COVID-19 Commercialization Transition Update

Dear Immunization Partners,

Please review the following COVID-19 vaccine update on the transition to commercialized vaccine and upcoming ordering process changes.

COMMERCIALIZATION TRANSITION ORDERING CHANGE

• On June 15, 2023, independent experts on the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to publicly discuss whether a change to the current vaccine strain composition of COVID-19 vaccines is necessary for the 2023-2024 fall/winter season. The VRBPAC voted to update the vaccine composition, and FDA subsequently advised those manufacturers planning to offer COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition. The anticipated availability of such vaccines is mid to late September 2023. These vaccines will be the first COVID-19 vaccines to be available directly from the manufacturers as part of the commercial market, rather than through the United States Government (USG).
• In anticipation of COVID-19 vaccines transition to the commercial market, the US Government will end distribution of COVID-19 vaccines through the current ordering system beginning August 3, 2023.
• While the transition to commercialization is not anticipated to begin until later this fall, the ending of the current ordering process will allow for vaccine in the field to be used prior to the transition to a commercial product(s)/new formulation.
• New orders can be placed through August 3, 2023 at 9am. Providers are encouraged to place new orders only if their current supply is unable to support their current administration rates through the anticipated arrival of the commercial product(s)/new formulation in late September.
• In the event a provider needs to place an order following the ordering deadline of August 3, 2023, please contact CHECCImms@michigan.gov with your VFC PIN, product name, NDC Code, and requested amount. Out-of-cycle orders will be reviewed on a case by case basis. 
• To prepare for this transition and to ensure vaccine coverage across the state, MDHHS is requesting that all COVID-19 Vaccine Providers complete a physical inventory count and balance MCIR inventories by August 2, 2023 EOD.
• For information on printing a physical inventory report and balancing your inventory, please review the Vaccine Inventory Module of the MCIR User Guide.
• As a reminder, providers are still required to report inventory in Vaccine Finder in addition to MCIR. Vaccine Finder inventory should be reported weekly by EOD on Fridays.
• MDHHS encourages providers to review administration data in MCIR to ensure adequate supply and to determine if orders need to be placed prior to the ending of the current ordering process on August 3, 2023.
• To review administration data in MCIR:
• Under Reports, select Vaccine.
• Select Doses Admin Report and enter a date range (recommended range May 1 – June 30, 2023). Change Vaccine Purchase Type to All and Submit.
• Return to the main page and select Retrieve Results to download the report.

COMMERCIALIZATION UPDATE FOR UNINSURED AND UNDERINSURED INDIVIDUALS

• CDC will continue to provide access to COVID-19 vaccines for uninsured individuals once vaccine becomes commercially available. 
• Uninsured and underinsured children will be able to receive COVID-19 vaccines through the existing Vaccines for Children (VFC) program.
• This program helps provide routinely recommended vaccines to children whose parents or guardians may not be able to afford them. Children eligible for VFC include those who are younger than 19 years of age and are Medicaid-eligible, uninsured, or underinsured with respect to vaccination (when served at Federally Qualified Health Centers or Rural Health Clinics) or are American Indian or Alaska Native.
• CDC VFC Program Information
• MDHHS VFC Program Information
• Uninsured adults will be able to receive COVID-19 vaccines through a new temporary program called the Bridge Access Program for COVID-19 Vaccines and Treatments. This program consists of two components:
• The first component utilizes existing public health infrastructure including state immunization programs, local health departments, and HRSA-supported health centers to provide COVID-19 vaccines to uninsured or underinsured (with respect to vaccination) adults.
• The second component will be implemented through contracts with pharmacy chains that will enable them to continue offering free COVID-19 vaccinations to the uninsured through their network or retail locations as has been done during the COVID-19 public health emergency. More information about the Bridge Access Program for COVID-19 Vaccines and Treatments can be found online at: Fact Sheet: HHS Announces ‘Bridge Access Program For COVID-19 Vaccines and Treatments’ to Maintain Access to COVID-19 Care for the Uninsured.

INVENTORY AND DISPOSAL MANAGEMENT

• The US Government will end distribution of COVID-19 vaccines through the current ordering system beginning August 3, 2023. Providers should maintain their inventories of EUA and/or BLA vaccines until the vaccine exceeds its shelf life, or the FDA announces a change to EUAs and/or BLAs, whichever occurs first.
• 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.
• Providers should maintain inventory of ancillary kits to continue administration of vaccinations to anyone who is eligible and wants an authorized vaccination. Providers are reminded that they can opt out of receipt of COVID-19 Ancillary Kits for certain vaccine products in MCIR.
• The expiration date printed on the exterior box of the ancillary kit does not apply to all the items contained in the kit. The expiration date found on the external label is based on the earliest expiration of any of the kit components. Providers should dispose of expired components in accordance with local, state, and federal requirements. Unexpired ancillary kits or items contained within can be shared domestically, at no charge, with other immunization programs within the practice, clinics and other sites offering healthcare services, or veterinary clinics. Ancillary kits cannot be donated outside of the U.S. or to organizations that will use the supplies outside the U.S.

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.

For assistance with MCIR, please contact your MCIR Regional Office.

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

Thank you,

Oakland County Health Division, Immunization Action Plan