Becoming a Pandemic Vaccine Provider in Oklahoma   Eligibility Any facility, organization, or health care provider licensed to possess vaccine, administer vaccine, or provide vaccination services in Oklahoma is eligible to enroll.    Only local County and City-County Health Departments and providers enrolled through the COVID-19 Vaccination Program Provider enrollment and approved by the Oklahoma State Department of Health (OSHD) can receive and administer COVID-19 vaccines in Oklahoma. You MUST ENROLL and receive approval in order to administer COVID-19 vaccinations in Oklahoma.   Provider Enrollment Process Enrollment must be done online. Once the enrollment is active, all responses will be automatically saved for a month; this lets you revisit, edit, and complete the enrollment during that month. If enrollment is not completed within a month, you will be required to start over. There is a limit of one enrollment per organization location/facility. Each facility within an organization is required to enroll separately.   Step 1: Complete COVID-19 Vaccination Program Provider Requirements and Legal Agreement Download and fill out the CDC COVID-19 Vaccination Program Provider Agreement. This must be saved as a PDF document to be uploaded in Step 2.  What you’ll need:

• This form requires signatures from the CEO and CMO (or equivalent). If an organization has multiple facilities enrolling, the same signed Provider Agreement can be used in each enrollment 

  Step 2: Complete the CDC COVID-19 Vaccination Program Provider Profile Information Fill out and submit the online enrollment. Once completed, download and save a copy for your records. What you’ll need:

• The PDF document of the Provider Agreement from Step 1
• Health care provider license numbers
• Answers to the enrollment questions 
  • If you are not already enrolled in the Oklahoma State Immunization Information System (OSIIS), the vaccine enrollment process will take you to the OSIIS agreement form. You will complete both enrollments during this process. For OSIIS questions, contact OSIISHelp@health.ok.gov. 
  • Regarding storage, if you do not have the capacity to continuously monitor your vaccine supply, you will be responsible for obtaining the equipment to do so.

• Information on facility refrigerators and freezers—name, model, storage space, temperatures

For current information on storage/handling and vaccine administration, see the CDC COVID-19 Vaccine Quick Reference Guide for Healthcare Professionals.    As of September 22, 2021, the following information is accurate   Step 3: Oklahoma State Department of Health Review Once approved, you will receive an email confirming the facility’s status as a COVID-19 vaccine provider. What to expect:

• You will NOT get a confirmation email when you submit your application
• The enrollment approval process can take up to 2 weeks
• Immunization Services will send a field agent to examine your office before you receive the first vaccine shipment
• Once your enrollment is processed, you will receive an email with information about how to order the vaccine 
• Currently, the time from enrollment to first vaccine shipment arrival is approximately 2 weeks 
• Once you are enrolled, OSDH will add you to their email communication list. In addition to email updates, OSDH announces updates on monthly vaccine provider calls 

  For enrollment help, visit the OSDH Provider Enrollment webpage or email the Immunization team at Immunize@health.ok.gov.    For questions about vaccine storage and administration, see the COVID-19 Vaccine Provider Frequently Asked Questions sheet.       COVID-19 Vaccine Provider Frequently Asked Questions   If I am already enrolled in the Vaccines for Children (VFC) Program, do I still need to complete the COVID-19 Vaccination Program Provider enrollment? Yes. Even if you are a VFC provider, you are still required to complete the COVID-19 Vaccination Program Provider enrollment.    What if I’m not enrolled in the Oklahoma State Immunization Information System (OSIIS)? If you are not already enrolled in the Oklahoma State Immunization Information System (OSIIS), the vaccine enrollment process will take you to the OSIIS agreement form. You will complete both enrollments during this process. For OSIIS questions, contact OSIISHelp@health.ok.gov.   How many vials of vaccine can I order? Is there a minimum number? You can order as many vials as you need. The CDC form indicates that there is a minimum number of vials that must be ordered. However, in the comment box you can specify the number of vials that you need, and your county health department will work with you to ensure that you receive that amount.    If I only have one patient wanting a vaccine, can I open a new vile (even if I don’t have any other patients scheduled to receive the vaccine)? What happens if I waste vaccine? The priority is to vaccinate people who want to get vaccinated, so if you need to open a vial for one person and the rest is wasted, that is acceptable. You are asked to report wastage in OSIIS.   How quickly do I need to distribute the vaccine after I receive it? There is no expected timeframe imposed by OSDH or CDC. The primary guidance is based on the expiration dates of the vaccines.   Where do I find updates about vaccine storage and expiration? For current information on vaccine storage, administration, and expiration, see the CDC COVID-19 Vaccine Quick Reference Guide for Healthcare Professionals. Once you are enrolled, OSDH will add you to their email communication list. In addition to email updates, OSDH announces updates on monthly vaccine provider calls.   After completing the COVID-19 Vaccination Program Provider enrollment, how long will it take for me to get the first shipment of vaccine? The current time from enrollment to first vaccine shipment arrival is approximately 2 weeks.    Can I administer the vaccine to anyone (e.g. patients not in my system)? You can decide how you take patients, how you advertise that you have the vaccine, and if you will require appointments. You must provide the vaccine free of cost to the patient, and you must provide all of the required documentation for the vaccine. Once you enroll, you can also enroll in Vaccine Finder. This will let the public know that your facility has vaccine. (Vaccine finder does not show how much vaccine you have, but it does show the user how to contact you to make an appointment.)    Can I administer other vaccines during the same appointment with a patient (e.g. COVID-19 vaccine and the flu vaccine)? COVID-19 vaccines and other vaccines may now be administered without regard to timing. This includes simultaneous administration of COVID-19 vaccine and other vaccines on the same day, as well as coadministration within 14 days. When deciding whether to co-administer another vaccine with COVID-19 vaccine, consider:

