CDC Clinical Considerations Updated for 2023-2024 Formulations of COVID-19 Vaccine
This email is being sent to local health officers, tribal health directors, COVID-19 vaccinators, COVID-19 vaccine stakeholders, HERC coordinators, VFC providers, and key DHS staff.
On September 15, the Centers for Disease Control and Prevention (CDC) issued updated clinical considerations to inform the administration of the 2023–2024 formulations of the Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine.
The Immunization Program's Policy and Procedure (P&P) Manual is expected to be updated later this week. A reminder that Local Health Departments (LHDs) cannot administer the 2023-2024 formulations of the Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine to the individuals detailed in the CDC clinical considerations until the Immunization Program’s P&P Manual is updated. All other vaccinators can vaccinate in accordance with the updated clinical guidance from the CDC.
Summary of recent changes to CDC clinical considerations
Below is a summary only and vaccinators should read the full update to the CDC clinical considerations for specific recommendations.
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Recommendations for use of the 2023–2024 formulations of Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine:
- Everyone ages 5 years and older is recommended to receive 1 dose of the updated (2023–2024 formula) mRNA COVID-19 vaccine.
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Children ages 6 months–4 years
- Initial vaccination: should receive either 2 doses of updated (2023–2024 formula) Moderna or 3 doses of updated (2023–2024 formula) Pfizer-BioNTech COVID-19 vaccine.
- Received previous mRNA doses: need 1 or 2 doses of updated (2023–2024 formula) Moderna or updated (2023–2024 formula) Pfizer-BioNTech COVID-19 vaccine, depending on the number of prior doses.
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People who are moderately or severely immunocompromised
- Initial vaccination: should receive a 3-dose series of updated (2023–2024 formula) Moderna or updated (2023–2024 formula) Pfizer-BioNTech COVID-19 vaccine.
- Received previous mRNA doses: need 1 or 2 doses of updated (2023–2024 formula) Moderna or updated (2023–2024 formula) Pfizer-BioNTech COVID-19 vaccine, depending on the number of prior doses.
- May receive 1 or more additional updated (2023–2024 formula) mRNA COVID-19 vaccine doses.
- Bivalent mRNA COVID-19 vaccines are no longer recommended in the United States
- Updated guidance for COVID-19 vaccination and myocarditis or pericarditis
- Updated guidance for COVID-19 vaccination and Multisystem Inflammatory Syndrome (MIS) in children (MIS-C) and adults (MIS-A)
- Reorganization and consolidation of sections on contraindications and precautions, including allergic reactions to COVID-19 vaccines.
Novavax status
The 2023-2024 formulation of the Novavax COVID-19 vaccine for individuals 12 and older is still pending Food and Drug Administration (FDA) approval. Once the FDA approves it, the CDC Advisory Committee on Immunization Practices (ACIP) recommendation that “the 2023-2024 (monovalent, XBB-containing) COVID-19 vaccines as authorized under Emergency Use Authorization (EUA) or approved by Biologics License Application (BLA) in persons ≥6 months of age” will apply to Novavax and the ACIP will not meet.
The earlier presentation of the Novavax COVID-19 vaccine is still currently authorized under Emergency Use Authorization for use as an alternative to the mRNA vaccines. Novavax vaccines already in the field were supplied by the federal government and must be managed according to the CDC COVID-19 Vaccine Provider Agreement.
FDA 2023-2024 authorized and approved COVID-19 vaccine information pages
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
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