Vaccine Storage and Handling Toolkit

Updated with Mpox Vaccines Storage and Handling Information Addendum

March 29, 2024

MARCH 2024

346940-A

VACCINESTORAGEANDHANDLINGTOOLKITMARCH

Table of Contents

The Vaccine Storage and Handling Toolkit has been updated to address proper storage, handling, transport and emergency handling of

vaccines. The addendum and resources sections are now separate documents. The addendum addresses the proper storage, handling

and transport of the mpox vaccine. The addendum will be updated will be updated as new vaccines are approved and as vaccination

information evolves. Please check the CDC Vaccine Storage and Handling Toolkit website (www.cdc.gov/vaccines/hcp/admin/stor-

age/toolkit/index.html) regularly for the most current version of the toolkit.

Introduction .........................................................................................................................................................................................................3

SECTION ONE: Vaccine Cold Chain ..............................................................................................................................................................5

SECTION TWO: Staff and Training .................................................................................................................................................................7

SECTION THREE: Vaccine Storage and Temperature Monitoring Equipment ......................................................................................9

SECTION FOUR: Vaccine Inventory Management ....................................................................................................................................18

SECTION FIVE: Vaccine Preparation ...........................................................................................................................................................21

SECTION SIX: Vaccine Transport ................................................................................................................................................................. 23

SECTION SEVEN: Emergency Vaccine Storage and Handling...............................................................................................................27

Glossary ............................................................................................................................................................................................................. 29

Disclaimer: This document provides best practices and Centers for Disease Control and Prevention (CDC) recommendations on storage,

handling, and transport of vaccines and diluents. It also provides information on vaccine storage and handling requirements related to

the Vaccines for Children program. Use of trade names and commercial sources in this toolkit is for identiﬁcation only and does not imply

endorsement by the U.S. Department of Health and Human Services (DHHS), the U.S. Public Health Service (PHS), or CDC.

VACCINE STORAGE AND HANDLING TOOLKIT

Introduction

Proper vaccine storage and handling are important factors in preventing and eradicating vaccine-preventable diseases.

Yet, each year, storage and handling errors result in revaccination of many patients and signiﬁcant ﬁnancial loss due

to wasted vaccines. Failure to store and handle vaccines properly can reduce vaccine potency, resulting in inadequate

immune responses in patients and poor protection against disease. Patients can lose conﬁdence in vaccines and

providers if they require revaccination because the vaccines they received may have been compromised.

This toolkit provides information, recommendations, and resources to assist you in properly storing and handling

your vaccine supply. The Centers for Disease Control and Prevention (CDC) Vaccine Storage and Handling Toolkit

brings together best practices from the General Best Practice Guidelines for Immunization* product information from

vaccine manufacturers, and results of scientiﬁc studies.

Implementing these best practices and recommendations will help protect your patients, safeguard your vaccine

supply, and avoid the unnecessary costs of revaccinating patients and replacing expensive vaccines.

For speciﬁc, detailed storage and handling protocols for individual vaccines, always refer to the manufacturer’s product

information vaccines licensed for use in the United States FDA* or contact the manufacturer directly.

Vaccines for Children Program

The Vaccines for Children (VFC) program provides vaccines at no cost to eligible children. VFC providers are

important partners in making sure VFC-eligible children receive viable, properly handled vaccine.

This toolkit provides general background information on many of the VFC storage and handling requirements and

illustrates best practices essential to safeguarding the public vaccine supply.

If you are a VFC provider or receive other vaccines purchased with public funds, consult your state or local

immunization program (referred to throughout this document as “immunization program”

) to ensure you are

meeting all mandatory storage and handling requirements that are speciﬁc or tailored to your jurisdiction.

You may see vendors use terms such as “VFC-compliant,” “CDC-compliant,” or “satisﬁes VFC requirements” in their marketing materials

or on their websites. In this context, "compliance" and related terms may lead consumers to incorrectly believe that CDC or the VFC

program has independently assessed and veriﬁed the quality of these products. CDC/VFC is not authorized to assess, validate, verify,

or endorse the products or services of private companies. Should you encounter this type of language in vendor marketing materials,

please keep in mind that neither CDC nor the VFC program has validated any product or service for compliance with CDC or VFC

program requirements or standards.

2024 Vaccine Storage and Handling Toolkit Updates

Changes to the 2024 Vaccine Storage and Handling Toolkit Transport System Recommendations for vaccine

transport during any emergency can be found in Emergency Transport Vaccine Storage and Handling.

COVID-19 vaccines are available on the commercial market. Please consult, product inserts and Emergency Use

Authorization (EUA) fact sheets for latest recommendations for storing, handling, and administering all COVID-19

vaccines. If you are a VFC provider or receive other vaccines purchased with public funds, consult your state or

local immunization program (referred throughout this document as “immunization program”) to ensure you are

meeting all mandatory storage and handling requirements that are speciﬁc or tailored to your jurisdiction. The

addendum and resources sections are now separate documents. The addendum provides proper storage, handling

and transport of the Mpox vaccine.

* ACIP recommendations: www.cdc.gov/vaccines/hcp/acip-recs/index.html

Manufacturers’ package inserts: Vaccines Licensed for Use in the United States | FDA

Immunization programs: www.cdc.gov/vaccines/imz-managers/awardee-imz-websites.html

Introduction

VACCINE STORAGE AND HANDLING TOOLKIT

How to Use the Vaccine Storage and Handling Toolkit

This toolkit outlines CDC recommendations for vaccine storage and handling.

This list shows the icons you will see throughout the toolkit and their meanings:

ICON DESCRIPTION



CDC Recommendation – CDC recommends this as a minimal action to protect your vaccine supply.

CDC Best Practice – CDC recommends best practices as additional actions, practices, and

procedures to enhance protection of your vaccine supply.

Additional CDC vaccine storage and handling information is available at:

• Vaccine storage and handling home page:

www.cdc.gov/vaccines/hcp/admin/storage-handling.html

(sign up for notiﬁcations about updates)

• Educational webinars and continuing education for health care providers:

www.cdc.gov/vaccines/ed/courses.html

• Contact information for state/local immunization programs:

www.cdc.gov/vaccines/imz- managers/awardee-imz-websites.html

• E-mail speciﬁc questions to CDC: [email protected]v

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION ONE: Vaccine Cold Chain

Proper vaccine storage and handling play critical roles in eorts to prevent vaccine-preventable diseases. Vaccines

exposed to storage temperatures outside the recommended ranges may have reduced potency, creating limited

protection and resulting in the revaccination of patients and thousands of dollars in wasted vaccine.

Proper storage and handling begin with an eective vaccine cold chain.

A cold chain is a temperature-controlled supply chain that includes all vaccine-related equipment and procedures. The

cold chain begins with the cold storage unit at the manufacturing plant, extends to the transport and delivery of the

vaccine and correct storage at the provider facility, and ends with administration of the vaccine to the patient.

Vaccine

manufacturing

Vaccine

distribution

Vaccine arrival

at provider facility

Vaccine storage and

handling at provider facility

Vaccine

administration

Manufacturer

responsibility

Manufacturer/

distributor

responsibility

Provider

responsibility

Cold Chain Flowchart

If the cold chain is not properly maintained, vaccine potency may be lost, resulting in an unusable vaccine supply.

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.

Exposure to any inappropriate conditions can aect potency of any refrigerated vaccine, but a single exposure to

freezing temperatures (0° C [32° F] or colder) can actually destroy potency. Liquid vaccines containing an adjuvant

can permanently lose potency when exposed to freezing temperatures.

SECTION ONE: Vaccine Cold Chain

VACCINE STORAGE AND HANDLING TOOLKIT

When the cold chain fails

Ensuring vaccine quality and maintaining the cold chain are shared responsibilities among manufacturers,

distributors, public health staﬀ, and health care providers.

An eﬀective cold chain relies on three main elements:

» Well-trained staﬀ

» Reliable storage and temperature monitoring equipment

» Accurate vaccine inventory management

Results of a cold chain failure can be costly.

1,2,3

General Best Practice Guidelines for Immunization states, “vaccine

exposed to inappropriate temperatures that is inadvertently administered should generally be repeated.”

A break in the cold chain can mean extra doses for patients, increased costs for providers, and damage to public

conﬁdence in vaccines.

More importantly, patients refusing revaccination can remain unprotected from serious, vaccine-preventable

diseases.

Vaccine appearance is not a reliable indicator that vaccines have been stored in appropriate conditions. For

example, inactivated vaccines—even when exposed to freezing temperatures—may not appear frozen, giving no

indication of reduced or lost potency.

By following a few simple steps and implementing CDC-recommended storage and handling practices, providers can

ensure patients receive high-quality vaccine that has not been compromised.

1. Department of Health and Human Services, Oce of Inspector General. Vaccines for Children Program: Vulnerabilities in Vaccine

Management, June 2012, oig.hhs.gov/oei/reports/oei-04-10-00430.asp.

2. Gazmararian JA, Oster NV, Green DC, Schuessler L, Howell K, et al. Vaccine storage practices in primary care physician oces: assessment

and intervention. Am J Prev Med 2002;23(4):246–53.

