Vaccine Storage and Handling Toolkit

Updated with COVID-19 and Mpox Vaccines Storage and Handling Information

Addendum added January, 2023

JANUARY 2023 CS296544-H
JANUARY 2023 VACCINE STORAGE AND HANDLING TOOLKIT 

Table of Contents

The Vaccine Storage and Handling Toolkit has been updated with an addendum to address proper storage, handling, transport, and 

emergency handling of COVID-19 and mpox vaccines. The addendum will be updated as new vaccine products are approved and 

vaccination information evolves. Please check the CDC Vaccine Storage and Handling Toolkit website (www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html) regularly for the most current version of the toolkit. The addendum can be found starting on page 51. 

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

Resources..........................................................................................................................................................................................................31

COVID-19 and Mpox Vaccine Storage and Handling Addendum..........................................................................................................51

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 3

Introduction

Proper vaccine storage and handling are important factors in preventing and eradicating many common vaccinepreventable 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 Advisory Committee on Immunization Practices (ACIP) 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 manufacturers’ product 

information and package inserts,

*

 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.

COVID-19 and Mpox Vaccine Storage and Handling Addendum

At this time, all COVID-19 and mpox vaccines are available to enrolled providers through the CDC’s COVID-19 

and Mpox Vaccination Programs (COVID-19 vaccination provider and Mpox vaccination provider program). 

This addendum provides specific guidance regarding proper storage and handling practices for these vaccines. 

Carefully review the information for these vaccines and considerations when integrating them into existing 

storage and handling practices. 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. 

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

Manufacturers’ package inserts: www.immunize.org/fda/

Immunization programs: www.cdc.gov/vaccines/imz-managers/awardee-imz-websites.html
4

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: NIPInfo@cdc.gov
VACCINE STORAGE AND HANDLING TOOLKIT 5

SECTION ONE: Vaccine Cold Chain

Proper vaccine storage and handling play critical roles in efforts 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 effective 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 affect 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.
6

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 ACIP’s General Best Practice Guidelines for Immunization states, 

“vaccine exposed to inappropriate temperatures that is inadvertently administered should generally be repeated.” 4

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, Office 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 offices: 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 offices. Pediatrics

2001;107(6):1–5.

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

general-recs/index.html.
VACCINE STORAGE AND HANDLING TOOLKIT 7

SECTION TWO:Staff and Training

Vaccine storage and handling practices are only as effective as the staff that implements them. Staff that is welltrained 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. 

Staff Training 

All staff 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-todate 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): 

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

important facility staff, as well as job descriptions, regularly used forms, and staff 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 staff on routine vaccine storage and handling and emergency SOPs. Keep SOPs near vaccine storage 

units and make sure staff 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 staff 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
8 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 staff 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 staff. 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) offers 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) offers 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/CentersOffices/OfficeofMedicalProductsandTobacco/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 9

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 left 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.
10 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 buffered temperature probe, which is the most accurate way to measure actual vaccine temperatures. 

Temperatures measured by a buffered 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 buffer are acceptable as long as the temperature monitoring system for the entire unit can be 

calibration-tested.
VACCINE STORAGE AND HANDLING TOOLKIT 11

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 buffered 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, affecting their accuracy. This testing ensures the accuracy of the device 

continues to conform to nationally accepted standards.

Mishandling a TMD can affect 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 affect temperature accuracy and may warrant checking against a known, calibrated TMD. Check with the device’s 

manufacturer for specific information on battery changes.
12 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 off.

 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 staff, custodians, electricians, 

and other workers not to unplug units.

 Label fuses and circuit breakers to alert people not to 

turn off power to a storage unit.

 Use caution when using power outlets that can be 

tripped or switched off 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 affected 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 13

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 difficult 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 software 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
14 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 15

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:

1. Any staff 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 staff 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 affected, if using a DDL

— Inventory of affected vaccines

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

— Any problems with the storage unit and/or affected 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 affected 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 affected 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 different information 

about the same event is provided to the same manufacturer, this can lead to different 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.
16 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 

efficiency.

• 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 17

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 sufficient 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 off 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 18

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. Staff 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 after 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. Tally Sheets
19 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.

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 sufficient 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 20

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 beyonduse date, or BUD, is the last date or time that a vaccine can be safely used after 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 after 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. 

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 after 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 after 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 21

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 leftover 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. After 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.
22 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 effectiveness. 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*

 or 

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 23

SECTION SIX: Vaccine Transport

Instructions for transport of some COVID-19 vaccine products may be different from those for other vaccines. Carefully 

review this section as well as the COVID-19 vaccine storage and handling addendum for information on specific 

COVID-19 vaccine products to ensure the vaccine is transported safely and the vaccine 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 

an emergency or off-site clinic or to ensure vaccines that are 

about to expire can be used rather than wasted. 

Vaccine Transport Situations

Vaccine transport to off-site or satellite facilities is different 

from both shipping and emergency transport. Shipping 

usually involves a professional carrier and a longer distance 

and time frame for moving vaccines between locations. 

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 transport recommendations may be the same, 

but there are also some differences.

Protecting Your Vaccine Supply

» Vaccine that will be used 

at an off-site or satellite facility should be 

delivered directly to that facility.

» 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† (e.g., 

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

clinic may run for up to 6 hours), unless guidance from the manufacturer differs.

 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 sufficient 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

• Hard-sided insulated containers or StyrofoamTM (Use in conjunction with the Packing Vaccines for Transport 

during Emergencies‡ tool. This system is only to be used in an emergency.)

• 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

†COVID-19 vaccine transport times may be different. Refer to COVID-19 vaccine product specific information in the COVID-19 Vaccine Addendum.

‡Packing Vaccines for Transport during Emergencies: www.cdc.gov/vaccines/hcp/admin/storage/downloads/emergency-transport.pdf
24 VACCINE STORAGE AND HANDLING TOOLKIT 

SECTION SIX: Vaccine Transport

Soft-sided containers specifically engineered for vaccine transport are acceptable. Do not use commercially available softsided food or beverage coolers because most are poorly insulated and likely to be affected 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 off-site 

clinic, bring only what is needed for the workday. 

Transport System Recommendations

Emergency Transport Transport for Off-Site Clinic, Satellite 

Facility, or Relocation of Stock

Portable Vaccine Refrigerator or Freezer Yes Yes

Qualified Container and Packout Yes Yes

Conditioned Water Bottle Transport System* Yes No

Manufacturer’s Original Shipping Container Yes (last resort only) No

Food/Beverage Coolers No 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.”

In emergency situations, a system using conditioned water bottles can 

be used. Manufacturers’ original shipping containers may also be used 

as a last resort in an emergency situation. 

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 and handling SOPs.

At a minimum, include the following procedures and protocols:

For all staff-facilitated transport:

• Identify trained staff 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. 

• 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.

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

†Manufacturers’ vaccine package inserts: www.immunize.org/fda/

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

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 vaccine during 

emergency situations.
VACCINE STORAGE AND HANDLING TOOLKIT 25

SECTION SIX: Vaccine Transport

Transporting Opened Multidose Vials

If absolutely necessary, a partially used vial may be transported to or from an off-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. U.S. Pharmacopeia includes guidance for transporting predrawn vaccine in syringes in 

the USP COVID-19 Vaccine Toolkit: Operational Considerations for Healthcare Practitioners. 

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 buffered 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).

Temperature Monitoring During Transport

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 buffered 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.

* Manufacturers’ vaccine package inserts: www.immunize.org/fda/

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

See the COVID-19 Vaccine Storage and Handling Addendum for more information. 
26 VACCINE STORAGE AND HANDLING TOOLKIT 

SECTION SIX: Vaccine 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 off-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 27

SECTION SEVEN: Emergency Vaccine Storage and Handling

Instructions for handling some COVID-19 vaccine products during an emergency may be different from those for other 

vaccines. Carefully review this section as well as the COVID-19 vaccine storage and handling addendum for information 

on specific COVID-19 vaccine products 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.*

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, and commercial 

pharmacies are some of the facilities that may be able to assist 

you. 

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.

Accessing Your Building after Hours

Emergency situations can arise outside of normal business hours, 

so maintain a relationship with your facility’s building manager 

and/or security staff. Ensure all staff 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 staff, if appropriate, and also make sure relevant staff has 

copies of this information available at home.

* The Center for Biologics Evaluation and Research (CBER) at the Food and 

Drug Administration (FDA) offers 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.

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.

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

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 hardsided insulated container or StrofoamTM 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.
28 VACCINE STORAGE AND HANDLING TOOLKIT 

SECTION SEVEN: Emergency 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 off 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 29

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 after 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 after 

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.
30 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 passive containers that do 

not require a power source and are “qualified” through laboratory 

testing under controlled conditions to ensure they achieve and 

maintain desired temperatures for a set amount of time.

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.
VACCINE STORAGE AND HANDLING TOOLKIT 31

RESOURCES

REFERENCE:Purpose-Built Vaccine Storage Units

Numerous vaccine storage units have entered the market that 

are designed specifically for the storage of vaccines. These units can 

take many physical forms. Some look like traditional stand-alone 

units, while others can take the form of dispensing or vending units, 

either with or without doors. Although these units may be similar 

to pharmaceutical-grade or medical-grade units, they are unique in 

that they are designed and tested to keep vaccines in appropriate 

storage conditions. If you are a VFC provider, your immunization 

program determines which purpose-built units meet VFC program 

requirements. Always check with your immunization program 

before purchasing any unit that will be used to store VFC vaccines. 

Features and considerations related to these types of units include 

the following:

Temperature Monitoring

• Many purpose-built units have multiple temperature probes or 

sensors. It is important that these probes or sensors have current 

Certificates of Calibration.

• Many of the purpose-built closed or doorless units may utilize air sensors (non-buffered probes). Since these units 

have very limited exposure to ambient air, the use of a buffered probe is not essential. 

• Many purpose-built units will have built-in digital data loggers with electronic interfaces that will allow you to track 

the continuous temperatures and/or provide min/max temperatures. If you are a VFC provider, always check to make 

sure that these satisfy the VFC program data logger requirements.

Vaccine Storage

• Many purpose-built units have undergone testing and temperature mapping so that the probe is in the most 

appropriate location.

• Although purpose-built units can have multiple temperature probes, a backup DDL is still needed for transport to a 

backup facility in an emergency.

• Many purpose-built units do not need water bottles to serve as thermal ballast.

VFC vaccine management

» Purpose-built units must have the ability 

to allow the user to separate public and 

private vaccine stock physically or virtually.

» If stock is separated virtually, an inventory 

printout†

 must be accessible upon request. 

» If unable to physically remove expired 

vaccine from a purpose-built unit 

immediately, the unit must be able to make 

expired vaccine inaccessible. 

†

The inventory printout should be used to answer 

storage and handling and inventory sections of the 

site visit reviewers guide.

