Vaccine Storage and Handling Questions and Answers

Yes. Vaccines that are stored in the refrigerator portion of a combination refrigerator/freezer should be moved away from the vent located in the refrigerator compartment. The cold air from the freezer is circulated into the refrigerator compartment to cool it, which can cause your vaccines to freeze.

Generally speaking, it is recommended to avoid the top shelf and the areas near vents due to temperature fluctuations. However, most pharmaceutical-grade units have more uniform temperatures than household units under normal operating conditions. During a power outage, the top shelf is an area of caution for all units as the temperatures increase most quickly there. In this instance, it would be best to check with the manufacturer to see if the top shelf is appropriate for storage in your unit.

Vaccines should not be stored in vegetable bins or the space occupied by vegetable bins. This area is commonly closer to the motor of the unit and the temperature is different from that in the body of the refrigerator. We recommend that you remove the vegetable bins and put bottles of water in that space to help maintain a constant temperature in your refrigerator.

No, biologics should never be stored with food or drinks.

Refrigerators and freezers used for vaccine storage must be dedicated for storage of vaccines only. If other medications and biological products must be stored in the same unit as vaccines, always store them below the vaccines and on a different shelf. This prevents contamination of the vaccines should the other products spill and reduces the likelihood of medication errors.

Place vaccine in the center of the storage unit, contained in original packaging, inside a designated storage container and positioned 2 to 3 inches from storage unit walls so air can circulate around the vaccines. Do not place vaccine in storage unit doors or on the top shelf of the refrigerator if the cooling vent from the freezer opens there. If the top shelf of the refrigerator must be used for vaccine storage, it would be best to place MMR on this shelf because MMR is not sensitive to freezing temperatures.
Arrange vaccines in rows or use trays, uncovered containers, or perforated bins, allowing space between rows to promote air circulation. Do not pack the storage unit too tightly. This can restrict air circulation and impact vaccine temperature. Place vaccines and diluents with the earliest expiration dates in the front of those with later expiration dates.

DHA-IHD recommends the use of bins, baskets, or some other type of uncovered containers that allow for organization and air circulation for vaccines and diluents within the storage unit. Storage in containers or bins can help maintain temperature longer, especially if power is lost.

Attach labels to shelves and containers to identify where each type of vaccine or diluent is stored. Include additional information such as age indications, gender or other information unique to the vaccine on the label. Store vaccines with similar packaging or names, or with both pediatric and adult formulations, on different shelves to minimize the risk of administration errors. Make sure to label the formulation “pediatric” or “adult,” if applicable. Color code the labels (e.g., one color for pediatric and one for adult vaccines). Prevent the storage of vaccines that sound or look alike next to each other, like DTaP and Tdap.

Yes. Human papillomavirus (HPV), Haemophilus influenzae type B (Hib), inactivated polio (IPV), Japanese encephalitis (JEV), meningococcal, measlesmumps-rubella (MMR), measles-mumps-rubella-varicella (MMRV), rabies, rotavirus, varicella, zoster, and some influenza vaccines are sensitive to light, causing loss of potency, so must be protected from light at all times. Store these vaccines at the appropriate temperatures in their boxes with the tops on until they are needed.

No. Storing loose vaccine vials outside of their boxes is not recommended. Keep vaccines in their original packaging with the lids on until ready for administration. Do not store loose vials or manufacturer-filled syringes outside of their packaging. This practice makes it more difficult to track expiration dates and manage inventory, increases the risk of administration errors, and exposes vaccine to light (check package insert for vaccine light sensitivity information).

Store diluent correctly within the temperature parameters outlined in the manufacturer’s package insert. Some diluents must be refrigerated, while others may be stored in the refrigerator or at room temperature (no warmer than 25°C/77°F). Whenever possible, store diluent next to corresponding vaccine. ACAM2000 diluent is shipped refrigerated with vaccine but should be stored at room temperature.

Conduct a vaccine and diluent inventory at a minimum monthly to ensure adequate supplies are on hand to meet demand. Ensure vaccines are stored in original packaging. Place rubber bands around boxes of like lot numbers to alert staff to a change in vaccine lot number. Rotate stock so that vaccines and diluents with the soonest expiration dates are moved to the front and are used first to avoid waste due to expiration. Check vaccine and diluent expiration dates a minimum of weekly to remove expired items from usable stock.

When the expiration date is marked with only a month and year, the vaccine or diluent may be used up to and including the last day of the month indicated on the vial. Any unused vaccine or diluent should not be used after this month has passed. If the expiration date printed on all vaccines and diluent vials and boxes includes the month/day/year the vaccine or diluent may be used up to and including this date. Monitor and rotate your vaccine supply carefully so that vaccines do not expire.