3. Bell KN, Hogue CJR, Manning C, Kendal AP. Risk factors for improper vaccine storage and handling in private provider oces. Pediatrics

2001;107(6):1–5.

4. Centers for Disease Control and Prevention. General Best Practice Guidelines for Immunization, www.cdc.gov/vaccines/hcp/acip-recs/general-

recs/index.html.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION TWO: Staff and Training

Vaccine storage and handling practices are only as eective as the sta that implements them. Sta that is well-

trained in general storage and handling principles and organization-speciﬁc storage and handling standard operating

procedures (SOPs) is critical to ensuring vaccine supply potency and patient safety.

Sta Training

All sta members who receive vaccine deliveries as well

as those who handle or administer vaccines should be

trained in vaccine-related practices and be familiar with

your facility’s storage and handling SOPs. If you are a VFC

provider or have vaccines purchased with public funds,

contact your immunization program

for speciﬁc state

requirements related to training, policies, and procedures.

Storage and Handling SOPs



CDC recommends your facility develop and

maintain clearly written, detailed, and up-to-

date storage and handling standard operating

procedures (SOPs). SOPs will help your facility stay organized, serve as a reference and training tool, and ensure

proper vaccine management. SOPs help ensure proper procedures are followed and problems are identiﬁed,

reported, and corrected. SOPs should also provide guidance for emergencies such as equipment malfunctions,

power failures, or natural disasters.

Storage and handling plans and SOPs should contain plans and information for three major areas (see the Vaccine

Storage and Handling SOP Worksheet, (page 35):

• General information—include contact information for vaccine manufacturers, equipment service providers, and

important facility sta, as well as job descriptions, regularly used forms, and sta training requirements

• Routine storage and handling SOPs—include information for all aspects of vaccine inventory management, from

ordering to monitoring storage conditions

• Emergency vaccine storage, handling, and transport SOPs—outline steps to be taken in the event of equipment

malfunctions, power failures, natural disasters, or other emergencies that might compromise vaccine storage

conditions

Worksheets to assist you in developing your organization's routine and emergency SOPs are located in the

resources section.



Train sta on routine vaccine storage and handling and emergency SOPs. Keep SOPs near vaccine storage

units and make sure sta knows where to ﬁnd them. Document all training completed with dates and participant

names.



Storage and handling training should be completed:

• As part of new employee orientation

• Annually as a refresher for all sta involved in immunization and vaccine storage and handling activities

• Whenever new vaccines are added to inventory

• Whenever recommendations for storage and handling of vaccines are updated

* Immunization programs: www.cdc.gov/vaccines/imz-managers/awardee-imz-websites.html

Online Training Resources

CDC’s You Call the Shots: Vaccine Storage and

Handling

†

is a free, online training module focused

on storage and handling requirements.

Check with your immunization program

and

professional organizations to see what vaccine

storage and handling training resources they oﬀer.

†

You Call the Shots: Vaccine Storage and Handling: www.cdc.

gov/vaccines/ed/youcalltheshots.html

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION TWO: Staff and Training

Vaccine Coordinator Recommendations



Designate a primary vaccine coordinator. This person

will be responsible for ensuring all vaccines are stored

and handled correctly and should be an expert on your

facility’s storage and handling SOPs.

Coordinator responsibilities should include:

• Ordering vaccines

• Overseeing proper receipt and storage of vaccine

deliveries

• Documenting vaccine inventory information

• Organizing vaccines within storage units

• Setting up temperature monitoring devices

• Checking and recording minimum/maximum temperatures at start of each workday

• Reviewing and analyzing temperature data at least weekly for any shifts in temperature trends

• Rotating stock at least weekly so vaccines with the earliest expiration dates are used ﬁrst

• Removing expired vaccine from storage units

• Responding to temperature excursions (out-of-range temperatures)

• Maintaining all documentation, such as inventory and temperature logs

• Organizing vaccine-related training and ensuring sta completion of training

• Monitoring operation of vaccine storage equipment and systems

• Overseeing proper vaccine transport (when necessary) per SOPs

• Overseeing emergency preparations per SOPs:

— Tracking inclement weather conditions

†

— Ensuring appropriate handling of vaccines during a disaster or power outage

‡

Coordinator responsibilities may be completed by the coordinator or delegated to appropriate sta. Ensure the

coordinator has trained the delegate(s) and documented competency for the speciﬁc tasks assigned.

* This is a VFC provider requirement.

† The Federal Emergency Management Agency (FEMA) oers a wide range of information on disaster preparedness: www.fema.gov/. The Center

for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) oers information concerning the storage and use of

temperature-sensitive biological products that have been involved in a temporary electrical power failure or ﬂood conditions:

www.fda.gov/AboutFDA/CentersOces/OceofMedicalProductsandTobacco/CBER/.

‡ The National Oceanic and Atmospheric Administration (NOAA) provides up-to-date information on U.S. weather conditions:

www.weather.gov/

www.goes.noaa.gov/

Staﬀ Training and

SOP Best Practices

» Review and update SOPs annually.

» Appoint an alternate vaccine coordinator to act

in the absence of the primary coordinator.

» The alternate coordinator, like the primary

coordinator, should be an expert in routine and

emergency SOPs.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION THREE: Vaccine Storage and Temperature Monitoring Equipment

It is important your facility has proper storage and monitoring equipment that is set up correctly, maintained

appropriately, and repaired as needed. This equipment protects patients from inadvertently receiving compromised

vaccine and your facility against costs of revaccinating patients, replacing expensive vaccines, and losing patient

conﬁdence in your practice.

Vaccine Storage Units: Refrigerator and Freezer Recommendations

There are several types of vaccine storage units available. Purpose-built units are speciﬁcally designed to store vaccines.

However, household-grade units are also an acceptable option for vaccine refrigeration under the right conditions.



Use purpose-built or pharmaceutical-grade units designed to either refrigerate or freeze. These units can be

compact, under-the-counter style or large.

Purpose-built units, sometimes referred to as “pharmaceutical-grade,” are designed speciﬁcally for storage of

biologics, including vaccines. These units often have:

• Microprocessor-based temperature control with a digital temperature sensor (thermocouple, resistance

temperature detector [RTD], or thermistor)

• Fan-forced air circulation with powerful fans or multiple cool air vents promoting uniform temperature and fast

temperature recovery from an out-of-range temperature.

Household-grade units can be an acceptable alternative to pharmaceutical-grade vaccine storage units. As the name

implies, these units are primarily designed and marketed for home use. However, the freezer compartment of this

type of unit is not recommended to store vaccines and there may be other areas of the refrigerated compartment that

should be avoided as well. If your facility provides frozen vaccine, a separate freezer unit is necessary.

Do not store any vaccine in a

dormitory-style or bar-style

combined refrigerator/freezer unit

under any circumstances.

These units have a single exterior

door and an evaporator plate/cooling

coil, usually located in an icemaker/

freezer compartment. These units pose

a signiﬁcant risk of freezing vaccines,

even when used for temporary storage.

(Note: Not all small storage units are

dormitory- or bar-style units. Compact,

purpose-built units for biologics can be

used to store vaccines.)

Storage unit doors

A door that is not sealed properly or le open unnecessarily not only aﬀects

the temperature in a unit, it also exposes vaccines to light, which can reduce

potency of some vaccines. Consider using safeguards to ensure the doors of

the unit remain closed—for example, self-closing door hinges, door alarms, or

door locks.

Storage Unit Best Practices

To fully ensure the safety of vaccines, equipment

should include a recommended unit with enough

space to accommodate your maximum inventory without crowding.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION THREE: Vaccine Storage and Temperature Monitoring Equipment

Storage Unit Placement

Good air circulation around the outside of the storage unit is important. Place a storage unit in a well-ventilated room,

leaving space between the unit, ceiling, and any wall. Nothing should block the cover of the motor compartment. The

unit should be ﬁrm and level, with the bottom of the unit above the ﬂoor. Make sure the unit door opens and closes

smoothly and ﬁts squarely against the body of the unit. If not secured properly, unit doors pose a particular risk to

maintaining appropriate internal temperatures of vaccine storage units. Studies ﬁnd most units work best when placed

in an area with standard indoor room temperatures, usually between 20° C and 25° C (68° F and 77° F). Check the

manufacturer-supplied owner’s manual for additional guidance on placement and spacing.

You may see vendors use terms such as “VFC-compliant,” “CDC-compliant,” or “satisﬁes VFC requirements” in their marketing

materials or on their websites. In this context, "compliance" and related terms may lead consumers to incorrectly believe that

CDC or the VFC program has independently assessed and veriﬁed the quality of these products. CDC/VFC is not authorized to

assess, validate, verify, or endorse the products or services of private companies. Should you encounter this type of language in

vendor marketing materials, please keep in mind that neither CDC nor the VFC program has validated any product or service for

compliance with CDC or VFC program requirements or standards.