Other Public

Other Public

Other Public

Other Public

Other Public

Other Public

VFC

VFC

VFC

VFC

VFC

VFC

VFC Private

VFC VFC Other Public Other Public

Other Public Other Public Private Private

1 2 3 4 5 6 7 8 9 Total Doses in Box - 5 VFC

10

1 2 3 4 5 6 7 8 9 Total Doses in Box - 5 VFC

10

VFC 1 2 3 4 5 6 7 8 9 Total Doses in Box - 5

10

VFC 1 2 3 4 5 6 7 8 9 Total Doses in Box - 5

10

VFC Total Doses in Box - 5 Other Public Total Doses in Box - 5 1 2 3 4 5 1 2 3 4 5

VFC Total Doses in Box - 5 Other Public Total Doses in Box - 5 1 2 3 4 5 1 2 3 4 5 VFC Total Doses in Box - 5 Other Public Total Doses in Box - 5 1 2 3 4 5 1 2 3 4 5

VFC Total Doses in Box - 5 Other Public Total Doses in Box - 5 1 2 3 4 5 1 2 3 4 5

VFC 1 2 3 4 5 6 7 8 9 Total Doses in Box - 5

10

VFC 1 2 3 4 5 6 7 8 9 Total Doses in Box - 5

10

VFC 1 2 3 4 5 6 7 8 9 Total Doses in Box - 5

10

VFC 1 2 3 4 5 6 7 8 9 Total Doses in Box - 5

10

1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 8 9 Mark off VFC doses as used. Mark off Other Public doses as used. 

1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 8 9 Mark off VFC doses as used. Mark off Other Public doses as used. VFC Total Doses in Box - 5 Other Public Total Doses in Box - 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 8 9 Mark off VFC doses as used.

Mark off Other Public doses as used. 

1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 8 9 Mark off VFC doses as used. Mark off Other Public doses as used. 

VFC

Total Doses in Box - 5

Other Public

Total Doses in Bo

1 2 3 4 5 1 2 3 4 

VFC

Total Doses in Box - 10

1 2 3 4 5 6 7 8 9 10
VACCINE STORAGE AND HANDLING TOOLKIT 32

RESOURCES

WORKSHEET: Vaccine Storage and Handling SOPs

Complete the following checklist and forms and store this information in an easily accessible area near 

the vaccine storage unit.

CHECKLIST OF GENERAL INFORMATION

» Up-to-date contact information

• Primary vaccine coordinator

• Alternate vaccine coordinator

• Additional staff to assist in emergencies

• Immunization program

• Vaccine manufacturers

• Refrigerator and freezer maintenance and repair 

companies

• Temperature monitoring device (TMD) companies

• Utility/power company

• Vaccine storage unit alarm company (if applicable)

• Generator repair company (if applicable)

• Sources for qualified containers and packouts

» Descriptions of the roles and responsibilities of the 

primary and alternate vaccine coordinators

» Information for each storage unit, including serial 

number, links to equipment websites, installation 

dates, and routine maintenance and repair records

» Samples of all vaccine-related forms used in your 

facility

» Protocols for staff education and training

CHECKLIST FOR ROUTINE STORAGE AND HANDLING

» Protocols for:

• Ordering and accepting vaccine deliveries

• Unpacking deliveries

• Managing inventory

• Storing each vaccine and diluent

• Placing vaccines and diluents in storage units

• Handling vaccines prior to administration

• Disposing of vaccines and supplies

• Monitoring storage unit and temperature

• Maintaining storage equipment and TMDs

• Responding to storage and handling problems

• Transporting vaccines to off-site/satellite facilities

CHECKLIST FOR EMERGENCY VACCINE STORAGE, HANDLING, AND TRANSPORT

» All contact information in Checklist for General 

Information as well as up-to-date contact information for:

• Alternative vaccine storage facility (one or more)

• Transportation of vaccines

» Vaccine storage unit specifications (type, brand, model 

number, serial number)

» Diagram of facility showing important elements, including 

doors, flashlights, packing materials, batteries, circuit 

breakers

» Keep a copy of emergency SOPs with emergency 

supplies and at multiple off-site locations such as homes 

of vaccine coordinator and alternate coordinator and 

with building manager, security staff, and alternative 

storage facility.

» Protocols for:

• Monitoring vaccines during a power outage

• Packing vaccines and diluents for emergency 

transport

• Transporting vaccines to and from an alternative 

vaccine storage facility

• Assessing whether vaccine can be used after an 

emergency

• Accessing your building and facility after hours
33 VACCINE STORAGE AND HANDLING TOOLKIT 

WORKSHEET: Vaccine Storage and Handling SOPs

RESOURCES

Store emergency information with emergency supplies.

STAFF CONTACT LIST

Name Title

Telephone Numbers 

home/cell/other E-mail Address

Primary Vaccine Coordinator

Alternate Vaccine Coordinator

EMERGENCY STAFF CONTACT LIST

Name Title

Telephone Numbers 

home/cell/other E-mail Address

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

List contacts in order of preference. Determine whether all or certain persons on the list should be contacted or if the first person reached is 

sufficient.
VACCINE STORAGE AND HANDLING TOOLKIT 34

WORKSHEET: Vaccine Storage and Handling SOPs

RESOURCES

GENERAL RESOURCES CONTACT LIST

Resources

Contact Person

Name/Title

Telephone Numbers 

home/cell/other E-mail Address

Local Health Department 

Immunization Program

State Health Department 

Immunization Program

Vaccine Manufacturers

Refrigerator Repair Company

Freezer Repair Company

Utility/Power Company

Temperature Monitoring 

Device Company

Vaccine Storage Unit Alarm 

Company (if applicable)

Generator Repair Company 

(if applicable)

ALTERNATIVE VACCINE STORAGE FACILITIES

Alternative Vaccine Storage 

Facility Name/Address

Contact Person

Name/Title

Telephone Numbers 

home/cell/other E-mail Address

1.

2.

3.

4.

TRANSPORTATION TO ALTERNATIVE VACCINE STORAGE FACILITIES

Emergency Resources

Name/Address

Contact Person

Name/Title

Telephone Numbers 

home/cell/other E-mail Address

Refrigeration Company

Refrigeration Company

(alternative)

Private Vehicle

Private Vehicle

(alternative)
35 VACCINE STORAGE AND HANDLING TOOLKIT 

WORKSHEET: Vaccine Storage and Handling SOPs

RESOURCES

PACKING MATERIAL SUPPLIERS CONTACT LIST

Emergency Resources Company Name

Contact Person

Name/Title

Telephone Numbers 

home/cell/other E-mail Address

Portable vaccine 

refrigerator/freezer units

Qualified containers and 

packout materials

Qualified containers and 

packout materials (alternative)

Packing materials

Packing materials (alternative)

VACCINE STORAGE UNIT SPECIFICATIONS

Type of Unit 

(Refrigerator or Freezer) Brand Model Number Serial Number

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.
VACCINE STORAGE AND HANDLING TOOLKIT 36

RESOURCES

Handling a Temperature Excursion in Your Vaccine Storage Unit

Any temperature reading outside ranges recommended in the manufacturers’ package inserts is considered a 

temperature excursion. Identify temperature excursions quickly and take immediate action to correct them. This can 

prevent vaccine waste and the potential need to revaccinate patients. 

Notify

» Notify the primary 

or alternate 

vaccine coordinator 

immediately or report 

the problem to a 

supervisor. 

» Notify staff by labeling 

exposed vaccines, “DO 

NOT USE,” and placing 

them in a separate 

container apart from 

other vaccines in the 

storage unit. Do not 

discard these vaccines.

Document

» Document details of the 

temperature excursion:

• Date and time

• Storage unit 

temperature (including 

minimum/maximum 

temperatures during 

the time of the event, if 

available)

• Room temperature, if 

available

• Name of the person 

completing the report

• General description 

of the event (i.e., what 

happened) 

• If using a digital data 

logger (DDL), determine 

the length of time 

vaccine may have been 

affected 

• Inventory of affected 

vaccines 

• List of items in the unit 

other than vaccines 

(including water bottles)

• Any problems with the 

storage unit and/or 

affected vaccines before 

the event 

• Other relevant 

information

Contact

» Contact your 

immunization program 

and/or vaccine 

manufacturer(s) for 

guidance per your 

standard operating 

procedures (SOPs).

» Be prepared to provide 

the immunization 

program or manufacturer 

with documentation 

and DDL data so they 

can offer you the best 

guidance.

Contact manufacturer 

for excursions:

Dynavax 1-844-375-4728

GlaxoSmithKline 1-888-825-5249

Massachusetts 

Biological Labs 1-888-825-5249

MedImmune 1-877-633-4411

Merck 1-800-672-6372

Pfizer 1-800-438-1985

Sanofi Pasteur 1-800-822-2463

Seqirus 1-855- 358-8966

Correct

» If the temperature 

alarm goes off 

repeatedly, do not 

disconnect the 

alarm until you have 

determined and 

addressed the cause. 

» Check the basics, 

including:

• Power supply

• Unit door(s)

• Thermostat settings

» If the excursion 

was the result of a 

temperature fluctuation, 

refer to the section, 

“Vaccine Storage and 

Temperature Monitoring 

Equipment,” in CDC’s 

Vaccine Storage and 

Handling Toolkit for 

detailed guidance on 

adjusting storage unit 

temperature to the 

appropriate range.

» If you believe the 

storage unit has 

failed, implement your 

emergency vaccine 

storage and handling 

SOPs. Never allow 

vaccines to remain in 

a nonfunctioning unit 

following a temperature 

excursion.
37 VACCINE STORAGE AND HANDLING TOOLKIT 

RESOURCES

Fahrenheit to Celsius and Celsius to Fahrenheit Conversion

°F °C °F °C °F °C °C °F °C °F

-22 -30 21 -6.1 64 17.8 -30 -22 13 55.4

-21 -29.4 22 -5.6 65 18.3 -29 -20.2 14 57.2

-20 -28.9 23 -5 66 18.9 -28 -18.4 15 59

-19 -28.3 24 -4.4 67 19.4 -27 -16.6 16 60.8

-18 -27.8 25 -3.9 68 20 -26 -14.8 17 62.6

-17 -27.2 26 -3.3 69 20.6 -25 -13 18 64.4

-16 -26.7 27 -2.8 70 21.1 -24 -11.2 19 66.2

-15 -26.1 28 -2.2 71 21.7 -23 -9.4 20 68

-14 -25.6 29 -1.7 72 22.2 -22 -7.6 21 69.8

-13 -25 30 -1.1 73 22.8 -21 -5.8 22 71.6

-12 -24.4 31 -0.6 74 23.3 -20 -4 23 73.4

-11 -23.9 32 0 75 23.9 -19 -2.2 24 75.2

-10 -23.3 33 0.6 76 24.4 -18 -0.4 25 77

-9 -22.8 34 1.1 77 25 -17 1.4 26 78.8

-8 -22.2 35 1.7 78 25.6 -16 3.2 27 80.6

-7 -21.7 36 2.2 79 26.1 -15 5 28 82.4

-6 -21.1 37 2.8 80 26.7 -14 6.8 29 84.2

-5 -20.6 38 3.3 81 27.2 -13 8.6 30 86

-4 -20 39 3.9 82 27.8 -12 10.4 31 87.8

-3 -19.4 40 4.4 83 28.3 -11 12.2 32 89.6

-2 -18.9 41 5 84 28.9 -10 14 33 91.4

-1 -18.3 42 5.6 85 29.4 -9 15.8 34 93.2

0 -17.8 43 6.1 86 30 -8 17.6 35 95

1 -17.2 44 6.7 87 30.6 -7 19.4 36 96.8

2 -16.7 45 7.2 88 31.1 -6 21.2 37 98.6

3 -16.1 46 7.8 89 31.7 -5 23 38 100.4

4 -15.6 47 8.3 90 32.2 -4 24.8 39 102.2

5 -15 48 8.9 91 32.8 -3 26.6 40 104

6 -14.4 49 9.4 92 33.3 -2 28.4

7 -13.9 50 10 93 33.9 -1 30.2

8 -13.3 51 10.6 94 34.4 0 32

9 -12.8 52 11.1 95 35 1 33.8

10 -12.2 53 11.7 96 35.6 2 35.6

11 -11.7 54 12.2 97 36.1 3 37.4

12 -11.1 55 12.8 98 36.7 4 39.2

13 -10.6 56 13.3 99 37.2 5 41

14 -10 57 13.9 100 37.8 6 42.8

15 -9.4 58 14.4 101 38.3 7 44.6

16 -8.9 59 15 102 38.9 8 46.4

17 -8.3 60 15.6 103 39.4 9 48.2

18 -7.8 61 16.1 104 40 10 50

19 -7.2 62 16.7 11 51.8

20 -6.7 63 17.2 12 53.6
VACCINE STORAGE AND HANDLING TOOLKIT 38

RESOURCES

SAMPLE:Stock Record and Tally Sheet

STOCK RECORD

Instructions: Use the monthly stock record to document inventory from new vaccine/diluent shipments and track weekly accounts of 