An opened multi-dose vial (MDV) of vaccine that has been stored and handled properly and is normal in appearance can be used through the expiration date printed on the vial unless there is a “beyond use date” (BUD) noted in the package insert. The BUD is the date or time after which an opened MDV cannot be used. For example, inactivated polio vaccine in a multi-dose vial can be used through the expiration date on the vial. For some vaccines, the manufacturer specifies that once the multi-dose vial has been entered or the rubber stopper punctured, the vaccine must be used within a certain number of days. This is the case for some inactivated influenza vaccines that indicate once the stopper of the multi-dose vial has been pierced, the vial must be discarded within 28 days. Vaccines in multi-dose vials that require reconstitution can be used through the expiration date printed on the label as long as the vaccine is not contaminated, or unless indicated otherwise by the manufacturer. Any vaccine not used within the BUD should be discarded. Specific information regarding the BUD can be found in the vaccine package inserts.

It is acceptable to put the Beyond Use Date (BUD) on the packaging; this may help when reviewing inventory. But a provider should always read the label on the vial before administering a vaccine. It is possible for a vial to be placed in the wrong box. So the vial label is the safest place to put the BUD. Vial labels are small and it may require putting an extra sticky label on the vial.

When manufacturer-filled glass syringes are not supplied with needles, the needles should be attached just before administration. If a needle is attached to a sealed manufacturer prefilled syringe, the syringe should be used or discarded at the end of the clinic day because the sterile seal has been broken.

Disposable syringes are meant for administration of vaccines, not for storage. The CDC recommends vaccines that have been drawn into syringes by the provider be discarded at the end of the clinic day. Manufacturer-filled syringes that have not been activated (i.e., have not had the needle guard removed or a needle attached) may be kept and used until their expiration date.

No. Diluents are not interchangeable, even diluents from the same manufacturer. Therefore, use only the specific diluent provided by the manufacturer for each type of vaccine to ensure adequate potency and safety of the resulting mixture.

Mark a multi-dose vial with the date it was first opened and mark reconstituted vaccine with the date and time it was reconstituted. This is important for two reasons: Some vaccines expire within a certain time after opening or after reconstitution. This may not be the same as the expiration date; and dating opened or reconstituted vials helps manage vaccine inventory by identifying which vials should be used first.

Vaccine manufacturers do not recommend pre-drawing vaccines in advance of large immunization events because no data exist on the stability of vaccines stored in general-use syringes that have been filled by end-users. If vaccine must be pre-drawn (e.g., during a flu drive, deployment line): Do not draw up vaccines before arriving at the immunization event – drawing up doses days or even hours before is not acceptable and each person administering vaccines should draw up no more than one multi-dose vial, or 10 doses, at a time. Any remaining vaccine drawn up in syringes and not administered, must be discarded at the end of the duty day and reported as a loss.

The expiration date for reconstituted multi-dose vials varies from product to product and the new expiration date and time will differ from that printed on the vial. For example, after reconstitution, MMR vaccine must be administered within 8 hours and must be kept at refrigerator temperature during this time. Consult the package insert for the most up-to-date information about expiration dates and times following reconstitution. Unused reconstituted vaccines kept beyond these limits should not be administered.

There are various requirements for the use of vaccines after reconstitution. Some manufacturers’ package inserts require that the vaccine be used or discarded in varying time frames ranging from 24 hours after reconstitution to immediately after reconstitution. While the specific timeframes are simple to interpret, there can be some confusion as to what the requirement of “immediately” actually means. The CDC considers “immediately” to be the reasonable time it takes to prepare and transport the vaccine to the patient to be administered. This would include any limited documentation that may be related to this process. It is up to the judgment of a provider to determine if a vaccine has not been used in the appropriate time. Some manufacturers have indicated to providers that “immediately” can be up to 30 minutes. The definition of “immediately” varies from manufacturer to manufacturer. Some do not have the data to put forth a general timeframe as to what “immediately” means. The CDC recommends that the provider contact the manufacturer any time there is a question about whether the vaccine has not been used in the appropriate timeframe.

First and foremost, rotate your vaccine supply so expensive vaccine does not expire in your refrigerator. If you discover expired vaccine, remove it from the refrigerator or freezer so that it is not inadvertently given to a patient. Expired vaccines and diluents should NEVER be administered, even if it is only 1 day past the expiration date. Whenever possible, unused single-dose vials, multi-dose vials, and manufacturer-filled syringes of vaccine and diluent (expired and/or compromised) may be returnable for credit by using a pharmaceutical reverse distributor program. Using this program provides a safe option for managing unused or expired vaccines while maintaining full compliance with regulating agencies. Contact your site’s pharmacy or logistics office for guidance on the use of this program.

