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Minnesota Department of Health
September 2, 2022
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.
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.
 
- 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.
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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.
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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.
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.
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