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Hello Immunization Partners,
On August 31, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUAs) for the Moderna and Pfizer-BioNTech COVID-19 vaccines. This amendment authorized bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The updated COVID-19 boosters include components of the original virus strain and the Omicron variant. This is called a bivalent COVID-19 vaccine.
The revised Emergency Use Authorization Fact Sheets for Moderna and Pfizer-BioNTech can be found here:
Pfizer-BioNTech:
Moderna:
On September 2, 2022, the Centers for Disease Control and Prevention (CDC) issued updates to their Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. The updates include guidance on the new bivalent booster recommendation for people ages 12 years and older, updated guidance for observation periods following COVID-19 vaccination and updated guidance on COVID-19 vaccination and multisystem inflammatory syndrome (MIS) in children (MIS-C) and in adults (MIS-A). For detailed clinical guidance, please refer to the clinical considerations.
Bivalent mRNA COVID-19 Booster Dose
People ages 12 years and older are recommended to receive 1 age-appropriate bivalent mRNA booster dose at least 2 months after completion of any FDA-approved or FDA-authorized monovalent primary series or previously received monovalent booster dose(s). This new booster recommendation replaces all prior booster recommendations for this age group.
- Monovalent mRNA vaccines are no longer authorized as a booster dose for people ages 12 years and older. However, monovalent mRNA vaccines are still authorized for primary series vaccination.
Information Regarding Children 5 through 11 Years of Age
The monovalent Pfizer-BioNTech (maroon cap vial with maroon-bordered label) is still authorized for a booster dose in persons 5 through 11 years of age who have completed a Pfizer-BioNTech primary series.
- Currently a booster dose using any COVID-19 vaccine is not authorized for children 5 through 11 years of age who received Moderna as a primary series or for children 6 months through 4 years of age.
Moderna bivalent booster dose is authorized for use in persons 18 years and older
Pfizer-BioNTech bivalent booster dose is authorized for use in persons 12 years and older
Please see CDC’s At-A-Glance COVID-19 Vaccination Schedules (cdc.gov) for a detailed look at the updated COVID-19 schedule.
Please see CDC’s Interim COVID-19 Immunization Schedule for Persons 6 months of Age and Older for a detailed look at the use of monovalent COVID-19 vaccines and bivalent COVID-19 boosters, along with the schedule for primary series and for the booster dose.
Bivalent COVID-19 Vaccine Storage and Handling:
Pfizer-BioNTech Bivalent COVID-19 Vaccine:
- Ultra-cold freezer storage -130°F to -76°F (-90°C to -60°C) until expiry
- No Standard Freezer Storage
- Refrigerate 35°F to 46°F (2°C to 8°C) up to 10 weeks without puncturing
Moderna Bivalent COVID-19 Vaccine:
- No Ultra-Cold Freezer Storage
- Freezer storage -58°F to 5°F (-50°C to -15°C) until expiry
- Refrigerate 35°F to 46°F (2°C to 8°C) up to 30 days without puncturing
Pfizer-BioNTech bivalent COVID-19 vaccine is expected to be packaged in 6-dose vials in cartons of 10 vials each (60 doses total), with a minimum order quantity of 300 doses. Moderna bivalent vaccine will be packaged in 5-dose vials in cartons of 10 vials each (50 doses total), with a minimum order quantity of 100 doses. Once punctured, each vial must be used within 12 hours. Similar to existing Moderna and Pfizer-BioNTech (gray cap) products, vials must be discarded less than or equal to 12 hours after the first puncture. Ancillary supplies will be provided, including a variety of 1-inch and 1.5-inch needles and syringes. An ancillary opt-out continues to be available for all non-diluent kits.
MDHHS is currently in the process of updating our Pfizer and Moderna vaccine resource guides. In addition, we are expecting updated CDC guidance documents (e.g., storage and handling summary, preparation, and administration summary, and standing orders). Once these are updated and available, we will be sure to share them with you.
Resources:
Clinical Guidance for COVID-19 Vaccination | CDC
At-A-Glance COVID-19 Vaccination Schedules (cdc.gov)
Stay Up to Date with COVID-19 Vaccines Including Boosters | CDC
Thank you for your continued efforts in helping to protect Michiganders from COVID-19!
The Immunization Nurse Education Team,
Andrea, Dianne, Heidi, Lisa, Sarah, and Terri
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