Maine Department of Health & Human Services sent this bulletin at 09/29/2022 11:10 AM EDT
To: Maine Immunization Program Providers
From: Maine Immunization Program
Subject: Pediatric Bivalent COVID-19 Vaccine
Date: September 29, 2022
If authorized by FDA, CDC anticipates a recommendation for bivalent COVID-19 vaccine as a booster for pediatric age groups in early to mid-October. Bivalent products expected to be under consideration include the bivalent Pfizer-BioNTech vaccine for children aged 5-11 years and bivalent Moderna vaccine in children aged 6-17 years, for those individuals who have already received their primary vaccine series.
Providers may now begin placing orders within ImmPact for the Pfizer-BioNTech bivalent COVID-19 vaccine for children 5-11 years of age.
The current Moderna bivalent presentation will be used for all age groups (6 years and older), however the volume and dosage is expected to differ by age as noted in more detail below.
Please be advised that although the bivalent COVID-19 vaccines may be ordered; vaccine administration can only begin following the official CDC recommendation.
The new bivalent COVID-19 vaccines will have the same storage and handling parameters as the original vaccine products:
Pfizer-BioNTech
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
Packaged in 10-dose vials in cartons of 10 vials each (100 doses total)
Requires diluent (note: providers will not be able to opt out of receiving ancillary kits)
This product is also expected to have the following characteristics:
Vial with an orange cap similar to the existing Pfizer-BioNTech product for this age group, but with a label that identifies it as a bivalent booster
Once punctured, each vial must be used within 12 hours.
Moderna COVID-19 Vaccine
NO ULTRA-COLD FREEZER STORAGE
Freezer storage (-50°C to -15°C) until expiry
Refrigerate (2°C to 8°C) up to 30 days without puncturing
Moderna bivalent COVID-19 vaccine is packaged in 5-dose vials in cartons of 10 vials each (50 doses total), with a minimum order quantity of 100 doses
The same vial (dark blue cap, gray border) and presentation for Moderna is expected to be used for all authorized age groups (people aged 6 years and older), but volume and dosage expected to differ by age:
Adolescents aged 12-17 years: same volume and dosage as for adults aged 18 years and older
Children aged 6-11 years: half the volume and dosage as for adults aged 18 years and older (drawn from the same vial). i.e., one vial yields double the number of doses when used for 6–11-year-olds as when used for people aged 12 years and older
Moderna bivalent COVID-19 vaccine does not require diluent
Once punctured, each vial must be used within 12 hours
The bivalent COVID-19 vaccine will be recommended to be administered as a single booster dose to those who previously completed a primary series of COVID-19 vaccine.
The minimum/maximum orders for each presentation will be as follows:
In order 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
Should you have any questions, please contact the Maine Immunization Program at 207-287-3746 or email ImmunizeME.DHHS@maine.gov..