Stabilizing Temperatures in New and Repaired Units

It may take 2 to 7 days to stabilize the temperature in a newly installed or repaired refrigerator and 2 to 3 days for a freezer.

Before using a unit for vaccine storage, check and record the minimum and maximum temperatures each workday for

2 to 7 days. If temperatures cannot be recorded digitally, check and record temperatures a minimum of two times each

workday. Once you have 2 consecutive days of temperatures recorded within the recommended range, your unit is

stable and ready for use.

Temperature Ranges

Refrigerators should maintain temperatures between 2° C and 8° C (36° F and 46° F)

. Freezers should maintain

temperatures between -50° C and -15° C (-58° F and +5° F). Ultra-cold freezers should maintain temperatures between

-90° C and -60° C (-130° F and -76° F) . Refrigerator or freezer thermostats should be set at the factory-set or midpoint

temperature, which will decrease the likelihood of temperature excursions.

Consult the owner’s manual for instructions on how to operate the thermostat. Thermostats are marked in various

ways and, in general, show levels of coldness rather than temperatures. The only way to know the temperature where

vaccines are stored is to measure and monitor it with a temperature monitoring device.

Temperature Monitoring Device (TMD)

Every vaccine storage unit must have a TMD. An accurate temperature history that reﬂects actual vaccine

temperatures is critical for protecting your vaccines. Investing in a reliable device is less expensive than replacing

vaccines wasted due to the loss of potency that comes from storage at out-of-range temperatures.



CDC recommends a speciﬁc type of TMD called a “digital data logger” (DDL). A DDL provides the most

accurate storage unit temperature information, including details on how long a unit has been operating outside the

recommended temperature range (referred to as a “temperature excursion”). Unlike a simple minimum/maximum

thermometer, which only shows the coldest and warmest temperatures reached in a unit, a DDL provides detailed

information on all temperatures recorded at preset intervals.

Many DDLs use a buered temperature probe, which is the most accurate way to measure actual vaccine temperatures.

Temperatures measured by a buered probe match vaccine temperatures more closely than those measured by

standard thermometers, which tend to reﬂect only air temperature. However, not all DDLs can measure ultra-cold

temperatures. For accurate ultra-cold temperature monitoring, it is essential to use an air-probe or a probe designed

speciﬁcally for ultra-cold temperatures.

Temperature data from a DDL can either be downloaded to a computer using special software or retrieved from a

website. The software or website may also allow you to set the frequency of temperature readings. Reviewing DDL data

is critical for vaccine viability, so it is important to decide whether independent software or a website program works

best for your facility.

* Probes that are permanently embedded in a buer are acceptable as long as the temperature monitoring system for the entire unit can be

calibration-tested.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION THREE: Vaccine Storage and Temperature Monitoring Equipment



Keep the data for 3 years so they can be analyzed for long-term trends and/or recurring problems. Those

receiving public vaccine may need to keep records longer as required by state regulations.



Use a DDL or other appropriate TMD for:

• Each vaccine storage unit

• Each transport unit (emergency or non-emergency)

Have at least one backup TMD in case a primary device breaks or malfunctions.



Use DDLs with the following features:

• Detachable probe that best reﬂects vaccine temperatures (e.g., a probe buered with glycol, glass beads, sand, or

Teﬂon®)

• Alarm for out-of-range temperatures

• Low-battery indicator

• Current, minimum, and maximum temperature display

†

• Recommended uncertainty of +/-0.5° C (+/-1° F)

• Logging interval (or reading rate) that can be programmed by the user to measure and record temperatures at

least every 30 minutes

Use DDLs with a current and valid Certiﬁcate of Calibration Testing.

Certiﬁcate of Calibration Testing

Calibration testing is done to ensure the accuracy of a temperature monitoring device’s readings against nationally

accepted standards.



A DDL’s Certiﬁcate of Calibration Testing should include:

• Model/device name or number

• Serial number

• Date of calibration (report or issue date)

• Conﬁrmation that the instrument passed testing

(or instrument is in tolerance)

• Recommended uncertainty of +/-0.5° C (+/-1° F) or less

To determine if a Certiﬁcate of Calibration Testing or Report of Calibration was issued by an appropriate entity, check to

see if the certiﬁcate indicates one or more of the following items about calibration testing:

• Conforms to International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC)

17025 international standards for calibration testing and traceability

• Performed by a laboratory accredited by International Laboratory Accreditation Cooperation (ILAC) Mutual

Recognition Arrangement (MRA) signatory body

• Traceable to the standards maintained by the National Institute of Standards and Technology (NIST)

• Meets speciﬁcations and testing requirements for the American Society for Testing and Materials (ASTM) Standard

E2877 Tolerance Class F or higher

• Refers to another acceptable accuracy validation method, such as comparison to other traceable reference standards or

tests at thermometric ﬁxed points



Calibration testing should be done every 2 to 3 years or according to the manufacturer’s suggested timeline.

TMDs can experience a “drift” over time, aecting their accuracy. This testing ensures the accuracy of the device

continues to conform to nationally accepted standards.

Mishandling a TMD can aect its accuracy. If a TMD is dropped, hit against the side of a storage unit, or is potentially

damaged in any way, its accuracy should be checked against another calibrated TMD. If there is any question about

accuracy, the device should be replaced or sent for calibration testing.

* Since these devices are typically battery-operated, you should have a supply of extra batteries on hand. If you are storing ultra-cold vaccine,

make sure your DDL is appropriate for ultra-cold monitoring. See the COVID-19 Vaccine Storage and Handling Addendum for more

information.

† Battery changes may aect temperature accuracy and may warrant checking against a known, calibrated TMD. Check with the device’s

manufacturer for speciﬁc information on battery changes.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION THREE: Vaccine Storage and Temperature Monitoring Equipment

Monitoring Vaccine Temperature and Vaccine Equipment

Monitoring vaccine storage equipment and temperatures are

daily responsibilities to ensure the viability of your vaccine

supply and the safety of your patients. Implementing routine

monitoring activities can help you identify temperature

excursions quickly and take immediate action to correct

them, preventing loss of vaccines and the potential need for

revaccination of patients.

Power Supply

Even with appropriate equipment and temperature

monitoring practices in place, power disruption can result in

destruction of the entire vaccine supply. Precautions should

always be taken to protect the storage unit’s power supply.



Plug in only one storage unit per electrical outlet to

avoid creating a ﬁre hazard or triggering a safety

switch that turns the power o.



Use a safety-lock plug or an outlet cover to prevent the

unit from being unplugged.



Post “DO NOT UNPLUG” warning signs at outlets and

on storage units to alert sta, custodians, electricians,

and other workers not to unplug units.



Label fuses and circuit breakers to alert people not to

turn o power to a storage unit.



Use caution when using power outlets that can be

tripped or switched o and avoid using:

• Built-in circuit switches (may have reset buttons)

• Outlets that can be activated by a wall switch

• Multi-outlet power strips

If built-in circuit switches, Uninterruptible Power Supply (UPS) unit, or power strip surge protection must be used, make

sure the device is rated to carry the maximum current as speciﬁed by the manufacturer of the refrigerator or freezer.

Additionally, consider how the device manages when the power is restored. Whether the device automatically restarts and

allows the equipment to run or has to be manually switched on should be considered and represented in Emergency Plans

and SOPs. Contact the unit manufacturer for any additional questions or guidance regarding circuit switches, power strips,

UPI, or surge protection.

If the entire storage unit is aected by a temperature excursion because of a power supply issue or unit malfunction,

refer to your facility’s emergency SOPs.

Certain types of TMDs have signiﬁcant limitations

and should not be used to measure temperatures

in a vaccine storage unit. These devices can be

diﬃcult to read and, because they only show the

temperature at the exact time they are checked,

may fail to detect temperatures outside the

recommended range.

CDC does not recommend the following TMDs:

» Alcohol or mercury thermometers, even if placed

in a ﬂuid-ﬁlled, biosafe, liquid vial

» Bimetal stem TMDs

» TMDs used for food

» Chart recorders

» Infrared TMDs

» TMDs that do not have a current and valid

Certiﬁcate of Calibration Testing

Please note: Some devices sold in hardware and

appliance stores are designed to monitor temperatures

for household food storage. They are not calibrated and

not accurate enough to ensure vaccines are stored within

the correct temperature range. Using these devices can

pose a signiﬁcant risk of damaging vaccines.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION THREE: Vaccine Storage and Temperature Monitoring Equipment

Organizing and Storing Vaccine

Correctly organizing and placing vaccines in a storage unit

helps prevent conditions that could reduce vaccine potency or

cause vaccine failure.



Store vaccines in their original packaging with lids closed

until ready for administration. Vials and manufacturer-ﬁlled

syringes should always be stored in their original packaging.

Loose vials or syringes may be exposed to unnecessary light,

potentially reducing potency, and may be more dicult to

track for expiration dates. They may also impact inventory

management and increase the risk of administration errors

because they may be confused with other vaccines. For

certain purpose-built units, it is recommended that vaccine be

stored outside of the packaging. If this is the case, follow the

manufacturer’s guidance for vaccine storage.



