DHS Supports FDA Authorization, CDC Recommendation for Updated Bivalent COVID-19 Vaccine Boosters for Individuals 12 Years of Age and Older
The Wisconsin Department of Health Services (DHS) supports the Centers for Disease Control and Prevention’s (CDC) recommendation individuals 12 years of age and older are now eligible to receive the updated Pfizer bivalent COVID-19 vaccine booster and that adults 18 years of age and older are now eligible to receive the updated Moderna bivalent COVID-19 vaccine booster.
After successful clinical trials and a rigorous review of all available data, the Food and Drug Administration (FDA) authorized on August 31 the emergency use of the updated Pfizer bivalent COVID-19 vaccine booster for individuals 12 years of age and the emergency use of the updated Moderna bivalent COVID-19 vaccine booster for individuals 18 years of age and older.
On September 1, the CDC’s Advisory Committee on Immunization Practices’ (ACIP) members recommended the updated Pfizer bivalent COVID-19 vaccine booster for individuals 12 years of age and older and the updated Moderna bivalent COVID-19 vaccine booster for individuals 18 years of age and older.
Later the same day, CDC Director Dr. Rochelle Walensky fully endorsed ACIP’s recommendations.
Pfizer bivalent COVID-19 vaccine booster authorized use
For people 12 years of age and older receiving a Pfizer bivalent COVID-19 vaccine booster, the following are authorized:
- Use as a single booster dose at least 2 months after any primary series, including Pfizer, Moderna, Johnson & Johnson or Novavax.
- Use as a single booster dose at least 2 months after any booster dose, including Pfizer, Moderna or Johnson & Johnson.
Moderna bivalent COVID-19 vaccine booster authorized use
For people 18 years of age and older receiving a Moderna bivalent COVID-19 vaccine booster, the following are authorized:
- Use as a single booster dose at least 2 months after any primary series, including Pfizer, Moderna, Johnson & Johnson or Novavax.
- Use as a single booster dose at least 2 months after any booster dose, including Pfizer, Moderna or Johnson & Johnson.
Updated bivalent COVID-19 boosters are now the recommended boosters
The FDA has removed emergency use authorization of the original monovalent mRNA COVID-19 vaccines for individuals 12 years of age and older.
- The Pfizer original monovalent COVID-19 vaccine is no longer authorized for individuals 12 years of age and older as a booster dose.
- The Moderna original monovalent COVID-19 vaccine is no longer authorized for individuals 18 years of age and older as a booster dose.
- 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 letters of authorization.
- Currently, the original monovalent Pfizer-BioNTech COVID-19 vaccine remains authorized for administration of a single booster dose for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine.
- Given this FDA action, FDA has advised that appointments for original monovalent Pfizer or Moderna boosters in people 12 years of age and older must be rescheduled for when locations have the updated COVID-19 bivalent vaccines available.
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.
Ordering information
Vaccinators can place orders for the updated Pfizer bivalent COVID-19 vaccine booster (12 years and older, gray cap) and the updated Moderna bivalent COVID-19 vaccine booster (18 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. These two new vaccines are shipping during the next few weeks and are expected to be available for vaccinations over the next several weeks.
DHS Recommends
Booster for individuals 12 years of age and older
- Updated Pfizer bivalent booster vaccine: A single dose booster administered at least 2 months after any primary series vaccination or prior booster dose.
Booster for adults 18 years of age and older
CDC Clinical Considerations and MMWR
The updated CDC Interim Clinical Considerations were released on September 2 and the MMWR is anticipated to be published soon.
Updated Emergency Use Authorization Fact Sheets
Previews of the bivalent booster vaccine packages and labels
Immunization Policy and Procedure Manual
The Immunization Program Policy and Procedure (P&P) Manual was updated on September 7. Local Health Departments (LHDs) can administer the Pfizer and Moderna updated bivalent COVID-19 boosters to the individuals detailed above per the Immunization Program P&P Manual. 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.
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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