From the ND Department of Health & Human Services - COVID-19 Vaccine Update: Bivalent (<6) Boosters

Today, the U.S. Food and Drug Administration amended the Emergency Use Authorizations (EUA’s) of the Moderna and Pfizer COVID-19 vaccine to authorize the use of bivalent COVID-19 formulations for pediatric populations. CDC has not yet issued their recommendation. We expect this recommendation to be issued within the next few days.

The Moderna Bivalent COVID-19 Vaccine is authorized for use as a single booster dose in individuals 6 months of age through 5 years of age and at least 2 months following the completion of a primary series with monovalent Moderna vaccine.

The Bivalent Pediatric Pfizer-BioNTech COVID-19 Vaccine is authorized for use as the 3rd dose in the Pfizer (<5) primary series in individuals 6 months through 4 years of age. With today’s authorization, the monovalent mRNA Pfizer (<5) COVID-19 vaccine is no longer authorized as the third dose in the primary series for individuals 5 years of age and younger. Children 6 months through 4 years of age who have already completed their three-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time. 

Providers are now able to order this product using our normal COVID-19 vaccine ordering channels. Deliveries to providers will be dependent upon receipt of product by NDHHS warehouse.”

• Before ordering 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?

 

Pfizer-BioNTech Bivalent (6 months- 4 years) COVID-19 Vaccine

• Age Indication: 6 months – 4 years
• Interval: Used as third dose in Primary Series (8 weeks after 2nd monovalent dose)
• Doses Per Vial: 10 doses
• Diluent required: 2.2mL
• Injection Volume: 0.2mL
• Minimum Package Quantity: 100 doses (ND HHS 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
• Beyond use time: 12 hours after first puncture
• Expiration: No expiration printed on the vial or carton
• NDIIS name: COVID19 PFR bivalent <5
• CVX: 302
• NDC: 59267-0609-02
• Pfizer HCW Bivalent Booster EUA
• Pfizer Public EUA

Moderna Bivalent COVID-19 Vaccine

• Age indication: 6 months – 5 years
• Interval: at least 2 months after receipt of primary series
• Injection Volume: 0.2mL
• Doses Per Vial: 2 doses
• Minimum Package Quantity: 100 doses (ND HHS 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
• Beyond use time: 8 hours after puncture
• Expiration: No expiration printed on the vial or carton
• NDIIS name: COVID19 MOD bivalent <6
• CVX: 230
• NDC: 80777-0283-99
• Moderna HCW Bivalent Booster EUA
• Moderna Public EUA