Check and record storage unit minimum and maximum

temperatures at the start of each workday. If your TMD

does not read minimum/maximum temperatures, then check

and record the current temperature a minimum of two times

per workday (at the start and end of the workday).

Record:

• Minimum/maximum temperature

• Date

• Time

• Name of person who checked and recorded the temperature

• Any actions taken if a temperature excursion occurred

If a reading is missed, leave a blank entry in the log.

Food and beverages should never be stored

in the unit with vaccines. If other biologics are

stored in the unit, vaccines should be stored

on the shelf above them.

Temperature Monitoring

Regular checks provide an

opportunity to inspect the

storage unit, reorganize any

misplaced vaccines, and remove any expired

vaccines. Check the temperature each time

vaccines are accessed in the unit.

Review storage unit temperature readings and

review continuous DDL soware or website

information weekly for changes in temperature

trends that might require action.

If there appears to be any ﬂuctuation in

temperature, troubleshoot the problem based

on additional information provided in this

toolkit, manufacturer manuals, and/or your

oﬃce storage and handling SOPs.

How to Store Vaccines

Place water bottles on the top shelf and ﬂoor and in the door

racks. Putting water bottles in the unit can help maintain stable

temperatures caused by frequently opening and closing unit doors or

a power failure.

Water bottles are not recommended for use with certain

pharmaceutical-grade and purpose-built units. For such units, follow

the manufacturer’s guidance.

do not

unplug

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION THREE: Vaccine Storage and Temperature Monitoring Equipment

Organizing and Storing Vaccine

To conﬁrm vaccines are stored correctly and to minimize the risk of administration errors, implement the following

practices:

» Store each type of vaccine or diluent in its original packaging and in a separate container.

» Position vaccines and diluents 2 to 3 inches from the unit walls, ceiling, ﬂoor, and door. If using a household-grade

unit, avoid storing vaccines and diluents in any part of the unit that may not provide stable temperatures or

suﬃcient air ﬂow, such as directly under cooling vents; in deli, fruit, or vegetable drawers; or on refrigerator door

shelves. The instability of temperatures and air ﬂow in these areas may expose vaccines to inappropriate storage

temperatures.

» Label shelves and containers to clearly identify where each type of vaccine and diluent is stored.

» Store vaccines and diluents with similar packaging or names or with pediatric and adult formulations on diﬀerent

shelves.

» Whenever possible, store diluent with the corresponding refrigerated vaccine. Never store diluent in a freezer.

» Avoid placing or storing any items other than vaccines, diluents, and water bottles inside storage units.

• If other medications and biological products must be stored in the same unit as vaccines, they must be

clearly marked and stored in separate containers or bins from vaccines.

—Potentially contaminated items (e.g., blood, urine, stool) should be properly contained and stored below

vaccines due to risk of contamination from drips or leaks.

—The freezer of a household-grade unit may be used for non-vaccine, medical storage, so long as the use

does not compromise the temperature range within the refrigerator compartment where vaccine is stored.

» Arrange vaccines and diluents in rows and allow space between them to promote air circulation.

» Place vaccines and diluents with the earliest expiration dates in front of those with later expiration dates.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION THREE: Vaccine Storage and Temperature Monitoring Equipment

Temperature Excursions

Temperature excursions or inappropriate storage conditions for any vaccine require immediate action. Any

temperature reading outside the recommended ranges in the manufacturers’ package inserts

is considered a

temperature excursion. In general, manufacturers analyze information about the magnitude of the temperature

excursion and the total amount of time that temperatures were out of range, as well as information about the vaccine in

question, to determine whether a vaccine is likely to still be viable.



CDC recommends the following steps in the event of a temperature excursion (see page 38):

1. Any sta who hears an alarm or notices a temperature excursion on the DDL should notify the primary or

alternate vaccine coordinator immediately or report the problem to their supervisor.

2. Notify sta by labeling exposed vaccines "DO NOT USE" and placing them in a separate container apart from

other vaccines (do not discard these vaccines).

3. The vaccine coordinator, supervisor, or if necessary, the person reporting the problem, should begin to document

the event with the following information

†

a. Date and time of the temperature excursion

b. Storage unit temperature as well as room temperature, if available (including minimum/maximum temperatures

during the time of the event, if available)

c. Name of the person completing the report and description of the event

‡

— General description of what happened

— The length of time vaccine may have been aected, if using a DDL

— Inventory of aected vaccines

— List of items in the unit (including water bottles) other than vaccines

— Any problems with the storage unit and/or aected vaccines before the event

— Other relevant information

4. Implement your facility SOPs to adjust unit temperature to the appropriate range. At a minimum, check the TMD

to make sure it is appropriately placed in the center of the vaccines.

5. Contact your immunization program and/or vaccine manufacturers per your SOPs for further guidance on whether

to use aected vaccines and for information about whether patients will need to be recalled for revaccination.

Be prepared to provide documentation of the event (e.g., temperature log data) to ensure you receive the best

guidance.

6. Complete your documentation of the event, including:

a. Action taken

— What you did with vaccine and how long it took to take action

— Whom you contacted and instructions received

— What you did to prevent a similar future event

b. Results

— Final disposition of aected vaccines (e.g., shortened expiration date per manufacturer, discarded, or returned)

— Other comments

* Manufacturers’ vaccine package inserts: www.immunize.org/fda/. Vaccines under an Emergency Use Authorization (EUA) will provide an EUA

Fact Sheet for Healthcare Providers with this information.

† The Immunization Action Coalition has developed a Temperature Monitoring Log and a Vaccine Storage Troubleshooting Record to support

these activities.

‡ Responses from vaccine manufacturers to events depend on information given by the provider to the manufacturer. If dierent information

about the same event is provided to the same manufacturer, this can lead to dierent recommendations on whether vaccine can be used or

whether patients need to be revaccinated. In addition, each event is unique, and manufacturer recommendations based on existing stability data

cannot be applied to future events that may appear to be similar.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION THREE: Vaccine Storage and Temperature Monitoring Equipment

Regular Maintenance of Vaccine Storage Units and

Temperature Monitoring Devices

Storage units and TMDs need regular maintenance to ensure proper

operation.



Conduct routine maintenance for all vaccine storage units and

related equipment so that your equipment functions at maximum

eciency.

• Check seals and door hinges.

• Clean coils and other components per manufacturer direction.

• Defrost manual-defrost freezers when the frost exceeds either 1 cm or the manufacturer’s suggested limit. Follow

the manufacturer’s instructions. While defrosting, store vaccines temporarily in another unit with appropriate

freezer temperatures.

• Clean the interior of each unit to discourage bacterial and fungal growth. Do so quickly to minimize the risk of a

temperature excursion.

• Test any backup generator quarterly and have it serviced annually.

Never allow vaccines to remain in a

malfunctioning unit for an extended

period of time. If you believe your unit has

failed, implement your emergency SOPs.

Troubleshooting Equipment Problems

Adjusting Storage Unit Temperatures

Storage unit temperatures may need to be adjusted over time. In some situations, thermostats may need to be reset in

summer and winter, depending on room temperature.

Temperature adjustments should be:

• Made by the primary or alternate vaccine coordinator, based on information from the TMD and temperature

monitoring log

• Performed at a time that is not during a busy workday when the unit door is being frequently opened and closed

Remember that temperatures within any storage unit will vary slightly, even with normal use. Therefore, before making

any adjustment:

• Conﬁrm the unit is securely plugged into a power source.

• Check the temperature inside the storage unit.

• Wait 30 minutes, without opening the door, to allow the temperature to stabilize and then check it again to determine

if the thermostat should be adjusted.

If you believe there could be an issue with your TMD, use your backup device to conﬁrm the temperature.

If you conﬁrm that an adjustment is needed:

1. Refer to the owner’s manual for detailed instructions.

2. Make a small adjustment toward a warmer or colder setting by turning the thermostat knob slowly to avoid going

outside the correct temperature range.

3. Once the adjustment is made, allow the temperature inside the unit to stabilize for 30 minutes without opening the

door.

4. Recheck the temperature.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION THREE: Vaccine Storage and Temperature Monitoring Equipment

5. Repeat these steps as needed until the temperature has stabilized

— between 2° C and 8° C (36° F and 46° F) for a refrigerator,

— between -50° C and -15° C (-58° F and +5° F) for a freezer, and

— between -90° C and -60° C (-130° F and -76° F) for an ultra-cold freezer.

6. Consider placing additional water bottles in the unit to help improve temperature stability.

Do not leave vaccines in a storage unit that does not

maintain temperatures within the recommended range.

If you are unable to stabilize the temperature in your unit

within the required range, or temperatures in the unit are

consistently at the extreme high or low end of the range,

your vaccine supply is at high risk. Use your SOPs to

identify an alternative unit with appropriate temperatures

and sucient storage space until the primary unit can be

repaired or replaced.

If you are using a combination storage unit, note

that adjustments to the freezer temperature can

adversely aﬀect the refrigerator compartment

temperature, possibly resulting in frozen vaccines in

the refrigerator.

