December 15, 2022
Dear Colleagues:
On December 9, the Food and Drug Administration (FDA) granted Emergency Use Authorization to Moderna for the bivalent booster for ages 6 months – 5 years, and Pfizer for use as the third dose in the primary series for 6 months – 4 years of age, but not for use as a bivalent booster. Those ages 5 and up were previously authorized for a Pfizer bivalent booster, and ages 6 and up were previously authorized for a Moderna bivalent booster.
Specifically:
- Children 6 months through 5 years of age who received the original (monovalent) Moderna COVID-19 Vaccine are now eligible to receive a single booster of the updated (bivalent) Moderna COVID-19 Vaccine two months after completing a primary series with the monovalent Moderna COVID-19 Vaccine.
- Children 6 months through 4 years of age who have not yet begun their three-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine or have not yet received the third dose of their primary series will now receive the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine as the third dose in their primary series following two doses of the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine.
- Children 6 months through 4 years of age who have already completed their three-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time. Children in this age group who already completed their primary series would still be expected to have protection against the most serious outcomes from the currently circulating omicron variant.
The Delaware Division of Public Health (DPH) expects supply of these bivalent doses for infants and toddlers to arrive in Delaware this week. As soon as supply is received, physicians may begin administration.
Additional administration notes:
Moderna Bivalent COVID-19 Vaccine
Moderna COVID-19 Vaccine for children 6 months through 5 years of age (dark pink capped vial with yellow-bordered label) is supplied in a 2-dose vial. These are NOT single-dose vials. This could cause confusion for vaccine administrators as no other vaccine is supplied in a 2-dose vial. The dosage/injection volume for each booster dose is 3 µg/0.2 mL. CDC recommends including this message in any provider trainings, e-mails, newsletters, etc. CDC Moderna COVID-19 clinical materials can be found here: Moderna COVID-19 Vaccine | CDC.
If a whole vial of this vaccine is inadvertently administered, it is a vaccine administration error and should be reported to Vaccine Adverse Event Reporting System (VAERS). In addition, providers should determine how the error occurred and put strategies in place to prevent it from happening again. The dose should NOT be repeated as a higher-than-authorized dose (2 times the correct dose) was administered.
Pfizer-BioNTech COVID-19 vaccine for children who age from 4 to 5 years during the primary series
FDA emergency use authorization (EUA) requires children who will turn from age 4 years to 5 years during the Pfizer-BioNTech COVID-19 vaccine primary series to complete the series they start, either the:
- 3-dose primary series recommended for children ages 6 months–4 years or
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Dose 1: Monovalent product for ages 6 months–4 years (maroon cap and label border)
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Dose 2: Monovalent product for ages 6 months–4 years (maroon cap and label border)
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Dose 3: Bivalent product for ages 6 months–4 years (maroon cap and label border)
- 2-dose primary series recommended for children ages 5–11 years
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Dose 1: Monovalent product for ages 5–11 years (orange cap and label border)
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Dose 2: Monovalent product for ages 5–11 years (orange cap and label border)
Because no other dosing options are authorized for this age transition, CDC’s guidance to administer the age-appropriate vaccine product and dosage based on age on the day of vaccination does NOT apply.
Some children aging from 4 to 5 years during the primary series may have already started a primary series before the EUA was amended on December 8, 2022. If these individuals have already received different Pfizer-BioNTech products for Dose 1 (monovalent product for ages 6 months–4 years [maroon cap and label border]) and Dose 2 (monovalent product for ages 5–11 years [orange cap and label border]), they should receive the bivalent product for ages 6 months–4 years (maroon cap and label border) for Dose 3 of the primary series. Even though a child in this scenario will be age 5 years for dose 3, they are NOT authorized to receive the product for ages 5–11 years (orange cap and label border) for dose 3.