doses used. At the end of each month, count inventory in storage unit(s) and compare with recorded balance. If physical count and 

recorded balance are different, record the actual (physical count) balance next to the previous recorded balance. Note the cause of

the discrepancy or if it is unknown. Start a new stock record every month, listing at the top the previous month’s balance as the new 

month’s starting balance.

Vaccine Type: Month and Year: 

Date 

Received 

or Usage 

Tallied

Person 

Receiving 

Shipment*

Arrival

Condition**

Vaccine 

or Diluent 

Name Manufacturer

Vial Type 

(SDV, MDV, 

MFS)***

Lot 

Number

Expiration 

Date

Expiration

Date After 

Reconstitution

Doses 

Received/

Balance 

Forward

Doses 

Used†

Balance 

(Doses)††

08/02/23 BEGINNING BALANCE FOR THE MONTH 2 N/A 2

08/09/23 1 1

08/15/23 LST G PPSV23 Merck MDV 03958 02/15/24 N/A 5 3 3

08/23/23 1 2

08/29/23 0 2

* The initials of the person who unpacked and checked the vaccines/diluents upon arrival

** G = Vaccines/diluents arrived in good condition

? = Condition of vaccines/diluents questionable and state and local health department 

immunization program and vaccine manufacturer(s) contacted. Document details/outcome on 

reverse side of stock record.

*** SDV = Single-dose vial 

MDV = Multidose vial

MFS = Manufacturer-filled syring

† Includes number of doses administered, wasted, unusable, expired, or transferred.

†† Enter the sum of “Total Doses Received/Balance Forward” minus “Total Doses Used.”

Vaccine 

Totals 7 5 2

Physical Stock 

Check (In Doses) 2

Difference

(“Balance” minus 

Physical Stock)

0

Balance Carried 

Forward (In Doses) 2

PPSV23 August 2023

Some state or local health department immunization programs have developed their own stock record for immunization providers. 

Contact program staff for information. If stock records are not available from your state or local health department or an

immunization information system (IIS), this stock record may be used.

TALLY SHEET

Instructions: Place a copy of this sheet on or near the refrigerator and freezer doors. Record the week (by date or week number). 

Write the vaccine/diluent names and indicate the storage location (refrigerator = R, freezer = F). Make a tick mark in the appropriate 

box for each dose of vaccine/diluent removed from the unit (i.e., each dose administered, wasted, unusable, expired, or transferred). 

At the end of the week, add the tick marks for each vaccine/diluent and update the totals on the appropriate stock record. File the 

completed tally sheet and replace with a new sheet.

Week: 

Storage Location 

(R or F)*

Vaccine or 

Diluent Name

Doses 

Administered

Doses 

Wasted

Doses 

Expired

Doses 

Unusable**

Doses Transferred 

(Viable)*** Total

F VAR IIII III ( 8 ) 8

R DTaP IIII IIII II ( 12 ) 12

R HepB IIII IIII II ( 12 ) 12

R IPV IIII IIII II ( 12 ) II 14

R HepA (pediatric) II ( 2 ) 2

R PPSV23 I ( 1 ) 1

* R = Refrigerator F = Freezer

** Some unusable doses (VFC vaccines or other vaccines purchased with public funds) may need to be returned to your state or local health 

department immunization program.

*** Viable vaccine doses transferred to your state or local health department immunization program or another facility.

August 19—23, 2023 (Week 3)

Some state or local health department immunization programs have developed their own tally sheets for immunization providers. 

Contact program staff for information. If tally sheets are not available from your state or local health department immunization

program or an immunization information system (IIS), this tally sheet may be used.
39 VACCINE STORAGE AND HANDLING TOOLKIT 

RESOURCES

Stock Record

Instructions: Use the monthly stock record to document inventory from new vaccine/diluent shipments and track weekly accounts of doses used. At the end of each month, count inventory in storage unit(s) and compare with recorded balance. If physical count and recorded balance are different, recordVaccine Type: record every month, listing at the top the previous month’s balance as the new month’s starting balance.the actual (physical count) balance next to the previous recorded balance. Note the cause of the discrepancy or if it is unknown. Start a new stock 

Month and Year: 

Date 

or Usage 

Received 

Tallied

Person 

Shipment*

Receiving Arrival

Condition**

Vaccine or 

Diluent Name Manufacturer

Vial Type 

(SDV, MDV, 

MFS)***

Lot 

Number

Expiration 

Date

Date After 

Expiration

Reconstitution

Doses 

Received/

Forward

Balance 

Used

Doses 

†

Balance 

(Doses)††

BEGINNING BALANCE FOR THE MONTH N/A

* The initials of the person who unpacked and checked the vaccines/diluents upon arrival**

? = Condition of vaccines/diluents questionable and state and local health department immunization 

G = Vaccines/diluents arrived in good condition

program and vaccine manufacturer(s) contacted. Document details/outcome on reverse side of stock record.

*** SDV = Single-dose vial 

MFS = ManufacturerMDV = Multidose vialfilled syring

† Includes number of doses administered, wasted, unusable, expired, or transferred.†† Enter the sum of “Total Doses Received/Balance Forward” minus “Total Doses Used.”

Vaccine 

Totals

Di(In Doses)Physical Stock Check 

fference (“Balance”

Balancminus Physical Stock)

e Carried 

Forward (In Doses)

Some state or local health department immunization programs have developed their own stock record for immunization providers. Contact 

program staff for information. If stock records are not available from your state or local health department or an immunization information system(IIS), this stock record may be used.
VACCINE STORAGE AND HANDLING TOOLKIT 40

RESOURCES

Tally Sheet Instructions: Place a copy of this sheet on or near the refrigerator and freezer doors. Record the week (by date or week number). Write the vaccine/ Week: vaccine/diluent and update the totals on the appropriate stock record. File the completed tally sheet and replace with a new sheet. removed from the unit (i.e., each dose administered, wasted, unusable, expired, or transferred). At the end of the week, add the tick marks for each diluent names and indicate the storage location (refrigerator = R, freezer = F). Make a tick mark in the appropriate box for each dose of vaccine/diluent 

Storage Location 

(R or F)*

Vaccine or Diluent 

Name

Doses 

Administered Wasted

Doses Doses 

Expired

Doses 

Unusable**

Doses Transferred 

(Viable)*** Total

* R = Refrigerator F = Freezer**

immunization program.Some unusable doses (VFC vaccines or other vaccines purchased with public funds) may need to be returned to your state or local health department 

***Viable vaccine doses transferred to your state or local health department immunization program or another facility.

program staSome state or local health department immunization programs have developed their own tally sheets for immunization providers. Contact 

ff for information. If tally sheets are not available from your state or local health department immunization program or an immunization

information system (IIS), this tally sheet may be used.
41 VACCINE STORAGE AND HANDLING TOOLKIT 

RESOURCES

HANDLE WITH CARE:Protect Your Vaccine | Protect Your Patients

REFRIGERATOR

Store vaccines 

between

2°C and 8°C 

(36°F and 46°F)

FREEZER

Store vaccines 

between

-50°C and -15°C 

(-58°F and +5°F)

» Keep your storage units and vaccines within the 

appropriate temperature ranges.

» Check and record storage unit min/max 

temperatures at start of each workday. If your 

device does not display min/max temperatures, then 

check and record current temperature a minimum 

of 2 times (at start and end of workday). Also 

check current temperature before accessing and 

administering vaccine.

» Take immediate action if temperatures are out of range.

» Keep vaccines in their original packages.

» Many vaccines should be protected from light (consult 

manufacturer’s product information).

» Check expiration dates and rotate your vaccine stock to 

keep most recent expiration dates at the front.
VACCINE STORAGE AND HANDLING TOOLKIT 42

RESOURCES

ALTO

WARNING LABELS:Do Not Adjust Refrigerator Controls

Do NOT adjust 

refrigerator or freezer 

temperature controls!

Notify 

(insert name/phone number)

/

if adjustment is necessary.

¡ NO cambie la 

temperatura del

refrigerador/congelator! 

Comuníquese con

(inserte nombre y número de teléfono aqui) /

si hay necesidad de

cambiar la temperatura. 
43 VACCINE STORAGE AND HANDLING TOOLKIT 

RESOURCES

ALTO

WARNING LABELS:Do Not Adjust Freezer Controls

¡ NO cambie la 

temperatura del

CONGELATOR!

Comuníquese con

(inserte nombre y número de teléfono aqui) /

si hay necesidad de

cambiar la temperatura. 

Do NOT adjust 

FREEZER

temperature controls!

Notify 

(insert name/phone number)

/

if adjustment is necessary. 
VACCINE STORAGE AND HANDLING TOOLKIT 44

RESOURCES

WARNING LABELS: Warning! Do Not Stop Power to Circuit Breaker

WARNING!

VACCINE IN STORAGE

DO NOT STOP POWER TO CIRCUIT BREAKER 

IN THE EVENT OF ELECTRICAL PROBLEM, IMMEDIATELY 

CONTACT AT . 
45 VACCINE STORAGE AND HANDLING TOOLKIT 

RESOURCES

¡NO desconecte

el Refrigerado! ALTO

Do NOT unplug

REFRIGERATOR!

WARNING LABELS: Warning! Do Not Unplug Refrigerator

WARNING!

DO NOT UNPLUG THE REFRIGERATOR

OR BREAK CIRCUIT. 

VACCINE IN STORAGE.

IN THE EVENT OF ELECTRICAL PROBLEM, IMMEDIATELY 

CONTACT: . /

(insert name/phone number)

/

¡AVISO!

NO DESCONECTE EL REFRIGERADOR

NI CORTE EL CIRCUITO. 

¡CONTIENE VACUNAS!

