Storage, Handling, & Inventory Monitoring For COVID-19 Vaccine
Proper vaccine storage and handling practices play a very important role in protecting individuals and communities from vaccine-preventable diseases. Failure to store and handle vaccines properly can reduce potency, resulting in inadequate immune responses in patients and poor protection against disease.
For specific, detailed storage and handling protocols for individual vaccines products, always refer to the manufacturers’ product information or contact the manufacturer directly.
New to storage and handling? Take the You Call the Shots, Vaccine Storage and Handling online training module.
- Health Alert Network Message 21-04: Guidance on COVID-19 Vaccines Receiving & Storage from Direct Delivery
- Health Alert Network Message 21-03: Guidance on COVID-19 Vaccines Receiving & Storage from Morris & Dickson
A cold chain is a temperature-controlled supply chain that includes all vaccine-related equipment and procedures. It begins with vaccine manufacturing and ends with vaccine administration. Vaccines must be stored properly from the time they are manufactured until they are administered. Potency is reduced every time a vaccine is exposed to an improper condition. This includes overexposure to heat, cold, or light at any step in the cold chain. Once lost, potency cannot be restored. Vaccine appearance is not a reliable indicator that vaccines have been stored in appropriate conditions.
An effective cold chain relies on three main elements:
- A well-trained staff
- Reliable storage and temperature monitoring equipment
- Accurate vaccine inventory management
COVID-19 vaccination providers must have proper storage and temperature monitoring equipment to meet the specific needs of the COVID-19 vaccine product(s) they have in their inventory. A purpose-built/pharmaceutical grade unit is preferred and designed specifically for storage of biologics, including vaccines. However, the CDC does not recommend COVID-19 vaccination providers purchase ultra-cold storage units because vaccines requiring these storage conditions are expected to be shipped in containers that can maintain ultra-cold temperatures for an extended period.
It is essential for each vaccine storage unit to have a temperature monitoring device (TMD) to ensure that vaccines are stored within the correct temperature range. The CDC recommends a digital data logger (DDL) to provide the most accurate storage unit temperature information, including details on how long a unit has been operating outside the recommended temperature range.
Storage unit temperatures must be monitored regularly. Usually, storage unit minimum and maximum temperatures must be checked and recorded at the start of each work day. If the DDL cannot measure minimum and maximum temperatures, then the temperatures must be checked and recorded twice each workday – at the beginning and end of the day. However, this requirement may vary based on the type of storage unit used.
Always record:
- Minimum/maximum temperature
- Date
- Time
- Name of person checking and recording temperature
- Actions taken if a temperature excursion occurred
Proper vaccine inventory management is essential for appropriate vaccine ordering and stock rotation and ensures your facility has the vaccines your patients need.
Vaccine deliveries should only be scheduled at times when staff is guaranteed to be present because vaccines must never be left unattended. To support efficient distribution of the vaccine, fill-day receiving hours should be available. When that is not possible, locations must be available during a four-hour window on a weekday other than Monday. All COVID-19 vaccine and ancillary kit deliveries will require a signature.
Upon arrival, shipments of refrigerated and frozen vaccine should be immediately examined for signs of damage and indication of a temperature excursion and to guarantee receipt of the appropriate vaccine types and quantities. Before opening ultra-cold vaccine shipments, make sure the vaccine can be quickly placed in an ultra-cold freezer or dry ice is available for re-icing the shipping container to ensure the vaccine remains at the appropriate ultra-cold temperature.
Vaccines and diluents must be carefully examined, stored at recommended temperatures, and documented using your facility’s vaccine inventory management process immediately after they arrive.
For centrally distributed vaccines, each kit will contain supplies to administer 100 doses of vaccine, including:
If a COVID-19 vaccine that requires mixing with diluent is ordered and shipped from CDC’s centralized distributor, a mixing kit that includes the necessary needles, syringes, and alcohol prep pads will also be automatically added to the order. For centrally distributed vaccines, providers will have the option to submit the order in a way that opts out of receiving the administration and mixing kits.
For vaccines that are shipped directly from the manufacturer, a combined kit will be included. This combined kit will include administration supplies (as noted above), mixing supplies, and vials of diluent to prepare the vaccine for use. Because it contains diluent, providers will not have the option to opt out of requesting this combined ancillary kit.
Ancillary supply kits will not include sharps containers, gloves, and bandages. Additional personal protective equipment (PPE) may be needed depending on vaccination provider site needs.
Update: Mega Kit content for Pfizer vaccine (12/15/2020)
Determining when a vaccine or diluent expires is a critical step in proper storage and handling. Understanding vaccine expiration dates can help save your practice time and money.
All vaccines have expiration dates, and some routinely recommended vaccines have a beyond use date (BUD), which is calculated based on the date the vial is first punctured and the storage information in the package insert.
For COVID-19 vaccines:
- The expiration date may change for some vaccines as more stability data become available.
- The EUA Fact Sheet for Healthcare Providers or manufacturer websites will provide more information about expiration dates and BUDs.
A temperature excursion is any temperature reading that is outside the recommended range for vaccine storage as defined by the manufacturer’s package insert or EUA Fact Sheet for Healthcare Providers.
Identify temperature excursions quickly and take immediate action to correct them.
For COVID-19 vaccines, contact the vaccine manufacturer or the Louisiana Department of Health Immunization Program if you experience temperature excursions.
