To receive one or more of the publicly funded COVID-19 vaccines, constituent products, and ancillary supplies at no cost, all COVID-19 providers must be able to adhere to the following requirements and sign a Redistribution Agreement. Agreement requirements and Redistribution Agreement are included in Section A (Step 1).
- Providers must administer COVID-19 Vaccine in accordance with all requirements and recommendations of CDC and CDC’s Advisory Committee on Immunization Practices (ACIP).
- Within 24 hours of administering a dose of COVID-19 Vaccine and adjuvant (if applicable), providers must record in the vaccine recipient’s record and report required information to the relevant state, local, or territorial public health authority. Details of required information (collectively, Vaccine-Administration Data) for reporting can be found on CDC’s website.
Providers must submit Vaccine-Administration Data through either
- The immunization information system (IIS) of the state and local or territorial jurisdiction or
- Another system designated by CDC according to CDC documentation and data requirements*.
Providers must preserve the record for at least 3 years following vaccination, or longer if required by state, local, or territorial law. Such records must be made available to any federal, state, local, or territorial public health department to the extent authorized by law.
- Providers must not sell or seek reimbursement for COVID-19 Vaccine and any adjuvant, syringes, needles, or other constituent products and ancillary supplies that the federal government provides without cost to the provider.
- Providers must administer COVID-19 Vaccine regardless of the vaccine recipient’s ability to pay COVID-19 Vaccine administration fees.
- Before administering COVID-19 Vaccine, providers must provide an approved Emergency Use Authorization (EUA) fact sheet or vaccine information statement (VIS), as required, to each vaccine recipient, the adult caregiver accompanying the recipient, or other legal representative.
- Providers' COVID-19 vaccination services must be conducted in compliance with CDC’s Guidance for Immunization Services during the COVID-19 Pandemic for safe delivery of vaccines.
- Providers must comply with CDC requirements for COVID-19 Vaccine management. Those requirements include the following:
- Providers must store and handle COVID-19 Vaccine under proper conditions, including maintaining cold chain conditions and chain of custody at all times in accordance with the manufacturer’s package insert and CDC guidance in CDC’s Vaccine Storage and Handling Toolkit, which will be updated to include specific information related to COVID-19 Vaccine;
- Providers must monitor vaccine-storage-unit temperatures at all times using equipment and practices that comply with guidance located in CDC’s Vaccine Storage and Handling Toolkit;
- Providers must comply with each relevant jurisdiction’s immunization program guidance for dealing with temperature excursions;
- Providers must monitor and comply with COVID-19 Vaccine expiration dates; and
- Providers must preserve all records related to COVID-19 Vaccine management for a minimum of 3 years, or longer if required by state, local, or territorial law.
- Providers must report the number of doses of COVID-19 Vaccine and adjuvants that were unused, spoiled, expired, or wasted as required by the relevant jurisdiction**.
- Providers must comply with all federal instructions and timelines for disposing COVID-19 vaccine and adjuvant, including unused doses.
- Providers must report moderate and severe adverse events following vaccination to the Vaccine Adverse Event Reporting System (VAERS).
- Providers must provide a completed COVID-19 vaccination record card to every COVID-19 Vaccine recipient, the adult caregiver accompanying the recipient, or other legal representative. Each COVID-19 Vaccine shipment will include COVID-19 vaccination record cards.
- Providers must comply with all applicable requirements as set forth by the U.S. Food and Drug Administration, including but not limited to requirements in any EUA that covers COVID-19 Vaccine. Providers must administer COVID-19 Vaccine in compliance with all applicable state and territorial vaccination laws.
* Oklahoma's IIS is the Oklahoma State Immunization Information System (OSIIS). If your organization is not enrolled in OSIIS, you must agree to the terms and conditions of the OSIIS Authorized Site Agreement while completing this enrollment. If state of Oklahoma decides to use another system to report vaccine administration data, we will notify you.
** The disposal process for remaining unused COVID-19 vaccine and adjuvant may be different from the process for other vaccines; unused vaccines must remain under storage and handling conditions noted in Item 7 until CDC provides disposal instructions; website URL will be made available.