SI HAY UN PROBLEMA CON LA ELECTRICIDAD, 

COMUNIQUESE INMEDIATAMENTE CON: 

. (inserte nombre y número de teléfono aqui)
VACCINE STORAGE AND HANDLING TOOLKIT 46

RESOURCES

¡NO desconecte

el Congelador! ALTO

Do NOT unplug

FREEZER!

WARNING LABELS: Warning! Do Not Unplug Freezer

WARNING!

DO NOT UNPLUG THE FREEZER OR 

BREAK CIRCUIT. 

VACCINE IN STORAGE.

IN THE EVENT OF ELECTRICAL PROBLEM, IMMEDIATELY 

CONTACT: . /

(insert name/phone number)

¡AVISO!

NO DESCONECTE EL CONGELADOR

NI CORTE EL CIRCUITO. 

¡CONTIENE VACUNAS!

SI HAY UN PROBLEMA CON LA ELECTRICIDAD, 

COMUNIQUESE INMEDIATAMENTE CON: 

. /

(inserte nombre y número de teléfono aqui)
47 VACCINE STORAGE AND HANDLING TOOLKIT 

RESOURCES

TRANSPORT LABELS:Refrigerate/Freeze Upon Arrival

REFRIGERATE

UPON ARRIVAL 

PERISHABLE 

NO DELAY!

DO NOT FREEZE | KEEP FROM HEAT 

FREEZE

UPON ARRIVAL 

PERISHABLE 

NO DELAY!

DO NOT REFRIGERATE | KEEP FROM HEAT 
VACCINE STORAGE AND HANDLING TOOLKIT 48

RESOURCES

TRANSPORT LABELS:Open Immediately: Refrigerate/Freeze Upon Receipt

OPEN IMMEDIATELY 

REFRIGERATE

UPON RECEIPT 

DO NOT FREEZE

OPEN IMMEDIATELY 

FREEZE

UPON RECEIPT 

DO NOT REFRIGERATE
49 VACCINE STORAGE AND HANDLING TOOLKIT 

RESOURCES

TRANSPORT LABELS: Fragile: Handle with Care

FRAGILE

LIQUID | GLASS

HANDLE WITH CARE

FRAGILE

HANDLE WITH CARE
VACCINE STORAGE AND HANDLING TOOLKIT 50

RESOURCES

TRANSPORT LABELS:Perishable: Rush

PERISHABLE

RUSH
VACCINE STORAGE AND HANDLING TOOLKIT 51

COVID-19 AND MPOX VACCINES ADDENDUM

COVID-19 AND MPOX VACCINES STORAGE AND HANDLING

This addendum to the Vaccine Storage and Handling Toolkit (January, 2023) provides information, 

recommendations, and resources to assist COVID-19 and mpox vaccination providers in properly storing and 

handling COVID-19 vaccines to meet the requirements of the Vaccination Program Provider Agreement. The toolkit 

brings together best practices from the Advisory Committee on Immunization Practices (ACIP) General Best 

Practice Guidelines for Immunization, product information from vaccine manufacturers, and results of scientific 

studies. Implementing the toolkit best practices and recommendations will help to safeguard the vaccine supply and 

ensure patients receive safe and effective vaccines. 

This addendum provides information on storage and handling best practices for COVID-19 vaccines and mpox 

vaccines. This addendum will be updated with specific storage and handling information for each vaccine product as it 

is authorized under an Emergency Use Authorization or approved by the Food and Drug Administration (FDA). 

Vaccination Provider Requirements

All COVID-19 and mpox vaccination providers participating in the U.S. COVID-19 Vaccination Program and U.S. 

Monkeypox Vaccination Program are required to sign a Vaccination Program Provider Agreement to receive 

delivery of any COVID-19 or mpox vaccine from the distributor or a vaccine manufacturer. The agreement must 

be completed by all public and private providers, provider organizations, and government-affiliated federal, state, 

territorial, and local providers. 

As part of the agreement, providers are required to:

• Store and handle vaccines under proper conditions, including maintaining cold chain conditions and chain of 

custody at all times in accordance with an EUA or vaccine package insert, manufacturer guidance, and CDC 

guidance in this toolkit. 

• Monitor storage unit temperatures at all times, using equipment and practices that comply with guidance in this 

toolkit.

• Comply with immunization program guidance for handling temperature excursions.

• Monitor and comply with vaccine expiration dates and beyond-use dates/times.

• Preserve all records related to vaccine management for a minimum of three years.

• Comply with federal instructions and timelines for disposing of vaccine and diluent (if applicable), including unused 

doses.

Emergency Use Authorization Storage and Handling Information

Specific, detailed storage and handling protocols for individual vaccines are provided in manufacturer package inserts 

for vaccines licensed by the Food and Drug Administration (FDA). However, some vaccines are currently authorized 

for use under an EUA so vaccination providers should refer to the Fact Sheet for Healthcare Providers Administering 

Vaccine and manufacturer information for detailed storage and handling information for each vaccine. 

Vaccine Cold Chain

Vaccines require a temperature-controlled environment. A cold chain is a temperature-controlled supply chain that 

includes all vaccine-related equipment and procedures. It begins with vaccine manufacturing and ends with vaccine 

administration. Vaccines must be stored properly from the time they are manufactured until they are administered. 

Potency is reduced every time a vaccine is exposed to an improper condition. This includes overexposure to heat, cold, 

or light at any step in the cold chain. Once lost, potency cannot be restored. 

An effective cold chain relies on three main elements: 

• Well-trained staff

• Reliable storage and temperature monitoring equipment

• Accurate vaccine inventory management

Vaccine appearance is not a reliable indicator that 

vaccines have been stored in appropriate conditions.
52 VACCINE STORAGE AND HANDLING TOOLKIT 

COVID-19 AND MPOX VACCINES STORAGE AND HANDLING

COVID-19 AND MPOX VACCINES ADDENDUM

Staff and Training

All staff members who receive vaccine deliveries as well as those who handle or administer vaccines should be trained 

in vaccine-related practices and procedures. As a resource for staff, this toolkit highlights storage and handling best 

practices to help protect the vaccine supply. In addition, CDC’s You Call the Shots: Vaccine Storage and Handling is 

a free, online training module focused on storage and handling requirements. Jurisdictions may also have specific 

requirements for storage and handling training, policies, and procedures.

All facilities must designate a primary vaccine coordinator

and an alternate (backup) coordinator who will be responsible 

for ensuring all vaccines are stored and handled correctly. The 

primary and alternate vaccine coordinators should be experts 

on your facility’s storage and handling procedures. 

See Section Two, "Staff and Training," in the toolkit for 

more detailed information.

Vaccine Storage and Temperature Monitoring Equipment

COVID-19 and mpox vaccination providers must have 

proper storage and temperature monitoring equipment to 

meet the specific needs of the vaccine product(s) in their 

inventory. This includes the correct vaccine storage unit(s), 

whether a refrigerator, regular freezer, or ultra-cold freezer. 

Purpose-built, also referred to as “pharmaceutical-grade,” 

units are preferred and designed specifically for storage of 

biologics, including vaccines. However, household-grade 

units can be an acceptable alternative in some situations. 

Most standard freezer units do not meet ultra-cold freezer 

requirements for storing vaccine between -60° C and -90° C 

(-76° F and -130° F).

It is essential that each vaccine storage unit has a temperature 

monitoring device (TMD) to ensure that vaccines are stored 

within the correct temperature range. CDC requires a specific 

type of TMD called a “digital data logger” (DDL) to monitor 

COVID-19 and mpox vaccines. A DDL provides the most 

accurate storage unit temperature information. Additionally, 

in the event of a temperature excursion (temperatures 

outside the correct range), a DDL can indicate how long 

and the temperatures the vaccine has been exposed to. This 

information is needed to determine the viability of the vaccine. 

Always use a DDL that can continously monitor storage unit 

temperatures and has a: 

• Buffered temperature probe 

• Current and valid certificate of Calibration Testing 

CDC recommends developing and maintaining 

clearly written, detailed, and up-to-date storage 

and handling standard operating procedures 

(SOPs). SOPs help ensure proper procedures are 

followed and problems are identified, reported, 

and corrected. SOPs should also provide direction 

for handling emergencies such as equipment 

malfunctions, power failures, or natural disasters.

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.)

Diluents

Vaccines often need to be mixed with a liquid 

product before administration. A diluent may be a 

normal saline product or may contain an adjuvant 

for vaccine effectiveness. Always follow the vaccine 

manufacturer’s guidance for use of the diluent. 

Diluents are not interchangeable and can only be 

used with the product for which they are provided.

DDLs for Ultra-Cold Temperatures

DDLs using a buffered temperature probe provide the 

most accurate measurement of vaccine temperatures. 

However, many manufacturers use pure propylene 

glycol (freezing point -59° C (-74° F)) or a glycol 

mixture with a warmer freezing point. For accurate 

ultra-cold temperature monitoring, it is essential to 

use an air-probe or a probe designed specifically for 

ultra-cold temperatures with the DDL.
VACCINE STORAGE AND HANDLING TOOLKIT 53

COVID-19 AND MPOX VACCINES STORAGE AND HANDLING

COVID-19 AND MPOX VACCINES ADDENDUM

Temperature Monitoring Requirements 

Staff must check and record temperatures at the beginning of each workday to determine if any excursions have 

occurred since the last temperature check.*

 Monitor and record storage unit temperatures following one of these 

options.

When recording include: 

• Minimum/maximum temperature†

• Date 

• Time

• Name of person checking and recording temperature

• Actions taken if a temperature excursion occurred

CDC has temperature logs can that can be used for recording this information. Temperature records must be kept for a 

minimum of three years, or longer if required by your jurisdiction.

Storing vaccines correctly in a vaccine storage unit is also critical to protect the vaccine and reduce the chance of 

vaccine administration errors if COVID-19 or mpox vaccine are stored with other vaccines. Best practices include:

• Place water bottles on the top shelf, floor, and in the door racks of vaccine storage units to help maintain stable 

temperatures that might be disrupted by frequently opening and closing unit doors. (Note: Water bottles are 

not recommended for use in in ultra-cold freezers or in all purpose-built or pharmaceutical-grade units—see 

manufacturer guidance.)

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

• Store vaccines and diluents in original packaging.

• Position vaccines and diluents two to three inches from the storage 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.

• 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. Of note, EUA 

vaccine labels may not include expiration dates. To help providers track expiration dates and beyond-use dates (BUDs), 

CDC has a COVID-19 Vaccine Expiration Date Tracking Tool on its website available. Also note that expiration dates 

may change as additional stability data become available. In addition, mpox vaccine and some COVID-19 vaccines must 

be used within a certain time frame (beyond-use date) if moved from one state to another (e.g., frozen to refrigerated). 

Providers should monitor/track the BUD to ensure vaccine is not used after the BUD has been reached.

See Section Three, "Vaccine Storage and Temperature Monitoring Equipment," for more detailed information 

about storage units, temperature monitoring equipment, and vaccine placement in vaccine storage units.

"Temperature Excursions"

Any temperature reading outside the range recommended by the manufacturer is considered a temperature excursion

and requires immediate action. To determine whether a vaccine is likely to still be viable, vaccine manufacturers 

will analyze information about the magnitude of the temperature excursion, including the total amount of time that 

temperatures were out of range. To provide the manufacturer with sufficient information to determine vaccine viability, 

CDC requires taking the following steps after a temperature excursion:

• Label the vaccine “Do Not Use” and store at the recommended temperature range until you receive manufacturer 

guidance. If it is a frozen vaccine that has been thawed, store in the refrigerator between 2° C and 8° C (36° F and 46° 

F) until you receive manufacturer guidance, as refreezing the vaccine may damage it. 

