CDC COVID-19 Vaccination Program Provider Requirements and Support

9/21/2023 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. Providers can now access these updated 2023–2024 COVID-19 vaccines through the commercial marketplace.

CDC COVID-19 Vaccination Program Discontinuing

With these FDA and CDC actions, the CDC COVID-19 Vaccination Program is discontinued as of September 12, 2023, as it applies to the administration of the bivalent Moderna and Pfizer-BioNTech mRNA COVID-19 vaccines previously provided by the US Government (USG).

See below for required close-out activities for enrolled providers, including those enrolled through the jurisdictions and through the Federal Retail Pharmacy Program (FRPP), 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 should no longer be administered.

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 vaccine (https://www.cdc.gov/media/releases/2023/p0912-COVID-19-Vaccine.html).

Program’s Novavax Component to Remain Operational Pending Approval/authorization of Updated Vaccine

Limited aspects of the CDC COVID-19 Vaccination Program will remain operational for purposes of administering existing USG-provided Novavax ancestral COVID-19 vaccine doses until the updated 2023–2024 Novavax monovalent XBB.1.5 variant COVID-19 vaccine is approved/authorized by FDA, as expected in the near future.

At that time, doses of that updated 2023–2024 Novavax COVID-19 vaccine will also become available for private purchase in the commercial marketplace. The Novavax component of the CDC COVID-19 Vaccination Program will also cease at that time, fully ending the CDC COVID-19 Vaccination Program.

Pending availability of an updated 2023–2024 monovalent XBB.1.5 Novavax COVID-19 vaccine, providers in the CDC COVID-19 Vaccination Program may continue to administer doses of in-stock USG provided doses of the existing ancestral Novavax COVID-19 vaccine to individuals whom the provider has determined should not wait for an updated 2023–2024 Novavax COVID-19 vaccine, and who otherwise are contraindicated for receipt of an updated 2023–2024 monovalent XBB.1.5 mRNA COVID-19 vaccine or refuse an mRNA COVID-19 vaccine.

Providers who continue to administer ancestral Novavax COVID-19 vaccine supplied by the USG are still bound by the terms of their original signed CDC COVID-19 Vaccination Program provider agreement, as updated by this website. See updates below.

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Details on the CDC COVID-19 Vaccination Program discontinuation and required closeout activities are noted below. (Updated September 21, 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 participating 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 ending, providers must:

• Report excess remaining bivalent mRNA 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.

Step Two: Interim Use of Ancestral Novavax COVID-19 Vaccine

Pending availability of an updated 2023–2024 monovalent XBB.1.5 Novavax COVID-19 vaccine, providers may continue to administer in-stock USG-provided doses of the existing ancestral Novavax COVID-19 vaccine.

The ancestral Novavax COVID-19 vaccine may be given to individuals whom the provider has determined should not wait for an updated 2023–2024 Novavax COVID-19 vaccine and who are contraindicated for receipt of an updated 2023–2024 monovalent XBB.1.5 mRNA COVID-19 vaccine or refuse an mRNA COVID-19 vaccine.

Providers who continue to administer ancestral Novavax vaccine supplied by the USG are still bound by the terms of their CDC COVID-19 Vaccination Program Provider Agreement, as updated by this website.

If the FDA approves or authorizes a 2023–2024 monovalent XBB.1.5 variant Novavax COVID-19 vaccine and it becomes available in the commercial marketplace, at that time:

• The monovalent ancestral Novavax COVID-19 vaccine will no longer be available through the CDC COVID-19 Vaccination Program.
• Excess remaining inventory of the Novavax ancestral doses will need to be reported using the wastage transaction in jurisdictional reporting systems.
• Doses of that vaccine will need to be properly disposed of according to state and local regulations.

Direct questions about anticipated reporting and disposal activities to your state or local immunization program.

Step Three: 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 Four: 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 Five: 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 ending, 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.

Pending availability of an updated 2023–2024 Novavax monovalent XBB-containing COVID-19 vaccine, Novavax ancestral strain COVID-19 Vaccine, Adjuvanted doses remain authorized to provide:

• A 2-dose primary series to people ages 12 years and older. The primary series doses are separated by 3–8 weeks. An 8-week interval between the first and second primary series doses might be optimal for some people ages 12 years–64 years, especially for males ages 12–39 years, as it might reduce the small risk of myocarditis and pericarditis associated with this vaccine.
• A booster dose in limited situations to people ages 18 years and older who previously completed primary vaccination using any FDA-approved or FDA-authorized COVID-19 vaccine; have not received any previous booster dose; and are unable (i.e., mRNA vaccine contraindicated) or unwilling to receive an mRNA vaccine and would otherwise not receive a booster dose. The Novavax booster dose can be administered at least 6 months after completion of any primary series.

Providers may also administer Novavax ancestral strain COVID-19 vaccine, Adjuvanted as described in CDC guidance as updated from time to time:

• Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States
• Emergency Use Instructions (see vaccine Fact Sheets)

All requirements of the CDC COVID-19 Vaccination Program provider agreement (as updated by this website), including those pertaining to recordkeeping, immunization reporting, administration fee limits, provision of an EUA Fact Sheet to the recipient, VAERS reporting, and vaccine handling, remain in effect for use of USG-provided Novavax COVID-19 vaccines.

