DHS Supports FDA Approval and Authorization, and CDC Recommendation for new 2023-24 COVID-19 Vaccine Formula
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.
The Wisconsin Department of Health Services (DHS) supports the Centers for Disease Control and Prevention’s (CDC) recommendation that:
- Everyone ages 5 years and older is recommended to receive 1 dose of a 2023–2024 mRNA COVID-19 vaccine.
- Children ages 6 months–4 years should complete a multi-dose initial series (2 doses of Moderna or 3 doses of Pfizer-BioNTech mRNA COVID-19 vaccine) with at least one dose of the 2023–2024 COVID-19 vaccine.
More details regarding recommendations for people who are moderately or severely immunocompromised will be included in the CDC Interim Clinical Considerations.
Note that the above recommendations are based upon initial information from the CDC and that the CDC Interim Clinical Considerations have not yet been released. Vaccinators should follow the specific CDC clinical guidance once it is published by the CDC.
On September 11, the U.S. Food and Drug Administration (FDA) took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death.
FDA’s actions related to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.
On September 12, the CDC director endorsed the CDC Advisory Committee on Immunization Practices (ACIP) recommendations.
FDA 2023-2024 authorized and approved COVID-19 vaccine information pages
Detailed FDA BLA (full approval) and EUA actions
- Approval of Comirnaty (COVID-19 vaccine, mRNA) to include the 2023-2024 formula, and a change to a single dose for individuals 12 years of age and older. Comirnaty was previously approved as a two-dose series for individuals 12 years of age and older.
- Approval of Spikevax (COVID-19 vaccine, mRNA) to include the 2023-2024 formula, a change to a single dose for individuals 12 years of age and older, and approval of a single dose for individuals 12 through 17 years of age. Spikevax was previously approved as a two-dose series for individuals 18 years of age and older.
- Authorization of Moderna COVID-19 vaccine for emergency use in individuals 6 months through 11 years of age to include the 2023-2024 formula and lower the age eligibility for receipt of a single dose from 6 years to 5 years of age. Additional doses are also authorized for certain immunocompromised individuals ages 6 months through 11 years, as described in the fact sheets.
- Authorization of Pfizer-BioNTech COVID-19 vaccine for emergency use in individuals 6 months through 11 years of age to include the 2023-2024 formula. Additional doses are also authorized for certain immunocompromised individuals ages 6 months through 11 years, as described in the fact sheets.
Previous bivalent vaccines are no longer authorized for use
The bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
Updated fact sheets
2023-24 COVID-19 vaccine formulation presentations descriptions
Moderna COVID-19 vaccine (2023-2024 formula) authorized for ages 6 months through 11 years is supplied in single dose vials. SPIKEVAX (2023-2024) formula approved for ages 12 years and older is supplied in single dose vials and single dose pre-filled syringes.
Moderna COVID-19 vaccine (2023-2024 formula) 6 months through 11 years of age
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, 0.25 mL dosage, for intramuscular use. Packaged in a carton containing 10, single dose vials. Blue cap.
SPIKEVAX (COVID-19 vaccine, mRNA) (2023-2024 formula) 12 years of age and older
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, 0.5 mL dosage, for intramuscular use. Packaged in a carton containing 10, single dose vials; 10, single dose pre-filled syringes; or 10 single dose blister-sealed pre-filled syringes. Blue cap.
Pfizer-BioNTech COVID-19 vaccine (2023-2024 formula), authorized for 6 months through 11 years, is supplied in 2 presentations: one for ages 6 months through 4 years and one for ages 5 through 11 years. COMIRNATY (COVID-19 Vaccine, mRNA) (2023-2024 formula), approved for ages 12 years and older.
Pfizer-BioNTech COVID-19 vaccine (2023-2024 Formula) 6 months through 4 years of age
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, 0.3 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use. Packaged in a carton containing 10, three-dose vials. Yellow cap. Dilute prior to use.
Pfizer-BioNTech COVID-19 vaccine (2023-2024 formula) 5 Years through 11 years of age
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, 0.3 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use. Packaged in a carton containing 10, single dose vials. Blue cap.
COMIRNATY (COVID-19 vaccine, mRNA) (2023-2024 formula) 12 years of age and older
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, 0.3 mL dosage, tris-sucrose formulation, for intramuscular use. Packaged in a carton containing 10, single dose vials or 10, single dose pre-filled syringes. Gray cap.
Ordering information
Privately purchased: With the transition of the 2023-24 COVID-19 vaccine to the private, commercial market, the processes for obtaining the vaccine have changed for vaccinators. Most COVID-19 vaccines will be purchased directly from the manufacturers and/or from your vaccine distributor or wholesaler from whom you order other vaccines. Note that COVID-19 vaccine doses for insured patients must be purchased on the private market.
For Vaccines for Children (VFC) providers: Within the next few days, an email communication will be sent by DHS to VFC providers that will provide more details on how to order the 2023-24 COVID-19 vaccine. Note that all VFC sites should carry and routinely offer COVID-19 vaccines for all eligible children. While other VFC vaccines will continue to be ordered via the Wisconsin Immunization Registry (WIR), DHS is planning to use an online survey for VFC providers to order for their VFC sites.
For Bridge Access Program (BAP) providers: Within the next week, an email communication will be sent by DHS to BAP providers that will provide more details on how to order the 2023-24 COVID-19 vaccine. CDC’s BAP will provide free COVID-19 vaccines for uninsured and underinsured adults through December 2024. Many BAP providers are also Vaccines for Adults (VFA) providers. While other VFA vaccines will continue to be ordered via WIR, DHS is planning to use an online survey for BAP providers to order COVID-19 vaccines.
Note: Redistribution of COVID-19 vaccine doses acquired through the VFC program and BAP, is not permitted. Therefore, the Wisconsin COVID-19 Vaccine Exchange is no longer active.
Vaccine storage information
Pfizer/Comirnaty: The vaccine will be shipped ultracold and can be stored ultracold until the expiration date. If removed from ultracold storage, the vaccine needs to be stored at 36–46 degrees Fahrenheit for up to 10 weeks.
Moderna/Spikevax: The vaccine can be stored at minus 58 degrees and 5 degrees Fahrenheit until the expiration date. If removed from that temperature range, it can be stored at 36–46 degrees Fahrenheit for up to 30 days.
Note: Ancillary kits will not be provided by any of the 2023-24 COVID-19 vaccine manufacturers.
CDC Clinical Considerations
The updated CDC Interim Clinical Considerations have not been released yet. DHS expects those to be published in the coming days.
Immunization Policy and Procedure Manual
The Immunization Program Policy and Procedure (P&P) Manual is expected to be updated next week, with timing dependent on the release of CDC Interim Clinical Considerations. 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 the CDC.
Upcoming CDC COCA Call: September 19
The CDC has announced a Clinician Outreach and Communication Activity (COCA) Call on September 19 at 1 p.m. During the call, presenters will provide updates about the latest recommendations and clinical considerations for administering influenza, COVID-19, and RSV vaccines to adults 60 years and older and discuss resources and communication strategies that may help facilitate older adult vaccination. Here is a link to the CDC webpage that will provide access to the call: https://emergency.cdc.gov/coca/calls/2023/callinfo_091923.asp
Staying Up to Date with Vaccines
We ask you to encourage people to stay up to date on all their recommended vaccines, including the COVID-19 vaccine.
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