• Document the date and length of time of the excursion, the storage unit temperature (minimum/maximum, if 

available), and inventory affected.

• Record any other relevant information.

• Contact the manufacturer and/or immunization program for guidance on whether to use affected vaccines and 

whether patients need to be recalled for revaccination.

• Document the event and actions taken for record-keeping requirements.

* Monitoring requirements may vary if you are using the manufacturer-provided shipping container for storage.

† If the DDL cannot display the minimum/maximum temperatures, record the current temperature at the beginning and end of each work day.

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.
54 VACCINE STORAGE AND HANDLING TOOLKIT 

COVID-19 AND MPOX VACCINES STORAGE AND HANDLING

COVID-19 AND MPOX VACCINES ADDENDUM

It is important to note that vaccine manufacturer responses 

to temperature excursion reports are dependent on 

information given by the provider to the manufacturer. 

Different information about the same event can lead to 

different recommendations on whether vaccine can be used 

or whether patients need to be revaccinated. In addition, 

each event is unique, and manufacturer recommendations 

cannot be applied to future events that may appear similar 

to past events. For manufacturer contact information 

for vaccine- and temperature-related questions, see the 

COVID-19 or mpox vaccines specific product information 

page in this addendum. 

See Section Three, "Vaccine Storage and Temperature 

Monitoring Equipment," for more additional 

information about recording and reporting temperature 

excursions. 

Vaccine Deliveries and 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. 

Maintaining the cold chain is the first step in vaccine 

inventory management. Vaccine deliveries must only be 

scheduled at times when staff is guaranteed to be present 

because vaccines can never be left unattended. To support 

efficient distribution of vaccine, full-day receiving hours 

should be available. When that is not possible, locations 

receiving vaccine and ancillary supply shipments must 

be available during a four-hour window on a weekday 

other than Monday. All COVID-19 vaccine and ancillary 

kit deliveries will require a signature. Deliveries of mpox 

vaccine do not require a signature.

Upon arrival, all shipments of vaccine must be 

immediately examined for signs of damage, for indication 

of a temperature excursion during transit, and to confirm 

receipt of the appropriate vaccine types and quantities. 

Before opening a vaccine shipment, ensure the vaccine 

and any diluent, if applicable, is immediately: 

• Stored at recommended storage conditions. 

• Documented using your facility's vaccine inventory 

management process. 

Vaccine inventory accounting includes keeping stock 

records to determine the type and amount of COVID-19 

and mpox vaccines your facility should stock to meet the 

needs of your patients. It also involves checking expiration 

dates regularly and rotating stock so that doses with the 

earliest expiration dates are placed in front of those with 

later dates. 

COVID-19 Vaccine Ancillary Supplies

COVID-19 vaccine shipments will include ancillary 

supplies: 

» Needles (various sizes for the population served)

» Syringes

» Alcohol prep pads

» Surgical masks and face shields for vaccinators

» COVID-19 vaccination record cards for vaccine 

recipients

» Vaccine needle and length guide 

» Diluent and mixing supplies (based on vaccine 

product)

Mpox vaccine shipments do NOT include 

ancillary supplies.

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.

See Section Four, "Vaccine Inventory Management," 

for additional information about vaccine inventory 

accounting measures.

Expired Vaccine

Determining when a vaccine or diluent expires is a 

critical step in proper storage and handling. 

Expired vaccines and diluents must be removed 

immediately from storage units to avoid inadvertently 

administering them. Manufacturers may have specific 

guidance on how to handle expired or compromised 

vaccines. However, open or broken vials and vaccine 

predrawn by providers cannot be returned and must be 

discarded according to your jurisdiction’s requirements. 

To help vaccination providers track expiration dates 

and beyond-use dates (BUDs), CDC has developed 

product specific tracking tools and labels: 

• COVID-19 Vaccine

• Mpox Vaccine
VACCINE STORAGE AND HANDLING TOOLKIT 55

COVID-19 AND MPOX VACCINES STORAGE AND HANDLING

COVID-19 AND MPOX VACCINES ADDENDUM

Vaccine Disposal

Medical waste disposal requirements are set by state environmental agencies and may vary from state to state. Your 

jurisdiction’s immunization program or environmental agency can provide guidance to ensure your facility’s vaccine 

disposal procedures comply with state and federal regulations. Vaccine manufacturers should also provide guidance 

about proper disposal of their products, including any unused vaccine. In some instances, unused vaccine may be 

returned to the manufacturer. Empty vaccine vials are usually not considered hazardous or pharmaceutical waste 

and do not require disposal in a biomedical waste container. However, check and comply with your jurisdiction’s 

requirements for disposal. 

Vaccine Preparation

Preparing vaccine properly is critical to maintaining the 

integrity of the vaccine during transfer from the manufacturer’s 

vial to the syringe and, ultimately, to the patient. CDC 

recommends preparing and drawing up vaccines just before 

administration. It is important to follow vaccine preparation 

instructions provided in the vaccine product’s Fact Sheet for 

Vaccination Providers or the manufacturer package insert.

Vaccine products may have different preparation 

requirements. Some should not be shaken, or the vaccine 

will be compromised and cannot be used. Carefully follow 

the manufacturer’s vaccine preparation guidance. Diluents, 

if applicable, are not interchangeable unless specified by the 

manufacturer. Vaccine mixed with the wrong diluent should 

never be administered. 

See Section Five, "Vaccine Preparation," for detailed 

information about vaccine preparation.

Vaccine Preparation Best Practices

» Prepare vaccines in a designated area away 

from any space where potentially contaminated 

items are placed.

» Always follow the manufacturer's instructions 

for preparing vaccine.

» Only prepare vaccines when you are ready to 

administer them.

» Always check expiration dates. If your facility 

stocks multiple vaccine products, always 

confirm 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.

Predrawing vaccine can result in waste when more 

is drawn up than needed. In the rare instances 

when it is necessary to predraw vaccines, it is 

important to follow recommended guidance to 

avoid compromising and wasting vaccine and 

to maintain the cold chain. Carefully follow the 

toolkit best practices for predrawing vaccine as 

well as any manufacturer guidance.

COVID-19 Vaccine Transport

In most instances, vaccine will be delivered directly to the 

facility where it will be administered to maintain the vaccine 

cold chain. However, there may be circumstances where 

vaccine needs to be redistributed or transported. This can 

occur if:

• A CDC Supplemental COVID-19 Vaccine Redistribution 

Agreement is in place for vaccine to be redistributed beyond 

the identified primary CDC ship-to site (i.e., for larger organizations whose vaccine is shipped to a central depot and 

requires redistribution to additional clinic locations).

• A jurisdiction immunization program or commercial partner needs to redistribute vaccine within the jurisdiction 

based on need or to keep vaccine from being wasted.

• Vaccine needs to be transported for satellite, temporary, or off-site clinics, including programs at long-term care 

facilities, or for administration to patients such as those in a home healthcare program.

Mpox Vaccine Transport

Mpox vaccine is shipped from Strategic National Stockpile (SNS) sites to vaccine depots. Before storing vaccine,

• Examine the shipment for signs of damage. 

• Check TempTale temperature monitoring device or DDL for temperature excursions.

If vaccine needs to be further transported (i.e., from vaccine depots to health departments or clinics), unpack vaccine 

from Credo Crates and repackage into an appropriate transport system as outlined in the Transport guidance here. 

Expiration date should be recorded when vials are separated from original packaging.
56 VACCINE STORAGE AND HANDLING TOOLKIT 

COVID-19 AND MPOX VACCINES STORAGE AND HANDLING

COVID-19 AND MPOX VACCINES ADDENDUM

In these instances, appropriate precautions must 

be taken to protect the vaccine. Vaccine must only 

be transported using appropriate packing materials 

that provide maximum protection. Follow specific 

jurisdiction and federal direction for transporting 

vaccine products. 

Transporting vaccine requires planning and 

preparation to ensure the cold chain is maintained. 

As a vaccination provider, you should carefully 

review Section Six, "Vaccine Transport," to ensure 

your facility has the appropriate procedures and 

supplies in place to safely transport vaccine. 

Transport guidance may vary based on the specific 

vaccine product.

The chart below shows general transport 

recommendations to maintain the vaccine cold chain 

in two situations: emergency transport and transport 

for use at off-site clinics or satellite facilities or for 

relocation of stock. Recommendations vary based 

on the situation. Some vaccine products may have 

specific transport guidance to ensure the cold chain 

is maintained and vaccine is protected. Refer to 

the relevant vaccine product information in this 

addendum for additional information.

COVID-19 Vaccine Transport Requirements

» Vaccine must be transported in a stable storage unit and 

monitored with a DDL. Record the time and minimum/

maximum temperature at the beginning of transport. 

In most instances, packing materials that vaccines were 

initially shipped in are not meant for reuse (the most 

common exception is ultra-cold vaccine shipping materials). 

» Transport equal amounts of vaccines, diluent (if needed), 

and supplies needed to administer and document vaccines. 

» Immediately upon arrival at the destination, the time 

and minimum/maximum temperature must be recorded. 

Vaccines should be stored in an appropriate storage unit 

with a DDL. If this is not possible, vaccines should be kept 

in the portable storage unit and the unit temperature 

recorded every time the portable unit is opened.

CDC recommends transporting vaccine in vials. However, 

there may be instances when the only option is to transport 

vaccine in a predrawn syringe prepared by the provider. This 

should only occur when vaccine is in a multidose vial. U.S. 

Pharmacopeia includes guidance for transporting predrawn 

vaccine in syringes in the USP COVID-19 Vaccine Toolkit: 

Operational Considerations for Healthcare Practitioners.

A partially used vial cannot be transferred from one 

provider to another or across state lines.

General Transport System Recommendations Emergency 

Transport

Transport for Off-Site Clinic, 

Satellite Facility, or Relocation 

of Stock

Portable Vaccine Refrigerator, Freezer, or Ultra-cold Freezer Yes Yes

Qualified Container and Packout Yes Yes

Conditioned Water Bottle Transport System Yes No

Manufacturer’s Original Shipping Container Yes (last resort only) No

Food/Beverage Coolers No No

Emergency Storage and Handling

Emergencies such as equipment failures, power outages, severe weather conditions, or natural disasters usually 

happen without warning and may compromise storage conditions. It is critical that vaccination providers have plans in 

place for emergency situations. Some key issues to remember include:

• 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.

• Having an on-site generator(s) prevents the need to transport vaccines to an alternative storage facility during a power outage.

• Emergency situations can arise outside of normal business hours, so your office staff as well your facility’s building manager 

and/or security staff, if appropriate, must understand how to implement your emergency operation plans or access your 

facility if necessary.

• Ensure your facility has the resources on hand to safely pack vaccines for transport during emergencies. 

