This message was sent to AIM, FAB, Health Systems, INE, IAP, LHD Health Officers, LHD Medical Directors, MACI, MACI 2, PH Imms Leads, MCIR Region Contacts, COVID-19 Vaccine Providers, and Imms All Staff. I apologize for any duplications

Dear Immunization Partners,

Please share the following information with providers in your jurisdiction.

Today, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will be meeting this Wednesday, April 19 from 11:00a.m. – 3:00p.m. ET to discuss updates to the clinical considerations for COVID-19 vaccine and how to proceed moving forward.  

No registration is required to watch these webcasts. To access the webcast link at the above date/time, please visit the Advisory Committee on Immunization Practices (ACIP) | CDC webpage and look for the yellow box on the right-hand side of the page.

After the ACIP meeting, MDHHS will send out further information regarding these upcoming changes. Until MDHHS receives guidance from CDC, please review FDA guidance and the respective EUAs for Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines.

MONOVALENT VACCINE ORDERING

• The monovalent Moderna and Pfizer COVID-19 vaccines are NO LONGER AUTHORIZED for use. Due to these changes, all monovalent COVID-19 products have been disabled for ordering and will no longer be available. EUAs for Novavax and J&J are unaffected by this change.
• Affected NDCs:
  • Pfizer:
    • 59267-0078-04
    • 59267-1000-02
    • 59267-1000-03
    • 59267-1025-03
    • 59267-1025-04
    • 59267-1055-04
  • Moderna:
    • 80777-273-98/15
    • 80777-273-99/10
    • 80777-275-99/05
    • 80777-279-99/05
  • Bivalent COVID-19 vaccines and Novavax will continue to be available. Please note, due to supply issues, Pfizer Under 5 bivalent vaccine may not be available for ordering at all times. Additional information will be distributed as necessary.

Please keep your monovalent mRNA vaccine supply in its current storage conditions until further instructions from CDC are received. 

If you have questions, please contact checcimms@michigan.gov.

Thank you,
MDHHS Division of Immunization