Repeated Alarm Alerts

If the temperature alarm goes o repeatedly, do not disconnect the alarm until you have determined and addressed

the cause. Do basic checks of the unit door, power supply, and thermostat settings. If the alarm continues to trigger or

the temperature remains out of range, transfer vaccines to a backup unit as directed by your SOPs. A repair technician

should check your equipment to determine the need for repair or replacement.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION FOUR: Vaccine Inventory Management

Proper vaccine inventory management is essential for appropriate vaccine ordering and stock rotation, and ensures

your facility has the vaccines your patients need. Vaccines are expensive, so making sure they are unpacked, stored,

prepared, administered, and transported correctly is critical.

Vaccine Delivery

Scheduling and Receiving Deliveries

Maintaining the cold chain is the ﬁrst step in vaccine inventory management. Sta members who might accept

vaccine deliveries should be trained to immediately notify the vaccine coordinator or alternate coordinator when

deliveries arrive. Vaccines must always be immediately checked and stored properly upon arrival.

Unpacking Deliveries

Vaccines and diluents must be carefully unpacked, stored at

recommended temperatures, and documented immediately

after they arrive. Do not place an unopened and/or unpacked

shipment box in a vaccine storage unit because the cool packs

shipped with the vaccine may make the packaged vaccine too

cold if placed inside the storage unit.

Never leave a vaccine shipping container unpacked

and unattended. If vaccines and diluents get too

warm, they cannot be used. Be sure all staﬀ knows

that vaccine deliveries require immediate attention.



Immediately examine shipments for signs of damage

and to guarantee receipt of the appropriate vaccine

types and quantities.

• Examine the shipping container and vaccines for signs

of physical damage.

• Check the contents against the packing list to be sure

they match.

— For frozen vaccines, the packing list will show the

maximum time vaccines can be in transit based on

shipment date.

• If the shipment includes lyophilized (freeze-dried)

vaccines, make sure they came with the correct type

and quantity of diluents.

• Immediately check both vaccine and diluent expiration

dates to ensure you have not received any expired or

soon-to-expire products.

• Immediately check the cold chain monitor (CCM), a

device used to monitor vaccine temperatures during

transport (if one was included) for any indication of a

temperature excursion during transit.

Stock Records

Use a stock record to account

for and document every dose of

vaccine. This record will help you keep track of your

inventory and can be in either paper or electronic

form. This record should be updated weekly and

include the vaccine delivery information below:

» Date of delivery and initials of the person who

unpacked the box

» Vaccine and diluent name and manufacturer

» Number and expiration date for each lot

» Number of doses received

» Condition of each vaccine and diluent upon

arrival

» CCM reading if included in the shipping

container

» Number of doses used

» Balance of remaining doses aer subtracting

the amount used

Note: State and local programs that have an

immunization information system (IIS) with vaccine

inventory accounting functions will require VFC

providers to use the IIS to track their inventory.

Vaccine Inventory Accounting

Stock Counts

Stock records are used to determine the type and amount

of vaccines your facility should stock to meet the needs of

your patients. At least once a month and before placing any

vaccine order, count all vaccine and diluent doses to make

sure the number of doses in the storage unit matches the

number of doses documented in the stock record. Always

check expiration dates while counting stock and remove any

expired doses immediately.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION FOUR: Vaccine Inventory Management

Tally sheets can help keep stock records up-to-date. Place tally sheets outside the storage unit door (or another

easily accessible location), and have staﬀ use tick marks to keep a count of every dose removed from the unit.

Tally Sheets

If the numbers in the storage unit do not match the doses documented in the stock record, enter the correct number

based on your count on a separate line below the old balance on your stock record. Make a note next to the new entry

indicating that your count conﬁrmed the new balance and sign it. Use the corrected balance for calculating stock

quantities in the future.

If you receive multiple doses of the same vaccine in the same presentation from the same lot with the same expiration

date, you can document these doses as one entry on the stock record. Indicate the total number of doses received,

regardless of how many vials or syringes the doses came in. For example, if you receive 10 single-dose vials of the same

vaccine with the same lot number and expiration date, you can make a single entry on the stock record, noting that 10

doses were received.

If there are discrepancies between the contents and the packing list or other concerns about the contents, immediately

notify the vaccine manufacturer. If you are a VFC provider or receive vaccines purchased with public funds, contact

your immunization program.

Diluents should be documented on a separate stock record and should equal quantities of corresponding vaccines.

At the end of each month, determine the total number of vaccine and diluent doses used that month and the amount

of stock still available. At the end of each year, use your stock record to determine the number of doses received for

the year and add up your monthly dose counts to get a total number of doses used. This information will help you

determine your facility’s needs and guide you in ordering so you can minimize future waste and reduce the need for

transfer and transport of vaccines. It will also help to make sure you have a sucient supply to meet your patients'

needs.

Vaccine Ordering



Order and stock only enough vaccine to meet patient needs.

†

Storing a larger volume than your facility needs can increase the risk of wasting vaccines if they expire before they can

be used or they are compromised in some way (e.g., due to mechanical failure of a storage unit).

Most facilities should also reorder based on patient needs after checking stock count. Vaccine orders usually arrive

within 1 to 2 weeks, but there can be delays. When possible,

avoid placing last-minute or rush orders to lessen the risk of

running out of vaccines.

Stock Rotation and Removal



Vaccine stock should be rotated and checked for

expired doses regularly. Any expired vaccines and

diluents should be removed immediately to avoid

inadvertently administering them. Arrange stock

for each vaccine type so that doses with the earliest

expiration dates are placed in front of those with later

expiration dates.

Contact your immunization program* to ﬁnd out if expired vaccines purchased with public funds can be returned.

* Contact your immunization program for details about speciﬁc state or local regulations impacting this activity.

† An adequate supply of vaccine varies for most providers, facilities, or immunization programs. It is recommended that reordering is done when

stock has been reduced to a 4-week inventory.

Arranging Your Stock

The vaccine coordinator (or other

designated person) should rotate vaccine and

diluent stock at least once a week, as well as each

time your facility receives a vaccine delivery. This will

ensure that vaccines expiring sooner are used ﬁrst.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION FOUR: Vaccine Inventory Management

Understanding Expiration Dates

All vaccine products, like other medications, have an expiration date,

sometimes referred to as the expiry date. The expiration date is

determined by the manufacturer.

The expiration date is the ﬁnal day that the vaccine can be

administered. Vaccines past the expiration date should NEVER be used.

Determining when a vaccine or diluent expires is a critical step in

maintaining proper storage and handling. Understanding vaccine

expiration dates can help save your practice time and money.

When the expiration date has only a month and year, the product may be used up to and including the last day of that

month. If a day is included with the month and year, the product may only be used through the end of that day.

In some instances, such as the examples for beyond-use date (BUD) below, vaccines must be used before the

expiration date on the label.

Beyond-Use Dates

Some vaccines have a beyond-use date/time. The Beyond-use date is diﬀerent from expiration date. The beyond-

use date, or BUD, is the last date or time that a vaccine can be safely used aer it has been moved from one storage

state to another (e.g., frozen to refrigerated) or prepared for patient use. It is a new deadline aer which the product

should not be used. The BUD varies by product and type of transition. This is sometimes also called a beyond-use

time if it falls on the same day at a diﬀerent time of day.

Unlike the expiration date that is determined by the manufacturer, the BUD is determined by the health care provider

using guidance provided by the manufacturer. The BUD replaces the manufacturer’s expiration date but never

extends it. Always use the earlier date between the two.

Not all vaccine products have a BUD. The package insert or Emergency Use Authorization (EUA) Fact Sheet for

Healthcare Providers will specify if there is a BUD and how to calculate it. Always review this informational material

to determine if a BUD applies. Examples of BUD include:

Reconstituted vaccines have a limited period for use once the vaccine is mixed with a diluent. If a reconstituted

vaccine is not used immediately, follow manufacturer guidance for storage conditions and time limits. Additional

information can be found here.

Multidose vials might have a speciﬁed period for use once they have been punctured with a needle. For example, the

package insert may state that the vaccine must be discarded 28 days aer the ﬁrst puncture with a needle. If the vial

is ﬁrst punctured on 06/01/2023, the BUD is 06/29/2023. The vaccine should not be used aer the BUD.

Manufacturer-shortened expiration dates may apply when vaccine is exposed to inappropriate storage conditions.

The manufacturer might determine the vaccine can still be used, but will expire on an earlier date than the date on

the label. The BUD should be noted on the vial label along with the initials of the person making the calculation.

Expiration Dates

The vaccine

coordinator (or other

designated person) should remove

expired vaccine and diluent immediately

from the inventory.

Vaccine Disposal

General vaccine disposal guidelines for:

• Expired or compromised vaccine—sometimes unused vaccine and diluent doses, unopened vials, expired vials,

and potentially compromised vaccine may be returned for credit, even if they must be discarded. Contact your

immunization program

and/or the vaccine manufacturer for vaccine-speciﬁc information.

• Open and broken vials and syringes, manufacturer-ﬁlled syringes that have been activated, and vaccine

predrawn by providers—these cannot be returned and should be discarded according to your state requirements.

