Updated bivalent COVID-19 boosters authorized for children 6 months to 5 years old

| December 29, 2022

Earlier this month, U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) expanded emergency use authorization (EUA) of Moderna and Pfizer-BioNTech bivalent vaccines for children 6 months and older.

Updated (bivalent) COVID-19 booster vaccines are formulated to boost immunity against the original coronavirus strain and protect against the newer omicron variant. Updated boosters are critical to provide optimal protection against the virus and address waning vaccine effectiveness over time.

The benefits of vaccinating children far outweigh the risks. The potential for a serious side effect or reaction to the vaccine is far less than the risk of serious outcomes or death from COVID-19 disease. Most children in this age group have not received a COVID-19 vaccine.

What providers need to know

  • Monovalent Pfizer 6mo – 4yr is NO LONGER AUTHORIZED as a 3rd dose in the standard 3-dose primary series.
  • Monovalent Pfizer 6mo – 4yr remains authorized as a 1st and 2nd dose in the standard 3-dose primary series.
  • Bivalent Moderna 6mo – 5yr is now authorized for administration as a booster dose at least 2 months after completion of the monovalent Moderna 6mo – 5yr 2-dose primary vaccine series. 
  • Mixing and Matching of these 6mo-4/5yr Bivalent Vaccines is NOT AUTHORIZED.

Presentations for 6-month and 4-, 5-year old patients

  • 6 months – 5 years old Bivalent Moderna
    • 2 doses per vial
    • Dose: 10mcg/0.2Ml
    • No dilution
    • Follow Moderna’s cold chain (stable at freezer temps until expiration and at refrigerated temps for 30 days)
    • Dark pink cap with yellow border
    • You can find the Bivalent Moderna 6mo – 5yr EUA here.
  • 6 months – 4 years old Bivalent Pfizer
    • 10 doses per vial
    • Dose: 3mcg/0.2mL
    • Dilution necessary
    • Follow Pfizer’s cold chain (stable at UlraCold temps until expiration date and at refrigerated temps for 10 weeks)
    • Maroon cap identical to the monovalent Pfizer-BioNTech for this age group
    • New label identifying the product as a bivalent vaccine (i.e., original and omicron BA.4/BA.5)
    • You can find the Bivalent Pfizer 6mo – 4yr EUA here.

Contacting the Health District’s Immunization Team

If you have any questions, please don’t hesitate to reach out to the Immunization Team through email at immunizations@kitsappublichealth.org or phone at (360) 728-2007. For more urgent matters, please call the main Health District phone number (360) 728-2235.

Additional Resources