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Hello Fellow COVID-19 Vaccine Providers,

The Michigan Department of Health and Human Services (MDHHS), Division of Immunization, has received several questions from you, our COVID-19 providers. These questions are related to different aspects of the COVID-19 vaccination program, so to help answer some of these questions, we are sending weekly tip sheets. Below is our tip for week #5.

Week #5 Educational Tip:

Note: This guidance is for COVID-19 providers. If you are both a VFC and COVID-19 provider, you must always follow the guidelines and requirements for VFC storage and handling.

Understanding and monitoring expiration dates:

Determining when a vaccine or diluent expires is an essential step in proper vaccine storage and handling. Administration of expired vaccine remains one of the top vaccine storage and handling errors. It is crucial for staff to understand how to read expiration dates to prevent patients from receiving invalid vaccine doses and to save your practice time and money. Suggestions on monitoring your expiration dates include:

• Video: Storing and Handling Vaccines: Expiration Date, Beyond-use Date, and Beyond-Use Time
• Make sure the correct expiration date is in MCIR, if it is wrong, correct it: How to Correct the Expiration Date in the MCIR
• Rotate stock at least weekly so vaccines with the earliest expiration dates are used first. This helps to avoid having/using expired doses
• Keep vaccine in its original packaging to avoid confusion
• When vaccine expires, check with the manufacturer to make sure the vaccine has not had an expiry extension before wasting
  • Mark vaccine as “DO NOT USE” and store at proper temperatures until you can verify its expiration date. Once the expiration is verified, remove expired vaccine from the storage unit to avoid using non-viable vaccine on patients
  • Dispose of vaccine in accordance with local regulations
  • Report expired vaccine as wastage in MCIR: How To Record No Longer Viable COVID-19 MDV (mcir.org); Create & Submit COVID Return Waste Report in the MCIR
• Before patient use, always check your vaccine and diluent expiration dates prior to, during, and after drawing up vaccine

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, e.g., 1/2023 can be used up to and including 1/31/2023. If a day is included with the month and year, the product may only be used through the end of that day, e.g., 1/19/2023 can only be used until the end of the day on 1/19/2023. Products that have been contaminated or compromised should not be used, regardless of the expiration date.

In some instances, such as when a manufacturer indicates there is a beyond-use date (BUD), vaccines must be used before the expiration date on the label. A BUD may need to be calculated when:

• A vial is first punctured, e.g., Pfizer COVID-19 vaccine must be used within 12 hours of the first puncture
• A vial is moved from one type of storage to another (moved from freezer to refrigerator), e.g., Pfizer must be used within 10 weeks when moved from Ultra-Cold Freezer to the refrigerator
• A vaccine is reconstituted
• A vaccine is drawn up into a syringe
• The maximum number of doses that can be withdrawn from a multidose vial (MDV) has been reached. Once the maximum number of doses are removed, the vial needs to be discarded, even if there is residual vaccine in the vial, e.g., Moderna red cap vial may only be punctured 20 times
• A manufacturer may shorten the expiration date when vaccine is exposed to inappropriate storage conditions (e.g., temperature excursions). The manufacturer might determine that the vaccine can still be used; however, it may expire on an earlier date than the original expiration date (short-dated)

If the vaccine has no BUD, the vaccine should be used by the expiration date indicated by the manufacturer.

Because the BUD replaces the expiration date, it should be noted on a label on the vial, the storage container, or on a log, along with the initials of the person making the calculation. See below for some suggestions on ways to keep track of an expiration date/BUD:

• Orange cap BUD labels: Pfizer-BioNTech COVID-19 Vaccine: 5 Through 11 Years of Age Beyond Use Date/Time (BUD) Tracking Labels for Vaccine During Freezer or Refrigerator Storage (cdc.gov)
• Purple cap BUD labels: Pfizer-BioNTech COVID-19 Vaccine: 12 Years of Age and Older (Purple Cap) • Beyond Use Date/Time (BUD) Tracking Labels for Vaccine During Freezer or Refrigerator Storage (cdc.gov)
• Gray cap BUD labels: Pfizer-BioNTech COVID-19 Vaccine: 12 Years of Age and Older (Gray Cap) Beyond Use Date/Time (BUD) Tracking Labels for Vaccine During Freezer or Refrigerator Storage (cdc.gov)
• Moderna BUD labels: Moderna COVID-19 Vaccine: Beyond Use Date/Time (BUD) Tracking Label for Vaccine During Refrigerator Storage (cdc.gov)
• Janssen (J&J) BUD labels: Janssen COVID-19 Vaccine Storage and Handling Label - Intended for Print Only (cdc.gov)
• COVID-19 Vaccine Expiration Date Tracking Tool (cdc.gov)

Please contact us if you have any questions or concerns at checcimms@michigan.gov.
Thank-you for helping to keep Michiganders safe from the COVID-19 virus,

The Immunization Nurse Education Team
Andrea, Dianne, Heidi, Sarah, and Terri