Any temperature reading outside the recommended range for vaccine storage is a temperature excursion. However, it is the total amount of time, or cumulative time, out of range that affects the viability of vaccine. Any time appropriate vaccine storage temperatures are in question, contact your Immunization Healthcare Specialist (IHS), Defense Logistics Agency-Troop Support Medical (DLA-TSM), and/or the U.S. Army Medical Materiel Agency Distribution Operations Center (USAMMA-DOC) for further guidance about whether or not a vaccine may be used. Above all, don't chart an out-of-range temperature and not act on it! DHA-IHD has created temperature recording logs and a troubleshooting record to document unacceptable vaccine storage events. These materials provide guidance on the appropriate steps to take in the event of a storage problem.

If vaccine is suspected to have been outside the recommended temperature range, the vaccine coordinator, supervisor, or if necessary, the person who discovered the problem should begin to document the event. Record the time and temperature of the storage unit when the power goes out, when the power is restored, and when the thermometer reading is back within the recommended range. Do not leave vaccine in a nonfunctioning storage unit. Immediately move the vaccine to a working storage unit at proper temperature. Label potentially compromised vaccine as “Do Not Use” and place it in a separate container apart from other products in the storage unit. Do not destroy, discard or use the vaccine until released from USAMMA-DOC and or DLA-TSM. The most current information for reporting a suspected vaccine compromise can be found at www.health.mil/coldchain.

The Emergency Vaccine Retrieval and Storage Plan provides up-to-date information regarding procedures to follow to protect and/or retrieve vaccines as quickly as possible when a potentially compromising situation occurs such as inclement weather conditions, natural disasters, or other emergencies that might disrupt power or flood any office where vaccine is stored. The immunization clinic vaccine coordinator should develop an Emergency Vaccine Retrieval and Storage Plan and keep it in a prominent and easily accessible location near the vaccine storage units.

In case of an emergency situation, having an established working agreement with at least one alternate storage facility with a backup generator where vaccine can be appropriately stored and monitored for the interim, can save thousands of dollars in vaccines.
Ensure that advanced arrangements are made with the facility(s) to store your vaccine when weather predictions call for inclement conditions (e.g., tornadoes, hurricanes, ice, severe snowstorms), when your vaccine storage equipment cannot be repaired, or when the power cannot be restored before the vaccine storage unit temperature rises above the recommended range.

Move the vaccine to a properly functioning storage unit with internal temperatures within the recommended ranges, then attempt to troubleshoot the problem. Do not allow the vaccine to remain in a nonfunctioning unit for an extended period of time while you attempt to resolve the problem. If you are unsure how long the storage unit will not be functioning properly or you determine that the problem cannot be corrected in time to maintain the internal temperature within the recommended range, activate your clinic’s Emergency Vaccine Retrieval and Storage Plan.

No. If you find that a vaccine has been exposed to an inappropriate temperature, determine the reason for the temperature alteration, mark the vaccine “Do Not Use,” and contact USAMMA-DOC and/or DLA-TSM to determine if the vaccine is still viable.

No, you must use a hard-sided or Styrofoam™ insulated cooler with at least 2-inch thick walls, or other approved mobile transport container capable of maintaining the required storage temperatures of 2°-8°C/36°-46°F with appropriate packing material and thermometer.

Attach labels to the outside of the container to clearly identify the contents as being valuable and fragile vaccines. Record vaccine type(s), quantity, date, time, and originating facility on a label on the outside of the container. Document the vaccine storage unit temperature at the time the vaccine is removed for transport.

You must use validated storage containers and packing protocols which assures product safety and efficacy. You may use hard-sided or Styrofoam™ insulated coolers with at least 2-inch thick walls, or other approved mobile transport container capable of maintaining the required storage temperatures of 2°8°C/36°-46°F. Thin-walled Styrofoam™ coolers, such as those purchased at grocery stores to hold beverages, are not acceptable. The containers should remain closed as much as possible, only the amount of vaccine needed at one time should be removed for preparation and administration, always include calibrated temperature-monitoring device to track temperatures during transport and storage, and the temperature inside the container should be read and documented at least hourly.

The IHD website has a webpage dedicated to vaccine storage and handling, which includes tools and products to help you build quality storage and handling practices. The CDC also has a vaccine storage and handling webpage that includes numerous resources including forms, checklists, posters, and guidelines on proper vaccine storage and handling.