Bivalent COVID-19 Vaccines Authorized for Use in Children
6 months - 4/5 years
The FDA has issued an EUA (emergency use authorization) for both a Moderna COVID-19 bivalent booster (for ages 6 months through 5 years) and a Pfizer-BioNTech bivalent vaccine (for ages 6 months - 4 years).
Please review the COVID-19 vaccine EUA fact sheets for the most up-to-date information on each vaccine.
Moderna Bivalent Booster (6 months - 5 years)
The Moderna Bivalent Booster (ages 6 months through 5 years) (NDC 80777-0283-99) is available to order in ASIIS. This product has a dark pink cap with a yellow border on the label. Each vial contains 2 doses (0.2 mL dose size).
This product follows similar storage guidelines as the Moderna products we are used to. However, there are a couple important differences to this product:
- Thaw in refrigerated conditions (between 2.0*C - 8.0*C) for 45 minutes
OR
- Thaw at room temperature between 15.0*C - 25.0*C for 15 minutes
- Once punctured the vial MUST be used within 8 hours
This product should be administered as a single booster dose to patients at least 2 months after the patient has completed primary vaccination.
Pfizer-BioNTech Bivalent (Maroon Cap) (6 months - 4 years)
The Pfizer-BioNTech Bivalent (ages 6 months through 4 years) (NDC 59267-0609-02) is available to order in ASIIS. This product looks identical to the Pfizer maroon cap product authorized for use as the first 2 doses in the primary series in ages 6 months through 4 years. Please ensure you are double-checking the NDCs and packaging labels prior to administration. Each vial contains 10 doses and each vial requires 2.2 mL diluent (0.2 mL dose size).
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This product follows the same storage guidelines as the Pfizer maroon cap product we are used to. This product should only be administered as the THIRD dose to patients as part of their primary series. This product should be administered as a single dose, 8 weeks after the patient receives the second dose of the monovalent age-appropriate Pfizer product. This product has NOT been authorized as a booster dose. Patients who have already received 3 doses of the Pfizer monovalent primary series (maroon cap) are not eligible at this time for an additional dose.
Additionally, the monovalent Pfizer-BioNTech COVID-19 vaccine (maroon cap) is no longer authorized for use as the third dose of the three-dose primary series in children 6 months through 4 years of age. The monovalent Pfizer-BioNTech COVID-19 vaccine (maroon cap) does, however, remain authorized for administration as the first two doses of the three-dose primary series in individuals 6 months through 4 years of age.
Resources
COVID-19 Vaccine Presentations Available to Order in ASIIS
Moderna BIVALENT BOOSTER Ages 6 mos - 5 yrs
Moderna FDA EUA for Bivalent Booster
Pfizer-BioNTech’s Monovalent & Bivalent COVID-19 Vaccine (Maroon Cap) Ages 6 mos - 4 yrs
Pfizer-BioNTech FDA EUA for Bivalent Booster
CDC’s Interim Clinical Considerations
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