VFC Vaccine Storage and Handling

A: CDC’s Vaccine Storage and Handling Toolkit is available on-line. Also available for print is the Vaccine Storage & Handling Guide [718KB, 77 pages].

A: General procedures for power outages are described in the Vaccine Storage and Handling Toolkit. Also available for print is the Vaccine Storage & Handling Guide [718KB, 77 pages].

All providers should have an Emergency Vaccine Retrieval and Storage Plan Worksheet [107 KB, 5 pages] prepared in advance to guide them in the event of a power outage or other emergency. This should include plans for alternative storage and transport of vaccines [8 MB, 12 pages]

Note: The following key messages for immunization providers:

A: Dormitory-style refrigerators should only be used to store a clinic's single-day supply of refrigerated vaccines and these vaccines should be returned to the main refrigerator storage unit at the end of each clinic day. Dormitory-style refrigerators are not adequate for long-term or permanent storage of biological products because they do not maintain appropriate temperatures.

Storage of VFC vaccine in refrigerators that are designed for use in small household spaces such as dorm rooms are never acceptable for permanent storage of VFC vaccines. Permanent storage is defined as the vaccine supply is maintained in the unit 24 hours a day/7 days a week.

"Dorm Style" refrigerators are acceptable for short-term storage of select VFC vaccines under very limited conditions which are listed below:

1. The purpose of using these units is for temporary storage when it is not reasonable for the staff administering the vaccine to go to the main storage unit to obtain vaccine for each and every patient.
2. The unit is never used for storing Varicella-containing vaccines
3. Only small amounts of inactivated vaccines can be maintained in these units. The amount of inactivated vaccines stored in the unit must never exceed the amount used in the clinic in one day.
4. The vaccine is returned to the main storage unit at the end of each clinic business day and vaccine is never stored in these units overnight or during periods of time when the practice is not open for business.
5. Each unit has a dedicated certified thermometer in place.
6. Temperatures are monitored and documented twice a day on temperature log specifically for that unit. Appropriate action is immediately taken when the temperatures are outside the appropriate range.
7. These units must be included and examined during the VFC compliance visit and corrective actions taken and documented by the awardee if any of the above conditions are not met.

A: Yes, these types of vaccine storage units are acceptable if they meet the following conditions:

1. The refrigerator and freezer compartments each have a separate external door, or
2. Units are stand-alone refrigerators and freezers

   Refrigerators or freezers used for vaccine storage must comply with the following requirements:

   • Be able to maintain required vaccine storage temperatures year-round;
   • Be large enough to hold the year's largest inventory;
   • At a minimum, have a working certified thermometer inside each storage compartment. Awardees may require VFC providers to have a calibrated certified thermometer inside each storage compartment. Calibration must be traceable to standards provided by the National Institute of Standards and Technology (NIST) (a U.S. Government agency within the Commerce Department) or a laboratory recognized by NIST. Calibration can be traceable to NIST using American Society for Testing and Materials (ASTM) methods for the calibration process;
   • Be dedicated to the storage of vaccines. (Food and beverages must not be stored in a vaccine storage unit because this practice results in frequent opening of the door and destabilization of the temperature.)

A: Merck, GSK and Wyeth's package inserts recommend storage temperatures for their products to be 2° - 8°C (36° - 46°F). On the other hand, Sanofi's package inserts state that their products should be stored at 2° - 8°C (35° - 46°F). I have spoken with both the manufacturers and FDA on this matter. This is a non-issue with the manufacturers. In addition, the FDA (CBER's Office of Vaccine Research and Review (OVRR)) does not have any official position on this rounding issue. However, it is the opinion of OVRR that four-tenths of a degree should not cause any problem with the quality of vaccines and 35°F is acceptable. As you know, the vaccines should not be exposed to freezing temperatures, particularly those vaccines containing aluminum adjuvants. The take home message is that the recommended temperature ranges are effective in keeping vaccine storage away from the dreaded 0°C (32°F).

A: CDC's position is to have providers store vaccine in their original containers to help protect the vaccine from damage due to storage errors, as well as, to decrease the possibility of administration errors from inadvertently confusing similarly packaged vaccines.