• Empty vaccine vials—most are not considered hazardous or pharmaceutical waste and do not require disposal in a

biomedical waste container.

†

However, check and comply with your state requirements for disposal.

Medical waste disposal requirements may vary from state to state because they are set by state environmental agencies.

Contact your immunization program

or state environmental agency for guidance to ensure your facility’s vaccine

disposal procedures comply with state and federal regulations.

* Contact your immunization program for details about speciﬁc state or local regulations impacting this activity.

† While vials are not usually considered hazardous or pharmaceutical waste, an empty RV dispensing tube or oral applicator is considered medical

waste and should be disposed of in a medical waste container.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION FIVE: Vaccine Preparation

Preparing Vaccine for Administration

Vaccine preparation is the ﬁnal step in the cold chain before administration. Handling vaccines with care is equally as

important as storing them properly.

Vaccine Preparation

» Prepare vaccines in a designated area away from any space where potentially contaminated

items are placed.

» Only prepare vaccines when you are ready to administer them.

» Before preparing the vaccine, always check the:

— Vial to ensure it is the correct vaccine

— Expiration date or beyond-use date/time to ensure it has not passed

» Always check expiration dates and conﬁrm that you have selected the correct vaccine.

» Only administer vaccines you have prepared. This is a quality control and patient safety issue and a best

practice standard of medication administration.

Diﬀerent types of vaccine vials

Single-Dose Vials

A single-dose vial (SDV) contains one dose and should be used one time for one patient. SDVs do not contain

preservatives to help prevent microorganism growth. Never combine leover vaccine from one SDV with another to

obtain a dose.

Only open an SDV when ready to use. Before you remove the protective cap, always check the vial to make sure you have

the correct vaccine. Once you remove the cap, you must use the vaccine because it may not be possible to determine if

the rubber seal has been punctured. Discard any unused SDVs without a protective cap at the end of the workday.

Multidose Vials

A multidose vial (MDV) contains more than one dose of vaccine. Because MDVs typically contain a preservative to help

prevent the growth of microorganisms, they can be entered or punctured more than once. Only the number of doses

indicated in the manufacturer’s package insert should be withdrawn from the vial. Aer the maximum number of doses

has been withdrawn, the vial should be discarded, even if there is residual vaccine or the expiration date has not been

reached.

MDVs can be used until the expiration date printed on the vial unless the vaccine is contaminated or compromised in

some way or there is a BUD noted in the package insert.

Never use partial doses from two or more vials to obtain a dose of vaccine.

Based on safe injection practices, CDC does NOT recommend the use of vial adapters, spikes, or other vial access

devices when withdrawing vaccine from a multidose vial. Leaving a vial access device inserted into a vial septum provides

a direct route for microorganisms to enter the vial and contaminate the ﬂuid.

Manufacturer-Filled Syringes

A manufacturer-ﬁlled syringe (MFS) is prepared and sealed under sterile conditions by the manufacturer. Activate an

MFS (i.e., remove the syringe cap or attach the needle) only when ready to use.

An MFS does not contain a preservative to help prevent the growth of microorganisms. Once the sterile seal has been

broken, the vaccine should be used or discarded by the end of the workday.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION FIVE: Vaccine Preparation

Reconstitution of Vaccine

Lyophilized (freeze-dried) vaccines are in either powder or pellet form and must be mixed with a liquid (diluent) in a

process known as “reconstitution” before being administered.

Diluents vary in volume and composition and are speciﬁcally designed to meet volume, pH balance, and the chemical

requirements of their corresponding vaccines. Refer to the manufacturer’s package insert for guidance on storage and

handling.

Diluents are not interchangeable unless speciﬁed by the manufacturer.

• Some diluents contain an antigen or an adjuvant needed for vaccine eectiveness. Even if the diluent is composed of

sterile water or saline, use only the diluent supplied with the vaccine to reconstitute it.

Never use a stock vial of sterile water or normal saline to reconstitute vaccines.

Never administer vaccine reconstituted with the wrong

diluent.

• If an incorrectly reconstituted vaccine has already been

administered, contact your immunization program

the vaccine manufacturer for revaccination guidance.

* Immunization programs: www.cdc.gov/vaccines/imz-managers/

awardee-imz-websites.html

Always check expiration dates on both diluents

and vaccines before reconstituting them.

†

† If you are a VFC provider or have other vaccines purchased

with public funds and must transfer vaccine to another facility

so it can be used before it expires, contact your immunization

program

for guidance on vaccine transport.

Predrawing Vaccine

Predrawing vaccines can result in waste if more are drawn up than

needed.



Draw up vaccines only at the time of administration. The

practice of preﬁlling syringes is discouraged for several reasons.

However, there may be rare instances when the only option is to

predraw vaccine.

If vaccines must be predrawn, adhere to the following best practices:

• Set up a separate administration station for each vaccine type to

prevent medication errors.

• Draw up vaccines only after arriving at the clinic site or mass

vaccination event. Drawing up doses days or even hours before

administering them is not a best practice because general-use

syringes are not designed for storage.

• Each person administering vaccines should draw up no more than

one MDV or 10 doses at one time.

• Once each predrawn dose is prepared, label the syringe with the vaccine name and dosage, the beyond-use date and

time, lot number, and the preparer’s initials. Additional pertinent information can be added, such as age range or

primary or booster dose, as needed.

• Monitor patient ﬂow to avoid drawing up unnecessary doses.

• Predraw reconstituted vaccine into a syringe only when you are ready to administer it. If a predrawn vaccine is not

used within 30 minutes of being reconstituted, follow manufacturer guidance for storage conditions and time limits.

A manufacturer may specify that an unused reconstituted vaccine can only be stored in the vial for a speciﬁed

amount of time.

• Predrawn syringes must be stored at the manufacturer-recommended temperatures throughout the clinic day.

• Discard any remaining vaccine in predrawn syringes at the end of the workday.

Never transfer predrawn reconstituted vaccine back into a vial for storage.

As an alternative to predrawing vaccines, use manufacturer-ﬁlled syringes for large vaccination clinics.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION SIX: Routine Vaccine Transport

Instruction for routine transport of some vaccine may vary. Carefully review manufacturer guidance for each vaccine

product to ensure the cold chain is maintained.

Transport, as described in this section, involves the movement

of vaccine between providers or other locations over a short

distance and time frame and is appropriate for events such

as o-site clinic or to ensure vaccines that are about to expire

can be used rather than wasted.

General Principles of Transport

Vaccine transport to o-site or satellite facilities is dierent

from both shipping and emergency transport. Shipping

usually involves a professional carrier and a longer distance

and time frame for moving vaccines between locations.

Protecting Your Vaccine Supply

» Vaccine that will be used at

an oﬀ-site or satellite facility

should be delivered directly to that facility.

» When delivering to a speciﬁc site, adequate

storage equipment and staﬀ should be in

place to provide appropriate oversight.

» If the facility doesn’t have the capacity to

refrigerate the vaccines, then a portable

vaccine storage unit or qualiﬁed container

and packout may be used with a DDL.

» If delivery to the speciﬁc site is not possible,

then vaccine can be transported in a stable

storage unit and monitored with a TMD.

» If the facility doesn’t have the capacity to

refrigerate the vaccines, then a portable

vaccine storage unit or qualiﬁed container

and packout may be used with a DDL.

» Develop an emergency plan or SOPs for

transporting vaccines and include procedures

and protocols for packing and transport.

Vaccine Transport

Vaccines from your supply should not be routinely

transported. In instances where the transport of vaccine

from your supply is necessary, take appropriate precautions

to protect your supply. Vaccines should only be transported

using appropriate packing materials that provide the

maximum protection.

Partially used vials cannot be transferred

between providers OR across state lines.

* Contact your immunization program for details about

speciﬁc state or local regulations impacting this activity.



The total time for transport alone or transport plus

clinic workday should be a maximum of 8 hours

†

unless guidance from the manufacturer diers (e.g.,

if transport to an o-site clinic is 1 hour each way, the

clinic may run for up to 6 hours).



Use a transport temperature monitoring log to

document temperatures and how long the vaccine is in

the portable storage container.



Transport diluents with their corresponding vaccines

to ensure there are always equal amounts of vaccines

and diluents for reconstitution.



Your facility should have a sucient supply of

materials needed for vaccine transport of your largest

annual inventory. Appropriate materials include:

• Portable vaccine refrigerator/freezer/ultra-cold freezer units (preferred option)

• Qualiﬁed containers and packouts

• Coolant materials such as phase change materials (PCMs) or frozen water bottles that can be conditioned

between 4° C and 5° C (39° F and 41° F)

• Insulating materials such as bubble wrap and corrugated cardboard—enough to form two layers per container

TMDs for each container between 4° C and 5° C (39° F and 41° F)

† COVID-19 vaccine transport times may be dierent. Refer to product inserts for vaccine speciﬁc information.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION SIX: Routine Vaccine Transport

Soft-sided containers speciﬁcally engineered for vaccine transport are acceptable. Do not use commercially available soft-

sided food or beverage coolers because most are poorly insulated and likely to be aected by room or outdoor temperatures.

