Bivalent COVID-19 Vaccines for Children Aged 6 Months Through 4 or 5 Years

To: Maine Immunization Program Providers

From: Maine Immunization Program

Subject: Bivalent COVID-19 Vaccines for Children Aged 6 Months Through 4 or 5 Years

Date: November 28, 2022

Starting this week, doses of bivalent Pfizer-BioNTech vaccine for children aged 6 months through 4 years and bivalent Moderna vaccine for children aged 6 months through 5 years are available for pre-ordering. Orders may be placed now and will continue through Thursday, December 6, 2022, at 9:00 AM.

Please be advised that although the vaccine is available to order, it cannot be administered until it has received final authorization from the Advisory Committee for Immunization Practices (ACIP).

PFIZER

Expected recommendations – pending authorization:

• Children aged 6 months through 4 years who received two doses of monovalent Pfizer-BioNTech COVID-19 vaccine will be authorized to receive a third dose of bivalent vaccine to complete their primary series.
• Children aged 6 months through 4 years who received three doses of monovalent Pfizer-BioNTech 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.

Storage & Handling:

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

• Ultra-cold freezer storage (-90°C to -60°C) until expiry
• 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 (providers will NOT be able to opt out of receiving ancillary kits)
• Dose 3mcg/0.2mL
• Minimum order quantity of 100 doses
• 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

Expected recommendations – pending authorization:

• Children aged 6 months through 5 years 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 a bivalent Moderna COVID-19 vaccine dose as a booster.
• Children aged 6 months through 5 years 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 a bivalent Moderna COVID-19 vaccine dose as a booster.

Storage & Handling:

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

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

For your facility to be eligible to place a vaccine order, please ensure that the following are up-to-date and complete:

• COVID-19 Vaccine Provider Agreement
• Current ImmPact User Agreement
• Current reconciliation of inventory

Ordering vaccine in ImmPact: The vaccines will be displayed as the following:

If you have any questions, please contact the Maine Immunization Program at (207) 287-3746 or email ImmunizeME.DHHS@maine.gov.

Thank you for your continued efforts to provide COVID-19 vaccine to everyone across the lifespan!