IMPORTANT: Updated mRNA COVID-19 Vaccine Approved/Authorized by the FDA AND BIVALENT mRNA COVID-19 Vaccines NO LONGER AUTHORIZED

Oakland County, Michigan sent this bulletin at 09/12/2023 12:21 PM EDT

This email is being sent to VFC, Non-VFC and Covid-19 Providers in Oakland County, Michigan by the Oakland County Health Division (OCHD) Immunization Action Plan (IAP)

Dear Immunization Partners,

UPDATED mRNA (MONOVALENT) COVID-19 VACCINE

  • On September 11, 2023, the U.S. Food & Drug Administration (FDA) took action to approve and authorize updated COVID-19 vaccines formulated to more closely target currently circulating variants and provide better protection against serious consequences to COVID-19, including hospitalization and death. These actions relate to the updated mRNA vaccines for 2023-2024 manufactured by Moderna and Pfizer-BioNTech.
  • An important note: Bivalent mRNA (Pfizer-BioNTech or Moderna) COVID-19 vaccines are NO LONGER authorized for use in the United States, per the FDA press release.
  • ACIP and CDC will issue additional guidance (including recommendations for use) Tuesday, September 12 following the ACIP meeting. MDHHS will share this information once it becomes available.
  • As we wait for ordering of the updated 2023-2024 monovalent COVID-19 vaccines to begin, there will be a short period when vaccination with mRNA COVID-19 vaccines will not occur. 
  • We anticipate the updated 2023-2024 vaccine will be available in the near future.
  • At this time, MCIR does not reflect assessment and forecasting for the updated monovalent COVID-19 vaccines, once CDC clinical guidance is shared, MCIR will be programmed to reflect the updated monovalent vaccine.

BIVALENT COVID-19 VACCINE INVENTORY AND DISPOSAL MANAGEMENT

  • The US Government will end distribution of COVID-19 vaccines through the current ordering system beginning September 12, 2023. Because the Bivalent mRNA (Pfizer-BioNTech or Moderna) COVID-19 vaccines are NO LONGER authorized for use in the United States, they should no longer be administered. Providers should maintain their inventories until further guidance is provided.
  • Any vial of vaccine that exceeds the shelf-life indicated by the manufacturer should be disposed in accordance with local regulations and processes currently being used to dispose of regulated medical waste.

Additional information on the transition to commercialized COVID-19 vaccine is forthcoming and will be shared as it becomes available. MDHHS appreciates your patience as we navigate this change.

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

Thank you,

Oakland County Health Division, Immunization Action Plan