• Whether the patient is behind or at risk of becoming behind on recommended vaccines
• The patient’s risk of vaccine-preventable disease
• The reactogenicity profile of the vaccines
• The likelihood of avoiding a missed opportunity to vaccinate

(COVID-19 vaccines were previously recommended to be administered alone, with a minimum interval of 14 days before or after administration of any other vaccines. This was out of an abundance of caution and not due to any known safety or immunogenicity concerns.)    If multiple vaccines are administered at a single visit, administer each injection in a different injection site. For adolescents and adults, the deltoid muscle can be used for more than one intramuscular injection. Best practices for multiple injections include:

• Label each syringe with the name and the dosage (amount) of the vaccine, lot number, the initials of the preparer, and the exact beyond-use time, if applicable.
• Separate injection sites by 1 inch or more, if possible.
• Administer the COVID-19 vaccines and vaccines that may be more likely to cause a local reaction (e.g., tetanus-toxoid-containing and adjuvanted vaccines) in different limbs, if possible.

  What if I don’t have a continuous monitoring mechanism? If you do not currently have the capacity to continuously monitor your vaccine supply, you will be responsible for obtaining continuous monitoring equipment before you receive OSDH approval.   Is myocarditis a contraindication for the COVID-19 vaccine?  The Centers for Disease Control and Prevention (CDC) safety committee has noted a “likely association” between the mRNA COVID-19 vaccines and myocarditis and pericarditis in some young adults. However, the CDC continues to recommend COVID-19 vaccination for all people 12 years and older. Clinicians should consult the Clinical Considerations: Myocarditis and Pericarditis after Receipt of mRNA COVID-19 Vaccines Among Adolescents and Young Adults for information on the diagnosis and treatment of cases of myocarditis and pericarditis. Healthcare providers should report all cases of myocarditis and pericarditis after COVID-19 vaccination to VAERS.   What’s the current status of the Novavax COVID-19 vaccine? Results from a Phase 3 clinical trial indicated 93% efficacy against predominantly circulating COVID-19 Variants of Concern and Variants of Interest. The vaccine was 100% effective against variants "not considered Variants of Concern/Interest." The vaccine also demonstrated 91% efficacy in high-risk populations. All COVID-19 hospitalizations/death occurred in the placebo group. The company intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements. Upon regulatory approvals, Novavax remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.   What about off-label use of the COVID-19 vaccine? Providers are responsible for adhering to all requirements outlined in the agreement. Specifically, providers must administer COVID-19 vaccines in accordance with all program requirements and recommendations of CDC, the Advisory Committee on Immunization Practices, and the U.S Food and Drug Administration (FDA). This applies to both EUA and FDA approved COVID-19 vaccines. Accordingly, use of these products outside of those that have been approved and authorized by FDA (often referred to as “off-label use”) is not recommended; it would violate the provider agreement and could expose providers to the following risks: 

• Administration of the product off label may not be covered under the PREP Act or the PREP Act declaration; therefore, providers may not have immunity from claims.
• Individuals who receive an off-label dose may not be eligible for compensation under the Countermeasures Injury Compensation Program after a possible adverse event.
• CDC has defined the scope of the CDC COVID-19 Vaccination Program in terms of how the USG-provided vaccines may be used in the program.  Providers giving off-label doses would be in violation of the CDC Program provider agreement potentially impacting their ability to remain a provider in the CDC program.
• Administration fees may not be reimbursable by payers.

 

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