CDC COVID-19 Vaccination Program Provider Requirements and Support

10/6/2023 Update

• On Monday, Sept. 11, 2023, the FDA took action authorizing and approving the updated 2023–2024 monovalent XBB.1.5 variant mRNA COVID-19 vaccines by Moderna and Pfizer-BioNTech. On September 12, 2023, CDC recommended use of these updated 2023–2024 COVID-19 vaccines in all individuals ages 6 months and older.
• And, on October 3, 2023, FDA authorized the updated 2023–2024 monovalent XBB.1.5 variant Novavax COVID-19 Vaccine, Adjuvanted, which is recommended by CDC for use in individuals 12 years and older.

CDC has also withdrawn previous recommendations for use of the earlier versions of COVID-19 vaccines.

CDC COVID-19 Vaccination Program Has Ended

With these FDA and CDC actions, the CDC COVID-19 Vaccination Program ended as of September 12, 2023, as it applied to the administration of the bivalent Moderna and Pfizer-BioNTech mRNA COVID-19 vaccines previously provided by the US Government (USG). Now, with FDA’s authorization on October 3, 2023, of the 2023–2024 Novavax COVID-19 Vaccine, Adjuvanted, the CDC COVID-19 Vaccination Program has fully ended as of October 3, 2023. All authorized/approved doses of COVID-19 vaccine in the United States are now the 2023–2024 formulas.

See below for required close-out activities for enrolled providers, including those enrolled through the jurisdictions and through the Federal Retail Pharmacy Program (FRPP), and other commercial partners, as well as federal and tribal entities participating in the CDC COVID-19 Vaccination Program.

Bivalent (Original and Omicron BA.4/BA.5 variant) Moderna and Pfizer-BioNTech mRNA COVID-19 vaccines and ancestral (Original) Novavax COVID-19 vaccines should no longer be administered; 2023-2024 versions should be administered instead.

With the end of USG-purchase of COVID-19 vaccines for administration through the CDC COVID-19 Vaccination Program, providers are encouraged to continue administering COVID-19 vaccines through their offices/pharmacies/other practices by:

• Commercially procuring doses of the updated 2023–2024 COVID-19 vaccine(s),
• Participating in the vaccines.gov vaccine locator service to help inform patients regarding availability of COVID-19 vaccine at their medical/pharmacy/other practice, and
• Otherwise informing their patients of CDC recommendations for receipt of the updated 2023–2024 monovalent XBB-containing COVID-19 vaccines.

Details on the CDC COVID-19 Vaccination Program discontinuation and required closeout activities are noted below. (Updated October 6, 2023)

This page serves as repository for any updates to the CDC COVID-19 Vaccination Program Provider Agreement, including recommendations, requirements, and other useful information for vaccination providers enrolled in the program.

CDC COVID-19 Vaccination Program Provider Agreement

UPDATES – CDC COVID-19 Vaccination Program Provider Agreement Requirements

Step One: Reporting and Disposal of Remaining USG-Provided Vaccine Inventory

From the Program’s beginning, the COVID-19 Vaccination Program Provider Agreement has required all enrolled providers to report the number of unused, spoiled, expired, or wasted vaccine doses. Now, with the Program ended, providers must:

• Report all excess remaining USG-provided COVID-19 vaccine inventory using the wastage transaction in their jurisdictional reporting systems.
• Properly dispose of those vaccines according to state and local regulations.

This reporting requirement is for inventory purposes only and will not be used to judge provider performance. Direct questions about disposal activities to your state or local immunization program.

Deadline – These reports and disposal of remaining doses must be completed by October 27, 2023.

Step Two: Check this CDC Provider Agreement Update Website for Additional Program Close-out Steps

Providers must check this website for any additional actions required to close out participation in the CDC COVID-19 Vaccination Program.

Step Three: Using Unexpired Ancillary Supplies

Until September 12, 2023, all COVID-19 vaccine in the United States had been purchased by the United States Government (USG) for administration exclusively through the CDC COVID-19 Vaccination Program. Providers are prohibited from selling USG-purchased COVID-19 vaccine doses.

In addition, until September 12, 2023, all ancillary supplies provided by the USG through the CDC COVID-19 Vaccination Program could only be used as part of the process for administering USG-provided COVID-19 vaccine doses.

