and Handling Requirements
Because they are highly temperature-sensitive, COVID-19 vaccine products must be stored and handled correctly to ensure efficacy and patient safety, while mitigating vaccine loss and risk of reduced effectiveness. The expected temperature range for different vaccines will vary, ranging from refrigerated (2°C to 8°C) to frozen (- 15°C to -25°C) to ultra-cold (-60°C to -80°C). (Check the official CDC website for the latest information on storage ranges.)
Currently, three of the leading vaccines must be stored within very different temperature ranges. Moderna’s version must be stored at a temperature of -4°F (-20°C), while the vaccines from BioNTech and Pfizer must be stored at -94°F (-70°C). Contrastingly, Johnson & Johnson's Janssen COVID-19 vaccine requires storage between 36°F and 46°F (2°C and 8°C). CDC also updated its Vaccine Storage and Handling Toolkit with a COVID-19 Vaccine Addendum, revised on March 4, 2021, that provides more detail.
Emphasis on Digital Data Logging
The playbook and toolkit guidance is crystal clear: every vaccine storage unit/container must have a temperature monitoring device (TMD). They also advise having at least one backup TMD in case a primary device breaks or malfunctions. Beyond this essential requirement, the CDC also highly recommends the use of digital data loggers (DDLs) with the following features:
- Local visual display of current temp + min and max temps
- Local alarm for out-of-range temps
- Local / visible low battery indicator
- A manual min/max reset button
- A recommended uncertainty of +/-0.5° C (+/-1° F)
- Buffer Temperature Probe for refrigerators and freezers, and air-probe for ultra-cold freezers
- Set logging interval to no more than 30 minutes
- Certificate of calibration testing / NIST-traceable
Note: some vaccine products needing storage at ultra-cold temperatures will require a DDL that can register these temperatures. To maintain accurate temperature monitoring of ultra-cold vaccines, it is imperative that an air-probe (bare probe) designed specifically for ultra-cold temperatures is used with the DDL.
We Are Here to Help
These comprehensive CDC requirements for storing and monitoring COVID-19 vaccines might seem overwhelming if your hospital does not have the right technology in place or is still relying on manual methods.
We are here to help make the process simple with our wireless Temperature Monitoring solution. For smaller hospitals, outpatient clinics, labs and pharmacies, we also offer the simple and self-deployed AeroScout Links solution.
Covering all regulatory compliance requirements, our trusted solution can store up to 5 years of temperature data. It also leverages the T15e Temperature Tag, a versatile temperature tag with a Wi-Fi based digital data logger, ideally suited for ultra-cold vaccine preservation.
As vaccines for COVID-19 are rapidly approaching, now is the time to ensure that your hospital is prepared for the critically important work ahead. We are here and ready to help Pharmacy Directors safely and efficiently store their COVID-19 vaccine resources.
Updated March 16, 2021