Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States

Overview of COVID-19 vaccination

These clinical considerations provide information to healthcare professionals and public health officials on use of COVID-19 vaccines. They are informed by:

Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control and Prevention (CDC)
COVID-19 vaccine approvalor Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA)
CDC’s Emergency Use Instructions (EUI) for FDA-approved vaccines
Emergency Use Listing (EUL) of COVID-19 vaccines by the World Health Organization (WHO)
ACIP’s general best practice guidelines for immunization (GBPG)
Expert opinion

COVID-19 vaccines

The following COVID-19 vaccines, categorized into three vaccine types, are currently authorized under an EUA by FDA and available for use in the United States:

mRNA vaccines
- Moderna COVID-19 Vaccine, Bivalent
- Pfizer-BioNTech COVID-19 Vaccine, Bivalent
Protein subunit vaccine
- Novavax COVID-19 Vaccine, Adjuvanted

The monovalent formulations of the two mRNA COVID-19 vaccines (COMIRNATY/Moderna COVID-19 Vaccine and SPIKEVAX/Pfizer-BioNTech COVID-19 Vaccine) should no longer be used for COVID-19 vaccination.

All currently available mRNA COVID-19 vaccines in the United States are formulated as a bivalent vaccine based on the original (ancestral) strain of SARS-CoV-2 and the Omicron BA.4 and BA.5 (BA.4/BA.5) variants of SARS-CoV-2.

Novavax COVID-19 Vaccine is formulated as a monovalent vaccine based on the original (ancestral strain) of SARS-CoV-2. Janssen COVID-19 Vaccine is no longer available in the United States.

None of the currently FDA-authorized COVID-19 vaccines are live-virus vaccines.

COVID-19 vaccine-specific FDA fact sheets and U.S. COVID-19 Vaccine Product Information can be consulted for a full list of ingredients and information on the conditions of use, storage and handling, preparation, and administration procedures.