COVID-19 Vaccine Provider Weekly Updates

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COVID-19 Vaccine Provider Weekly Updates

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Minnesota Department of Health

September 2, 2022

 


Bivalent booster doses authorized by FDA and recommended by ACIP

On Wednesday, Aug. 31, 2022, the Food and Drug Administration (FDA) authorized new bivalent booster doses for both Pfizer and Moderna vaccines. The Pfizer-BioNTech COVID-19 vaccine, bivalent (original and omicron ba.4/ba.5) booster dose is authorized for 12 years of age and older. The Moderna COVID-19 vaccine, bivalent (original and omicron AB.4/BA.5) booster dose is authorized for 18 years and older.

The Advisory Committee on Immunization Practices (ACIP) voted to recommend them on Thursday, Sept. 1, 2022.

The recommendation is for one bivalent booster dose to be given at least 2 months after completing the primary series or any previous booster. Either bivalent booster can be used interchangeably.

The FDA has also revised the emergency use authorization (EUA) of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to remove the use of the monovalent COVID-19 vaccines for booster administration in individuals 12 years of age and older.

For details on CDC’s recommendations and FDA’s authorization, refer to the following media statements: CDC Recommends the First Updated COVID-19 Booster  and Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose.

The EUA fact sheets for healthcare providers and recipients and caregivers have been updated and can be found on FDA’s Comirnaty and Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccines  webpage. MDH will update their materials once CDC updates the Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States with these new recommendations.

 

Bivalent booster dose labels

The new bivalent booster dose labels and vials look very similar to the original vaccine vials. Make sure you differentiate the monovalent and bivalent vaccines to prevent administration errors.  Consider dot stickers, highlighters, separate color bins, etc.

Both manufacturers’ bivalent vaccines have gray label boarder, but different injection volumes.

  • Pfizer 12 years and older vaccine labels for both monovalent and bivalent vials will have identical gray cap/gray label border presentation with only the wording different.
  • Moderna bivalent vaccine will have dark blue cap/gray boarder that looks similar to the monovalent product for ages 6-11.
pfizer labelModerna label

Ordering and shipping timelines for bivalent boosters for people age 12 years and older

  • The pre-order event for Moderna and Pfizer bivalent boosters was closed in the Minnesota Immunization Information Connection (MIIC) on Tuesday, Aug. 30.
  • The next ordering event for bivalent boosters for people 12 years and older will open on Thursday, Sept. 8.
  • Shipping Timelines:
    • McKesson and Pfizer began shipping orders following the EUA with minimal orders being delivered this week.
    • No Pfizer or Moderna vaccine will be delivered on Labor Day Monday, Sept. 5.
    • No Moderna vaccine will be delivered on Tuesday, Sept. 6, following Labor Day.
    • CDC anticipates that approximately 85% of bivalent pre-book orders to be delivered by Tuesday, Sept. 6 with the remainder of doses being delivered throughout the week. Please continue to check your email for shipment confirmations.

 

Temporary pause of ordering for monovalent COVID-19 vaccine for primary series in people age 12 years and older

The MIIC ordering event for monovalent vaccines is temporarily paused for MDH and vaccine providers to evaluate current supply on hand. On Aug. 31 the FDA approved EUA for bivalent mRNA COVID-19 vaccines for people 12 years of age and older as booster doses.

Ordering for monovalent primary series vaccine will reopen Sept. 12 and we ask that you evaluate your current inventory and uptake for primary series doses before ordering more monovalent vaccine. If your site has evaluated your current inventory and need vaccines before Sept. 12, please email health.mdhvaccine@state.mn.us.

Tool for minimizing wastage of monovalent COVID-19 vaccine

An online tool is available for registered COVID-19 providers to help prevent vaccine wastage, facilitate redistribution, and match sites to those who need doses.

Before you place an order for COVID-19 vaccine in MIIC for monovalent COVID-19 vaccine that can be used for primary series only in people 12 years and older, review our online tool Smartsheet: COVID-19 Vaccine Available for Redistribution. Since its public launch, we have been able to prevent the wastage of over 150,000 COVID-19 vaccine doses.

MDH has a contracted courier that can aid in the redistribution of COVID-19 vaccine as needed. Please note, this is also an opportunity to receive vaccine in quantities less than the minimum shipment size.

Providers with excess inventory of COVID-19 vaccine doses that would better serve the community if they were redistributed to other sites should fill out the Vaccine Available Form located on the same webpage. If you have questions regarding this tool, please email health.mdhvaccine@state.mn.us.

 

Pfizer and Moderna bivalent vaccine trainings

Pfizer and Moderna COVID-19 vaccine trainings now include information on their new bivalent vaccine presentations. More information including links to attend educational sessions can be found at Pfizer: Medical Updates & Immunization Site Training for All Healthcare Providers led by Pfizer Vaccines US Medical Affairs and National Educational Webinars: "Moderna COVID-19 Vaccine, Bivalent".  Moderna is also offering daily interactive office hours found at Regional Medical Affairs Office Hours: "Moderna COVID-19 Vaccine, Bivalent".

Find previous bulletins at COVID-19 Vaccine Provider Updates.