IMPORTANT: CDC Expands the COVID-19 Bivalent Vaccine to Include Children Ages 6 Months through 5 Years (edited from MDHHS email)

Oakland County, Michigan sent this bulletin at 12/13/2022 10:01 AM EST

This email is being sent to VFC, Non-VFC and Covid-19 Providers in Oakland County, Michigan by the Oakland County Health Division (OCHD) Immunization Action Plan (IAP)

Dear Immunization Providers,

Please share the following information with your staff.

Following FDA action, CDC expanded the use of bivalent COVID-19 vaccines for children ages 6 months through 5 years. Most children in this age group have not received any doses of a COVID-19 vaccine. CDC is working to increase parent and provider confidence in COVID-19 vaccines and improve uptake among the 95% of children who are not vaccinated or who have not completed the COVID-19 vaccine primary series. Please discuss immunization status with parents/guardians and ensure their child(ren) are up to date with COVID-19 and other vaccines. Michiganders can reach out to their doctor, nurse, local pharmacy, or health department, or visit vaccines.gov for additional information and to schedule an appointment. Co-administration of COVID-19 bivalent vaccine with other vaccines, such as flu, is strongly encouraged at the same visit.

Updated COVID-19 vaccines are formulated to protect against some of the more recently circulating variants. Most importantly, COVID-19 vaccines are critical to providing ongoing protection as immunity wanes and the virus continues to mutate.

COVID-19 vaccines have undergone—and will continue to undergo—the most intensive safety monitoring in U.S. history. Parents/guardians can play an active role in monitoring the safety of these vaccines by signing themselves and their children up for v-safe – personalized and confidential health check-ins via text messages and web surveys where they can easily share with CDC how they feel after getting a COVID-19 vaccine. 

Distribution and shipping of bivalent vaccines (Pfizer-BioNTech and Moderna) for those 6 months through 5 years is expected to begin as early as Monday, December 12 across the country and in Michigan. The vaccines will be available at thousands of provider practices, pharmacies, Federally Qualified Health Centers (FQHC), local health departments, clinics, and other locations next week. At this time, pre-booking thresholds have been met, but additional ordering opportunities are expected to open this week to all COVID-19 providers.

Details for Bivalent COVID-19 vaccines for children ages 6 months through 5 years:

Pfizer-BioNTech:

  • Children ages 6 months through 4 years who have had 2 doses of Pfizer monovalent primary series will receive a Pfizer bivalent vaccine as their third primary dose.  Children who have already completed a Pfizer-BioNTech 3-dose monovalent primary series are not recommended at this time for a bivalent COVID-19 vaccine.
  • Bivalent (maroon cap with maroon label) NOTE: the following language printed on the vial and carton will be the ONLY differentiation of the bivalent vaccine from the monovalent vaccine for this age group.“Pfizer-BioNTech COVID-19 Vaccine, Bivalent, Original and Omicron BA.4/BA.5, Dilute Prior to Use, Age 6m to <5y”
    • 10 doses per vial with dilution
    • Dosage/injection volume for each booster is 0.2 mL vaccine with 2.2 mL of dilution

Moderna:

  • Children ages 6 months through 5 years who previously completed a Moderna primary series are eligible to receive a Moderna bivalent booster 2 months after their final primary series dose.
    • Bivalent (dark pink cap with yellow-bordered label)
    • 2 doses per vial, no dilution
    • Dosage/injection volume for each booster dose is 0.2mL

Pfizer/Moderna Note: Children ages 5 years or older who complete a Moderna primary series may receive either the previously authorized bivalent Pfizer-BioNTech booster dose or the newly authorized bivalent Moderna booster dose at least 2 months after completion of the Moderna primary series. If under 5 with a completed Moderna primary series, children are recommended to receive a bivalent Moderna booster.

Important Note: Please continue to check all monovalent COVID-19 vaccine for shelf-life extensions. Monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines may be used in primary series administration and several products (including bivalent) were recently granted additional shelf-life extensions.

Below is a list of resources related to the recommendations. CDC updated the Interim Clinical Considerations on December 9, 2022. Further guidance from MDHHS regarding the updated clinical consideration will be shared during the week of December 12, 2022.

You can find these and other COVID-19 vaccine information on the Michigan Department of Health and Human Services (MDHHS) website at COVID-19 Vaccine Provider Guidance and Educational Resources (michigan.gov).

Thank you for helping to protect Michiganders from vaccine preventable diseases.

Oakland County Health Division, Immunization Action Plan