In order to help fill gaps in preparation, storage, handling, and administration of newer COVID-19 vaccines, USP led the development of a COVID-19 Vaccine Handling Toolkit. This guide, available for U.S. and international providers, offers operational considerations developed with support from pharmacy, nursing, and government agencies to improve practices at vaccine provider sites. This final phase of vaccine storage, handling, and administration is referred to as the “last 25 feet”.
The USP toolkit starts with recommendations for vaccine preparation, including selecting appropriate locations for vaccine preparation that support cleanliness and avoiding contamination. This part of the toolkit also describes best practices to ensure staff has the appropriate education and training to safely prepare vaccines, including recommendations related to hygiene and garbing.
Next, the USP COVID-19 Vaccine Handling Toolkit includes recommendations for storage, handling, and transport of vaccines. The toolkit suggests facilities have a Quality Management System (QMS) in place that incudes specific Standard Operating Procedures (SOPs) to ensure staff understands and follows procedures, and to ensure problems are identified and acted on appropriately (USP recommends contacting state or local immunization programs for sample SOPs as needed).
This section of the toolkit also focuses on ensuring providers have appropriate cold storage units to safeguard vaccines. Continuous monitoring of vaccines is required and using digital data loggers with external displays is preferred. Monitoring systems should be calibrated using NIST traceable reference thermometers to ensure the accuracy of temperature readings. USP recommends that calibration testing should occur every 1-2 years or according to the manufacturer’s recommendation.
The USP COVID-19 Vaccine Handling Toolkit is consistent with guidance in the CDC Vaccine Storage and Handling Toolkit related to the use of pharmaceutical-grade refrigerators and freezers designed for storing medications and vaccines. Other types of cold storage units may be considered, but providers should be aware that household-type units may have areas within the cabinet that should not be used for vaccines due to risks of temperature excursions, including the risk of freezing. If a provider uses a frozen vaccine, a separate freezer is necessary according to the CDC. The USP toolkit also reinforces that dormitory-style units should never be used to store vaccines.
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Safeguarding vaccines in the “last 25 feet” is critical to ensuring the effectiveness and safety of vaccine administration programs. Recommendations from organizations such as USP and CDC are not intended to replace facility’s SOPs or guidance from local/state requirements but are resources to consider as COVID-19 vaccine administration programs and policies are developed.
Recommendations included in the USP COVID-19 Vaccine Handling Toolkit, including using appropriate vaccine refrigerators and freezers, are designed to help improve the safety and efficiency of COVID-19 vaccine administration at provider sites.
This guide is updated by the USP as new information is available. Please refer to the USP COVID-19 Vaccine Handling Toolkit for the most current information.
To learn about Helmer Scientific's vaccine storage solutions, visit our website.
Helmer Scientific has created the article, “Emerging Vaccine Storage Standards”, to share additional information about these emerging standards. Please use the link below to download this article.