See Section Seven, "Emergency Vaccine Storage and Handling," for additional information about monitoring 

and handling vaccine during an emergency.
VACCINE STORAGE AND HANDLING TOOLKIT 57

COVID-19 AND MPOX VACCINES STORAGE AND HANDLING

COVID-19 AND MPOX VACCINES ADDENDUM

Additional Resources

• ACIP’s General Best Practice Guidelines for Immunization: 

www.cdc.gov/vaccines/hcp/ acip-recs/general-recs/index.html

• Educational webinars and continuing education for healthcare providers: 

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

• Emergency Use Authorization: 

www.youtube.com/watch?v=iGkwaESsGBQ&feature=youtu.be

• Epidemiology and Prevention of Vaccine-Preventable Diseases:

www.cdc.gov/vaccines/pubs/pinkbook/index.html

• FDA Center for Biologics Evaluation and Research (CBER) 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/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/

• Federal Emergency Management Agency (FEMA) information on disaster preparedness: 

www.fema.gov/

• Immunization Action Coalition Refrigerator and Freezer Temperature Log Sheets and Vaccine Troubleshooting 

Record: 

www.immunize.org/va/va52_temperature-logs-iac.pdf

• Jurisdiction immunization programs:

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

• Packing Vaccines for Transport during Emergencies:

www.cdc.gov/vaccines/recs/storage/downloads/emergency-transport.pdf

• You Call the Shots: Vaccine Administration:

www2.cdc.gov/vaccines/ed/vaxadmin/va/ce.asp

• You Call the Shots: Vaccine Storage and Handling: 

www2a.cdc.gov/nip/isd/ycts/mod1/courses/sh/ce.asp

• Vaccine Administration home page:

www.cdc.gov/vaccines/hcp/admin/admin-protocols.html

• Vaccine Storage and Handling home page: 

www.cdc.gov/vaccines/recs/storage/default.htm (sign up for notifications about updates) 

• Vaccine Storage and Handling Toolkit web page: 

www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html

Disclaimer: Use of trade names and commercial sources in the addendum 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 the Centers for Disease Control and Prevention (CDC). You may see vendors use terms such as “CDC-compliant,” 

or “satisfies federal COVID-19 vaccine response requirements” in their marketing materials or on their websites. In 

this context, “compliance” and related terms may lead consumers to incorrectly believe that CDC has independently 

assessed and verified the quality of these products. CDC 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 CDC has not validated any product or service for compliance with vaccination provider 

requirements or standards as outlined in the COVID-19 and Mpox Vaccination Provider Agreement.
VACCINE STORAGE AND HANDLING TOOLKIT 58

VACCINE STORAGE AND HANDLING TOOLKIT:COVID-19

COVID-19 AND MPOX VACCINES ADDENDUM

COVID-19 Vaccine (Pfizer-BioNTech)

Products: Pfizer-BioNTech COVID-19 Vaccine (Monovalent/Bivalent Gray cap Age 12 and Older), (Monovalent/Bivalent Orange Cap 

Ages 5 through 11), (Monovalent/Bivalent Maroon Cap Ages 6 months through 4 years) 

Manufacturer Website: www.cvdvaccine.com

Manufacturer Phone Number: 1-877-829-2619 (1-877-VAX-CO19)

CDC Clinical Guidance for Pfizer-BioNTech COVID-19 Vaccine:www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html

Ages: 6 months through 4 years 

(Maroon capped vial and bordered label)

MONOVALENT 

Primary Series

(Dose 1 & 2)

BIVALENT

Primary Series

(Dose 3)

Ages: 5 through 11 years 

(Orange capped vial and bordered label) 

MONOVALENT

Primary Series

BIVALENT

Booster Dose 

Ages: 12 and older

(Gray capped vial and bordered label) 

MONOVALENT

Primary Series

BIVALENT

Booster Dose

Single-dose and 

Multidose Vials

Vaccine Temperature Ranges:

▪ Ultra-cold: -90oC and -60oC (-130oF and -76oF) until the expiration date

▪ Refrigerated: 2oC and 8oC (36oF and 46oF) for up to 10 weeks

Vaccine Storage Unit(s):

▪ Ultra-cold freezer

▪ Refrigerator

Temperature Monitoring Device: For accurate temperature monitoring, use a digital data logger (DDL) able to measure minimum 

and maximum temperatures..

▪ Ultra-cold freezer: Use a DDL with an air-probe or a probe designed specifically for ultra-cold temperatures. 

▪ Refrigerator: Use a DDL with a detachable probe that best reflects vaccine temperatures (e.g., probe buffered with glycol, glass 

beads, or Teflon®). 

Delivery:

▪ Vaccine arrives in a thermal shipping container at temperatures between -90oC and -60oC (-130oF and -76oF) with dry ice or 

between -25oC and -15oC (-13oF and 5oF). 

▪ Ancillary supplies kit(s), including diluent if needed, will arrive in a separate shipment from the the vaccine. Each kit includes the 

number of supplies needed to support the number of doses ordered. Vaccine for ages: 

» 6 months through 4 years requires diluent 

» 5 through 11 years requires diluent 

» 12 years and older does NOT require diluent

▪ Follow the manufacturer's guidance for unpacking the vaccine and returning the temperature monitoring device and container, 

if indicated. (www.cvdvaccine-us.com/5-11-yearsold/storage-and-handling). 

▪ Dispose of the single-use thermal shipping container. Do NOT use the thermal shipping container for storage.

▪ Ancillary supply kits will be delivered separately from the vaccine and have been reconfigured to support the number of doses ordered. 

Note: There are no ancillary supplies for Pfizer-BioNTech vaccine for persons 12 years of age and older (gray-capped vial)
59 VACCINE STORAGE AND HANDLING TOOLKIT 

COVID-19 AND MPOX VACCINES ADDENDUM

Vaccine (Pfizer-BioNTech) COVID-19

Storage Information: Vaccine can be stored in an ultra-cold freezer or a refrigerator following routine storage and handling best 

practices. Do NOT store in the thermal shipping container or a freezer.

Ultra-Cold Freezer

Store unpunctured vials between -90oC and -60oC (-130oF and -76oF) until the expiration date.

» Store vials upright in the tray or box protected from light 

» Use Pfizer-BioNTech's expiration date tool at lotexpiry.cvdvaccine.com

Refrigerator

Store unpunctured vials between 2oC and 8oC (36oF and 46oF) for up to 10 weeks

» Store the vaccine vials upright.

» Protect from light.

» Do NOT refreeze thawed vaccine.

» Use CDC’s beyond-use date labels for Pfizer-BioNTech COVID-19 Vaccine.

Temperature Monitoring:

Ultra-cold freezer or refrigerator:

Storage unit temperatures must be monitored regularly, checked, and recorded to determine if any temperature excursions 

have occurred since the last temperature check. For accurate temperature monitoring, use a digital data logger (DDL) with a 

detachable probe that best reflects vaccine temperatures.

» Most digital data loggers display the minimum maximum (min/max) temperatures. Check and record the min/max 

temperature at the start of each workday. (preferred method)

» If the digital data logger is unable to display min/max temperatures, check and record the current temperature at the 

start and end of each workday.

Transport:

CDC does not recommend routine transport of vaccines. Ideally, vaccines should be delivered directly to the facility where they will 

be used. If vaccines must be transported, follow: 

▪ Manufacturer's guidance

▪ CDC Pfizer-BioNTech COVID-19 Transport Summary

▪ Routine vaccine storage and handling transport guidance outlined in this toolkit. 

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

a predrawn syringe. U.S. Pharmacopeia includes guidance for transporting predrawn vaccine in syringes in the USP COVID-19 

Vaccine Toolkit: Operational Considerations for Healthcare Practitioners.
60 VACCINE STORAGE AND HANDLING TOOLKIT 

COVID-19 AND MPOX VACCINES ADDENDUM

Vaccine (Pfizer-BioNTech) COVID-19

Vaccine Preparation and Administration:

Use the correct product based on the age of the recipient. 

Vial cap color Monovalent 

Maroon Cap

Bivalent 

Maroon Cap

Monovalent

Orange Cap

Bivalent

Orange Cap

Monovalent

Gray Cap

Bivalent

Gray Cap 

Ages 6 months through 4 years 5 through 11 years 12 years and older

Supplied in:

MDV*: 10 doses 

per vial 

Requires diluent 

MDV*: 10 doses 

per vial

Requires diluent

MDV*: 10 doses 

per vial 

Requires diluent 

MDV*: 10 doses 

per vial 

Requires diluent

MDV*: 6 doses 

per vial

 No diluent 

MDV*: 6 doses per 

vial

SDV*: 1 dose

No diluent 

* MDV=multidose vial; SDV=single-dose vial

▪ Frozen vaccine must be thawed prior to use. 

▪ Thaw vaccine between 2°C and 8°C (36°F and 46°F) or between 8° C and 25° C (46° F and 77° F). The amount of time needed 

to thaw vaccine varies based on the temperature and number of vials. 

» Unpunctured vials may be held between 8° C and 25° C (46° F and 77° F) for a total of 12 hours. 

▪ Single-dose vials contain 1 dose of vaccine. Use a new vial for each recipient. 

▪ Mix vaccine with diluent if indicated. Use a new vial of diluent for each vial.

Diluent Maroon capped vial 

6 months through 4 years 

Orange capped vial 

5 through 11 years

Gray capped vial 

12 years and older 

0.9% sodium chloride; 

preservative free diluent

Monovalent Bivalent Monovalent Bivalent Monovalent Bivalent

SDV and MDV

2.2 mL 2.2mL 1.3 mL 1.3 mL NONE NONE 

▪ During vaccine preparation, gently swirl after thawing and between each withdrawal from a multidose vial. Do not shake the 

vial. If shaken, contact the manufacturer. 

▪ Administer by intramuscular (IM) injection using a new needle and syringe for each injection. 

» Punctured vials maybe be kept between 2°C and 25°C (35°F to 77°F) for up to 12 hours. Discard the vial and any 

remaining vaccine after 12 hours. 

▪ Discard vials (multidose or single dose) when there is not enough vaccine to obtain a complete dose. Do NOT combine residual 

vaccine from multiple vials to obtain a dose.

Special Considerations:

▪ To determine the expiration date use Pfizer-BioNTech's expiration date tool at lotexpiry.cvdvaccine.com.

▪ If unable to access the tracking tool, count out 12 months using the month printed on the vial as month 1. The vaccine expires 

on the last day of the 12th month. For example, the vial has January 2023 printed on it. December 2022 would be the 12th 

month and the vaccine would be expired December 31, 2023. 