Providers may now use ancillary supplies provided by the USG through the CDC COVID-19 Vaccination Program to administer their commercially purchased vaccines.

Note: The expiration date printed on the exterior box of the CDC ancillary kit does not apply to all items in the kit. The date on the external label is based on the earliest expiry of any of the kit’s components.

Providers may exercise discretion and continue using unexpired kit components (e.g., needles and syringes) until they expire. Dispose of expired components in accordance with state and local requirements.

Unexpired ancillary kits or the items contained within cannot be sold or otherwise exchanged for anything of value, but can be shared domestically, at no charge, with other immunization programs, including:

• Other clinics within the practice
• Other sites offering healthcare services
• Veterinary clinics

Per federal funding requirements, ancillary kits cannot be donated outside of the United States or to organizations that will use the supplies outside the US.

Again, USG-provided ancillary supplies cannot be sold.

Step Four: Participate in Vaccines.gov vaccine locator service

During the CDC COVID-19 Vaccination Program, the website Vaccines.gov helped the public find the USG-provided COVID-19 vaccines they needed. With the Program over, Vaccines.gov will become a resource for locating providers administering the 2023–2024 COVID-19 vaccines both in the private commercial marketplace and through CDC’s Bridge Access Program.

Providers already participating in Vaccines.gov (including those whose data previously was updated by the jurisdiction public health agency) can update their information using the instructions in the Provider Resources section of Vaccines.gov.

Providers not previously enrolled in Vaccines.gov will follow a different process. Instructions will be forthcoming.  Check back on this webpage.

Notwithstanding uses or disclosures otherwise allowed by law, providers are prohibited from using or disclosing data collected from vaccine recipients for and through the CDC COVID-19 Vaccination Program for commercial marketing purposes or for any other purpose not allowed under this updated provision of the COVID-19 Vaccination Provider Agreement. Such data include COVID-19 vaccination registration information and vaccine administration data. These data are collected solely for the purposes of the CDC COVID-19 Vaccination Program and must be maintained in a manner that protects the integrity of the CDC COVID-19 Vaccination Program by only being used or disclosed for the purposes of the COVID-19 Vaccination Program and other limited purposes that promote public health, advance positive patient outcomes, and promote health equity.

This prohibition is not intended to limit communications by health care providers to vaccine recipients with whom the provider has an existing relationship prior to contact about COVID-19 vaccination.

The following are not included in the above prohibition:

• Communications regarding receipt of an additional dose of COVID-19 vaccine
• Communications to vaccine recipient for public health purposes
• Communications to vaccine recipients involving pharmacy or clinical services of the provider, personalized to the vaccine recipient’s medical needs, even if those services are not directly related to COVID-19 vaccination
• Availability of other vaccines (e.g., shingles, pneumococcal conjugate, seasonal influenza, routine childhood vaccines)
• Clinical emails
• Disease screening services
• Communications about the availability of programs to manage particular health conditions (e.g., asthma, diabetes, heart disease)

In addition, de-identified, aggregate datasets can be used by providers and shared with other partners for public health, population health, and health equity purposes.

Communications with COVID-19 vaccine recipients involving the store component of any pharmacy or other provider enrolled in the CDC COVID-19 Vaccination Program are considered prohibited commercial marketing. For example, text, e-mail, mail, or other communications to COVID-19 vaccine recipients about products on sale in the store are prohibited as commercial marketing.

COVID-19 vaccination registration information and vaccine administration data collected in the course of participation in the CDC COVID-19 Vaccination Program cannot be sold, for direct or indirect remuneration, even with permission of the vaccine recipient.

Individuals becoming aware of any suspected fraud or abuse related to the CDC COVID-19 Vaccination Program or violations of provider agreement requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services at 1-800-HHS-TIPS or TIPS.HHS.GOV.

• Providers are no longer required to complete CDC COVID-19 Vaccination Record Cards.

• Separate from participation in the CDC COVID-19 Vaccination Program, vaccinating providers must submit vaccine administration data for all covered vaccines through the immunization information system (IIS) of the state and local or territorial jurisdiction, as applicable.
• Enrolling in your jurisdiction/state-based IIS system