All organizations and providers participating in the CDC COVID-19 Vaccination Program:

• Must administer USG-provided COVID-19 Vaccine at no out-of-pocket cost to the recipient.
• May not deny anyone vaccination with USG-provided vaccine based on the vaccine recipient’s coverage status or network status.
• May not charge an office visit or other fee if USG-provided COVID-19 vaccination is the sole medical service provided.
• May not require additional medical services to receive USG-provided COVID-19 vaccination.
• May seek appropriate reimbursement from a program or plan that covers COVID-19 Vaccine administration fees for the vaccine recipient, such as:
  • Vaccine recipient’s private insurance company
  • Medicare or Medicaid reimbursement
• May not seek any reimbursement, including through balance billing, from the vaccine recipient for receipt of USG-provided COVID-19 vaccine.

Find more information about vaccine administration and reporting requirements.

Providers must document Novavax ancestral strain COVID-19 vaccine administration in their medical record systems within 24 hours of administration and use their best efforts to report administration data to the relevant system for the jurisdiction (i.e., Immunization Information System [IIS]) as soon as practicable and no later than 72 hours after administration.

All COVID-19 vaccination providers must report Novavax ancestral strain COVID-19 vaccine inventory weekly into Vaccines.gov.

In some jurisdictions, providers may report vaccine inventory to the jurisdiction’s IIS for the jurisdiction to upload into Vaccines.gov. If you have questions about the process for your jurisdiction, please contact your jurisdiction’s immunization program.

For those provider agreements not specifying vaccine administration data to be recorded or reported, the following applies:

After administering a dose of Novavax ancestral strain COVID-19 vaccine, record to the extent not already recorded in the vaccine recipient’s record all information marked below by an asterisk and report the following required vaccine administration data to the appropriate entity noted in the agreement:

1. Administered at location/facility name/ID
2. Administered at location type
3. Administration address (including Company)*
4. Recipient name and ID*
5. Recipient date of birth*
6. Recipient sex*
7. Recipient race
8. Recipient ethnicity
9. Recipient address*
10. Administration date*
11. CVX (product)*
12. NDC (national drug code)
13. Dose number*
14. Lot number (Unit of Use [UoU] or Unit of Sale [UoS])*
15. MVX (manufacturer)*
16. Sending organization (name of the Agency submitting the report)
17. Vaccine administering provider’s name and suffix*
18. Administering provider’s address, if different than the administration address*
19. Vaccine administration site (on the body)*
20. Vaccine expiration date*
21. Vaccine route of administration*
22. Vaccine series

www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html

Vaccines must be stored and handled properly from the time they are manufactured until they are administered to maintain the cold chain, thus protecting the potency and effectiveness of the vaccine and ensuring vaccine recipients are fully and safely protected from vaccine-preventable diseases.

As part of the COVID-19 Vaccination Provider Agreement, providers are required to:

• Store and handle COVID-19 vaccines under proper conditions, including maintaining cold chain conditions and chain of custody at all times in accordance with an EUA or vaccine package insert, manufacturer guidance, and CDC guidance in the Vaccine Storage and Handling Toolkit.
• Monitor storage unit temperatures at all times, using equipment and practices that comply with guidance in the toolkit.
• Comply with immunization program guidance for handling temperature excursions.
• Monitor and comply with COVID-19 vaccine expiration dates.
• Preserve all records related to COVID-19 vaccine management for a minimum of three years, or longer as required by the agreement or law of the jurisdiction.
• Comply with state and local regulations and timelines for disposing of COVID-19 vaccine and diluent, including used doses.

Find detailed information regarding COVID-19 Vaccine storage and handling requirements at CDC Vaccine Storage and Handling Toolkit.

(https://vaers.hhs.gov/reportevent.html)

The Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in vaccines used in the United States. VAERS accepts and analyzes reports of adverse events (AEs) after a person has received a vaccination.

Healthcare providers who administer COVID-19 vaccines should report the following to VAERS:

• Vaccine administration errors, whether or not associated with an adverse event (AE)
• Serious AEs regardless of causality. Serious AEs per FDA are defined as:
  • Death
  • A life-threatening AE
  • Inpatient hospitalization or prolongation of existing hospitalization
  • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
  • A congenital anomaly/birth defect
  • An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above
• Cases of myocarditis after a Pfizer-BioNTech, Moderna, Novavax, or Janssen COVID-19 vaccine
• Cases of pericarditis after a Pfizer-BioNTech, Moderna, Novavax, or Janssen COVID-19 vaccine
• Cases of Multisystem Inflammatory Syndrome in children and adults
• Cases of COVID-19 that result in hospitalization or death

Healthcare providers are also encouraged to report to VAERS any additional clinically significant AEs following vaccination, even if unsure whether vaccination caused the event.

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 participating 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 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 except when administering ancestral Novavax vaccine through the Vaccination Program.
• Providers must continue to submit vaccine administration data through either the immunization information system (IIS) of the state and local or territorial jurisdiction or through other designated electronic systems, according to state and local requirements.
• Enrolling in your jurisdiction/state-based IIS system