• On October 20, 2021, the FDA authorized a booster dose of Moderna COVID-19 under the existing Emergency Use Authorization. In response, Moderna sent a letter to alert vaccination providers that the volume of the booster dose is 0.25mL, which is half the dose provided in the primary series. Other key issues contained in the letter include:
  • Volume of the booster dose is 0.25mL. This is half the dosage recommended in the primary series.
  • Populations eligible for booster vaccine 
    • 65 years of age and older
    • 18 through 64 years of age at high risk of severe COVID-19
    • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
  • Storage and Handling
    • During storage, minimize exposure to room light.
    • The Moderna COVID-19 Vaccine multiple-dose vials are stored frozen between -50° to -15°C (-58° to 5°F). Store in the original carton to protect from light.
    • Do not store on dry ice or below -50°C (-58°F). Use of dry ice may subject vials to temperatures colder than -50°C (-58°F).
    • Vials may be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use.
    • Vials may be stored between 8° to 25°C (46° to 77°F) for a total of 24 hours.
    • After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F). Vials should be discarded 12 hours after the first puncture.
    • A maximum of 20 doses (booster and/or primary doses) may be withdrawn from the vial. Do not puncture the vial stopper more than 20 times. 
    • When 20 doses have been withdrawn, the vial and any residual vaccine should be discarded appropriately.
    • Thawed vials can be handled in room light conditions.
    • Do not refreeze once thawed
  • Vial sizes-The Moderna COVID-19 Vaccine is supplied in two multiple-dose vial presentations:
    • A multiple-dose vial containing 5.5 mL (Moderna 10)
    • A multiple-dose vial containing 7.5 mL (Moderna 14)
  • When extracting only booster doses or a combination of primary series and booster doses, the maximum number of doses that may be extracted from either vial presentation should not exceed 20 doses. Do not puncture the vial stopper more than 20 times.
  • A copy of the letter is attached and may also be found at Moderna COVID-19 Vaccine DHCP Letter-Fact Sheet 10.20.21.pdf.

• On October 21, 2021, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for a booster shot of COVID-19 vaccines in certain populations.
  • CDC has updated its Clinical Considerations to help providers better understand these recommendations.Individual benefit-risk assessment considerations for receiving a booster dose

• The U.S. Food and Drug Administration (FDA) received the recommendation of its independent advisory panel, the Vaccine and Related Biological Products Advisory Committee (VRBPAC), to expand the Emergency Use Authorization (EUA) of the Pfizer-BioNTech C0VID-19 vaccine to include children from the ages of 5 through 11 years.The VRBPAC recommendation and FDA’s coming action on that recommendation are only the first two review steps the vaccine must undergo before it can be administered to children. The next step is for the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) to meet November 2 to discuss the administration of the vaccine to this age group, followed by the final decision by CDC Director Dr. Rochelle Walensky. Only when this process is complete would children ages 5 to 11 years be eligible for vaccination.
  • Click here to view the Full Press Release from Dr. Avula

• Moderna continues to update data regarding extension of expired doses. A total of 78 lots have been approved for extension, but challenges within IT systems have slowed the progress considerably.
  • Moderna vaccine have been processed for expiry extension and provide an additional 2 months of expiry. The product must be maintained in the frozen state for the extension to be applicable (extension does not apply to thawed vials). 
  • Moderna’s look up tool remains the official indicator of product expiry.

• Moderna Inventory and Wastage Tracking
  • Inventory Reporting:
    • Only report unopened product in the refrigerator in whole doses
      • Example: Moderna 14 x 10 unopened vials on the shelf = 140 doses reported through inventory channels
    • Do NOT count opened/punctured products. Do not count half doses or whole doses from opened/punctured product
  • Wastage reporting:
    • Continue to maintain reporting of wastage in whole doses up to 14 doses.
      • Example: Moderna 14 – If 4 doses are administered from a single vial, 10 doses should be  reported as waste through currently existing channels.
    • Do NOT count half doses as waste when reporting.
      • Example- During a full day in a clinic, 1 primary dose is administered and 5 booster half-doses are administered from a Moderna 14 vial.
      • COUNT the total number of doses administered, regardless of volume or series and subtract this from the total number of identified doses in the vial.-  For a Moderna 14 dose vial, a total of 6 people are vaccinated (1 primary and 5 booster shots); 14 - 6 = 8 doses wasted.
    • Vial size – number of vaccines administered = waste

• SSRP Report for Districts & Channels
  • All District and Channel leads can continue to use the SSRP report within the "Districts Reports" tab. There, all SSRP transactions can be searched by provider Vtrcks number. We are currently working to add the District/Channel into the report.

For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

• Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers!

Upcoming Events

• Updated: VDH's Feeling Sick Comparison Chart - On If You're Sick webpage and Resources and Support – Coronavirus page under Exposure and Illness. Updates were made to the frequency of some COVID-19 symptoms
• Updated:  VDH's COVID-19 Vaccination FAQ - Updates were made to questions in the booster doses section
•  Holiday Celebrations - Includes CDC tips for safer ways to celebrate the holidays