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Wisconsin COVID-19 Vaccine Program |
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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 Updated Bivalent COVID-19 Vaccine Boosters for Pediatric Age Groups
The Wisconsin Department of Health Services (DHS) supports the Centers for Disease Control and Prevention’s (CDC) recommendation children 5-11 years of age are now eligible to receive the updated Pfizer bivalent COVID-19 vaccine booster and that children and adolescents 6-17 years of age are now eligible to receive the updated Moderna bivalent COVID-19 vaccine booster.
On October 12, the Food and Drug Administration (FDA) authorized the emergency use of the updated Pfizer bivalent COVID-19 vaccine booster for children 5-11 years of age and the emergency use of the updated Moderna bivalent COVID-19 vaccine booster for children and adolescents 6-17 years of age.
In a related action, the FDA also removed the Pfizer COVID-19 monovalent (orange cap) vaccine from emergency use authorization as a single booster for children 5-11 years of age. This product is still authorized for use as a primary series.
On October 12, following the FDA action, the CDC director signed a decision memo that the Pfizer and Moderna updated bivalent boosters can be used for these expanded age groups. The CDC also supported the FDA decision to remove the Pfizer COVID-19 monovalent (orange cap) vaccine from emergency use authorization as a single booster for children 5-11 years of age.
With this latest FDA authorization and CDC recommendation, everyone 5 years of age and older is now eligible to receive the updated bivalent COVID-19 vaccine booster.
Pfizer updated bivalent COVID-19 vaccine booster authorized use
For children 5-11 years of age and older receiving a Pfizer bivalent COVID-19 vaccine booster (orange cap), the following are authorized:
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Use as a single booster dose at least 2 months after any primary series, including Pfizer, Moderna, Johnson & Johnson or Novavax.
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Use as a single booster dose at least 2 months after any booster dose, including Pfizer, Moderna or Johnson & Johnson.
Moderna updated bivalent COVID-19 vaccine booster authorized use
For children 6-17 years of age receiving a Moderna bivalent COVID-19 vaccine booster (dark blue cap), the following are authorized:
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Use as a single booster dose at least 2 months after any primary series, including Pfizer, Moderna, Johnson & Johnson or Novavax.
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Use as a single booster dose at least 2 months after any booster dose, including Pfizer, Moderna or Johnson & Johnson.
- The letter to healthcare providers with important prescribing information is available at Moderna DHCP Letter Bivalent 10122022 (fda.gov).
Pfizer updated bivalent COVID-19 vaccine booster volume and dosage
A different vial (orange cap) and presentation is approved for children 5-11 years of age than for people ages 12 years and older (gray cap). The volume and dosage are also different for children 5-11 years of age compared to people ages 12 and older.
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The Pfizer monovalent COVID-19 vaccine will continue to be used for the primary series in children 5-11 years of age. This vaccine has an identical orange cap and orange vial border as the bivalent vaccine for this age group.
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It is important to differentiate between the two vaccine products to ensure children 5-11 years of age receive the appropriate vaccine at the appropriate time.
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The Pfizer bivalent vaccine vial for use as a booster for children 5-11 years of age is labeled “Pfizer-BioNTech COVID-19 Vaccine, Bivalent Original and Omicron BA.4/BA.5.” The Pfizer monovalent vaccine vial for use as a primary series for children 5-11 years of age is labeled “Pfizer-BioNTech COVID-19 Vaccine.”
Moderna updated bivalent COVID-19 vaccine booster volume and dosage
The same Moderna bivalent vaccine vial (dark blue cap) labeled “MODERNA COVID-19 VACCINE, BIVALENT” will be used for both children 6-11 years of age (vaccine vials specifically labeled for the age group 6-11 years of age will not be available) and people ages 12 years and older for Moderna but the volume and dosage differ by age.
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Adolescents 12-17 years of age are administered the same volume and dosage (0.5mL) as previously for adults ages 18 years and older. This means people ages 12 years and older are now to be administered a 0.5mL volume and dosage.
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Children 6-11 years of age are administered half the volume and dosage (0.25mL) as people ages 12 years and older (previously for adults ages 18 years and older).
- The letter to healthcare providers with important prescribing information is available at Moderna DHCP Letter Bivalent 10122022 (fda.gov).
Ordering information and Ancillary Kits
Vaccinators can place orders for the updated Pfizer bivalent COVID-19 vaccine boosters for children 5-11 years of age (orange cap) and for people ages 12 and older (gray cap), as well as the updated Moderna bivalent COVID-19 vaccine booster for children 6-11 years of age (dark blue cap) and for people ages 12 years and older (dark blue cap) by completing the COVID-19 Vaccine Ordering Survey. This is the same process that is used to order all COVID-19 vaccines.
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When ordering the updated Moderna bivalent COVID-19 vaccine booster, vaccinators need to specifically select whether they are ordering it for children 6-11 years of age OR for people ages 12 years and older.
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This is necessary because the updated Moderna bivalent COVID-19 vaccine booster for children 6-11 years of age requires two ancillary kits per minimum dose order to accommodate up to 10 doses per vial as opposed to up to 5 doses per vial for people ages 12 years and older.
Updated bivalent COVID-19 boosters are now the recommended boosters
The FDA has now removed emergency use authorization of the original monovalent mRNA COVID-19 vaccines for individuals 5 years of age and older as booster doses.
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The Pfizer original monovalent COVID-19 vaccine is no longer authorized for individuals 5 years of age and older as a booster dose.
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The Moderna original monovalent COVID-19 vaccine is no longer authorized for individuals 18 years of age and older as a booster dose.
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These original monovalent vaccines continue to be authorized for use for administration of a primary series for individuals 6 months of age and older as described in the EUAs. Please do not waste out your on-hand inventory, as access to primary vaccination remains critical.
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 updated Pfizer and Moderna bivalent COVID-19 vaccine boosters to verify that individuals have received at minimum their COVID-19 primary series vaccination and are receiving the update bivalent boosters as booster doses.
CDC Clinical Considerations
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 Pfizer and Moderna updated bivalent COVID-19 boosters 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 folks 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 folks 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.
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