▪ Expired vaccine or vaccine past the BUD, should NEVER be administered. To prevent this, use CDC expiration date and BUD 

tracking tools. 
VACCINE STORAGE AND HANDLING TOOLKIT 61

VACCINE STORAGE AND HANDLING TOOLKIT:COVID-19

COVID-19 AND MPOX VACCINES ADDENDUM

COVID-19 Vaccine (Moderna)

Products: Moderna COVID-19 Vaccine (Monovalent primary series 6 months through 5 years, Monovalent primary series 6 through 

11 years, Monovalent primary series12 years and older, Bivalent booster doses 6 months through 5 years of age and Bivalent booster 

doses 6 years and older)

Manufacturer Website: www.modernatx.com/covid19vaccine

Manufacturer Phone Number: 1-866-MODERNA (1-866-663-3762)

CDC Clinical Guidance for Moderna COVID-19 Vaccine: www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html

Ages: 6 months 

through 5 years

MONOVALENT

(blue capped vial with 

magenta-bordered label)

Ages: 6 months 

through 5 years

BIVALENT

(pink capped vial with 

yellow-bordered label)

Ages: 6 through 

11 years 

MONOVALENT

(blue capped vial with 

purple-bordered label)

Ages: 12 years 

and older

MONOVALENT

(red capped vial with 

blue-bordered label)

Ages: 6 years 

and older

BIVALENT

(blue capped vial with 

gray-bordered label)

Vaccine Temperature Ranges:

Unpunctured vials may be stored:

▪ Frozen: -50oC and -15oC (-58oF and 5oF) until the expiration date

▪ Refrigerated: 2oC and 8oC (36oF and 46oF) up to 30 days

Vaccine Storage Unit(s):

Unpunctured vials may be stored in the:

▪ Freezer 

▪ Refrigerator

Temperature Monitoring Device: For accurate temperature monitoring, use a digital data logger (DDL) with a detachable probe 

that best reflects vaccine temperatures (e.g., probe buffered with glycol, glass beads, or Teflon®) able to measure minimum and 

maximum temperatures.

Delivery:

▪ Vaccine arrives frozen between -50oC and -15oC (-58oF and 5oF). Examine the shipment for signs of damage. 

▪ Ancillary supplies kit(s), including diluent if needed, will arrive in a separate shipment from the the vaccine. Each kit includes the 

number of supplies needed to support the number of doses ordered.

▪ Follow the manufacturer's guidance for unpacking the vaccine. Each box has a TagAlert temperature monitoring device that 

should be checked.
62 VACCINE STORAGE AND HANDLING TOOLKIT 

COVID-19 AND MPOX VACCINES ADDENDUM

Vaccine (Moderna) COVID-19

Storage Information: Vaccine can be stored in a freezer or refrigerator following routine storage and handling best practices. 

Freezer

Store unpunctured vials between -50oC and -15oC (-58oF and 5oF) until the expiration date.*

» Store vials upright in the tray or box protected from light

» Do not store with dry ice or below -50°C (-58°F)

» Determine the expiration date by scanning the QR code on the outer carton or go to modernacovid19global.com/viallookup

Refrigerator

Store unpunctured vials between 2oC and 8oC (36oF and 46oF).

» Do NOT refreeze thawed vaccine.

» Store vials upright in the tray or box protected from light.

» Use tracking labels to monitor the beyond-use date.

Punctured vials may be stored between 2°F and 25°C (36°F and 77°F) for up to 12 hours.

Transport:

CDC does not recommend routine transport of vaccines. Ideally, vaccines should be delivered directly to the facility where they will 

be used. If vaccines must be transported, follow: 

▪ Manufacturer's guidance 

▪ CDC Moderna COVID-19 Transport Summary

▪ Routine vaccine storage and handling transport guidance outlined in this toolkit

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

a predrawn syringe. U.S. Pharmacopeia includes guidance for transporting predrawn vaccine in syringes in the USP COVID-19 

Vaccine Toolkit: Operational Considerations for Healthcare Practitioners.

Vaccine Preparation and Administration:

Use the correct product based on the age of the recipient.

Vial cap color

Monovalent 

Blue capped vials 

with magentabordered label 

Bivalent 

Pink capped vials 

with yellowbordered label 

Monovalent 

Blue capped vial 

with purplebordered label 

Monovalent 

Red capped 

vial with bluebordered label 

Bivalent 

Dark blue capped 

vial with graybordered label 

Supplied in 

multidose vial 10 doses per vial 

2 doses per vial

These vials should 

not be confused with 

single dose vials.

Once 2 doses have been 

removed, discard the 

vial.

5 doses per vial 10 primary doses 

6 through11 years 

of age: 

10 doses per vial

12 years of age 

and older: 

5 doses per vial

*These temperatures are within the appropriate range for routinely recommended vaccines BUT the temperature range for this vaccine is tighter. If storing the vaccine in a 

freezer with routinely recommended vaccines, carefully adjust the freezer temperature to the correct temperature range for this vaccine.
VACCINE STORAGE AND HANDLING TOOLKIT 63

COVID-19 VACCINE ADDENDUM

Vaccine (Moderna) COVID-19

▪ Frozen vaccine must be thawed prior to use. 

▪ Thaw vaccine between 2°C and 8°C (36°F and 46°F) or between 8° C and 25° C (46° F and 77° F). The amount of time needed to 

thaw vaccine varies based on the temperature and number of vials. 

▪ Unpunctured vials may be held between 8°C and 25°C (46°F and 77°F) for a total of 24 hours. 

▪ Do NOT dilute. 

▪ During vaccine preparation, gently swirl after thawing and between each withdrawal from a multidose vial. D0 not shake the vial. 

If shaken, contact the manufacturer. 

▪ Administer by intramuscular (IM) injection using a new needle and syringe for each injection. 

▪ Punctured vials maybe be kept between 8°C and 25°C (46°F and 77°F) for up to 12 hours. Discard the vial and any remaining 

vaccine after 12 hours. 

▪ Discard the multidose vial when there is not enough vaccine to obtain a complete dose. Do NOT combine residual vaccine from 

multiple vials to obtain a dose.

Special Considerations:

▪ To determine the expiration date of a vial, scan the QR code located on the vial or carton. The QR code will bring up a website. 

Choose the lookup option, enter the lot number, and the expiration date will be displayed. You can also access the website 

directly: www.modernatx.com/covid19vaccine-eua.
VACCINE STORAGE AND HANDLING TOOLKIT 64

VACCINE STORAGE AND HANDLING TOOLKIT:COVID-19

COVID-19 AND MPOX VACCINES ADDENDUM

COVID-19 Vaccine (Janssen)

Product: Janssen COVID-19 Vaccine (Johnson & Johnson)

Manufacturer Website: www.janssencovid19vaccine.com

Manufacturer Phone Number: 1-800-565-4008

CDC Clinical Guidance for Janssen COVID-19 Vaccine: www.cdc.gov/vaccines/covid-19/info-by-product/janssen/index.html

Vaccine Temperature Range:

▪ Refrigerated: 2oC and 8oC (36oF and 46oF) until the expiration date*

Vaccine Storage Unit:

▪ Refrigerator

Temperature Monitoring Device: For accurate temperature monitoring, use a digital data logger (DDL) with a detachable probe 

that best reflects vaccine temperatures (e.g., probe buffered with glycol, glass beads, or Teflon®).

Delivery:

▪ Vaccine arrives refrigerated between 2oC and 8oC (36oF and 46oF). Examine the shipment for signs of damage. Shipments have 

two cartons; each carton contains 10 multidose vials (50 doses), 100 doses total.

▪ Each box has two temperature monitoring devices (WarmMark monitor and FreezeMark indicator) that should be checked 

following the manufacturer's guidance. 

▪ Ancillary kits will be delivered separately from the vaccine and include enough supplies to administer 100 doses of vaccine.

Storage Information: Vaccine can be stored in a refrigerator following routine storage and handling best practices.

Refrigerator

Store between 2oC and 8oC (36oF and 46oF)

» Unpunctured vaccine vials should be stored until the expiration date. 

» The expiration date may be extended as more stability data become available. Contact the manufacturer to determine if 

the expiration date has been extended prior to discarding vaccine. Use CDC’s expiration date tracking tool to document 

expiration date changes. 

» Punctured vaccine vials may be stored in the refrigerator for up to 6 hours. 

» Protect vaccine from light. 

» DO NOT FREEZE.

*These temperatures are within the appropriate range for routinely recommended vaccines BUT the temperature range for this vaccine is tighter. If storing the vaccine in a 

refrigerator with routinely recommended vaccines, carefully adjust the refrigerator temperature to the correct temperature range for this vaccine.
65 VACCINE STORAGE AND HANDLING TOOLKIT 

COVID-19 AND MPOX VACCINES ADDENDUM

Vaccine (Janssen) COVID-19

Transport:

CDC does not recommend routine transport of vaccines. Ideally, vaccines should be delivered directly to the facility where they will 

be used. If vaccines must be transported, follow routine vaccine storage and handling transport guidance outlined in this toolkit. 

Use CDC's transport temperature log to record temperatures and time in transport. Adhere to the following transport requirements:

Refrigerated transport (2° C to 8° C; 36° F to 46° F): 

▪ Vaccine must be transported in insulated containers qualified to maintain a temperature range of 2°C to 8°C (36°F to 46°F) for 

the duration of transport.

▪ Take care to ensure vaccine does not freeze during transport. 

▪ CDC recommends the total time for transport alone or transport plus clinic workday should be a maximum of 8 hours.

▪ Punctured vials can be transported at refrigerated temperatures. Once punctured, the refrigerated vials must be used within 

6 hours. Transport time counts as part of the 6-hour time limit.

▪ Vaccine vials may be transported more than once.

▪ When transport is complete, vaccine should immediately be placed in a vaccine storage unit between 2°C and 8°C (36°F and 

46°F).

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

vaccine in a syringe. U.S. Pharmacopeia includes guidance for transporting predrawn vaccine in syringes in the USP COVID-19 

Vaccine Toolkit: Operational Considerations for Healthcare Practitioners.

▪ Transportation guidance and considerations are outlined in CDC’s Transportation Summary for this product.

Vaccine Preparation and Administration:

▪ After puncturing the multidose vial stopper, store vaccine in the refrigerator for up to 6 hours (2°C to 8°C [36°F to 46°F]) or at 

room temperature for up to 2 hours (maximally 25°C [77°F]). 

» Discard the vaccine if not used during this time.

▪ Each multidose vial contains 5 doses. 

▪ Do NOT mix vaccine with diluent. 

▪ During vaccine preparation, gently swirl before first puncture and between each withdrawal. Do NOT shake the vial. If the vial 

is shaken, contact the manufacturer. 

▪ Discard vial when there is not enough vaccine to obtain a complete dose. Do NOT combine residual vaccine from multiple vials 

to obtain a dose. 

▪ Administer by IM injection

Special Considerations:

▪ The expiration date is NOT printed on the vaccine vial or carton. To determine the expiration date:

» Scan the QR code on the outer carton, or

» Call 1-800-565-4008, or

» Visit www.vaxcheck.jnj.

▪ Write the expiration date on the carton. Use CDC’s expiration date tracking tool to document expiration date changes.
VACCINE STORAGE AND HANDLING TOOLKIT 66

VACCINE STORAGE AND HANDLING TOOLKIT:COVID-19

COVID-19 AND MPOX VACCINES ADDENDUM

COVID-19 Vaccine (Novavax)

Product: Novavax COVID-19 Vaccine (recombinant, adjuvanted), 12 years and older (Royal blue cap primary and booster series)

Manufacturer Website: www.novavaxcovidvaccine.com

Manufacturer Phone Number: 1-844-NOVAVAX (1-844-668-2829)

CDC Clinical Guidance for Novavax COVID-19 Vaccine: www.cdc.gov/vaccines/covid-19/info-by-product/novavax/index.html

Vaccine Temperature Range:

▪ Refrigerated: 2°C and 8°C (36°F and 46°F) until the expiration date

Vaccine Storage Unit:

▪ Refrigerator

Temperature Monitoring Device: For accurate temperature monitoring, use a digital data logger (DDL). 

