Guidance for vaccine storage and monitoring is developed by experts at the Centers for Disease Control and Prevention. State Vaccine for Children (VFC) programs require that participating practices implement this guidance as a minimum. They may also choose to require stricter criteria for their programs. The CDC guidance is intended to keep vaccines stored safely, so that they are not exposed to temperatures at which they could lose potency and become ineffective.
Vaccine manufacturers offer product-specific information, including:
At what temperature the vaccine should be stored.
How to store and use a diluent to reconstitute a vaccine (if needed).
When to discard a vaccine.
In January 2020, the CDC updated their Vaccine Storage and Handling Toolkit. The following describes the main changes made:
The 2020 Toolkit includes monitoring instructions for temperature monitoring devices (TMD) that do not read min/max temperatures:
TMD without min/max temperatures should be checked a minimum of two times per day, at the start and end of the workday.
Record: min/maximum temperature, date, time, name of person who checked and recorded the temperature, any actions taken if a temperature excursion occurred. Leave a blank entry in the log if a reading is missed.
The 2020 Toolkit states that defrosting manual-defrost freezers should occur "when the frost exceeds either 1 cm or the manufacturer's suggested limit."
CDC clarified storage unit temperatures:
Refrigerator temperature should measure between 2°C and 8°C (34°F and 46°F)
Although vaccines can be correctly stored anywhere within the aforementioned temperature range, storage unit temperatures should still aim midpoint of 5°C to avoid temperature excursions.
If Beyond Use Date (BUD) is not indicated on a vaccine, the expiration date provided by the manufacturer should be used.
Portable vaccine storage unit:
"a type of powered refrigerator or freezer unit specifically designed for use during vaccine transport. These are passive units that require a power source to function. Please note that some active units are 'qualified' to maintain desired temperatures for a set amount of time in the event of a power loss."
Qualified container and pack out:
"a type of container and supplies specifically designed for use when packing vaccines for transport. They are passive containers that do not require a power source and are 'qualified' through laboratory testing under controlled conditions to ensure they achieve and maintain desired temperatures for a set amount of time."