Please note, all eligibility and product information is subject to change pending FDA and CDC action. Please refer to CDC's Operational Guidance for more information on anticipated eligibility and product information.
It is possible that in the next few weeks FDA will authorize and CDC will recommend bivalent COVID-19 vaccines as third doses for infants and toddlers, including the third dose in the Pfizer initial series and the first booster dose of Moderna vaccine.
Because Moderna might be authorized as a booster dose and Pfizer as part of the primary series, mixing brands might not be authorized for these third doses.
Pfizer Bivalent Third Dose
- Eligibility:
- For those 6 months - 4 years that have received two doses of the Pfizer monovalent COVID-19 vaccine.
- It is possible that infants/toddlers who received three Pfizer monovalent doses will be considered as having completed their primary series and ineligible to receive an additional bivalent dose.
- Vaccine Product Information:
- 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)
- Packaged in 10-dose vials in cartons of 10 vials each (100 doses total)
- Dose 3mcg/0.2mL
- The minimum quantity for pre-orders is 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 Bivalent Booster
- Eligibility:
- For those 6 months - 5 years that have received two doses of the Moderna monovalent COVID-19 vaccine.
- Vaccine Product Information:
- 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)
- Packaged in 2-dose vials in cartons of 10 vials each (20 doses total)
- Dose 10mcg/0.2mL
- The minimum quantity for pre-orders is 100 doses
- Vial with dark pink cap and yellow border on the label
- Once punctured, each vial must be used within 8 hours
Allocations and Pre-Orders
Prior to a potential EUA, there will be a limited pre-ordering period, allowing vaccines to be shipped immediately following EUA. CDC has provided allocations for Pfizer and Moderna pre-orders.
- myCAvax pre-ordering window for LHJs/MCEs/Providers is now open through Friday, December 2 by 5PM.
- Pre-orders will be transmitted to CDC on Monday, December 5, by 3PM.
- Doses that are pre-ordered will begin being processed for delivery following EUA. Expected delivery information is not yet available as it will depend on the EUA.
- Routine ordering for the new products and the small orders timeline [Pfizer only through the TPR (AmerisourceBergen)] will be shared once we receive more information. The regular order cadence will continue for existing approved COVID-19 vaccine products.
- Please see the pre-ordering calendar below for more information.
