Congratulations on your hard work! You would be surprised at the number of people who, just like you, do a careful job of recording temperatures, but then they fail to act on them when the temperatures go out of range. Always take immediate action when you notice an out-of-range temperature. You may need to move the vaccines temporarily to a more reliable storage unit and determine the source of the problem. It may be something quite fixable (e.g., excessive lint or dust on the coils), and you will be back in business after you determine that the temperature is back in range after a few hours.
Above all, don’t chart an out-of-range temperature and not act on it! Immunize.org has created temperature recording logs and a troubleshooting record to document unacceptable vaccine storage events. The CDC Storage and Handling Toolkit contains detailed guidance on the management of a temperature excursion. See pages 15–17 at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf. Refer to the addendum to the toolkit for specific guidance on COVID-19 and mpox vaccines.
July 26, 2023
No. You should not use it until you know more. If you find that a vaccine has been exposed to an inappropriate temperature, try to determine the reason for the temperature excursion, mark the vaccine “Do Not Use,” and contact the manufacturer or the state or local health department to determine if the vaccine may be used without concern that its effectiveness has been diminished.
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, identify an alternative unit with appropriate temperatures and sufficient storage space until the primary unit can be repaired or replaced.
July 26, 2023
This is a complex question that requires case-by-case review. First, while you’re assessing the situation, return the vaccine to proper storage temperatures and mark it “Do Not Use.” Then, contact your state or local immunization program or the appropriate vaccine manufacturer(s) to discuss the potential usability of the vaccine. They will need to consider several variables related to vaccine storage conditions. For example, their guidance will be affected by the type and accuracy of the temperature monitoring device, whether the temperature probe was in a liquid or was reading the temperature of the air, the type of vaccine involved, the length of time of the excursion, etc.
In general, if it can be reliably determined that the vaccine in question was not stored below 32°F and the manufacturer’s stability data concurs, most immunization programs and vaccine manufacturers would not recommend wasting the vaccine or revaccinating recipients.
July 26, 2023
If administered vaccine is found to be stored at an inappropriate temperature, whether too cold or too warm, the provider should contact the state health department to determine whether the vaccine dose is invalid. If the vaccine dose is determined to be invalid, another dose should be given. This applies to both inactivated and live vaccines. If the damaged vaccine was a live virus vaccine (e.g., MMR, MMRV, VAR), you should wait at least 4 weeks after the previous (damaged) dose was given before repeating it. If the damaged vaccine was an inactivated vaccine, you can give the repeat dose on the same day you gave the damaged dose or at any other time, with one exception. The exception is Shingrix (herpes zoster vaccine), which should be repeated at least 28 days later due to the potential for increased side effects due to the chemical adjuvant it contains to enhance its effectiveness. If you prefer, you can perform serologic testing to check for immunity for certain vaccinations (e.g., measles, rubella, hepatitis A, diphtheria, varicella, and tetanus).
July 26, 2023
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. CDC recommends the following best practices.
- 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. A sign is available from Immunize.org at www.immunize.org/catg.d/p2090.pdf.
- Label fuses and circuit breakers to alert people not to turn off power to a storage unit. A label is available from Immunize.org at www.immunize.org/catg.d/p2091.pdf.
- 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.
Include this information as well as what to do if a vaccine storage temperature excursion occurs in your facility’s emergency Standing Operating Procedures.
July 26, 2023