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 Permitting Additional Bivalent COVID-19 Booster Dose to Select Individuals, Retirement of Monovalent mRNA Vaccines, and Changes in COVID-19 Vaccination Schedule
The Wisconsin Department of Health Services (DHS) supports the Centers for Disease Control and Prevention’s (CDC) actions that are summarized below:
- Current bivalent vaccines are to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations.
- Previously authorized mRNA COVID-19 monovalent vaccines manufactured by Moderna and Pfizer-BioNTech are no longer authorized for use in the U.S. and should not be administered.
- Individuals 65 years of age and older who have received a single dose of the bivalent vaccine may receive one additional dose at least four months following their initial bivalent dose.
- Most individuals with certain kinds of immunocompromise who have received a bivalent COVID-19 vaccine may receive a single additional dose of a bivalent COVID-19 vaccine at least 2 months following a dose of a bivalent COVID-19 vaccine with additional doses administered at the discretion of, and at intervals determined by, their healthcare provider.
- Most individuals, depending on age, previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a dose of a bivalent vaccine may receive a single dose of a bivalent vaccine.
- Most individuals who have already received a single dose of the bivalent vaccine are not currently eligible for another dose. The FDA intends to make decisions about future vaccination after receiving recommendations on the fall strain composition at an FDA advisory committee in June.
- Most unvaccinated individuals may receive a single dose of a bivalent vaccine, rather than multiple doses of the monovalent vaccines.
- Children 6 months through 5 years of age who are unvaccinated may receive a two-dose series of the Moderna bivalent vaccine (6 months through 5 years of age) OR a three-dose series of the Pfizer-BioNTech bivalent vaccine (6 months through 4 years of age). Children who are 5 years of age may receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.
- Children 6 months through 5 years of age who have received one, two or three doses of a monovalent COVID-19 vaccine may receive a bivalent updated vaccine, but the number of doses that they receive will depend on the vaccine and their vaccination history.
On April 18, the FDA announced the changes and CDC endorsed them on April 19.
With this latest FDA authorization and CDC recommendation, the Pfizer-BioNTech and Moderna COVID-19 bivalent vaccines are the only COVID-19 vaccines authorized under most circumstances. The EUAs for the bivalent vaccines have been amended.
Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
- For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.
Moderna COVID-19 Vaccine Fact Sheets and Materials
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
- For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.
Pfizer-BioNTech COVID-19 Vaccine Fact Sheets and Materials
The Johnson & Johnson/Janssen and Novavax monovalent non-mRNA vaccines will continue to be authorized. Any restrictive language already in place around the use of either of these monovalent vaccines remains. Note that all the remaining Johnson & Johnson/Janssen vaccine doses expire by May 6, 2023. The Novavax vaccine will be available for at least the next several months.
Ordering information
The bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are available for ordering through the COVID-19 Vaccine Ordering Survey.
Disposal and reporting of the monovalent Moderna and monovalent Pfizer-BioNTech vaccines
The monovalent Moderna and monovalent Pfizer-BioNTech vaccines are no longer authorized for use. CDC now recommends the use of bivalent vaccines for all recommended mRNA COVID-19 vaccine dose(s).
To minimize the risk of administration error, vaccinators should:
Wisconsin Immunization Registry verification
Vaccinators are encouraged to check WIR and/or a patient’s CDC vaccination card before administering the bivalent Pfizer and bivalent Moderna COVID-19 vaccines to verify that individuals are meeting the authorized uses noted above.
CDC Clinical Considerations
The updated CDC Interim Clinical Considerations were released on April 22 with specific guidance relating to the COVID-19 vaccination schedule for persons with immunocompromise expected to be available soon.
Immunization Policy and Procedure Manual
The Immunization Program Policy and Procedure (P&P) Manual is in the process of being updated and the updates will be finalized sometime later this week. A reminder that Local Health Departments (LHDs) cannot administer the Pfizer and Moderna updated bivalent 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.
Encouraging Vaccination with the Bivalent Vaccine
We urge you to continue conversations with people who have not received the bivalent vaccine.
Less than 25% of Wisconsinites have received a bivalent COVID-19 vaccine. It is especially important for older people, people with chronic health conditions, people who are pregnant, and young children to get a bivalent vaccine to prevent severe disease.
We need a strong focus on increasing the number of residents that have received the bivalent vaccine. You can find several resources to support these conversations on the DHS COVID-19 Vaccine Partner and Vaccinator Resources webpage.
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