COVID-19 Vaccine Provider Weekly Updates

Minnesota Department of Health sent this bulletin at 11/29/2022 01:08 PM CST
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COVID-19 Vaccine Provider Weekly Updates

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Minnesota Department of Health

November 29, 2022

 

Bivalent COVID-19 vaccine for children under 6 years old

In the coming weeks, the Food and Drug Administration (FDA) is expected to authorize the bivalent COVID-19 booster for children under 6 years old. It is not anticipated that the Advisory Committee on Immunization Practices (ACIP) will meet, but CDC will make a recommendation following the Emergency Use Authorization (EUA).

The bivalent vaccines for both Pfizer and Moderna will be available for pre-order in MIIC – see details below. Vaccine is expected to ship when the EUAs are published. Sites can begin administering vaccine once the CDC has published the recommendation.

At this time, we expect children in this age group will need to receive two doses of monovalent COVID-19 vaccine before receiving a dose of bivalent COVID-19 vaccine. More details on what is currently expected for each vaccine are below. Mix-and-match use is NOT expected to be authorized.

Like the previous bivalent vaccines, the label and vials look very similar to the original, monovalent vaccine. Make sure the products are separated to prevent administration errors.

Pfizer COVID-19 bivalent vaccine

  • It is expected that children age 6 months through 4 years who received two doses of monovalent Pfizer COVID-19 vaccine will be authorized to receive a third dose of bivalent vaccine to complete their primary series.
  • Children who received one dose of monovalent Pfizer COVID-19 vaccine will need to receive a second dose of monovalent Pfizer COVID-19 vaccine before receiving a dose of bivalent Pfizer COVID-19 vaccine.
  • It is expected that children age 6 months through 4 years who received three doses of monovalent Pfizer COVID-19 vaccine to complete their primary series will NOT be authorized to receive a booster dose of bivalent COVID-19 vaccine at this time.

Expected characteristics of Pfizer bivalent COVID-19 vaccine for children age 6 months through 4 years:

  • Ultra-cold freezer storage (-90°C to -60°C) until it expires. NO FREEZER STORAGE (-25°C to -15°C). Refrigerate (2°C to 8°C) up to 10 weeks without puncturing.
  • Requires 2.2 mL diluent per vial (will NOT be able to opt out of receiving ancillary kits).
  • Packaged in 10-dose vials in cartons of 10 vials each, minimum order 100 doses.
  • Dose 3mcg/0.2mL.
  • Maroon cap identical to the monovalent Pfizer-BioNTech product for this age group, new label identifying the product as a bivalent vaccine (i.e., Original and Omicron BA.4/BA.5).
  • Once punctured, each vial must be used within 12 hours.

Moderna COVID-19 bivalent vaccine

  • It is expected that children age 6 months through 5 years will need to complete their primary series of two doses of monovalent vaccine before being eligible for the Moderna bivalent booster dose. The booster dose in this age group is also half the original vaccine dose.
  • Children who received one dose of monovalent Moderna COVID-19 vaccine will need to receive a second dose of monovalent Moderna COVID-19 vaccine to complete their primary series before receiving bivalent Moderna COVID-19 vaccine as a booster.

Expected characteristics of Moderna bivalent COVID-19 vaccine for children age 6 months through 5 years:

  • NO ULTRA-COLD FREEZER STORAGE (-90°C to -60°C); Freezer storage (-50°C to -15°C) until it expires. Refrigerate (2°C to 8°C) up to 30 days without puncturing.
  • Does not require diluent (will be able to opt out of receiving ancillary kits).
  • Packaged in 2-dose vials in cartons of 10 vials each, minimum order 100 doses.
  • Dose 10mcg/0.2mL.
  • Vial with dark pink cap and yellow border on the label.
  • Once punctured, each vial must be used within 8 hours.

Pre-ordering event in MIIC

  • The pre-order event for bivalent vaccine boosters for under 6 years will open in MIIC on Wednesday, Nov. 30 and will remain open until Monday, Dec. 5 at 4 p.m.
  • Delivery is expected after the EUA is published. Depending on when the EUA is complete, vaccines may be delivered as early as the week of Dec. 12. We will share updates on confirmed delivery dates.
  • After the EUA is issued, we encourage sites to plan for a pause on third dose administration of the Pfizer monovalent vaccine for children age 5 years and younger until sites are ready to give the bivalent third dose for this age group.

Considerations for pre-orders

  • The Pfizer bivalent vaccine is only for the third dose of the primary series given after two doses of monovalent vaccine.
  • The Moderna bivalent vaccine is for a booster only after a complete primary series of the monovalent vaccine.
  • Do not over-order during this pre-order opportunity. There will be more opportunities to order vaccine.
  • Consider ordering a small amount to have on hand for the first two weeks after the recommendation, then assess your practice's demand and order more. Order fewer doses if you will not begin vaccinating until the second week.
  • Pre-orders cannot be modified once we have submitted them to CDC.
  • You must be enrolled in the COVID-19 vaccine program to order COVID-19 vaccine. For details on how to enroll, refer to COVID-19 Vaccine Provider Registration.

Please contact health.mdhvaccine@state.mn.us with questions.

Preventing COVID-19 vaccine errors

With multiple formulations of COVID-19 vaccine in use and the similarities of labels and cap colors, make sure you differentiate each formulation to prevent administration errors. Consider dot stickers, highlighters, colored rubber bands, separate color bins, etc. to distinguish between each vaccine.

Use the following Pfizer and Moderna Wall Charts for a quick view of each of the formulations:

All staff who administer vaccines need competency-based education and training prior to administering vaccine. To lessen the chance of an error, ensure that the seven rights of vaccine administration have been performed:

  1. Right patient
  2. Right time
  3. Right vaccine or diluent
  4. Right dosage
  5. Right route, needle length, and technique
  6. Right site
  7. Right documentation

If a vaccine error does occur refer to: CDC: Interim Clinical Considerations for Use of COVID-19 Vaccines: Appendix D. Vaccine administration errors and deviations.

Consider offering only one brand of COVID-19 vaccine

With the increase in products including bivalent vaccine for all age groups, COVID-19 vaccination has become more and more complex. This can lead to increased staff time, storage space, vaccine administration errors, and wastage. Provider sites are encouraged to offer Pfizer or Moderna vaccine, but not both. It is helpful to be aware of other providers in your area that offer the alternate brand if you have people who only want a specific product. 

Find previous bulletins at COVID-19 Vaccine Provider Updates.