▪ Refrigerator: Use a DDL with a detachable probe that best reflects vaccine temperatures (e.g., probe buffered with glycol, glass 

beads, and or Teflon®).

Delivery:

▪ Vaccine arrives in a qualified shipping container at temperatures between 2°C and 8°C (36°F and 46°F). The vial has a royal blue 

cap and royal blue border on the label.

▪ Unpack vaccine immediately upon arrival at clinic and check the cold chain monitor (CCM) for any indication of a temperature 

excursion during transit.

▪ Check expiration date by scanning the QR on the outer carton or go to www.novavaxcovidvaccine.com

▪ Ancillary supplies including needles, syringes, and vaccination record cards will arrive separately from the vaccine.

Storage Information: Vaccine can be stored in a refrigerator following routine storage and handling best practices.

Refrigerator

Store between 2°C and 8°C (36°F and 46°F) until the expiration date.

» Store vaccine in the original packaging.

» Protect from light.

» Use storage labels to help staff easily identify the vaccine within the storage unit.

» Once punctured, Novavax COVID-19 Vaccine must be used within 6 hours.

— Note when (time) the vial is first punctured and use within 6 hours.

— Discard vial and any remaining vaccine after 6 hours.
67 VACCINE STORAGE AND HANDLING TOOLKIT 

COVID-19 AND MPOX VACCINES ADDENDUM

Vaccine (Novavax) COVID-19

Transport: 

CDC does not recommend routine transport of vaccines. Ideally, vaccines should be delivered directly to the facility where they will 

be used. If vaccines must be transported, follow routine vaccine storage and handling transport guidance outlined in this toolkit. 

Use CDC’s transport temperature log to record temperatures and time in transport. Adhere to the following transport requirements: 

Refrigerated transport (2° C to 8° C; 36° F to 46° F): 

▪ Vaccine must be transported in insulated containers qualified to maintain a temperature range of 2°C to 8°C (36°F to 46°F) for 

the duration of transport. 

▪ Take care to ensure vaccine does not freeze during transport. 

▪ CDC recommends the total time for transport alone or transport plus clinic workday should be a maximum of 8 hours. 

▪ Punctured vials can be transported at refrigerated temperatures. Once punctured, the refrigerated vials must be used within 6 

hours. Transport time counts as part of the 6-hour time limit. 

▪ Vaccine vials may be transported more than once. 

▪ When transport is complete, vaccine should immediately be placed in a vaccine storage unit between 2°C and 8°C (36°F and 46°F). 

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

vaccine in a syringe. U.S. Pharmacopeia includes guidance for transporting predrawn vaccine in syringes in the USP COVID-19 

Vaccine Toolkit: Operational Considerations for Healthcare Practitioners. 

▪ Transportation guidance and considerations are outlined in CDC’s Transportation Summary for this product. 

Vaccine Preparation and Administration:

▪ After puncturing the multidose vial stopper, store vaccine in refrigerator for up to 6 hours (2°C to 25°C (35°F to 77°F).

» Discard the vaccine if not used during this time. 

▪ Each multidose vial contains 10 doses.

▪ Do NOT mix vaccine with diluent.

▪ During vaccine preparation, gently swirl before first puncture and between each withdrawal. Do NOT shake the vial. If the vial 

is shaken, contact the manufacturer.

▪ Discard vial when there is not enough vaccine to obtain a complete dose. Do NOT combine residual vaccine from multiple vials 

to obtain a dose.

▪ Administer by IM injection.

Special Considerations:

▪ The expiration date is NOT printed on the vaccine vial or carton. To determine the expiration date, visit www.novavaxcovidvaccine.

com. 

▪ Write the expiration date on the carton. Use CDC’s expiration date tracking tool to document expiration date changes. 
VACCINE STORAGE AND HANDLING TOOLKIT 68

VACCINE STORAGE AND HANDLING TOOLKIT:COVID-19

COVID-19 AND MPOX VACCINES ADDENDUM

MPOX Vaccine (JYNNEOS)

Product: JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating)

Manufacturer Website: jynneos.com

Manufacturer Phone Number: 1-844-422-8274

CDC Clinical Guidance for Mpox Vaccine: www.cdc.gov/poxvirus/monkeypox/clinicians/vaccines/vaccine-considerations.html

Vaccine Temperature Range:

Unpunctured vials may be stored: 

▪ Frozen: Between -25°C and -15°C (-13°F and 5°F) until the expiration date

▪ Refrigerated: Between 2oC and 8oC (36oF and 46oF) for up to 8 weeks

Punctured vials may be stored: 

▪ Refrigerated between 2oC and 8oC (36oF and 46oF) for up to 8 hours

Temperature Monitoring Device: For accurate temperature monitoring, use a digital data logger (DDL) with a detachable probe 

that best reflects vaccine temperatures (e.g., probe buffered with glycol, glass beads, or Teflon®).

Delivery:

▪ Vaccine is shipped from Strategic National Stockpile (SNS) sites to vaccine depots.

▪ Vaccine arrives frozen between -25°C and -15°C (between -13°F and 5°F)

▪ Examine the shipment for signs of damage. Each box contains 20 vials.

▪ Each box has a TempTale temperature monitoring device or DDL that should be checked following SNS guidance.

▪ If vaccine needs to be further transported (i.e., from vaccine depots to health departments or clinics), unpack vaccine from Credo 

Crates and repackage into an appropriate transport system as outlined in the Transport guidance below. Expiration date should 

be recorded when vials are separated from original packaging.

Storage Information: Vaccine can be stored in a freezer or refrigerator following routine storage and handling best practices. 

Individual guidance for each storage unit is as follows:

Freezer

Unpunctured vials may be stored frozen between -25°C and -15°C (-13°F and 5°F) until the expiration date.*

» The expiration date may be extended as more stability data become available. As the expiration date approaches, contact the 

manufacturer to determine if the expiration date has been extended prior to discarding vaccine. 

» Store vaccine vials upright in the original package when possible.

» Protect vaccine from light. 

* These temperatures are within the appropriate range for routinely recommended vaccines BUT the temperature range for this vaccine is narrower. If storing the vaccine in a 

freezer with routinely recommended vaccines, carefully adjust the freezer temperature to the correct temperature range for this vaccine.
69 VACCINE STORAGE AND HANDLING TOOLKIT 

COVID-19 AND MPOX VACCINES ADDENDUM

Vaccine (JYNNEOS) MPOX

Refrigerator

Unpunctured vials may be stored in the refrigerator between 2oC and 8oC (36oF and 46oF) for up to 8 weeks from 

thawing. This updated information has been provided by the vaccine manufacturer based on available supportive stability 

data. Please note that this differs from the package insert, which states that the vaccine may be kept at 2°C to 8°C (36°F to 46°F) 

for 12 hours (Section 2.2 Preparation and Administration and 16.2 Storage Conditions).

» Once thawed, vaccine cannot be refrozen.

» Use CDC’s JYNNEOS beyond-use date (BUD) labels to track how long the vaccine has been in the refrigerator.

— If the expiration date shown on the carton is earlier than the 8 weeks after vial was first thawed, write the expiration 

date on the box or container holding the vaccine vials.

— As the 8-week deadline approaches, contact the manufacturer to determine if the expiration date has been extended 

prior to discarding vaccine. 

» Store vaccine vials upright. 

» Protect vaccine from light. 

» Use vaccine vials stored in the refrigerator before removing additional vials from the freezer.

Punctured vials should be stored at refrigerated temperatures (between 2°C and 8°C) for up to 8 hours. Place the vial 

back in the refrigerator after drawing up each dose. Do NOT leave vaccine vial out at room temperatures in between doses.

Transport: 

Frozen transport is preferred if vaccine must be transported. 

Frozen transport:

JYNNEOS vaccine may be transported frozen between -25°C and -15°C (-13°F and 5°F) for 72 cumulative hours (e.g., vaccine 

transported for 2 hours today has 70 hours of transport time remaining). 

» Transport using a portable freezer or qualified container to maintain between -25°C and -15°C (-13°F and 5°F) with DDLs.

» When you have completed the vaccine transport for the day, remove any remaining vials from the transport container, and 

place vials immediately in freezer.

» Complete the information on the bottom portion of the label indicating the time in transport and hours remaining for 

transport.

» Store vaccine upright in the freezer between -25°C and -15°C (-13°F and 5°F) until the expiration date, if freezer capacity is 

available, or in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 8 weeks from thawing. 

Refrigerated transport: 

JYNNEOS vaccine may be transported between 2oC and 8oC (36oF and 46oF) for 12 cumulative hours (e.g., vaccine transported 

for 2 hours today has 10 hours of transport time remaining).

» Transport using a portable refrigerator or qualified container to maintain between 2oC and 8oC (36oF and 46oF) with digital 

data loggers.

» When you have completed vaccine transport for the day, remove any remaining vials from the transport container and then 

place vials immediately in refrigerator.

» Complete the information on the bottom portion of the label indicating the time in transport and hours remaining for 

transport.

» Store vaccine upright in the refrigerator between 2oC and 8oC (36oF and 46oF) for up to 8 weeks. 
70 VACCINE STORAGE AND HANDLING TOOLKIT 

COVID-19 AND MPOX VACCINES ADDENDUM

Vaccine (JYNNEOS) MPOX

 Vaccine Preparation and Administration:

▪ Each vial contains one subcutaneous dose or approximately five intradermal doses. 

▪ Discard vial when there is not enough vaccine to obtain a complete dose. Do NOT combine residual vaccine from multiple vials 

to obtain a dose.

▪ Frozen vaccine must be thawed at room temperature for 10 minutes before using.

▪ Do NOT refreeze thawed vaccine.

▪ With the vial upright, gently swirl the vaccine for 30 seconds.

▪ Examine the vaccine. It should be a milky light yellow to pale white colored suspension. Do not use if liquid contains other 

particulate matter or is discolored.

▪ Once punctured, the vaccine must be stored in the refrigerator and used within 8 hours. 

▪ Administer by subcutaneous or intradermal injection. 

Special Considerations:

▪ Unpunctured vials may be held at room temperature for up to 6 cumulative hours. No additional stability data at room 

temperature is available. 

Predrawn vaccine

Predrawing vaccines can result in waste if more are drawn up than needed. In addition, once vaccines are drawn into syringes, 

it is difficult to tell them apart, which can lead to administration errors, and such errors must be reported to the Vaccine 

Adverse Event Reporting System. However, there may be rare instances when the only option is to predraw JYNNEOS vaccine.

If vaccines must be predrawn:

» Predrawn vaccine must be labeled with vaccine name, lot number, date and time prepared, preparer’s initials, and MUST 

BE refrigerated.

» Predrawn syringes must be stored at the manufacturer-recommended refrigerated temperatures throughout the clinic 

day.

» A separate clean administration station for each vaccine type should be set up to prevent medication errors.

» Vaccines should be drawn up into syringes 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 10 doses at one time.

» Patient flow should be monitored to avoid drawing up unnecessary doses.

» If a predrawn vaccine is not used within 8 hours of being drawn, the dose should be discarded.

» Predrawn vaccine should never be transferred back into a vial for storage.