CDC Simplifies COVID-19 Vaccine Recommendations

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.

On Tuesday, April 18^th  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. On Wednesday, April 19^th, following the CDC Advisory Committee on Immunizations Practices (ACIP) meeting, CDC endorsed the FDA amendment to simplify COVID-19 mRNA vaccination schedules.

These changes include:

• CDC’s new recommendations allow an additional updated (bivalent) vaccine dose for adults ages 65 years and older and additional doses for people who are immunocompromised. This allows more flexibility for healthcare providers to administer additional doses to immunocompromised patients as needed.
• Monovalent (original) mRNA COVID-19 vaccines are no longer recommended for use in the United States.
• CDC recommends that everyone ages 6 years and older receive an updated (bivalent) mRNA COVID-19 vaccine, regardless of whether they previously completed their (monovalent) primary series.
• Individuals ages 6 years and older who have already received an updated mRNA vaccine do not need to take any action unless they are 65 years or older or immunocompromised.
• For young children, multiple doses continue to be recommended and will vary by age, vaccine, and which vaccines were previously received.

Alternatives to mRNA COVID-19 vaccines remain available for people who cannot or will not receive an mRNA vaccine. CDC’s recommendations for use of (monovalent) Novavax or Johnson & Johnson’s Janssen COVID-19 vaccines were not affected by the changes made today.

CDC, ACIP, and MDHHS will continue to monitor COVID-19 disease levels and vaccine effectiveness in the months ahead and look forward to additional discussion around potential updates this fall.

MDHHS will send out further information regarding these changes once updated clinical guidance has been released by CDC. Until that time, please review FDA guidance and the respective EUAs for Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines, or visit CDC’s Stay Up To Date webpage for more details. EUAs for Novavax and J&J are unaffected by this change.

MONOVALENT VACCINE ORDERING

• The monovalent Moderna and Pfizer COVID-19 vaccines are NO LONGER RECOMMENDED for use. Due to these changes, all monovalent COVID-19 products have been disabled for ordering and will no longer be available. 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

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,
Division of Immunization