COVID-19 Vaccination Program Operational Guidance

HHS Commercialization Transition Guide

This guidance from HHS provides direction to those participating in the COVID-19 Vaccination Program as the USG stops distributing COVID-19 vaccines through its current ordering system and the vaccines transition to traditional pathways for procurement, distribution and payment of COVID-19 vaccines. The document also includes information on:

• Exceptional orders after full-scale ordering closes
• Guidance on inventory and disposal management of vaccine and ancillary supplies
• Data reporting requirements
• CDC programs for uninsured individuals
• Anticipated vaccine schedule for fall
• Planning considerations

Additional guidance from CDC will become available in the days ahead.

Single-Dose Vials – Pfizer (12+) Updated COVID-19 Vaccine

The following document provides information on single-dose vials of the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine for people 12 years of age and older. Single-dose vials are available for ordering, providing greater flexibility for vaccine administration partners to expand access and availability of the updated vaccine.

CDC Fall Vaccination Operational Planning Guides

On June 30, 2022, the U.S. Food and Drug Administration (FDA) advised manufacturers seeking to update their COVID-19 vaccines to add an Omicron BA.4/5 spike protein component to the current vaccine composition to create a bivalent booster vaccine. This operational planning guide includes details about the bivalent COVID-19 booster.

CDC Novavax COVID-19 Vaccination Operational Planning Guide

On July 13, 2022, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Novavax COVID-19 vaccine for use among people ages 18 years and older for primary series vaccination. On July 19, 2022, CDC’s Advisory Committee on Immunization Practices (ACIP) recommended use of the Novavax COVID-19 vaccine in this population. The Novavax COVID-19 vaccine is administered as a two-dose primary series, with the doses given 3 weeks apart. A limited number of doses of Novavax COVID-19 vaccine will be distributed and not all providers are expected to carry Novavax COVID-19 vaccine. This operational planning guide includes details about the Novavax product.

The COVID-19 Vaccination Program Interim Operational Guidance for Jurisdictions Playbook

The interim playbook serves as an interim playbook for state, territorial (including the U.S.-affiliated Pacific Islands [USAPI], tribal, and local public health programs and their partners on how to plan and operationalize a vaccination response to COVID-19 within their jurisdictions. Many, but not all, of the COVID-19 Vaccination Program activities described may overlap with routine activities; routine immunization and pandemic influenza program activities can serve as a foundation for COVID-19 vaccination planning.

COVID-19 Vaccination Eligibility Guidance

The following information provides eligibility guidance for federal, state, and local jurisdictions as well as those enrolled in the federal pharmacy program.

Key Operational Considerations for Jurisdictions Planning to Operate COVID-19 Vaccination Clinics

This guidance provides information that informs the planning and operations of all types and sizes of vaccination clinics, including key considerations to maximize throughput at vaccination sites in large venues, drive-through vaccination clinics, and smaller-scale mobile vaccination venues.