This email is being sent to local health officers, tribal health directors, COVID-19 vaccinators, COVID-19 vaccine stakeholders, HERC coordinators, and key DHS staff.
DHS Supports FDA Authorization, CDC Recommendation for Bivalent COVID-19 Vaccine for Children Under 5 Years of Age
The Wisconsin Department of Health Services (DHS) supports the Centers for Disease Control and Prevention’s (CDC) recommendation that children 6 months through 4 years of age are now eligible to receive the bivalent Pfizer COVID-19 vaccine as the third dose as part of their primary series and that children 6 months through 5 years of age are now eligible to receive the bivalent Moderna COVID-19 vaccine as a booster dose after completion of their two-dose primary series.
On December 8, 2022, the Food and Drug Administration (FDA) authorized the emergency use of the bivalent Pfizer COVID-19 vaccine for children 6 months through 4 years of age and the emergency use of the bivalent Moderna COVID-19 vaccine for children 6 months through 5 years of age.
With this latest FDA authorization and CDC recommendation, nearly everyone 6 months of age and older is now eligible to receive the bivalent COVID-19 vaccine.
Bivalent Pfizer COVID-19 vaccine
For children 6 months through 4 years of age receiving a bivalent Pfizer COVID-19 vaccine (maroon cap), the following are authorized, use as a third dose in the three-dose Pfizer primary series at least 2 months after second monovalent Pfizer dose of the Pfizer primary series.
Of note, children who received one dose of monovalent Pfizer COVID-19 vaccine would need to receive a second dose of the monovalent Pfizer COVID-19 vaccine before receiving a dose of bivalent Pfizer COVID-19 vaccine.
Additionally, a bivalent booster is not currently authorized for children ages 6 months through 4 years who have received a Pfizer three-dose primary series.
Bivalent Moderna COVID-19 vaccine
For children 6 months through 5 years of age receiving a bivalent Moderna COVID-19 vaccine (dark pink cap), the following are authorized, use as a single booster dose at least 2 months after a completed monovalent Moderna primary series.
Mix and match use of bivalent Pfizer and Moderna COVID-19 vaccines currently not FDA authorized for this age group
Since the bivalent Pfizer COVID-19 vaccine is authorized as part of the Pfizer pediatric primary series and the bivalent Moderna COVID-19 vaccine is authorized a booster after completion of the monovalent Moderna pediatric primary series, mix-and-match use is not FDA authorized at this time.
However, please note that children 5 years of age who complete a monovalent Moderna COVID-19 primary series may receive either the bivalent Pfizer COVID-19 booster dose or the bivalent Moderna COVID-19 booster dose at least 2 months after completion of the monovalent Moderna COVID-19 primary series.
Bivalent Pfizer COVID-19 vaccine primary series volume and dosage
The bivalent Pfizer vaccine vial (maroon cap) labeled “Pfizer-BioNTech COVID-19 Vaccine, Bivalent” with text directly under it reading “Original and Omicron BA.4/BA.5” will now be used for the third dose of the primary series for children 6 months through 4 years of age. The vaccine vial is further labeled “Age 6m to < 5y.”
There are ten (10) doses per vial and children 6 months through 4 years of age are administered a dose volume of 0.2mL.
Note that the monovalent Pfizer COVID-19 vaccine for children 6 months through 4 years of age that will continue to be used for the first and second doses of the primary series, and the bivalent Pfizer COVID-19 vaccine for children 6 months through 4 years of age that will now be used for the third dose of the primary series are both supplied in multiple dose vials with maroon caps and labels with maroon borders and must be diluted prior to use. It is important to carefully read the labels to differentiate between the vaccines to ensure children 6 months through 4 years of age receive the appropriate vaccine for each primary series dose.
A “Dear Healthcare Provider” letter from Pfizer regarding the “Change in Third Dose of 3-Dose Primary Series” and important prescribing is available on the FDA website.
Bivalent Moderna COVID-19 vaccine booster volume and dosage
The bivalent Moderna vaccine vial (dark pink cap) labeled “Moderna COVID-19 Vaccine, Bivalent” with text directly under it reading “Original and Omicron BA.4/BA.5” will be used for children 6 months through 5 years of age. The vaccine vial is further labeled “BOOSTER DOSES ONLY” with text directly under it reading “Age 6m through 5y.”
There are two (2) doses per vial and children 6 months through 5 years of age are administered a dose volume of 0.2mL. Note that this bivalent Moderna vaccine booster has a shorter shelf life after first puncture (discard after 8 hours) than the current bivalent Moderna booster presentation for people 6 years of age and older (discard after 12 hours).
A “Dear Healthcare Provider” letter from Moderna with important prescribing information is available on the FDA website.
Special Situations for COVID-19 Vaccination of Children and Adolescents: Age Transitions and Interchangeability
CDC has created a fact sheet to address situations where children and adolescents transition from a younger to an older age group during COVID-19 vaccination.
Ordering information
The bivalent Pfizer COVID-19 vaccine for children 6 months through 4 years of age (maroon cap), as well as the bivalent Moderna COVID-19 vaccine for children 6 months through 5 years of age (dark pink cap) are expected to be available for ordering later today. When the vaccines become available, vaccinators can place orders for them by completing the COVID-19 Vaccine Ordering Survey. This is the same process that is used to order all COVID-19 vaccines.
Wisconsin Immunization Registry verification
Vaccinators are encouraged to check the Wisconsin Immunization Registry (WIR) and/or a patient’s CDC vaccination card before administering the bivalent Pfizer and Moderna COVID-19 vaccines to verify that individuals are meeting the authorized uses noted previously.
CDC Clinical Considerations
The updated CDC Interim Clinical Considerations were released on December 9.
Updated Emergency Use Authorization Fact Sheets
Immunization Policy and Procedure Manual
The Immunization Program Policy and Procedure (P&P) Manual will be updated later this week. A reminder that Local Health Departments (LHDs) cannot administer the bivalent Pfizer and Moderna COVID-19 vaccines to the individuals detailed above until the Immunization Program P&P Manual is updated. All other vaccinators can vaccinate in accordance with the updated clinical guidance from CDC.
Staying Up to Date with Vaccines
We ask you to encourage people to stay up to date on all their vaccines, including the COVID-19 vaccine.
It is important for Wisconsinites to stay up to date with COVID-19 vaccines and receive all recommended doses, when eligible. CDC recently streamlined the definition of staying up to date on COVID-19 vaccines.
Primary Series Vaccination
We urge you to continue conversations with people who are not yet vaccinated.
While booster doses are an important step in increasing access to enhanced protection for people across Wisconsin, there remains large populations of people who are unvaccinated and who are at risk of serious illness and death.
We need a strong continued focus on increasing primary vaccination. You can find several resources to support these conversations on the DHS COVID-19 Vaccine Partner and Vaccinator Resources webpage.
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