From the ND Department of Health - Vaccine Updates

Posted 3 months ago

Bivalent Moderna (18 years and older)

As you know, the Bivalent Moderna COVID-19 product has been unavailable for order in North Dakota due to supply chain delays. North Dakota has received a new allocation of this product (5,500 doses). With this new allocation and more expected to be released each week, ordering will now open for this product. Please order this product using the normal COVID-19 ordering process.

Bivalent Booster Doses (5-11 years old)

Bother Moderna and Pfizer plan to apply for an Emergency Use Authorization (EUA) for their Bivalent Booster COVID-19 vaccines for use in children 5-11 years old. This vaccine may be available for use in the United States in early October (~October 10th). Below are some planning assumptions and points to keep in mind as we move through this planning process.

  • It is anticipated that the monovalent (original) COVID-19 vaccines will no longer be authorized as a booster dose in people 5-11 years old after authorization of the bivalent product. Providers should counsel patients on the possibility of delaying their booster dose until the bivalent product is available.
    • It is expected that people who have completed any COVID-19 vaccine primary vaccination or any number of prior COVID-19 vaccine booster doses will be able to receive a bivalent COVID-19 vaccine booster dose, if eligible based on age and interval since last dose.
    • Providers should plan to keep the “original” formulation of COVID-19 on hand in order to administer primary doses to individuals who have not yet completed their primary series.
    • It is also likely that the Moderna bivalent COVID-19 vaccine will be authorized for 12-17 year olds.
  • Pfizer-BioNTech Bivalent (5-11) COVID-19 Vaccine
  • Doses Per Vial: 10 doses
  • Likely will be available for ages 5-11 years.
  • Diluent required: 1.3mL
  • Minimum Package Quantity: 100 doses (NDDoH warehouse will breakdown shipments into smaller quantities)
  • Storage Conditions:
    • Ultra-cold freezer storage (-90°C to -60°C) until expiry
    • NO FREEZER STORAGE
    • Refrigerate (2°C to 8°C) up to 10 weeks without puncturing
  • Moderna Bivalent COVID-19 Vaccine – Same product as the current adult bivalent formation but volume and dosage expected to differ. Providers may not administer adult bivalent product to anyone under the age of 18 at this time.
  • Doses Per Vial: 5 doses adult (0.5mL) doses
  • Likely will be available for ages:
    • 12-17 years: same volume as dosage as for adults
    • 6-11 years: half the volume and dosage as adults
  • Minimum Package Quantity: 100 doses (NDDoH warehouse will breakdown shipments into smaller quantities)
  • Storage Conditions:
    • NO ULTRA-COLD FREEZER STORAGE
    • Freezer storage (-25°C to -15°C) until expiry
    • Refrigerate (2°C to 8°C) up to 30 days without puncturing
  • Providers will not be able to feely order bivalent Pfizer (5-11yo) bivalent boosters at this time. The initial round of allocations will be sent out next week.
    • Allocations will be determined based on historical 5-11 year old vaccine administration.
    • Pre-ordered vaccine will begin being processed for delivery following EUA. Expected delivery dates will be dependent on the actual EUA date.
    • If you are receiving vaccine through the warehouse (less than 300 or 100 doses) this may slightly affect your delivery date.
  • There will be no allocation for Moderna (5-11yo) bivalent doses as the same adult product will be used.
  • Before accepting an allocation please consider the following questions:
    • Can I adequately store this number of vials along with my influenza, adult bivalent and other routine vaccines?
    • Using your previous COVID-19 vaccine uptake to estimate, can I use all of this vaccine within the time allowed in the refrigerator?
    • Do I plan to administer vaccine at community-based mass clinics?
  • There will be a limited number of vaccines available in the initial role out of this vaccine. Similarly to when vaccine was first available in the United States clinics should limit wastage as much as possible and plan to only open a vial if you have a plan for all of the doses.
    • Consider temporarily moving towards a mass vaccination model to limit wastage.
  • Bivalent boosters will be available during influenza vaccination season. Providers should consider offering influenza vaccine and other routinely recommended vaccines along with COVID-19 boosters.

Educational Materials:

Bivalent COVID-19 Bivalent Booster Dose FAQ

Adult COVID-19 Flowchart