The same shipping materials the vaccines were initially shipped in should rarely, if ever, be used as they are not meant for

reuse. This could put the cold chain and, ultimately, the viability of the vaccine, at risk.

Transport of Vaccines

It is always safest to have vaccines delivered directly to a facility with a vaccine storage unit ready to receive

the shipment, but this is not always possible. If necessary, vaccines may be transported using a portable vaccine

refrigerator with a temperature monitoring device placed with the vaccines. If a portable vaccine refrigerator is not

available, qualiﬁed containers and packouts with a TMD in each container can be used. For transport to an o-site

clinic, bring only what is needed for the workday.

Routine Transport System Recommendations

Container Transport for Oﬀ-Site Clinic, Satellite Facility, or Relocation of Stock

Portable Vaccine Refrigerator or Freezer Yes

Qualiﬁed Container and Packout Yes

Conditioned Water Bottle Transport System

Manufacturer’s Original Shipping Container No

Food/Beverage Coolers No

Coolants for Transport

PCMs between 4° C and 5° C (39° F and 41° F) can also be

purchased to maintain proper temperatures. Follow the

manufacturer’s instructions

†

for use to reduce the risk of

freezing vaccines during transport.

Do not use frozen gel packs or coolant packs from

original vaccine shipments to pack refrigerated vaccines.

They can still freeze vaccines even if they are conditioned or

appear to be “sweating.”

Transport Planning and Preparation

Improper packing for transport is as risky for vaccines as a

failed storage unit.



Include vaccine packing and transport protocols in

your routine and emergency storage. At a minimum,

include the following procedures and protocols:

For all sta-facilitated transport:

• Identify trained sta to pack vaccines as well as

primary and backup vehicles and drivers for transport

in advance.

• Consider renting a refrigerated truck if you have a

large quantity of vaccines or need to transport vaccines

an extended distance.

• Take an inventory of your vaccines and record actions to protect the vaccines during transport.

• Open unit doors only when necessary and only after completing all preparation for packing and moving vaccines.

• If using a company or personal vehicle, only transport vaccines inside the passenger compartment (not in the

trunk or bed of a truck, which may be too hot or too cold).

• Move transport containers directly to a vehicle that is already at a comfortable temperature, neither too hot nor too cold.

* Packing Vaccines for Transport during Emergencies: www.cdc.gov/vaccines/hcp/admin/storage/downloads/emergency-transport.pdf

† Manufacturers’ vaccine package inserts: www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states

Transporting mRNA Vaccines

» Transport vials in the tray/

carton whenever possible.

» Protect vials as much as possible from drops,

shocks, and vibration.

» Secure storage containers during transport.

» Protect from light. Avoid exposure to direct

sunlight and ultraviolet light.

If individual vials must be transported:

» Place vials with padding materials like bubble

wrap or similar materials to prevent breaking.

» Keep vaccine vials upright whenever possible.

» Label the container and vials, appropriately

including beyond-use date/time.

» Transport vaccine in vials.

» Refer to the manufacturer package insert for

additional guidance.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION SIX: Routine Vaccine Transport

• Avoid leaving containers in areas where they are exposed to direct sunlight.

• Check vaccine temperature upon arrival at the alternative vaccine storage facility and store vaccines at

recommended temperatures immediately.

• Check with your immunization program

for additional guidance and resources on emergency transport of

vaccines, particularly in major emergencies.

Transporting Opened Multidose Vials

If absolutely necessary, a partially used vial may be transported to or from an o-site/satellite facility operated by the

same provider, as long as the cold chain is properly maintained. However, a partially used vial cannot be transferred

from one provider to another or across state lines.

Transporting Predrawn Syringes

CDC recommends transporting vaccine in vials. However, there may be instances when the only option is to transport

predrawn vaccine in a syringe. For example, MFSs are recommended for large vaccination clinics, however, there may

be rare instances when the only option is to predraw vaccine for o-site clinics.

Transporting Diluents

Transport diluents with their corresponding vaccines so there are always equal amounts of vaccines and diluents for

reconstitution. Follow the manufacturer’s guidance

†

for speciﬁc temperature requirements.

If diluents stored at room temperature (20° C to 25° C [68° F to 77° F]) are going to be transported with refrigerated

vaccines, they should be refrigerated in advance for as long as possible so they do not raise the container temperature

when placed with refrigerated vaccines.

Never freeze diluents—not even during transport.

Place an insulating barrier like bubble wrap between the diluents and conditioned water bottles or phase change materials.

Transporting Frozen Vaccines



If frozen vaccines must be transported, use a portable vaccine freezer unit or qualiﬁed container and packout

that maintains temperatures between -50° C and -15° C (-58° F and +5° F) or -90° C and -60° C (-130° F and -76° F)

for ultra-cold transport.

Follow these steps for transporting frozen vaccines:

• Place a TMD (preferably with a buered probe) in the container as close as possible to the vaccines.

• Immediately upon arrival at the destination, unpack the vaccines and place them in a freezer at a temperature range

between -50° C and -15° C (-58° F and +5° F) or -90° C and -60° C (-130° F and -76° F) for ultra-cold freezer storage.

Any stand-alone freezer that maintains these temperatures is acceptable.

• Record the time that vaccines are removed from the storage unit and placed in the transport container, the

temperature during transport, and the time at the end of transport when vaccines are placed in a stable storage unit.

Do not use dry ice, even for temporary storage

‡

. Dry ice might expose the vaccines to temperatures colder than -50° C (-58° F).

* Immunization programs: www.cdc.gov/vaccines/imz-managers/awardee-imz-websites.html

† Manufacturers’ vaccine package inserts: www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states

‡ The only exception to this is for transport of COVID-19 Vaccine (Pfizer) which can be transported at ultra-cold temperatures using dry ice.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION SIX: Routine Vaccine Transport

Temperature Monitoring During Transport

Regardless of how the vaccine is moved (i.e., car, professional carrier, snowmobile, boat, small plane), if vaccines are

packed by health care provider, the BUD should be applied using manufacturer guidance.

Use a continuous TMD, preferably a DDL with the capability to measure minimum/maximum temperatures, for

monitoring and recording temperatures while transporting vaccines:

• The TMD should have an accuracy of +/-0.5° C (+/-1° F).

• Place buered probe material in a sealed vial directly with the vaccines.

• Keep the TMD display on top of vaccines so you can easily see the temperature.

• Record the time and minimum/maximum temperature at the beginning of transport.

Temperature Monitoring after Transport



Immediately upon arrival at the destination, vaccines should be stored in an appropriate storage unit with a

TMD. Be sure to follow these guidelines for monitoring and recording storage unit temperature:

• If the device displays minimum/maximum temperatures, this information should be checked and recorded.

• If the device does not display minimum/maximum temperatures, then the current temperature should be

checked and recorded a minimum of two times (at the start and end of the workday).

If vaccines cannot be stored in an on-site storage unit, they should be kept in the portable vaccine storage unit using

the following guidance:

• If using a DDL that records minimum/maximum temperatures, only check and record temperatures each time

the portable vaccine storage unit is opened. If the TMD measures current temperatures only, place the probe as

close as possible to the vaccines, and check and record temperatures hourly.

• Keep the container closed as much as possible.

• For o-site clinic use, remove only one multidose vial or 10 doses at a time for preparation and administration

by each person administering vaccines.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION SEVEN: Emergency Transport Vaccine Storage and Handling

Instructions for handling vaccine products during an emergency may be dierent from those for other vaccines.

Carefully review this section as well as the manufacturer guidance to ensure the vaccine cold chain is maintained

during an emergency.

Emergencies like equipment failures, power outages, severe

weather conditions, or natural disasters usually happen without

warning and may compromise vaccine storage conditions. In

addition to vaccine transport planning, you should make plans to

prepare for emergencies.

Vaccine Transport During Emergencies

Emergency transport usually involves relocating vaccines

to protect them when a facility’s ability to store vaccines is

compromised (e.g., because of power loss). Depending on the

situation, some general principles of vaccine transportation

recommendations may be the same, but there are also some

dierences such as:

• A system using conditioned water bottles can be used during

emergency situations.

• Manufacturers’ original shipping containers may also be used

as a last resort in an emergency situation.

• Hard-sided insulated containers or Styrofoam™ (Use in

conjunction with the Packing Vaccines for Transport during

Emergencies

†

tool can be used only in an emergency.

*The Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) oers information concerning the storage

and use of temperature-sensitive biological products that have been involved in a temporary electrical power failure or ﬂood conditions:

www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ProductSecurity/ucm147243.htm.

† Packing Vaccines for Transport during Emergencies: www.cdc.gov/vaccines/hcp/admin/storage/downloads/emergency-transport.pdf

Vaccines may remain inside a nonfunctioning

unit as long as appropriate temperatures are

maintained. Monitor your DDL to determine

when additional action should be taken.

If an alternative vaccine storage

facility is not available

If you cannot ﬁnd an alternative vaccine

storage facility within a reasonable distance,

or if you cannot reach your alternative facility,

you can use portable vaccine refrigerator/

freezer units (if power source is available),

qualiﬁed containers and packouts, or a hard-

sided insulated container or Styrofoam™ using

the Packing Vaccines for Transport during

Emergencies tool. Always place a TMD with

the vaccines and carefully monitor the TMD to

ensure vaccines remain within the appropriate

temperature range. Temporary storage

containers should remain closed, and vaccines

can only be stored safely for as long as the

containers are validated to maintain proper

storage temperatures.

The Packing Vaccines for Transport during

Emergencies tool

†

describes a system in which

properly conditioned frozen water bottles

can be used as a coolant when transporting

vaccines during emergency situations.

Container

Transport for Oﬀ-Site

Clinic, Satellite Facility, or

Relocation of Stock

Portable Vaccine Refrigerator

or Freezer

Yes

Qualiﬁed Container

and Packout

Yes

Conditioned Water Bottle

Transport System

†

Yes

Manufacturer’s Original

Shipping Container

Yes

(last resort only)

Food/Beverage

Coolers

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION SEVEN: Emergency Transport Vaccine Storage and Handling

Emergency Equipment Backup Options

Alternative Storage Facility

No piece of vaccine storage equipment is infallible. At

some point, equipment will fail because of a power outage,

breakdown, or normal wear and tear.



Establish a working agreement with at least one

alternative storage facility even if you have a generator

as backup equipment. Make sure you have 24-hour access

to this facility. Hospitals, long-term care facilities, state

depots, the Red Cross, ﬁre stations, packing plants, grocery

stores, funeral homes and commercial pharmacies are

some of the facilities that may be able to assist you.

Ensure the alternative storage facility has a dedicated unit

or shared space that can maintain temperatures at the

appropriate range. Note that shared spaces may not be able to

maintain temperatures at the recommended ranges for your

vaccine supply.

Your facility may also choose to have a backup storage unit so

that vaccine may not have to be packed and/or moved to an

alternative storage facility if the primary storage unit fails.

Temperature monitoring at alternative storage sites:

Vaccine temperature should be maintained when stored at an alternative facility during an emergency. Temperatures

should be monitored and documented in temperature logs when storing vaccines during an emergency. Sometimes

getting temperature logs before an emergency is not feasible. However, provider should conﬁrm that the emergency

unit can maintain the required vaccine temperature range between 2-8°C. This could be completed by locating the

speciﬁcations for the make/model of the storage unit online.

Accessing Your Building after Hours

Ensure the alternative storage facility has a dedicated unit or shared space that can maintain temperatures at the

appropriate range. Note that shared spaces may not be able to maintain temperatures at the recommended ranges for your

vaccine supply.

Emergency situations can arise outside of normal business hours, so maintain a relationship with your facility’s building

manager and/or security sta. Ensure all sta members are familiar with emergency SOPs, including after-hours roles and

responsibilities.

Your facility’s storage and handling SOPs should include instructions for accessing your vaccine storage units

when the building is closed, with a building map/diagram and locations of:

• Spare batteries

• Flashlights

• Keys

• Locks

• Circuit breakers

• Emergency transport equipment and materials

Keep information on after-hours building access and security procedures with SOPs and with building management

and security sta, if appropriate, and also make sure relevant sta has copies of this information available at home.

Generators and backup battery

power sources

Having an on-site generator prevents the need to

transport vaccines to an alternative storage facility

during a power outage.

» Keep suﬃcient fuel on hand to continuously run

the generator for at least 72 hours.

» A generator should be tested quarterly and

serviced annually.

A backup battery power source can be used in lieu

of a generator.

» Backup battery power sources should be tested

quarterly and serviced annually.

» Check the manufacturer’s guide for testing.

VACCINE STORAGE AND HANDLING TOOLKIT

SECTION SEVEN: Emergency Transport Vaccine Storage and Handling

Power Outages

Monitoring Unit Temperature during a Power Outage

If your storage unit has an external temperature monitoring

display that you can check without opening the unit door, take the

following steps:

• Record room temperature (if possible) and the temperature

inside the unit as soon as the power goes out.

• Record minimum and maximum temperatures reached inside

the unit during the outage.

• Temperature excursions should be avoided, if possible, by using emergency plans and SOPs for transport and

alternative storage. However, if temperatures have fallen outside of the recommended range, follow your procedures

for temperature excursions.

If you cannot monitor the temperature inside the unit without opening the door and you do not have an alternative

facility with power where the vaccines can be stored or other emergency vaccine storage SOPs, wait until power is

restored and then take the following steps:

• Record the room temperature (if possible) and the temperature inside the unit.

• If using a DDL, document the length of time the power was o and the minimum and maximum temperatures during

that period.

• If temperatures inside the unit have already fallen outside of the recommended range, follow your procedures for

temperature excursions. Even if an excursion has occurred, move your vaccines to an alternative storage unit or

location where they can be stored at appropriate temperatures, if possible. Make sure to separate and mark these

vaccines “Do NOT Use” until a decision can be made about whether the vaccines can still be used.

During a power outage, only open the

storage unit door if:

» Power is restored.

» It is determined that the vaccines need to

be packed in separate storage containers

and/or transported to an alternative

storage facility.

VACCINE STORAGE AND HANDLING TOOLKIT

Glossary

Buﬀered temperature probe Temperature probe designed to prevent false readings by protecting

the thermometer from sudden changes in temperature that can

occur when opening a refrigerator door. A probe is “buﬀered” by

immersing it in a vial ﬁlled with liquid (e.g., glycol, ethanol, glycerin),

loose media (e.g., sand, glass beads), or a solid block of material (e.g.,

Teﬂon®, aluminum).

Beyond-use date (BUD) The date or time aer which a vaccine should not be administered,

stored, or transported. The BUD should never exceed the

manufacturer’s original expiration date.

Calibration Professional measurement of the accuracy of a temperature

monitoring device’s readings against nationally accepted standards.

Cold chain monitor (CCM) Generally, a single-use device that monitors the temperature inside

a vaccine shipping container. CCMs should be thrown away aer

being checked. CCMs are stored in a separate compartment of the

shipping container (a CCM may not be included when vaccines are

shipped directly from the manufacturer).

Conditioned water bottles Frozen water bottles that have been submerged under lukewarm

water until the ice block inside can spin freely.

Digital data logger (DDL) An electronic device that records data digitally over time or in

relation to location either with a built-in or external instrument or

sensor.

Diluent A diluting agent (e.g., a liquid) added to reconstitute lyophilized

vaccine before administration. Manufacturers of these vaccines also

supply the matching diluent.

Dormitory-style (bar-style) storage

unit

A combination refrigerator/freezer unit with one exterior door and

an evaporator plate (cooling coil), which is usually located inside an

icemaker compartment (freezer) within the refrigerator. These units

have been shown to pose a signiﬁcant risk of freezing vaccines, even

when used for temporary storage.

Fan-forced air circulation Technology using powerful fans or multiple cool air vents inside the

unit that promote uniform temperature and fast temperature

recovery.

Household-grade storage unit A storage unit that is primarily sold for home use.

Lyophilized Freeze-dried; usually referring to a vaccine that is freeze-dried into a

powder or wafer.

Minimum/maximum temperature A vaccine storage unit’s coldest and warmest temperature readings

during a set period of time.

VACCINE STORAGE AND HANDLING TOOLKIT

Glossary

Phase change materials (PCMs) Engineered packing supplies that help control container

temperatures during vaccine transport or shipping.

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.

Potency A vaccine’s strength or eﬀectiveness; in the context of this toolkit,

potency refers to a vaccine’s response to environmental conditions.

Presentation Type of packaging for a vaccine (e.g., single-dose vial, multidose vial,

manufacturer-ﬁlled syringe, etc.).

Purpose-built /pharmaceutical-grade

unit

Unit that are speciﬁcally designed to store vaccines.

Qualiﬁed container and packout A type of container and supplies speciﬁcally designed for use

when packing vaccines for transport. They are containers that are

“qualiﬁed” through laboratory testing under controlled conditions

to ensure they achieve and maintain desired temperatures for a set

amount of time.

Standard operating procedures

(SOPs)

A set of step-by-step instructions compiled by an organization to

help workers carry out complex routine or emergency operations.

SOPs aim to achieve eﬃciency, quality output, and uniformity of

performance, while reducing miscommunication and preventing

failure to comply with industry regulations and best practices.

Stand-alone storage unit A storage unit that operates independently of any other device or

system for its desired function (i.e., a refrigerator that only functions

as a refrigerator or a freezer that only functions as a freezer).

Temperature excursion Any temperature reading that is outside the recommended range for

vaccine storage as deﬁned in the manufacturer’s package insert.

Tolerance Compliance with nationally accepted standards for the calibration

limits of temperature monitoring equipment. The equipment can

either be considered “in” or “out” of tolerance.

Traceability An unbroken chain of measurements and associated uncertainties.

Uncertainty The quantiﬁcation of the doubt about the measurement result.